A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes
Identifieur interne : 002823 ( Pmc/Curation ); précédent : 002822; suivant : 002824A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes
Auteurs : Michael H. Chung [États-Unis] ; Barbra A. Richardson [États-Unis] ; Kenneth Tapia [États-Unis] ; Sarah Benki-Nugent [États-Unis] ; James N. Kiarie [Kenya] ; Jane M. Simoni [États-Unis] ; Julie Overbaugh [États-Unis] ; Mena Attwa [Kenya] ; Grace C. John-Stewart [États-Unis]Source :
- PLoS Medicine [ 1549-1277 ] ; 2011.
Abstract
Michael Chung and colleagues show that intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure, whereas use of an alarm device had no effect.
Url:
DOI: 10.1371/journal.pmed.1000422
PubMed: 21390262
PubMed Central: 3046986
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<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS Med</journal-id><journal-id journal-id-type="iso-abbrev">PLoS Med</journal-id><journal-id journal-id-type="publisher-id">PLoS</journal-id><journal-id journal-id-type="pmc">plosmed</journal-id><journal-title-group><journal-title>PLoS Medicine</journal-title></journal-title-group><issn pub-type="ppub">1549-1277</issn><issn pub-type="epub">1549-1676</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">21390262</article-id><article-id pub-id-type="pmc">3046986</article-id><article-id pub-id-type="publisher-id">10-PLME-RA-5949R2</article-id><article-id pub-id-type="doi">10.1371/journal.pmed.1000422</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline"><subject>Infectious Diseases/HIV Infection and AIDS</subject><subject>Public Health and Epidemiology/Global Health</subject></subj-group></article-categories><title-group><article-title>A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes</article-title><alt-title alt-title-type="running-head">Counseling and Alarm on Adherence: An RCT</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Chung</surname><given-names>Michael H.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref><xref ref-type="corresp" rid="cor1"><sup>*</sup></xref></contrib><contrib contrib-type="author"><name><surname>Richardson</surname><given-names>Barbra A.</given-names></name><xref ref-type="aff" rid="aff4"><sup>4</sup></xref><xref ref-type="aff" rid="aff5"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Tapia</surname><given-names>Kenneth</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Benki-Nugent</surname><given-names>Sarah</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kiarie</surname><given-names>James N.</given-names></name><xref ref-type="aff" rid="aff6"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Simoni</surname><given-names>Jane M.</given-names></name><xref ref-type="aff" rid="aff7"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Overbaugh</surname><given-names>Julie</given-names></name><xref ref-type="aff" rid="aff8"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Attwa</surname><given-names>Mena</given-names></name><xref ref-type="aff" rid="aff9"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>John-Stewart</surname><given-names>Grace C.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Department of Global Health, University of Washington, Seattle, Washington, United States of America</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Department of Medicine, University of Washington, Seattle, Washington, United States of America</addr-line></aff><aff id="aff3"><label>3</label><addr-line>Department of Epidemiology, University of Washington, Seattle, Washington, United States of America</addr-line></aff><aff id="aff4"><label>4</label><addr-line>Department of Biostatistics, University of Washington, Seattle, Washington, United States of America</addr-line></aff><aff id="aff5"><label>5</label><addr-line>Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America</addr-line></aff><aff id="aff6"><label>6</label><addr-line>Department of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya</addr-line></aff><aff id="aff7"><label>7</label><addr-line>Department of Psychology, University of Washington, Seattle, Washington, United States of America</addr-line></aff><aff id="aff8"><label>8</label><addr-line>Division of Human Biology, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America</addr-line></aff><aff id="aff9"><label>9</label><addr-line>Coptic Hospital, Nairobi, Kenya</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Mills</surname><given-names>Edward J.</given-names></name><role>Academic Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1">McMaster University, Canada</aff><author-notes><corresp id="cor1">* E-mail: <email>mhchung@uw.edu</email></corresp><fn fn-type="con"><p><ext-link ext-link-type="uri" xlink:href="http://www.icmje.org/">ICMJE</ext-link> criteria for authorship read and met: MHC BAR KT SBN JNK JAS JO MA GCJS. Agree with the manuscript's results and conclusions: MHC BAR KT SBN JNK JAS JO MA GCJS. Designed the experiments/the study: MHC BAR JAS MA GCJS. Analyzed the data: MHC BAR KT SBN JNK. Collected data/did experiments for the study: MHC JNK. Enrolled patients: MHC. Wrote the first draft of the paper: MHC. Contributed to the writing of the paper: MHC BAR KT SBN JNK JO GCJS. Oversaw virological aspects of the study, including data collection and integrity: JO.</p></fn></author-notes><pub-date pub-type="collection"><month>3</month><year>2011</year></pub-date><pub-date pub-type="epub"><day>1</day><month>3</month><year>2011</year></pub-date><volume>8</volume><issue>3</issue><elocation-id>e1000422</elocation-id><history><date date-type="received"><day>17</day><month>8</month><year>2010</year></date><date date-type="accepted"><day>19</day><month>1</month><year>2011</year></date></history><permissions><copyright-statement>Chung et al.</copyright-statement><copyright-year>2011</copyright-year><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.</license-p></license></permissions><abstract abstract-type="toc"><p>Michael Chung and colleagues show that intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure, whereas use of an alarm device had no effect.</p></abstract><abstract><sec><title>Background</title><p>Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.</p></sec><sec><title>Methods and Findings</title><p>A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49–1.01; <italic>p = </italic>0.055) and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml) (HR 0.41; 95% CI 0.21–0.81; <italic>p = </italic>0.01) compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65–1.32; <italic>p = </italic>0.7) or viral failure (HR 0.99; 95% CI 0.53–1.84; <italic>p = </italic>1.0) compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution.