Select Abstracts from Elements of Success: An International Conference on Adherence to Antiretroviral Therapy, December 4-7, 2003, Dallas, Texas, USA
Identifieur interne : 002C32 ( Istex/Corpus ); précédent : 002C31; suivant : 002C33Select Abstracts from Elements of Success: An International Conference on Adherence to Antiretroviral Therapy, December 4-7, 2003, Dallas, Texas, USA
Auteurs : Ross G. Hewitt ; Katharine E. StewartSource :
- Journal of the International Association of Providers of AIDS Care [ 1545-1097 ] ; 2004-01.
English descriptors
- KwdEn :
- 2los angeles, Active antiretroviral therapy, Adherence, Adherence assessment, Adherence care, Adherence counseling, Adherence counselors, Adherence education, Adherence failure, Adherence intervention trial, Adherence interventions, Adherence issues, Adherence levels, Adherence program, Adherence rates, Adherence ratio, Adherence specialist, Adherence support, Adherent, Administration actions, African american, African americans, Antiretroviral, Antiretroviral adherence, Antiretroviral medication, Antiretroviral medications, Antiretroviral pill burden, Antiretroviral regimen, Antiretroviral regimens, Antiretroviral therapy, Antiretroviral treatment, Asymptomatic patients, Average number, Baseline, Baseline survey, Care provider, Case management, Case management program, Chris hani baragwanath hospital, City university, Client groups, Clinic, Clinic staff, Clinic visit, Clinic visits, Clinical trial, Community interventions, Community research initiative, Composite adherence score, Control group, Demographic data, Disease control, Dos, Dosing, Dosing frequency, Drug users, Educational support, Educational video, Eligible women, Erie county, First visit, First year postpartum, Group meetings, Haart, Haart adherence, Haart doses, Health behavior change, Health clinic, Health professionals, Health professions, Health sciences, Health services, Healthcare, Healthcare providers, Healthcare system, Hepatitis, Human virology, Hunter college, Illicit drug, Immune function, Immune system, Important aspects, Institutional barriers, International conference, Intervention, Intervention group, Interventions need, Jiapac, Kansas city, Lipodystrophic symptoms, Literacy levels, Lower pill burden, Major reason, Many interventions, Mcauley health center, Measurement tool, Medical appointments, Medical care, Medical care postpartum, Medical services, Medical visits, Medication, Medication adherence, Medication complexity, Medication regimens, Methodological challenges, Multiple factors, Naive patients, National adherence program, Negative affective states, Next steps, Nurse educator, Nursing telephone intervention, Observational study, Outpatient, Outreach worker, Participant, Patient adherence, Patient education, Patient population, Patients benefit, Patio, Patio club, Peer approach, Peer counseling, Peer counselors, Percent report, Pharmacist, Pharmacy records, Pill burden, Pill count, Pill count group, Pill counts, Pillbox, Pillbox organizer, Pilot project, Pilot study, Poor adherence, Postpartum, Postpartum medication adherence, Postpartum women, Practical advice, Primary care, Primary spanish speaker, Project heart, Prospective study, Provider, Randomized adherence intervention, Regimen, Reliable transportation, Research unit, Retrospective chart review, Satellite clinic, Side effects, Significant differences, Skills building, Social support, Social worker, Social workers, Southern california, State medicaid, State university, Study participants, Study sample, Substance abuse, Therapy, Therapy days, Time point, Treatment adherence, Treatment adherence coordination, Treatment success, Undetectable, Unobserved doses, Usual patient education, Vaginal delivery, Viral, Viral load, Viral load levels, Viral loads, Viral suppression, Virologic, Virologic failure, Virologic outcome, Virologic outcomes, Virologic response, Week visit, Weekly basis, Weidle 1los angeles county department, Years postpartum.
- Teeft :
- 2los angeles, Active antiretroviral therapy, Adherence, Adherence assessment, Adherence care, Adherence counseling, Adherence counselors, Adherence education, Adherence failure, Adherence intervention trial, Adherence interventions, Adherence issues, Adherence levels, Adherence program, Adherence rates, Adherence ratio, Adherence specialist, Adherence support, Adherent, Administration actions, African american, African americans, Antiretroviral, Antiretroviral adherence, Antiretroviral medication, Antiretroviral medications, Antiretroviral pill burden, Antiretroviral regimen, Antiretroviral regimens, Antiretroviral therapy, Antiretroviral treatment, Asymptomatic patients, Average number, Baseline, Baseline survey, Care provider, Case management, Case management program, Chris hani baragwanath hospital, City university, Client groups, Clinic, Clinic staff, Clinic visit, Clinic visits, Clinical trial, Community interventions, Community research initiative, Composite adherence score, Control group, Demographic data, Disease control, Dos, Dosing, Dosing frequency, Drug users, Educational support, Educational video, Eligible women, Erie county, First visit, First year postpartum, Group meetings, Haart, Haart adherence, Haart doses, Health behavior change, Health clinic, Health professionals, Health professions, Health sciences, Health services, Healthcare, Healthcare providers, Healthcare system, Hepatitis, Human virology, Hunter college, Illicit drug, Immune function, Immune system, Important aspects, Institutional barriers, International conference, Intervention, Intervention group, Interventions need, Jiapac, Kansas city, Lipodystrophic symptoms, Literacy levels, Lower pill burden, Major reason, Many interventions, Mcauley health center, Measurement tool, Medical appointments, Medical care, Medical care postpartum, Medical services, Medical visits, Medication, Medication adherence, Medication complexity, Medication regimens, Methodological challenges, Multiple factors, Naive patients, National adherence program, Negative affective states, Next steps, Nurse educator, Nursing telephone intervention, Observational study, Outpatient, Outreach worker, Participant, Patient adherence, Patient education, Patient population, Patients benefit, Patio, Patio club, Peer approach, Peer counseling, Peer counselors, Percent report, Pharmacist, Pharmacy records, Pill burden, Pill count, Pill count group, Pill counts, Pillbox, Pillbox organizer, Pilot project, Pilot study, Poor adherence, Postpartum, Postpartum medication adherence, Postpartum women, Practical advice, Primary care, Primary spanish speaker, Project heart, Prospective study, Provider, Randomized adherence intervention, Regimen, Reliable transportation, Research unit, Retrospective chart review, Satellite clinic, Side effects, Significant differences, Skills building, Social support, Social worker, Social workers, Southern california, State medicaid, State university, Study participants, Study sample, Substance abuse, Therapy, Therapy days, Time point, Treatment adherence, Treatment adherence coordination, Treatment success, Undetectable, Unobserved doses, Usual patient education, Vaginal delivery, Viral, Viral load, Viral load levels, Viral loads, Viral suppression, Virologic, Virologic failure, Virologic outcome, Virologic outcomes, Virologic response, Week visit, Weekly basis, Weidle 1los angeles county department, Years postpartum.
Url:
DOI: 10.1177/154510970400300103
Links to Exploration step
ISTEX:87BA68DF6C82BD5F27AA4E9B59EAAD5FD4D92D10Le document en format XML
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Hewitt</name><affiliation><mods:affiliation>State University of New York at Buffalo and Erie County Medical Center, Buffalo, New York, USA</mods:affiliation></affiliation></author><author wicri:is="90%"><name sortKey="Stewart, Katharine E" sort="Stewart, Katharine E" uniqKey="Stewart K" first="Katharine E." last="Stewart">Katharine E. Stewart</name><affiliation><mods:affiliation>University of Arkansas, Little Rock, Arkansas, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of the International Association of Providers of AIDS Care</title><idno type="ISSN">1545-1097</idno><idno type="eISSN">2325-9582</idno><imprint><publisher>Sage Publications</publisher><pubPlace>Sage CA: Thousand Oaks, CA</pubPlace><date type="published" when="2004-01">2004-01</date><biblScope unit="volume">3</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="12">12</biblScope><biblScope unit="page" to="28">28</biblScope></imprint><idno type="ISSN">1545-1097</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1545-1097</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>2los angeles</term><term>Active antiretroviral therapy</term><term>Adherence</term><term>Adherence assessment</term><term>Adherence 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adherence</term><term>Postpartum women</term><term>Practical advice</term><term>Primary care</term><term>Primary spanish speaker</term><term>Project heart</term><term>Prospective study</term><term>Provider</term><term>Randomized adherence intervention</term><term>Regimen</term><term>Reliable transportation</term><term>Research unit</term><term>Retrospective chart review</term><term>Satellite clinic</term><term>Side effects</term><term>Significant differences</term><term>Skills building</term><term>Social support</term><term>Social worker</term><term>Social workers</term><term>Southern california</term><term>State medicaid</term><term>State university</term><term>Study participants</term><term>Study sample</term><term>Substance abuse</term><term>Therapy</term><term>Therapy days</term><term>Time point</term><term>Treatment adherence</term><term>Treatment adherence coordination</term><term>Treatment success</term><term>Undetectable</term><term>Unobserved doses</term><term>Usual patient 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Hewitt MD</name><affiliations><json:string>State University of New York at Buffalo and Erie County Medical Center, Buffalo, New York, USA</json:string></affiliations></json:item><json:item><name>Katharine E. Stewart PhD, MPH</name><affiliations><json:string>University of Arkansas, Little Rock, Arkansas, USA</json:string></affiliations></json:item></author><articleId><json:string>10.1177_154510970400300103</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>other</json:string></originalGenre><qualityIndicators><score>5.512</score><pdfVersion>1.4</pdfVersion><pdfPageSize>612 x 792 pts (letter)</pdfPageSize><refBibsNative>false</refBibsNative><abstractCharCount>0</abstractCharCount><pdfWordCount>13530</pdfWordCount><pdfCharCount>88148</pdfCharCount><pdfPageCount>17</pdfPageCount><abstractWordCount>1</abstractWordCount></qualityIndicators><title>Select Abstracts from Elements of Success: An International Conference on Adherence to Antiretroviral Therapy, December 4-7, 2003, Dallas, Texas, USA</title><genre><json:string>other</json:string></genre><host><title>Journal of the International Association of Physicians in AIDS 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<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Hewitt</surname><given-names>Ross G.</given-names></name><degrees>MD</degrees><aff>State University of New York at Buffalo and Erie County Medical Center, Buffalo, New York, USA</aff></contrib></contrib-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Stewart</surname><given-names>Katharine E.</given-names></name><degrees>PhD, MPH</degrees><aff>University of Arkansas, Little Rock, Arkansas, USA</aff></contrib></contrib-group>
<pub-date pub-type="ppub"><month>01</month><year>2004</year></pub-date><volume>3</volume><issue>1</issue><fpage>12</fpage><lpage>28</lpage><custom-meta-wrap><custom-meta xlink:type="simple"><meta-name>sagemeta-type</meta-name><meta-value>Other</meta-value></custom-meta><custom-meta xlink:type="simple"><meta-name>search-text</meta-name><meta-value> 12 JIAPAC Vol. 3, No. 1, January/March 2004 1 A nursing telephone intervention to improve medication adherence Bunting SM, Newman C, Ivins D, Harrell L. Medical College of Georgia, Augusta Background: The purpose of this study was to evaluate the effectiveness of a nursing telephone intervention to help persons with HIV manage their adherence to HIV medications. The specific aim of the study was to test the hypothesis that there would be no difference in medication adherence between participants randomly assigned to receive usual patient education and support from clinic staff (the control group), and the intervention group to receive, in addition to the usual patient education and support, a telephone call (once a week for 12 weeks) that provides an individualized program of education, community referrals, and counseling. Methods: Participants were recruited by their caregivers (n=95), had the study explained to them, and gave informed consent. Adherence was measured by electronic caps and by self-report, as well as viral loads and CD4 counts. Participants were assigned to the intervention or control treatment group. Results: This was a Repeated Measures Design and follow-up data were difficult to collect because of difficulty in maintaining communication with participants over the four months of the study. Many subjects recruited at baseline were dropped from all analyses due to incomplete data, resulting in a sample size of 17 in the intervention group and 24 in the control group. For this reason, generalizations to the population of HIV subjects should not be made. Significant differences between groups within time point, or between time points within group were found for adherence using the cap as a measurement tool, viral load, CD4 counts, and adherence using the self-report as the measurement tool. The intervention group had significantly lower mean viral loads than the control group at both time point 1 (p=0.0003) and time point 2 (p=0.0030). For CD4 counts, differences between the intervention and control groups were seen. At time point 3 (p=0.0021) the intervention group had significantly higher mean CD4 counts than the control group. Conclusions: In future research, phone disconnections will be countered with letters and with mailed phone cards. The researchers are developing the strategy of a closer working partnership with the clinic staff who make the appointments and who often have a relationship with the patients. Suggestions for future intervention strategies include the provision of cell phones for participants. 2 Evaluation of the efficacy of a randomized intervention trial to improve antiretroviral adherence among HIV-positive patients experiencing treatment failure Farthing C, Javanbakht M, Prosser P, Herr R, Grimes T, Weinstein M. AIDS Healthcare Foundation, Los Angeles, CA Background: It is well documented that a high level of adherence to taking medication is essential for a good outcome with antiretroviral therapy. Many interventions have been designed to improve patient adherence, but some patients prove resistant to nearly all efforts to persuade them to adhere to therapy. We developed a special intensive intervention for these recalcitrant individuals to see if we could achieve therapeutic success. Methods: We designed a randomized, controlled trial to assess the impact of a case management (CM) intervention, as compared to the standard of care (SOC) in our clinics among patients experiencing treatment failure as a result of non-adherence. The CM group met with a treatment advocate once a week for the first three months, every other week for the next three months, and once a month for the remaining six months of the study for adherence support using an individualized adherence plan to address the unique circumstances of each patient. The patients were paid a US$10 travel stipend for each visit, and an additional US$20 incentive payment each time viral load dropped significantly (>3-fold) or remained undetectable. Efficacy was measured in terms of changes in viral load, CD4 counts, medication adherence (as measured by pill counts and Medication Events Monitoring System (MEMS) caps recording of one antiretroviral (ARV) medication), and perceived barriers to adherence. Preliminary results for the participants enrolled thus far are presented here. Select abstracts from Elements of Success: An International Conference on Adherence to Antiretroviral Therapy, December 4-7, 2003, Dallas, Texas, USA Ross G. Hewitt, MD (Chair) State University of New York at Buffalo and Erie County Medical Center, Buffalo, New York, USA Katharine E. Stewart, PhD, MPH (Co-Chair) University of Arkansas, Little Rock, Arkansas, USA Editor's Note: As HIV treatments improve in ease, tolerance, and efficacy, the most important factor influencing treatment success remains adherence. Following are select abstracts from an international conference at which 200-plus physicians and allied health professionals gathered to discuss how to improve adherence among their HIV-positive patients. Abstracts JIAPAC Vol. 3, No. 1, January/March 2004 13 Results: Among the 64 participants enrolled thus far, mean baseline CD4 count was 119 cells/µL (SD = 9), and mean plasma HIV RNA level was 4.5 log10 copies/mL (SD = 0.7). Among the 22 participants with four-month follow-up data available, mean follow-up viral load was decreased by 1.3 log10 in the CM group, and increased by 0.1 log10 in the SOC group (p=0.005). Furthermore, in terms of immune function, 67 percent of participants in the CM group were able to achieve CD4 counts greater than 200 cells/µL as compared to 14 percent in the SOC group (p=0.02). Conclusions: This adherence case management intervention appears to be remarkably acceptable, feasible, and effective in increasing adherence, reducing viral load, and improving immune function. In addition, this study demonstrates that, because of the complexity of the factors behind adherence, it is important that patients are supported with individualized medication management programs. 3 The index of readiness as a predictor of adherence Enriquez M,1 Gore P,2 O'Connor M,3 McKinsey D.4 1University of North Carolina, Chapel Hill, NC, 2ACT, Iowa City, Iowa, 3Midtown ID Clinic, Kansas City, MO, 4University of Kansas, Kansas City, KS Background: The purpose of this phase II prospective observational study was to further examine the relationship between the level of readiness for health behavior change and adherence by HIV-positive individuals (n=36) who had previously failed treatment due to non-adherence. This study was a follow-up to an initial study with previously non-adherent HIV- positive males (n=19) which indicated that higher Index of Readiness (IR) scores were associated with subsequent adherence to antiretroviral medications. Methods: This was a prospective and observational study. Participants completed the IR, an instrument measuring readiness to initiate health behavior change, prior to beginning new regimens of antiretroviral medications. After six months, participants were divided into two mutually exclusive groups: those who reached and sustained viral suppression, and those who did not. Results: Participants who experienced and sustained viral suppression had significantly higher scores on the IR subscales and the total IR score, compared to participants who did not reach viral suppression (p < .05). Results from this study further support the hypothesis that readiness may be a key component in successful adherence, and that the IR may be useful in the assessment of the ability of individual's to adhere to antiretroviral medications. Conclusions: This study further supports our belief that the IR may have clinical utility for identifying those individuals who are ready or not ready to adhere to antiretroviral medications. Further, the IR could assist clinicians when determining whether or not to start treatment with antiretroviral medications. Finally, interventions could be developed that enhance readiness leading to increased adherence. 4 The impact of pharmacist-based intervention in an HIV clinic Lamberjack K. College of Pharmacy, Ohio State University, Columbus, OH Background: To determine whether providing pharmacist-based medication and adherence counseling improves adherence in HIV patients who are currently non-compliant with highly active antiretroviral therapy (HAART). Methods: Adherence was monitored through self-reporting at each visit during the year the patients were followed. Individual pillboxes and drug regimen calendars were used to further facilitate compliance among the subject group. Individual pharmacist counseling and compliance education was provided at each visit. Results: Twenty-six patients, of varying background and age, were targeted for intervention based on their non-compliance to HAART. Prior to intervention, 17 patients had poor compliance, seven patients had moderate compliance, and only two patients had excellent compliance. After the intervention, only two patients had a compliance score of poor, eight patients were moderately compliant, and 16 patients achieved an excellent compliance rating. Sixteen patients had a decrease in viral load, four patients had no change, and the remaining six patients had an increase in viral load. Before intervention, ten patients had a CD4 count <200 cells/µL, ten patients had a CD4 count of 200 to 499, and six patients had a CD4 count >500. After intervention, eight patients had a CD4 count of <200, eight patients had a CD4 count of 200 to 499, and 10 patients had CD4 counts >500. Conclusions: The results suggest that extensive education and counseling by a pharmacist in an HIV clinic can result in increased patient medication compliance, a decreased viral load, and increased CD4 count. 5 Enhancing best practices in adherence: A pilot project to improve and support clinic-based adherence services Knus D. University of Minnesota Department of Medicine, Minneapolis, MN Issues: The issues are clinic-based adherence training, education, and support. Description: Providing adherence services support and improving capacity for these services in HIV clinical settings have been the goal of the pilot project conducted by the Minnesota Site of the Midwest AIDS Education and Training Center in 2003. This project provides tailored clinic-based adherence services. Services include provision of: on-site assessment of current adherence practices; on-site multidisciplinary adherence clinical training; individualized adherence documentation tools; patient education materials; patient adherence toolkits (pillboxes, watches, calendars, etc.); provider resource materials; and follow-up and consultation as often as clinics request. Clinic-identified training includes improving client adherence counseling, understanding principles of adherence, and adherence best practices, creating an efficient documentation system for monitoring patient adherence education and encounters, and training on new adherence support tools. The presentation would include an adherence toolkit demonstration and lessons learned. 14 JIAPAC Vol. 3, No. 1, January/March 2004 Lessons learned: As the "one-size-fits-one" approach is necessary for adherence with patients, so too has been our experience with clinics. Clinics are busy: bringing current adherence tools, patient educational materials (HIV brochures, medication charts), and up-to-date adherence research to their interdisciplinary teams, has provided value-added services for their patients. We have expanded our own definition of "universal access" to respond to requests to provide training and tools to case managers in AIDS service organizations and other allied health professionals who provide care for persons living with HIV. Recommendations: This project could be adapted for use by AIDS Education and Training Centers and others who deliver clinical training. The next steps for this program are to insure its sustainability in continuing to provide resources and training for clinics involved in the program, as well as for new clinical sites requesting services. 6 Methodological challenges to evaluating highly active antiretroviral therapy (HAART) adherence interventions: Desperately seeking solutions Simoni J, Frick P, Pantalone D,1 Turner B.2 1University of Washington, Seattle, WA, 2University of Pennsylvania, Philadelphia, PA Background: The seriousness and urgency of the problems associated with adherence to antiretroviral medications have sparked increasing attention to this issue. Many interventions to enhance adherence are in place, although few have been subjected to rigorous empirical evaluation. One reason for the nascent stage of development of this literature is the multitude of methodological challenges it poses. Methods: We scanned the published literature for studies evaluating interventions to enhance HAART adherence, and determined the existing methodological issues and challenges in order to improve future studies. Results: From the review of the literature, we identified multiple challenges that adherence researchers will have to address before we can obtain the data needed to improve our interventions. These include: 1) the lack of theoretical concep- tualization; 2) the plethora of preliminary or pilot studies; 3) inappropriate samples that make the interpretation of results difficult; 4) difficulty distinguishing which aspect of a compre- hensive intervention is effective; 5) problems developing reliable and valid assessment measures of adherence; 6) lack of knowledge concerning appropriate duration and timing of interventions. Conclusions: We conclude with suggestions for strategies to address some challenges, as well as the acknowledgement that there are no simple solutions to others. Suggestions include: 1) emphasis on sound theory; 2) more randomized controlled trials; 3) more homogenous or HAART-naive samples; 4) multi-arm studies that evaluate specific aspects of more comprehensive interventions; 5) researcher mutually agreed- upon assessment measures across studies; 6) study designs that specifically assess interventions implemented at different times in the course of treatment, for different durations and different intensities. 