</p></sec><sec><title>Conclusions</title><p>Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials gov <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov/ct2/show/NCT00273780?term=NCT00273780&rank=1">NCT00273780</ext-link></p></sec><sec><title></title><p><italic>Please see later in the article for the Editors' Summary</italic></p></sec></abstract><abstract abstract-type="editor"><title>Editors' Summary</title><sec id="s1a1"><title>Background</title><p>Adherence to HIV treatment programs in poor countries has long been cited as an important public health concern, especially as poor adherence can lead to drug resistance and inadequate treatment of HIV. However, two factors have recently cast doubt on the poor adherence problem: (1) recent studies have shown that adherence is high in African HIV treatment programs and often better than in Western HIV clinics. For example, in a meta-analysis of 27 cohorts from 12 African countries, adequate adherence was noted in 77% of subjects compared to only 55% among 31 North America cohorts; (2) choice of antiretroviral regimens may impact on the development of antiretroviral resistance. In poor countries, most antiretroviral regimens contain non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as nevirapine or efavirenz, which remain in the patient's circulation for weeks after single-dose administration. This situation means that such patients may not experience antiretroviral resistance unless they drop below 80% adherence—contrary to the more stringent 95% plus adherence levels needed to prevent resistance in regimens based on unboosted protease inhibitors—ultimately, off-setting some treatment lapses in resource-limited settings where NNRTI-based regimens are widely used.</p></sec><sec id="s1a2"><title>Why Was This Study Done?</title><p>Given that adherence may not be as crucial an issue as previously thought, antiretroviral treatment programs in sub-Saharan Africa may be spending scarce resources to promote adherence to the detriment of some potentially more effective elements of HIV treatment and management programs. Although many treatment programs currently include adherence interventions, there is limited quality evidence that any of these methods improve long-term adherence to HIV treatment. Therefore, it is necessary to identify adherence interventions that are inexpensive and proven to be effective in resource-limited settings. As adherence counseling is already widely implemented in African HIV treatment programs and inexpensive alarm devices are thought to also improve compliance, the researchers compared the impact of adherence counseling and the use of an alarm device on adherence and biological outcomes in patients enrolled in HIV programs in rural Kenya.</p></sec><sec id="s1a3"><title>What Did the Researchers Do and Find?</title><p>The researchers enrolled 400 eligible patients (newly diagnosed with HIV, never before taken antiretroviral therapy, aged over 18 years) to four arms: (1) adherence counseling alone; (2) alarm device alone; (3) both adherence counseling and alarm device together; and (4) a control group that received neither adherence counseling nor alarm device. The patients had blood taken to record baseline CD4 count and HIV-1 RNA and after starting HIV treatment, returned to the study clinic every month with their pill bottles for the study pharmacist to count and recorded the number of pills remaining in the bottle, and to receive another prescription. Patients were followed up for 18 months and had their CD4 count and HIV-1 RNA measured at 6, 12, and 18 months.</p><p>Patients receiving adherence counseling were 29% less likely to experience poor adherence compared to those who received no counseling. Furthermore, those receiving intensive early adherence counseling were 59% less likely to experience viral failure. However, there was no significant difference in mortality or significant differences in CD4 counts at 18 months follow-up between those who received counseling and those who did not. There were no significant differences in adherence, time to viral failure, mortality, or CD4 counts in patients who received alarm devices compared to those who did not.</p></sec><sec id="s1a4"><title>What Do These Findings Mean?</title><p>The results of this study suggest that intensive adherence counseling around the time of HIV treatment initiation significantly reduces poor adherence and virologic treatment failure, while using an alarm device has no effect. Therefore, investment in careful counseling based on individual needs at the onset of HIV treatment initiation, appears to have sustained benefit, possibly through strengthening the relationship between the health care provider and patient through communication, education, and trust. Interactive adherence counseling supports the bond between the clinic and the patient and may result in fewer patients needing to switch to expensive second-line medications and, possibly, may help to decrease the spread of resistant HIV. These findings define an adherence counseling protocol that is effective and are highly relevant to other HIV clinics caring for large numbers of patients in sub-Saharan Africa.</p></sec><sec id="s1a5"><title>Additional Information</title><p>Please access these Web sites via the online version of this summary at <ext-link ext-link-type="uri" xlink:href="http://dx.doi.org/10.1371/journal.pmed.1000422">http://dx.doi.org/10.1371/journal.pmed.1000422</ext-link>.</p><list list-type="bullet"><list-item><p>UNAIDS provides information about <ext-link ext-link-type="uri" xlink:href="http://www.unaids.org/en/resources/unaidspublications/2010/">HIV treatment strategies</ext-link></p></list-item><list-item><p>The American Public Health Association has information about <ext-link ext-link-type="uri" xlink:href="http://www.apha.org/programs/resources/HIV+-+AIDS/reshivregimens.htm">adherence to HIV treatment regimens</ext-link></p></list-item><list-item><p>The US Department of Health and Human Services has <ext-link ext-link-type="uri" xlink:href="http://www.aidsinfo.nih.gov/ContentFiles/WhatisTreatmentAdherence_FS_en.pdf">information for patients about adherence to HIV treatment</ext-link></p></list-item><list-item><p>The World Health Organization provides information about <ext-link ext-link-type="uri" xlink:href="http://www.who.int/hiv/topics/pharmacovigilance/en/index.html">HIV treatment pharmacovigilance</ext-link></p></list-item></list></sec></abstract><counts><page-count count="11"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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