7 The role of depression in non-adherence among postpartum HIV-positive women Madru N, Gordon D, Morris A. Community Research Initiative of New England, Springfield, MA Background: Research shows a decrease in women's adherence to HIV medical care postpartum. This study explores factors thought to influence postpartum adherence Methods: A retrospective, interviewer-administered survey was created to investigate various factors influencing medical adherence in postpartum HIV-positive women, including stress and depression, and social support. Eligible women were six months to three years postpartum, and lived with the infant for at least six months. Results: Twenty-one eligible women were contacted. Eight women were unable to participate due to a variety of psychosocial issues. Thirteen were interviewed. Mean age was 28.7 years. Mean number of children was 2.9. There were: nine Latinas, two African Americans, one multiethnic, one White, and one primary Spanish speaker. Seventy percent received welfare/ disability benefits, and 92 percent of the births were covered by state Medicaid. Thirty-one percent were homeless. Eighty-five percent scored high for stress and depression. Of those, seven reported poor adherence to HIV medications during the first year postpartum, although this did not reach significance (p=0.19). Forty-six percent reported that they often missed medications due to depression or feeling overwhelmed. Women who received help with medication adherence reported the following strategies to be useful: reminders from others to take their medications; connecting their dosing schedule to an existing routine; use of a pillbox; and internal motivation. Women's suggestions to improve adherence to medications and medical visits included: relief from depression; reminder calls; having a car; lower pill burden; and support from another person. Conclusions: This cohort of women indicated a multitude of impediments to postpartum medication adherence including depression, although in this limited study, stress and depression did not predict non-adherence. Nevertheless, further investigation with larger numbers could improve understanding of depression as a component for non-adherence in postpartum women. 8 Reliable transportation as a factor in postpartum adherence to HIV medication therapy Gordon D, Madru N, Morris A. Community Research Initiative of New England, Springfield, MA Background: Previously our group reported a decline in women's adherence to HIV medical care postpartum. We designed this pilot to probe factors thought to impact postpartum adherence among women in a small city. Methods: A retrospective, interviewer-administered survey was developed to measure medication adherence, stress, depression, social support, housing, transportation, disclosure, and abuse. Eligible women were six months to three years postpartum, and had lived with the infant for at least six months postpartum. Results: Twenty-one eligible women were contacted. Eight were unable to participate due to various issues, including a lack of transportation and scheduling conflicts. Thirteen were JIAPAC Vol. 3, No. 1, January/March 2004 15 interviewed. Mean age was 28.7 years. Mean number of children was 2.9. There were: nine Latinas, two African Americans, one multiethnic, one White, and one primary Spanish speaker. Thirty-eight percent had at least a high school diploma or general equivalency diploma. Ninety-two percent of births were covered by state Medicaid. Postpartum, 70 percent received welfare/disability benefits. Thirty-one percent were homeless. Fifty-four percent reported poor adherence to HIV medications during the first year postpartum. Most common reasons for missing medications postpartum were: simply forgot (10/13), and busy with other things (8/13). All women with unreliable transportation reported poor medication adherence (p=0.048). There was no association with the particular method of trans- portation used. Having one's own car did not impart reliability. Women's suggestions to improve adherence to medications and medical visits were: having a car; reminder calls; no depression; lower pill burden; and support from another person. Conclusions: This cohort of women reported a multitude of impediments to postpartum medication adherence. In this small series of urban women, lack of reliable transportation was the most significant risk factor. It seems likely that this finding is an indicator of a larger set of socioeconomic issues that impact many HIV-positive mothers' ability to be adherent. The findings from this pilot will be especially helpful in planning future investigations. 9 Integrating HIV primary care and adherence support into outpatient substance abuse treatment Mullen B, Keruly J, Lucas G, Moore R. Johns Hopkins University, Baltimore, MD Issues: The high prevalence of medical and psychosocial co-morbidity among HIV-infected drug users needs to be addressed comprehensively in order to maximize treatment outcomes. Such individuals may benefit from integrated substance abuse and medical treatment. Description: A Ryan White-funded, HIV satellite clinic was initiated two years ago in an outpatient substance abuse program specializing in treatment of clients with co-morbidities. This satellite clinic is a component of a large academic HIV practice that affords tertiary care if needed. The HIV medical team has integrated into the organizational culture of the substance abuse facility. The recovery service offers two programs and maintains an average of 200 to 250 clients. The smaller program has women only, methadone-based with HIV seroprevalence of 20 to 25 percent. The larger co-ed program averages 150 to 200 clients with HIV seroprevalence of 45 to 50 percent. HIV primary care, triage, social service advocacy, and referrals to psychiatry and other specialties are coordinated for clients utilizing the integrated clinic. Adherence to HIV medical appointments and antiretroviral medications is supported through both formal and informal modalities. A subset of clients is receiving modified directly observed antiretroviral therapy. Lessons learned: The integration of HIV primary care services into an addiction treatment setting has resulted in improved access, adherence with both appointments and antiretroviral regimens. For example: the clinic visit rate for the on-site HIV clinic for fiscal year 2002 was 72 percent, compared to 63 percent for the hospital-based HIV clinic. Recommendations: Given the complexity of the lives of HIV- infected drug users, integrated service models may be effective where the dual epidemics of substance abuse and HIV intertwine. 10 Adherence to highly active antiretroviral therapy (HAART) and medical care among HIV and hemodialysis (HD) patients: A joint initiative between the Institute of Human Virology (IHV) and the Independent Dialysis Foundation (IDF) Jeffries C, Gilliam B. University of Maryland Institute of Human Virology (IHV), Baltimore, MD Issues: HIV patients on HD spend three days a week receiving treatment, and are often expected to visit their HIV provider for routine care and monitoring. In a pilot study, patients stated that they would prefer to have all their care in one place, thus making it easier for them to adhere to their numerous renal medications and HAART. Given that 63 percent of patients in Baltimore fail their antiretroviral regimen within one year, and those with HIV and End Stage Renal Disease (ESRD) face a higher mortality rate, it was necessary to tailor a program to meet their needs. Description: In an effort to provide comprehensive HIV care and increase HAART adherence among dialysis patients, the IHV has collaborated with a nearby HD center to deliver accessible HIV care to its patients while they are on HD. An IHV provider holds clinic two days a week for all shifts. Furthermore, the clients have on-site access to HD social workers, behavioral medicine specialists, nurses, and nutritionists, all whom have knowledge of HIV care. The patients benefit from comprehensive care, which includes HIV, adherence, and intensive HAART education, on-site blood draws, HIV and HD medical care, and coordination of transportation to all medical appointments. Most importantly, the clients have developed a trusting relationship with their providers. Lessons learned: It is possible to provide comprehensive HIV primary care at a HD center with success. This joint pilot program has led to increased HAART adherence and HIV care. All have up-to-date vaccinations and annual screenings, 5/6 (83 percent) of patients receiving HAART have viral loads <50 copies/mL, and patient surveys state the program has made it easier for them to adhere to their HAART and medical care. Next steps: The program hopes to expand to other HD centers in the state with high concentrations of HIV cases. Additionally, we hope to develop a directly observed therapy HAART regimen to be given following HD at the center. 11 Perinatal adherence: Mistakes we made Levison J,1 Peters M, Hansen I,2 Lewis S.3 1Baylor College of Medicine, Houston, Texas, 2Harris County Hospital District, Houston, TX, 3University of Texas Health Sciences Center, Houston, TX Issues: Adherence in HIV-positive perinatal patients improves a woman's chance of being a candidate for a vaginal delivery, yet it remains elusive. 16 JIAPAC Vol. 3, No. 1, January/March 2004 Description: The Harris County Hospital District Women's Program provides prenatal care for HIV-positive clients. A nurse educator explains the antiretroviral regimens in detail. At every prenatal visit the clinician asks, "How are you doing with taking your medications?" and/or "How many times in a week do you forget to take your medicines?" The majority of our patients achieve a viral load <400 copies/mL, and are candidates for vaginal delivery. However, our system does not work for every patient. In Case 1, a patient heard the emphasis on taking her antiretroviral medication every 12 hours, but interpreted the instructions to mean that she should skip a dose if she is an hour or two late. In Cases 2 and 3, patients began antiretrovirals and achieved undetectable viral loads by the second trimester, but did not fully realize the importance of continuing to take their medications without fail. This led to a viral load rebound. In Case 4, a patient had a slower-than-expected drop in viral load. We discovered that, in spite of verbal and written instructions to take her medications twice daily, she had been taking one of them only once a day. She realized her error while watching a video in our clinic. Lessons learned: In addition to stressing the importance of taking antiretroviral medications on schedule, we need to: 1) address how to deal with missed doses; 2) remind patients that achieving an undetectable viral load is the first step, but must be followed by maintaining a low viral load; and 3) assess literacy and provide multiple forms of educational material (written, oral, visual). Next steps: Consider quantitative measures of understanding, such as a questionnaire or true/false evaluation, to assess patient understanding and retention of knowledge immediately after giving instructions and repeated two months later. 13 Actual doses per day of successful antiretroviral regimens Clay P. University of Missouri, Kansas City School of Pharmacy, Division of Pharmacy Practice, Kansas City, MO Background: Providers are making simpler dosing for an antiretroviral regimen a top priority in the decision process. What has not been taken into account when assessing the success of these patient's regimens are the co-morbid diseases, and their respective therapies and influence on total daily pill burden and dosing frequency. This study assesses the actual number of pills and times per day patients with undetectable viral loads take medications. Methods: A concurrent and retrospective chart review was conducted, identifying all patients with an undetectable viral load (<50 copies/mL). Data were collected on demographics; US Centers for Disease Control and Prevention (CDC) AIDS classification; initial viral load and CD4 count prior to the start of therapy; type of antiretroviral regimen; duration of therapy; most recent viral load and CD4 count; and co-morbid diseases and their treatment regimens. Descriptive statistics are provided only. Results: One hundred and seventeen patients were found to have undetectable viral loads. Demographics included (means (± 95 percent CI)): age 40 years (1.7); 105 males; 37 percent minority; 63 percent CDC class B or C (53 with AIDS diagnosis); initial viral load 82,149 copies/mL (35,000), and CD4 443 cells/µL (58); duration of time from diagnoses to start of antiretrovirals five years (0.8). Therapy characteristics were: 38 percent on protease inhibitor regimen, 32 percent of non-nucleoside-based regimen, duration of therapy 2.81 years (0.4), average CD4 change +237 cells/µL. Twenty-three patients were on opportunistic infection medications, 93 (80 percent) had co-morbid disease, with an average number of co-morbid diseases of 2.27 per patient. Mean number of pills per day was 13 (1.3), and doses per day were 2.6 (0.3). Conclusion: While improving the tolerability of antiretroviral medications and improving dosing frequency, the vast majority of HIV-infected persons have other diseases that must be taken into consideration before deciding on a particular regimen based on dosing frequency. 14 Fixed-dose combination zidovudine/lamivudine is associated with improved antiretroviral adherence in Medicaid populations Jordan J, Carranza-Rosenzweig J,1 Chernicoff H,2 Delea T.3 1GlaxoSmithKline Inc., Research Triangle Park, NC, 2Health Benchmarks Inc., Woodland Hills, CA, 3PAI, Brookline, MA Background: This study was done to evaluate in Medicaid- insured populations, whether fixed-dose combinations (FDC) improve HIV-infected patients' adherence to antiretroviral therapy (ART). Methods: Using data from two Medicaid insurance claims databases, we compared adherence in patients receiving Combivir (COM), a fixed-dose combination of zidovudine (ZDV) and lamivudine (3TC), versus ZDV and 3TC as separate pills (SP). The study sample consisted of ART-naive patients aged more than 18 years with greater than two prescriptions (Rx) for COM or SP and greater than 60 days of follow-up. Adherence to COM and SP was based on refill period (RP), the time between filling of a prescription and the next refill date. Adherence was calculated in two ways: 1) therapy days supplied with RP ("adherence ratio"); and 2) therapy days supplied minus RP ("therapy days missed"). Means were calculated for each patient across their RPs. Multivariate logistic regression was used to compare treatment groups based on: 1) mean adherence ratio less than 95 percent; and 2) mean therapy days missed greater than three. Poisson regression was used to compare the adjusted number of RPs per year where adherence was less than 95 percent. Covariates included age, sex, ethnicity, region, symptomatic HIV, substance abuse, hepatitis B, number of physician office visits, infectious diseases specialist care, pill count, and other ARTs received. Results: The study sample consisted of 1,605 patients receiving COM, and 507 receiving SP. Combivir was associated with a lower risk of adherence failure. Relative to SP, adjusted COM odds ratio for adherence less than 95 percent was 0.37 (p<0.0001), while that for greater than three therapy days missed was 0.43 (p<0.0001). Yearly number of RPs where adherence less than 95 percent was 2.7 for COM, and 4.3 for SP (p<0.0001). Conclusions: Patients in Medicaid populations who receive FDC tablets, such as COM, may be more likely to adhere to ART than those receiving the same therapies as SPs. JIAPAC Vol. 3, No. 1, January/March 2004 17 15 The impact of an adherence program on obtaining interpretable therapeutic drug monitoring (TDM) concentrations of antiretroviral (ARV) medications Catanzaro L, Slish J, Esch L, DiFrancesco R, Maliszewski M, Hewitt R, Morse G. School of Pharmacy and Pharmaceutical Sciences, School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York and Erie County Medical Center, Buffalo, NY Background: An established adherence pharmacology program was integrated with a TDM service to examine the impact of the program on obtaining interpretable protease inhibitor (PI) and efavirenz (EFV) concentrations. Methods: Patients were referred to the adherence program for TDM sampling. Patients were excluded if they were not on their current ARV regimen for at least 14 days prior to sampling. Prior to the appointment, patients were instructed to record the date and time of the last three doses of the ARV medications to be assayed, and to hold the morning doses of their ARV medications in order to obtain trough concentrations. An interview was conducted to obtain adherence, concomitant medication, and current side-effect information. Current laboratory and resistance data were obtained from the chart. Samples were analyzed using a Clinical Laboratory Improvement Act (CLIA)- certified high performance liquid chromatography assay. Results were evaluated using concentrations for PIs and EFV previously reported in the literature. Results: Thirty-three TDM concentrations were obtained from 24 patients between November 2002 and June 2003. Twenty-one patients received pre-visit instructions in person, by phone, or by mail. Of these patients, 16 had blood samples obtained within two hours of the targeted trough time. Twenty-three patients reported no missed doses within the previous two days. Thirteen patients took all three doses prior to sampling within one hour of the correct administration time. Of the 33 concentrations, two could not be interpreted due to assay interference, and one due to sample timing. Thirty TDM interpre- tations were provided: 17 within the expected concentration range, 10 below, and three above. Conclusions: The adherence program played a vital role in providing important patient-related information that allowed for interpretation of TDM results whether they were in the expected range or not. 16 Acceptability and retention in the weekly directly delivered therapy (DDT) program among antiretroviral (ARV)-naive indigent women initiating highly active antiretroviral therapy (HAART) Nykyforchyn M,1 Morgan G, Noyola E, Laufamn L,2 Zerai T, Douglas G,3 Visnegarwala F.4 1University of Texas Health Science Center, Houston, TX, 2Baylor College of Medicine, Houston, TX, 3Harris County Hospital District, Houston, TX, 4Baylor College of Medicine, Houston, TX Background: Non-adherence to antiretroviral therapy (ART) is a barrier to virologic suppression. The DDT program is a prospective study, which evaluates a novel adherence intervention strategy of weekly delivery of all HAART doses (in a bubble pack) by an outreach worker (OW), followed by gradual weaning. The aim is to create a model of liaison between the patients and the healthcare system, thus helping patients to utilize the system to their advantage. Methods: Subjects are ART-naive women initiating HAART. Women meet with a project coordinator for baseline psychosocial assessment and introduction to peer OW. The OW and subject designate a place and time for the OW to deliver ART to patients, and for check-in interview. The OW delivers ART in bubble pack containers to patients. The OW p/u previous bubble packs to determine quantity of medications used. Zung scale was used to assess depression. Virologic outcomes and immunologic outcomes were evaluated. Results: Since the protocol was initiated 12 weeks ago, 11 women have enrolled: median age was 46 years; 82 percent were Black; all had AIDS; and 36 percent reported active drug use. Baseline mean/median VL (log10) and CD4 count were 3.8/5.58 copies/mL and 51/28 cells/µL. Mean Zung score was 46; 18 percent were clinically depressed and required psychiatric care. Six patients have follow-up data; 66.6 percent had VL <400 with a mean of 2.2 log drop; mean CD4 increase was 110 cells/µL. All 11 remain in the study; 95 percent of scheduled OW visits were kept with an average of seven contacts per patient; 91 percent report taking greater than 95 percent ART; 9 percent report taking half to most ART. High adherence levels were confirmed by pharmacist recount of returned bubble packs. Conclusions: The weekly contact with the OW has a short- term impact on virologic outcomes. Patients are receptive to delivery of medications, demonstrating openness to the OW. Longer follow-up data of patients enrolled in this model of community-based intervention will be presented. 17 JACQUES Initiative: An open, non-randomized, observational study to examine the feasibility and sustainability of various treatment support modalities for patients starting antiretroviral therapy (ART) for HIV infection Spencer D, Amoroso A, Davis C, Redfield R, and members of the Division of Clinical Care and Research of the IHV. University of Maryland, Institute of Human Virology and Biotechnological Institute, Baltimore MD Issues: One of the greatest treatment challenges with antiretroviral use is adherence. The stringent level of adherence needed for durable long-term virologic suppression has been difficult to impossible for many patients. As many as six out of 10 patients in urban environments such as our own, fail therapy in the first year. Novel care delivery models are necessary to abate the dismal failure rates and trends of worsening HIV resistance in our cities. Description: We have developed a highly supportive care delivery system for the administration of ART. The intervention includes a range of intense educational workshops involving patients, family, and friends. A range of treatment options includes various modalities of Directly Observed Therapy (DOT) and self-administered therapy. The initiative has been ongoing for five months and 40 patients have been enrolled. Lessons learned: Preliminary data reveal the first 15 patients 18 JIAPAC Vol. 3, No. 1, January/March 2004 starting ART have achieved a non-detectable viral load. Six- month data will be presented on all patients. An unanticipated benefit has been an improvement in the behavior of establishing healthcare as a priority, improved access to healthcare, and increased enrollment into clinical trials. Recommendations: These include treatment preparation, highly supportive therapy, and multidisciplinary collaborations, such as addictions, psychiatry, and social work services, in providing treatment for people living with HIV. 18 Monitoring adherence to antiretroviral therapy (ART) using a composite adherence score: A pilot program Hardy H, Stanic A,1 Tataronis G,2 Traxler T, Hall J,3 Skolnik P.4 1Boston Medical Center/Massachusetts College of Pharmacy and Health Sciences, Boston, MA, 2Massachusetts College of Pharmacy and Health Sciences, Boston, MA, 3Boston Medical Center, Boston, MA, 4Boston Medical Center/Boston University School of Medicine, Boston, MA Background: Poor adherence to ART represents one of the primary reasons for sub-optimal viral suppression in HIV-infected persons, yet no "gold standard" exists to measure it. Since multiple factors affect adherence, its optimal measurement is likely to require gathering information on several variables. Methods: We developed a composite adherence score (CAS) to evaluate this hypothesis and to determine if CAS represents a reliable tool to monitor adherence. Composite adherence score was generated using self-reported adherence, pharmacy refill, pill count, dosing frequency, and administration require- ments. Changes in quality of life (SF-12), readiness to take and adhere to ART, understanding HIV disease, and treatment goals were measured over time. Results: From October 2002 to October 2003, 55 HIV-infected patients were enrolled in the adherence program. Thirteen patients completed 24 weeks, and results are summarized below. N = 55 N =13 Age (mean, 1 SD) 42 (1-12) 43 (1-14) Male gender (%) 60 77 Race (%) Black 64 54 Hispanic 20 23 White 15 23 Education High school graduate (%) 69 77 Risk factors for HIV (%) Heterosexual 76 69 Viral load 134,000 134,000 (mean, 1 SD) (1-175,000) (1-195,000) T-cell count 212 247 (mean, 1 SD) (1-185) (1-180) Eleven patients achieved the primary endpoint (viral load (VL) <400 copies/mL at week 24, or 2 log drop in VL from baseline). Two of the patients did not have a VL available at week 24. Sixty-four percent (7/11) of the patients achieved a CAS >5 (good adherence), and 36 percent (4/11) had a CAS <5 but >3 (partial adherence). The correlation between the mean CAS and mean VL at week 12 and 24 did not reach statistical significance (r =-0.43, p = 0.24). However, when analyzed in the absence of one outlier patient, the correlation was statistically significant (r = -0.89, p < 0.05). Patients' self-reported readiness remained high, and a trend toward improved quality of life was observed. Conclusion: Although additional data are needed, CAS might be a useful adherence-monitoring tool. 19 The effects of social support on an HIV-positive population Plummer M, Simoni J, Huang B. University of Washington, Seattle, WA Background: The benefits of highly active antiretroviral therapy (HAART) exist in the shadow of two related areas of concern: the psychological sequelae of HIV/AIDS, and the problem of medication adherence. Rates of depression, anxiety, and life stress are consistently elevated in the HIV-positive population. These negative affective states are of particular concern in this community as they may interfere with medication adherence. For this reason, interventions that diminish the psychological toll of HIV/AIDS are essential. The benefits of HAART are contingent upon consistently high medication adherence. Yet, research demon- strates that 40 to 60 percent of those prescribed HAART are less adherent than what is required for HAART to be effective. Therefore, interventionsmustbedevelopedtoincreasemedicationadherence. Methods: The present study was conducted at an outpatient HIV clinic in the Bronx, and examined the feasibility and effectiveness of a community-based intervention aimed at improving adherence by increasing social support. Participants who were randomly assigned to the "Buddy" condition received three months of peer support from "Buddies" (adherent patients who had been trained to provide social support). Contact consisted of phone calls between the Buddies and study participants, as well as biweekly group meetings to which all Buddies and participants were invited. All participants completed baseline, three-month, and six-month questionnaires. The authors hypothesized that the level of participation in the Buddy condition (measured by attendance at group meetings) would predict levels of social support, and that social support would predict levels of negative affect. Finally, negative affect was hypothesized to predict medication adherence at follow-up. Results: The sample of 136 patients was comprised primarily of African-American and Hispanic men, and women (46 percent and 41 percent, respectively). The hypothesized model was evaluated using structural equation modeling, and results indicated that it was a good fit for the data (RMSEA = 0.0, CFI = 1.0). Conclusion: Participants who attended a greater number of group meetings experienced increases in social support, which in turn predicted decreases in negative affective states. These decreases in negative affect were predictive of medication adherence at six-month follow-up. 20 The Patio Club: A not-so-traditional approach to the traditional support Gibson C, Suelter J. Kansas City Free Health Clinic, Kansas City, MO JIAPAC Vol. 3, No. 1, January/March 2004 19 Issues: The presentation deals with HIV and hepatitis co-infection, and the issues that clients face with managing both of these diseases: contracting and living with multiple hepatitis infections; the isolation that clients experience with hepatitis and/or HIV infection; monetary issues faced by clients while undergoing hepatitis treatments and/or with an HIV diagnosis (eg, temporary disability versus quitting your job due to side effects of medications); adherence to medications (eg, patient versus provider responsibilities); managing your diet and overall well-being while on treatments and/or medication; and mental health issues experienced by the co-infected client, such as depression and anxiety. Description: The Patio Club is a peer-led social support group for individuals infected with HIV and/or hepatitis. The concept for the group derived from another support group that met at another location. A number of participants would meet informally outside on the patio after the formal meeting would end. Once winter hit, it became too cold for the group to continue socializing on the patio after their meeting. The Kansas City Free Health Clinic brought the group inside, and the concept for the Patio Club was developed. Many of the participants are co-infected, as well as the facilitator. The group facilitator is positive for HIV and hepatitis. He has also completed the treatments for hepatitis infection. This group has been one of the most successful support groups at the Kansas City Free Health Clinic to date. This is attributed to the peer approach it is based on. The group was designed using the Dr. Jeff Kelly's Popular Opinion Leader (POL) model. The group meets weekly for about one hour. The group has developed its own mission statement and currently operates on that premise. The Patio Club mission statement is "Honesty, Open- mindedness, and Willingness:" honesty with their providers and each other; open-mindedness to deal with the mental stress related to their diagnosis; and willingness to adhere to medications, appointments, and meetings. Technical assistance for the group and its facilitator is provided by a number of professionals. They are as follows: Dr. Patrick Clay, HIV Pharmacist at the Kansas City Free Health Clinic, provides educational support; staff at Roche Pharmaceuticals provides educationalsupport;staffat Schering-Plough and GlaxoSmithKline Pharmaceuticals provides funding and educational support; and Carla Gibson, Prevention Manager at the Kansas City Free Health Clinic, provides program design, implementation, and educational support. Lessons learned: For the clinic, the biggest lesson learned from this intervention has been the need for utilizing the peer approach to ensure the success of support group interventions. Another lesson is choosing your facilitator from the community from which you are targeting for the intervention to improve effectiveness and outcomes. The outcome (lesson learned) for the participants of the Patio Club is learning personal responsibility and improved adherence in managing HIV and hepatitis infections. Recommendations: More funding needs to be made available for peer-led support interventions. There is a need to develop home-based educational interventions for those clients too sick to attend groups. There needs to be increased community awareness around HIV and hepatitis co-infections. 21 Doing time in prison, doing life with HIV: The Springboard Model for successful outcomes upon release Vandenberg G. Springboard Transitional Case Management Program, San Francisco, CA Background: The purpose of the Springboard Transitional Case Management Program is to reduce recidivism, and to promote treatment adherence, access to care, and prevention for positives among HIV-positive inmates released from three California state prisons to the San Francisco Bay Area. Methods: This innovative program employs a variety of strategies to achieve its goals. Among these strategies are: a) pre-release discharge planning; b) transitional housing in the immediatepost-releaseperiod;c)useofharm-reductionprinciples; d) working with parole departments; e) use of restorative justice principles; f) the power of peers; g) linkage to on-site primary medical care and pharmacy services; and h) linkage to vocational training and community colleges. Results: Since 1999, the program has served an average of 75 clients each year with transitional case management, primary care, and housing. The rate of re-incarceration among program participants has not exceeded 35 percent during each of these years (as compared to California's statewide average of 65 percent to 70 percent). During the February 2003 program period, only 13 clients (19 percent of all clients served) were returned to prison. From March 2002 through February 2003, 61 (91 percent) of the 67 clients who had been released showed up for their first medical appointment. They had their medical status assessed, and had developed a medical treatment plan with their primary care provider, including discussion of antiretroviral treatment. The remaining six clients were lost to follow-up immediately upon their release. Despite restrictive program rules, client satisfaction survey ratings have been within the 90th percentile range for the entire period of the program's existence. Conclusions: There are two conclusions: 1) Health education and prevention efforts, primary care, and transitional case- management services need to be culturally competent in design and implementation, in order to effectively reduce harm and positively affect patient outcomes of inmates living with HIV/AIDS (and their sexual and needle-sharing partners), before and after release from incarceration; 2) Interventions need to be tailored to the specific circumstances of the correctional setting and communities of release. 22 Initiation of an outpatient pharmacist-based adherence education program in a rural, southeast, resource-poor, majority-minority clinic setting Jones M, McKenney L. Brody School of Medicine, Greenville, NC Background: Our infectious diseases (ID) clinic at East Carolina University (ECU) with two other community health centers (CHCs) serve approximately 2,000 patients living with HIV/AIDS from over 33 counties in North Carolina. Our HIV population is majority-minority in race, 40 to 50 percent female, and mostly underserved in the healthcare system. Ignorance, denial, and shame are endemic in this rural, medically underserved, hard-to-reach patient population. In this setting, the Brody Medication Adherence Clinic with the pharmacist- clinician is uniquely positioned to improve patient clinical outcomes. 20 JIAPAC Vol. 3, No. 1, January/March 2004 Methods: Organize an outpatient adherence clinic. Improve patients' quality of life by decreasing HIV-related complications. Identify clinical/financial outcome goals; identify patient barriers to adherence; improve medication access; and provide patient- focused counseling and intervention strategies in resource-poor settings. Assist healthcare providers in disease management and continuity of care. Results: Fifty-eight percent of patients had a mean increase in CD4 count of 52 cells/mm3, 73 percent of patients had a mean decline in viral load (VL) of 1.04log, and 49 percent had a VL <400 copies/mL, despite a high percentage of patients with multi-drug resistant (MDR)-HIV. Emergency room visits were estimated at 5 percent, and 0.5 hospital days were estimated per patient visit. Estimates were similar to the clinic overall, yet reflect a patient subset with increased risk of MDR-HIV and low CD4 count. Conclusions: Patients benefit from the clinic pharmacist interventions as evidenced by suppressed VL. Additional benefits are a strengthened immune system, improved quality of life, decreased drug-related adverse effects, improved side-effect management, decreased utilization of medical services from HIV-related complications, and increased continuity of care. The healthcare team benefits from the pharmacist provided education, training, and routine monitoring of medication- related issues for continuity of care within the patient population. The organization benefits from improved quality of care, patient satisfaction, and cost savings for people living with HIV/AIDS with more effective utilization of medical services. 23 Challenging institutional barriers to providing adherence care: Creating comprehensive HIV treatment adherence coordination with low-income, uninsured, HIV-positive patients in a community care clinic Homer E. Montrose Clinic, Houston, TX Issues: Multidisciplinary HIV treatment adherence coordination requires significant and extraordinary cooperation between various providers of service to HIV-positive patients. This presentation will explore the yearlong process of implementing a comprehensive adherence coordination approach in a primary care clinic serving over 1,100 HIV-positive patients. Description: A multidisciplinary Adherence Task Force that includes the clinic medical director has been meeting biweekly to create and implement adherence strategies and interventions. HIV service disciplines have, independently of one another, developed unique beliefs and approaches to address the adherence needs of the HIV-positive client. This presentation will also explore institutional barriers to adherence resulting from poor communication and ineffective interaction between these approaches. The tools and activities utilized by the clinic include social workers attending the first doctor's visit and the nurse medication education session with each client, followed by the social worker communicating his or her adherence assessment as appropriate in these sessions. Other tools are real-time reports of viral load and CD4 count lab values to all relevant staff; an all-clinical staff adherence alert procedure; and extensive monitoring of client refill request, script fill, and medication pick-up activity. Lessons learned: A significant shift has occurred in the approach to clients. Prior to coordinated adherence care, individual clinicians may have noted adherence problems, but tried to address it via his or her relationship with the client, rather than taking a team approach. Reports from staff indicate finding and intervening in adherence issues with clients who previously would have been under the radar. As well, increased adherence cooperation between clinicians in different disciplines has been noted. Institutional barriers continue to be present, but there is a new attitude of naming these barriers and continually addressing them. Currently, 80 percent of the clinic's HIV- positive patients are on highly active antiretroviral therapy (HAART) with 67 percent having viral load <10,000 copies/mL. 24 An intervention to improve highly active antiretroviral therapy (HAART) adherence and reduce drug use: A pilot study Parsons JT, Rosof EJ, Thomason BT, Punzalan JC. City University of New York, Hunter College, New York, NY Issues: A pilot study developed and tested a behavioral intervention that aimed at improving adherence to HAART and decreasing illicit drug use. Directly addressing adherence and drug use together is ideal, in light of the research on the connections--physiological, cognitive, and behavioral--between them. Description: The eight-session intervention combines Motivational Interviewing (MI) and Cognitive Behavioral Skills Building. The main goals of the pilot study were to: 1) confirm the ability to recruit drug users taking HAART; 2) demonstrate the ability to retain participants; and 3) evaluate behavior change from baseline to three months post-treatment. Sample consisted of 14 men who were recruited in two weeks. Eleven (78.6 percent) participants completed the intervention, 12 participants (85.7 percent) completed the post-test. Mean age was 44. Mean CD4 count and viral load was 570.43 cells/µL and 27,972.79 copies/mL. Mean number of reported missed HAART doses in the past 30 days at baseline was 5.14. Mean days of illicit drug use, in the 30 days prior to baseline, was 17.64. Significance (p = .005) was found for the reduction in drug use days post-treatment. Trends were in the direction of positive change for missed medication (5.58 at baseline to 0.92 post- treatment). Therapists found clients related to the material. This may be explained by MI that addresses clients at their level of readiness to change, and treatment being delivered through a system where modules are chosen based on individual needs. Lessons learned: Findings of the pilot suggest that this is, in fact, a population seeking treatment for drug use and help with adherence to HAART, and that they are willing to come to a research center for this help. It appears, too, that participants will likely complete the treatment and follow-up assessments. Finally, the findings suggest that the treatment style and materials used are valuable to participants, and that positive behavior change can occur as a result of the treatment. Recommendations: We will apply for a grant to evaluate this intervention on a large scale. Findings from this study, and the research on the direct and indirect connections between drug use and adherence, suggest that looking at these two behaviors simultaneously may give HIV-positive people who use drugs the best chance to improve their health and live longer. JIAPAC Vol. 3, No. 1, January/March 2004 21 25 Comparing the accuracy of patient recall to pill count of patients on antiretroviral therapy in South Africa Pakendorf A. Chris Hani Baragwanath Hospital, Soweto, South Africa Background: The Perinatal HIV Research Unit (PHRU) is situated at Chris Hani Baragwanath Hospital in Soweto, South Africa. The unit is currently conducting a research project (OPERA) on 100 HIV-infected patients (70 adult patients and 30 pediatric patients) who are receiving antiretroviral therapy. Most of the patients come from Soweto, the community surrounding the hospital. Soweto is an area with low income and high unemployment. Methods: This study was a cross-sectional, prospective study. The patients were scheduled for clinic visits once every three months. A research assistant interviewed the patients at one of those visits. The interview collected demographic data on the patients, issues and problems related to adherence, and the quality of their relationships with healthcare workers. The patients were asked, specifically, to recall how they used the antiretroviral medications over the past seven days. During the clinic visit the pharmacist also monitored the adherence through pill counts. The data on the seven-day recall were compared to the data on the pill counts. The results obtained from the patient's seven-day recall were expressed as a percentage of antiretroviral medications used over the total amount that should have been used for the previous seven days' prescription, as compared to the percentage of pills presumed to have been taken over the total number of pills required to be taken in any period closest to the date of the interview. On the basis of the findings, patients were placed into two groups, adherent and non-adherent subjects. Adherence was defined as a level of more than or equal to 95 percent. Results from these two groups were analyzed using a Fisher Exact Test. Results: A total of 43 patients were interviewed. Of those, 40 patients' seven-day recall data could be analyzed. In this group, 90 percent (36/40) of the patients were reported to be adherent, and 10 percent (4/40) of the patients were reported to be non-adherent. In the pill count group, 32 patients' results could be analyzed. In this group, 72 percent (23/32) of patients were found to adherent, and 28 percent (9/32) were found to be non-adherent. When the two groups were compared using a Fisher Exact Test, no significant association was found. Conclusions: From the results, the data suggest that patients may either have had difficulty with recall, or exhibited response bias, such as giving a socially desirable response (eg, that they adhered to the regimen). Given the fact that they could say how they were to follow regimen, knowledge of the regimen did not appear to be a factor in their non-compliance. This also suggests that patient education regarding the regimen was effective. In the pill count group, more than 70 percent of the patients were found to be more than or equal to 95 percent adherent. This figure, when seen in the context that the patients are not in a clinical trial, and that the follow-up for missed visits is not as strict as would be the case in a clinical trial, is very positive. Further research needs to be conducted to determine the barriers to patients' adherence. 26 Health-related quality of life and adherence motivation in patients with HIV disease treated by long-term highly active antiretroviral therapy (HAART) Mayer V, Mikulecky M, Stanekova D, Habekova M, Mokras M. AIDS Center, Institute of Preventive and Clinical Medicine, Bratislava, Slovakia Background: In an initial exploratory cross-sectional study, the health-related quality of life (QOL) was investigated in 28 asymptomatic HIV-infected patients, and patients experiencing at least one condition indicative of AIDS, treated with HAART for 23 to 45 months, in order to assess better their concerns and to evaluate care delivery in relation to adherence. Methods: Viral load and CD4 counts were studied as described, and for the QOL scoring, the Medical Outcome Study 35 item 1 Health Survey was used. Data were evaluated by non- parametric statistical methods. Results: From the asymptomatic patients, the relatively best QOL was exhibited by those with viremia <500 HIV RNA copies/mL and less severe immunodeficiency. The lowest QOL scores reported cases with low CD4 counts and high viremia. Perceiving treatment to be effective was felt as motivating to adhere but also weakened, in some cases, the belief of the necessity to continue strict adherence. On the other hand, lowered expectancies related to failing treatment worsened in some cases the cooperation with physicians. Conclusion: Individualized, flexible approach, and effort in dedicating time to patients is stressed. 27 The development of an innovative, culturally- sensitive video to introduce concepts of adherence in Soweto, South Africa Wong I,1 Munyoro J.2 1Yale University School of Medicine, New Haven, CT, 2Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa Issues: Preliminary work performed by the author in South Africa has indicated the dearth of medication-taking experience of black South Africans. It was concluded that room exists for patient education, regarding basic pharmacology and medication-taking habits, and that visual/video methods may be of particular use. Description: A 15-to-20-minute educational video in which basic drug-taking concepts, as well as practical advice on how to improve adherence, were presented. The content of the video was based on current adherence data, as well as a small focus group of adherence counselors. After taking a 16-point baseline survey of drug-taking knowledge, 30 HIV-positive patients were shown the completed educational video. Immediately post-video, they were given a second questionnaire to assess their knowledge. Lessons learned: Baseline surveys indicated that more than 63 percent of patients lacked understanding regarding at least one aspect of medication-taking, including the need to take antiretroviral (ARV) medications at specific times, the treatability of side effects, and the consequences of forgetting each dose. Post-video, the percentage of patients who lacked complete 22 JIAPAC Vol. 3, No. 1, January/March 2004 understanding of the tested objects fell to 46 percent, with the majority of patients having increased their score on the baseline survey. This includes increased knowledge of strategies to reduce missed doses. Continued follow-up is necessary to assess whether the improved knowledge post-video correlates to increased adherence to ARV medications. Recommendations: The dramatization of the necessity of adherence is clearly important. A key element of the video's success was the utilization of a three-pronged approach including: 1) question and answer format (in the form of a mock doctor-patient encounter); 2) a narrative sketch (in which actors depict correct and incorrect medication-taking procedures); and 3) a documentary portion including practical advice from adherence counselors. The video sections were interspersed with humorous commercial length segments regarding adherence. 28 National Adherence Program: An integral intervention Trevino S,1 Moreno F,2 Vazquez RM,3 Gomez JM.4 1Hospital General de Zona No 8. IMSS, Mexico, 2Hospital ABC, Mexico, 3Universidad de Guadalajara, Mexico, 4Virology Unit, Roche Mexico Issues: The wide range of factors involved in adherence, as well as the evidence of its direct association with the success of antiretroviral (ARV) treatments, make necessary an integral intervention aimed to cover the most important aspects regarding these necessities. Description: The National Adherence Program is a proposal of Roche Mexico to the community living with HIV, which arises as a response to the intervention necessities for the improve- ment of adherence to ARV treatments of patients living with HIV in Mexico. This program includes: diffusion of the importance of adherence among physicians; diffusion of the necessity of taking medicines properly at sites where the HIV community meets; and an adherence workshop focusing the coverage of the most important aspects regarding adherence failure (education, motivation, and planning), conducted by a physician, a psychologist, and a HIV patient. The workshop arises from the research of the necessities, as well as from the search of factors related among patients and physicians through various cities in Mexico, concluding with similar factors, as well as supporting those reported in literature as the most important and transcendental ones for adherence to ARV treatments. Lessons learned: Currently the workshop operates in 26 cities in the country working with local teams as of September 2002, and 870 patients have been included. Initial evaluation results at 12 and 48 weeks have been accepted in the abstract, "Impact evaluation in adherence through participation in support workshops in Mexico," to be presented at the 9th European AIDS Conference next November. Recommendations: At present we are detecting the point where the initial workshop impact may be lost, and the type of boosting required, as well as the features to be covered, in order to impact the factors affecting multi-treated patients. 31 Psychological barriers of adherence to antiretroviral therapy (ART) Boly L, Cafaro V, Dyner T. Private Practice, San Francisco, CA, Shared Perspectives on Therapies, San Francisco, CA Background: Understanding factors affecting adherence to ART remains important. Many studies find that "forgetting" is the major reason that patients miss doses. Methods: A survey was given to 100 consecutive HIV-positive patients attending a private practice clinic. Patients completed the survey anonymously. They were asked questions regarding their self-image, and questions to assess reasons for missing medication doses. Results: All patients were men who have sex with men, and six patients also had a history of intravenous drug use. The mean age of the patients was 51 (range: 26 to 83 years). The majority had a college degree (59 percent), and was under the care of the same physician for a mean of 7.4 years (range: first visit approximately 16 years). Ninety-four percent of the patients returned their surveys. Regarding self-assessment, 57 percent of the patients currently had positive self-images, 19 percent had mixed feelings about themselves; and 18 percent were feeling depressed. Most felt conflicted taking ART; 41 percent had psychological issues surrounding ART; 34 percent had side-effect issues; and 21 percent felt no conflict. Likewise, most patients felt conflicted about missing doses; 50 percent felt guilty; and 10 percent felt the virus would become resistant to ART. However, 19 percent of patients did not miss doses, and 6 percent felt better not taking ART. The three main reasons that patients missed doses were: needing to take a break from their medications (44 percent); experiencing side effects (29 percent); and forgetting (17 percent). The three top feelings for taking doses were related to: the reminder of being HIV- positive (51 percent); dealing with side effects (29 percent); and being tied to taking ART (22 percent). In this cohort of patients, 37 percent missed ART one to two times per month; 22 percent did not miss ART; 18 percent were off treatment; 11 percent missed once every three to six months; and 7 percent missed ART once to twice a week. Conclusions: "Forgetting" to take ART reflects both cognitive and motivational components. In this cohort of patients from a private clinic, individual psychological barriers affecting adherence to ART differ. Discussing these barriers with patients may improve patient adherence. 32 Utility of adherence assessment approaches in clinical practice Dougherty J, Capizzi J, Sreedharan G,1 Sola A,2 Cassidy D.3 1Multnomah County Health Department, Portland, OR, 2Public Health Research, Portland, OR, 3Multnomah County Health Department, Portland, OR Issues: The utility of three-day missed dose adherence, and other approaches for assessing highly active antiretroviral therapy (HAART) adherence are examined. Description: The project was an SPNS-funded evaluation of an HIV clinic-based HAART adherence support program. The monthly assessment of medication regimens; self-reported adherence rates; other information about missed doses and medication-taking behavior; barriers to adherence; and other variables for 196 participants over a two-and-a-half-year period JIAPAC Vol. 3, No. 1, January/March 2004 23 were the basis for the quantitative and qualitative evaluation findings. Narrative responses from monthly interviews of all participants, and from an independent semi-structured interview of a participant sample facilitated the interpretation of quantitative data. Lessons learned: While self-reported three-day missed dose adherence rates were related to disease outcome and viral load levels in focused studies, the utility of that method for assessing individuals in clinical practice is questionable. Insufficient samples of medication-taking behavior; variable time periods over which to sample behavior; rate calculation differences; and a more variable relationship between self- reports and viral load levels in individuals are less good aspects of n-day missed dose methods. Asking about doses missed over three days for each medication did not offer any advantages over simpler questions about missed doses when sensitivity, specificity, predictive positive value, and survival functions of the screening methods were compared. The context and consequences of the missed dose self-reporting process were frequently described as aversive by clients. Recommendations: Simpler, less time consuming, less aversive, and more useful self-report methods of assessing HAART medication-taking in individuals should be developed. Simpler adherence assessment approaches would allow more time for providers and other clinical staff to ask about and address client barriers to adherence. Replacing assessment of "bad behavior" with solution-focused assessment approaches also may have positive effects on client-provider relationships and on health outcomes. 33 Adherence referral Kreiger B. Matthew 25 AIDS Services, Henderson, KY Issues: We needed an easy-to-use assessment form for our prevention case manager to determine clients needing to be referred to the adherence specialist. Description: We developed an adherence-screening tool to assess the client for adherence issues using a quantifiable system. Each adherence issue recognized with this form was given a numerical value. If the client's score was 20 or greater, then he/she would be referred to the adherence specialist for counseling. Any employee can interview the client using this form or have the client complete the form. This enables the staff to use a quantifiable referral system that can also be used to assess for a quantifiable improvement. Lessons learned: This is a quick form that can be used to assess if a client meets criteria for adherence counseling. This form has been an effective tool for our organization. Recommendations: It is important to have an adherence program in place to use this system. The staff should be prepared to address the issues brought up when utilizing this form. 34 Pillbox organizer educational program for low-literacy HIV clients Baker B. Palm Beach County Health Department, Belle Glade, FL Background: Many low-literacy clients have difficulty mentally organizing the requirements of the highly active antiretroviral therapy (HAART) medication schedule. A pillbox organizer was developed for clients' use at home. The pillbox was refilled with medications, on a weekly basis by nurse-specialists. The weekly meeting with patients to re-issue HAART medications became an occasion for nurses to monitor compliance and correct misunderstandings. This study was undertaken to evaluate the impact of the program on patients' laboratory measurements. Methods:Thispre-test,post-test,single-group,quasi-experimental design used retrospective chart review of 27 HIV-infected adults from the C.L. Brumback Health Center in Belle Glade, Florida. The patients were all black, of Caribbean ethnicities or African Americans, and most had low literacy levels. Medical charts were reviewed to compare CD4 counts and HIV viral load measurements from before and after three months of the pillbox program. Results: Over the three-month period the mean viral load decreased from 184,258 copies/mL to 39,673 copies/mL. The change in the log viral load was significant (paired-data t-test, p < .001). Over the same three-month period mean CD4 counts increased from 224 to 238 cells/µL. This change, as measured by paired t-test of log CD4 count, did not reach significance. (p = .091) Conclusions: The significant reduction in HIV viral load, and the increase, although not significant, of CD4 counts support the efficacy of this simple intervention to improve the patients' understanding of the disease and facilitate HAART adherence. The pillbox organizer, with adequate education on its use, is a simple tool that healthcare professionals can use to promote adherence among patients who face multiple challenges and have low literacy levels. 35 The association between demographics, drug, or alcohol use to recent self-reported highly active antiretroviral therapy (HAART) adherence among patients entering an adherence intervention trial in Los Angeles, California Garland W, Wohl A, Cheng S,1 Squires K, Larsen R, Kovacs A,2 Witt M,3 Hader S, Weidle P.4 1Los Angeles County Department of Health Services, Los Angeles, CA, 2Los Angeles County/University of Southern California Medical Center, Los Angeles, CA, 3Harbor/University of California Los Angeles Medical Center, Torrance, CA, 4US Centers for Disease Control and Prevention, Atlanta, GA Background: There are inconclusive associations between HAART adherence and demographics, drug, or alcohol use. We report a preliminary analysis of factors associated with self-reported HAART adherence among patients entering an adherence intervention trial. Methods: HIV-infected patients who had been on HAART greater than 30 days before entering a randomized clinical trial of three adherence support programs for HAART were asked whether they missed any doses of HAART in the past two weeks before they entered the trial. We evaluated the association between missing any HAART and demographics, alcohol use, or drug use. 24 JIAPAC Vol. 3, No. 1, January/March 2004 Results: From November 2001 through July 2003, 123 patients (62 percent Latino; 24 percent African American; 80 percent males; 40 percent more than 40 years old; 63 percent foreign- born; 33 percent current smokers; and 55 percent with an annual income less than US$10,000) were assessed. In the past month, 22 percent of patients reported injection or non- injection drug use; 24 percent reported alcohol use greater than two times per week; 26 percent reported alcohol use less than three times per week; and 50 percent reported no alcohol use. Twenty-four percent reported missing any HAART doses in the past two weeks. No association was found between missing any HAART and race/ethnicity [(White vs. Latino OR=0.75, 95 percent CI=0.33-1.74); (White vs. African American OR=0.72, 95 percent CI=0.26-1.97)], male vs. female (OR=1.47, 95 percent CI=0.54-3.99), age (OR=1.01, 95 percent CI=0.44-2.34), foreign-born (OR=0.72, 95 percent CI=0.31-1.662), smoking (OR=1.47, 95 percent CI=0.63- 3.45), income (OR=0.76, 95 percent CI=0.33-1.72), alcohol use [(no alcohol vs. >two times/week OR=0.98, 95 percent CI=0.37-2.60), (no alcohol vs .05) were found between time 1 and time 2 on the other five measures of adherence support, including average time spent with HIV/AIDS patients (average of 15 to 30 minutes, 59 percent versus 62 percent), frequency of oral discussion used as the main education tool (97 percent versus 91 percent), the frequency that providers always discussed the coordination of HAART- taking behaviors with patients; and daily routines (18 percent versus 22 percent). Conclusions: While most measures of adherence support did not differ significantly between time 1 and time 2, providers have increased the frequency of HAART adherence education provided over time. This difference should be described and accounted for in adherence intervention studies. 26 JIAPAC Vol. 3, No. 1, January/March 2004 41 Correlation between adherence and virologic outcomes over three years in a cohort of 254 naive patients that initiated antiretroviral treatment in 1998 Codina C,1 Martmn M,1 Tuset M,1 Del Cacho E,1 Mirs JM,1 Alberdi A,2 Ribas J.1 1Pharmacy Service and 2Infectious Diseases Department, Hospital Clinic, Barcelona Background: The goal of antiretroviral therapy is to reduce viral replication in order to enable the recovery of the host's immune system. However, extremely high levels of adherence are required to ensure this objective. The aim of this study is to correlate adherence and virologic outcomes in naive patients initiating highly active antiretroviral therapy (HAART). Methods: All naive patients who initiated HAART in Hospital Clinic Barcelona in 1998 (n=254) were included and followed over a period of three years. Adherence was measured every four months though pill counts or pharmacy records (when pill counts were not possible). Patients were classified into four groups: SBC (patients whose adherence levels remained at >95 percent over the three years); SC (patients whose adherence levels remained at >90 percent over the three years (excluding SBC)); CI (patients whose adherence levels remained at >90 percent only during some periods of the three years), MC (patients whose adherence levels never reached >90 percent). Viral load was determined on each visit, and virologic failure was considered tobetwoconsecutivedeterminationsof3,200copies/mL.Voluntary treatment interruptions were considered virologic failures also. Results: After three years, adherence levels were: 41 patients SBC (16.14 percent); 22 patients SC (8.66 percent); 77 patients CI (30.31 percent); 114 patients MC (44,88 percent). Over these three years, the number of patients who obtained virologic outcomes was: 32/41 patients SBC (78.04 percent); 17/22 patients SC (77.27 percent); 48/77 patients CI (62.33 percent); and only 12/14 patients MC (10.52 percent). The correlation between adherence levels and virologic failure was evaluated though survival analysis (log-rank test), comparing the time until virologic failure of the SBC, SC, CI, and MC patients. Overall, median time until virologic failure was 20 months, six months in the MC group. Time until virologic failure was significantly shorter in the MC group compared with CI (p<0.00005), SC (p<0.00005), and SBC (p<0.00005). Time until virologic failure tended to be shorter in the CI group compared with SC (p=0.1118) and SBC (p=0.1705); however this was not statistically significant. There were no significant differences between SC and SBC (p=0.9392). 43 Lipodystrophic symptoms and antiretroviral adherence in persons infected with HIV/AIDS Corless IB,1 Kirksey KM,2 Kemppainen J,3 Nicholas PK, McGibbon C,4 Davis SM.5 1MGH Institute of Health Professions, Boston, MA, 2California State University-Fresno, Fresno, CA, 3University of North Carolina-Wilmington, Wilmington, North Carolina, 4MGH Institute of Health Professions, Boston, MA, 5Massachusetts General Hospital, Boston, MA Background: Lipodystrophy-associated manifestations remain a challenge for persons infected with HIV disease and their care-providers. Symptomatic HIV disease and side effects of medications have been implicated in antiretroviral medication non-adherence. This study was designed to determine the relationship between time of initial diagnosis with HIV, presence and type of lipodystrophic symptoms, and adherence to medication regimens in persons with HIV/AIDS. Methods: Using a cross-sectional, descriptive design, the sample was composed of 165 persons from three outpatient HIV settings in Boston (Massachusetts), Fresno (California), and Victoria (Texas). Participants were asked to complete a questionnaire comprised of socio-demographic questions, quality-of-life scales, and open-ended questions regarding presence and types of lipodystrophy-associated symptoms, and how these physical changes made them feel. Adherence was measured using the Morisky Medication Adherence Scale (MMAS). Results: On a Likert-type scale ranging from 0 to 4, with 0 indicating "very adherent" and 4 indicating "non-adherent," the mean score on the MMAS was 1.44 (SD 1.33). This finding demonstrated that the participants consistently took their medications despite self-reports of significant numbers of HIV disease and treatment-related body fat changes. However, not all of these individuals were lipodystrophic. Further analysis contrasted those with and without lipodystrophy, and those with lipohypertrophy and lipoatrophy regarding their antiretroviral adherence. Conclusions: These findings help to clarify the disparate findings regarding lipodystrophy and medication adherence. 44 The relationship between antiretroviral pill burden and virologic response in persons with HIV-1 infection Belden KA, DeSimone JA, Sebastian S, Babinchak TJ. Thomas Jefferson University Hospital, Philadelphia, PA Background: There has been a recent trend towards the use of lower antiretroviral pill burden regimens in the treatment of HIV-1- infected persons. One study has correlated a lower antiretroviral pill burden with improved response to highly active antiretroviral therapy (HAART) in clinical trial participants. This relationship, however, has not been analyzed outside of the clinical trial setting. Objective: We need to determine the relationship between antiretroviral pill burden and virologic response in persons with HIV-1 infection. Methods: A retrospective chart review of HIV-1-infected persons seen at our University HIV clinic between 1996 and 2002 was performed. Baseline demographic data was collected. Patients meeting the following criteria were included: antiretroviral naive; maintained on the same antiretroviral regimen for at least 24 weeks; and HIV viral load and CD4 count available at baseline and 24 to 48 weeks after therapy initiation. All other patients, including study participants, were excluded. Results: Three hundred and seventy-eight charts were reviewed; 91 patients met inclusion criteria. Patients were divided into three pill burden groups: group 1 (one to five pills per day, n=30), group 2 (six to 10 pills per day, n=26), and group 3 (11 to 16 pills per day, n=35). Demographics and baseline values were similar in each group. Eighty-seven percent of group 1 patients, JIAPAC Vol. 3, No. 1, January/March 2004 27 69 percent of group 2 patients, and 74 percent of group 3 patients achieved an undetectable HIV viral load at 24 to 48 weeks. These differences were not statistically significant by a chi-square test for trend (p=0.25). However, in patients with a baseline HIV viral load of <100,000 copies/mL, 94 percent of group 1 patients, 71 percent of group 2 patients, and 74 percent of group 3 patients were undetectable at 24 to 48 weeks. Though not statistically significant (p=0.07), there was a trend towards improved virologic outcome with a lower pill burden in these patients. Conclusions: This analysis of persons in an urban HIV practice revealed no statistically significant relationship between antiretroviral pill burden and virologic outcome. Thus, antiretroviral pill burden may not be associated with treatment success in the non-clinical trial setting. However, for persons with a baseline HIV viral load <100,000 copies/mL, a trend towards improved virologic outcome was noted in those prescribed fewer than six pills per day. Reproduction in larger multicenter analyses may help clarify these findings. 45 Antiretroviral medication complexity and adherence McDonnell M, DiIorio C, McCarty F, Yeager K, Wang T, Iverson H, Weaver L. Schools of Nursing and Public Health, Emory University, Atlanta, GA Background: Antiretroviral therapy (ART) has changed the course of HIV disease. Near perfect adherence is necessary to maintain an undetectable viral load, and prevent opportunistic infections and hospitalizations. The complexity of ART medications and regimens has been implicated as a factor related to non- adherence. However, few studies have focused on the many aspects of medication complexity. This paper examines the relationship of the components of medication complexity (pill burden, dosage frequency, administration actions, and side effects) to adherence. Methods: Data from the first 145 participants who completed the first of three follow-up assessments in a larger adherence trial were analyzed to determine the relationship of medication complexity (AMCI) to self-reported adherence (UCSF, AGAS). Descriptive and correlational analyses were conducted. All participants received HIV care at a large comprehensive HIV clinic. Results: Eighty-four percent of the participants were African American, and 66 percent were male. Participants' regimens included 14 antiretroviral medications (PI, NNRTI, NRTI), and the average regimen consisted of three medications. Average dosing was twice a day, and participants reported doing an average of two actions per day in order to take their pills. Self- reported adherence over the past 30 days was significantly negatively correlated with the total AMCI score, and the components of the AMCI, such as average number of pills per day in the regimen, number of administration actions, and side effects. A preliminary complexity score for each antiretroviral medication was also calculated based on participants' self-reports. Conclusions: Adherence to ART is negatively affected by the complexity of the antiretroviral regimen. Average number of pills per day, the number of actions the patient performs related to ingesting or storing the medication, and the side effects and amount of distress they cause significantly affect one's ability to adhere. 46 The patient-provider relationship and adherence to highly active antiretroviral therapy (HAART) Krantz S, Russell J. University of Missouri-Kansas City, Kansas City, MO Background: The importance of adherence with HAART in ensuring optimal treatment outcomes has long been agreed upon. There is less agreement on the factors that are associated with adherence. One promising area of inquiry is in the nature of the patient-provider relationship. Four studies completed since 1995 have agreed that the nature of the relationship between the provider and the patient may be more important in adherence than the type of provider. Methods: This study extends this work by comparing adherent and non-adherent clients in one high-volume HIV clinic in a midwestern city, where adherence rates were particularly high, and where the approach to client treatment places a premium upon the role of the client in treatment decisions and the importance of the patient-provider relationship. One hundred and thirty (108 adherent and 22 non-adherent) clients comprised the sample. Adherence was determined by clinic staff, using established procedures. The indicator of the patient-provider relationship was operationalized as "satisfaction with the care provider" as measured by a slightly modified version of the "medical care subscale" of the Patient Satisfaction Questionnaire (PSQ) (Ware, Snyder, and Wright, 1976, A and B). Client groups were compared on demographic variables and PSQ scores. Results: While there were some demographic differences between groups, two-way analysis verified the absence of an interaction between adherence status and demographic data, indicating differences in satisfaction were uninfluenced by demographics. Client groups differed significantly on "perception of interpersonal manner of care provider" (p=.018), "care provider conduct total" (p < .001), and "quality total" (p=.017). Conclusions: These findings are consistent with earlier work in the area, and underscore the potential importance of the patient-provider relationship as a focus of care. 47 Improving HIV medication adherence by reducing alcohol use Parsons JT, Rosof EJ, Punzalan JC. City University of New York, Hunter College, New York, NY Issues: Positive Living through Understanding and Support (Project PLUS) is an intervention study aimed at improving adherence to HIV medication, and reducing alcohol use among HIV-positive men and women in New York City. Description: This eight-session, individual intervention is a combination of Motivational Interviewing and Cognitive Behavioral Skills Building. Specific skills-building sessions are chosen based on individual needs of each client and are assessed through a case conceptualization. Some of these topics include: coping with triggers to drink; coping with triggers to skip medication; managing cravings; managing thoughts; managing side effects; social support; increasing pleasant activities; communication with healthcare providers; managing negative moods; and making time for self. Participants are randomly placed into this treatment condition or a control condition 28 JIAPAC Vol. 3, No. 1, January/March 2004 which consists of eight individual sessions emphasizing education around HIV, alcohol use, and Hepatitis C. Assessments are done at baseline, three, six, nine, 12, and 15 months. The sample at this time includes 101 participants. Eighty-two percent are men; 49 percent are African American; 25.5 percent are Latino; 12.7 percent are White; and 7.8 percent are mixed race. Mean CD4 count is 425.43 cells/µL. Mean score on the Alcohol Use Disorders Identification Test (AUDIT) is 18.19. Lessons learned: Patients have engaged in both treatment and education conditions, and retention for the study is 89 percent. The study expects to recruit a total of 400 participants. Next steps: Attention to retention through reminder calls, post cards, and attentiveness to client needs, such as childcare, transportation, and flexibility with scheduling, will continue. 48 Directly Observed Therapy (DOT) for HIV treatment among adolescents: Preliminary experience with two patients Chaguturu S, Mitty J,1 MacLeod C,2 Urbana B, Pugatch D, Flanigan T.3 1Brown University, Providence, RI, 2The Miriam Hospital, Providence, RI, 3Brown University, Providence, RI Background: There are increasing numbers of adolescents living with AIDS in America. Initial reports have documented low rates of adherence to antiretroviral therapy (ART) among adolescents. Directly Observed Therapy for ART has been used for populations at high risk for poor adherence, and might serve this population. Methods: Physicians refer HIV-positive patients with a history of poor adherence to ART for DOT. Outreach workers (OWs) meet subjects daily and observe them taking their dose. If the subject is on twice-daily regimen, they take the evening dose on their own, and the OW records adherence to non-observed doses at the next visit. Visits are tapered according to the participant's readiness. Interview and plasma viral load (PVL) data are collected at baseline, one month, and then every three months. Results: Twenty-five patients were enrolled, two of whom are adolescents. Case 1: The participant is a 17-year-old male, ART-experienced, who received DOT visits for one month. During that time, he had a drop in PVL (750,000 to 68,627 copies/mL), and increase in CD4 counts (10 to 74 cells/µL). He missed one appointment, and did not report missing any unobserved doses. Directly Observed Therapy was stopped because he moved out of state. The participant described DOT as helpful with adherence. Case 2: The participant is a 19-year-old male, ART-experienced, who received DOT for seven months. He had no change in PVL or CD4 counts. He missed 30 percent of appointments, and self-reported missing 15 percent of unobserved doses. The participant reported lack of family support, frequent job changes, and fear of stigma as obstacles to adherence. Conclusions: These two cases, one successful and one unsuccessful, illustrate the complex issues surrounding DOT in adolescents. Directly Observed Therapy, as currently used, may not be adequate to address the specific needs of this population. Given their unique barriers, such as social stigma and unstable living environments, more research will be needed to determine how DOT should be implemented in adolescents. </meta-value> </custom-meta></custom-meta-wrap></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Select Abstracts from Elements of Success: An International Conference on Adherence to Antiretroviral Therapy, December 4-7, 2003, Dallas, Texas, USA</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Select Abstracts from Elements of Success: An International Conference on Adherence to Antiretroviral Therapy, December 4-7, 2003, Dallas, Texas, USA</title></titleInfo><name type="personal"><namePart type="given">Ross G.</namePart><namePart type="family">Hewitt</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>State University of New York at Buffalo and Erie County Medical Center, Buffalo, New York, USA</affiliation></name><name type="personal"><namePart type="given">Katharine E.</namePart><namePart type="family">Stewart</namePart><namePart type="termsOfAddress">PhD, MPH</namePart><affiliation>University of Arkansas, Little Rock, Arkansas, USA</affiliation></name><typeOfResource>text</typeOfResource><genre type="other" displayLabel="other" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-7474895G-0">other</genre><originInfo><publisher>Sage Publications</publisher><place><placeTerm type="text">Sage CA: Thousand Oaks, CA</placeTerm></place><dateIssued encoding="w3cdtf">2004-01</dateIssued><copyrightDate encoding="w3cdtf">2004</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><relatedItem type="host"><titleInfo><title>Journal of the International Association of Providers of AIDS Care</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">1545-1097</identifier><identifier type="eISSN">2325-9582</identifier><identifier type="PublisherID">JIA</identifier><identifier type="PublisherID-hwp">spjia</identifier><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><detail type="issue"><caption>no.</caption><number>1</number></detail><extent unit="pages"><start>12</start><end>28</end></extent></part></relatedItem><identifier type="istex">87BA68DF6C82BD5F27AA4E9B59EAAD5FD4D92D10</identifier><identifier type="ark">ark:/67375/M70-9X8G6WCW-T</identifier><identifier type="DOI">10.1177/154510970400300103</identifier><identifier type="ArticleID">10.1177_154510970400300103</identifier><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-0J1N7DQT-B">sage</recordContentSource></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/document/87BA68DF6C82BD5F27AA4E9B59EAAD5FD4D92D10/metadata/json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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