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<title xml:lang="en">Factors Associated with Lack of Viral Suppression at Delivery among HAART-Naïve HIV-Positive Women in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study</title>
<author>
<name sortKey="Katz, Ingrid T" sort="Katz, Ingrid T" uniqKey="Katz I" first="Ingrid T." last="Katz">Ingrid T. Katz</name>
<affiliation>
<nlm:aff id="A1">Brigham and Women’s Hospital, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
<affiliation>
<nlm:aff id="A2">Massachusetts General Hospital Center for Global Health, Boston, Massachusetts, USA</nlm:aff>
</affiliation>
<affiliation>
<nlm:aff id="A3">Harvard Medical School, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Leister, Erin" sort="Leister, Erin" uniqKey="Leister E" first="Erin" last="Leister">Erin Leister</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Kacanek, Deborah" sort="Kacanek, Deborah" uniqKey="Kacanek D" first="Deborah" last="Kacanek">Deborah Kacanek</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Hughes, Michael D" sort="Hughes, Michael D" uniqKey="Hughes M" first="Michael D." last="Hughes">Michael D. Hughes</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Bardeguez, Arlene" sort="Bardeguez, Arlene" uniqKey="Bardeguez A" first="Arlene" last="Bardeguez">Arlene Bardeguez</name>
<affiliation>
<nlm:aff id="A5">University of Medicine and Dentistry of New Jersey, Newark, New Jersey, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Livingston, Elizabeth" sort="Livingston, Elizabeth" uniqKey="Livingston E" first="Elizabeth" last="Livingston">Elizabeth Livingston</name>
<affiliation>
<nlm:aff id="A6">Duke University School of Medicine, Durham, North Carolina, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Stek, Alice" sort="Stek, Alice" uniqKey="Stek A" first="Alice" last="Stek">Alice Stek</name>
<affiliation>
<nlm:aff id="A7">University of Southern California Keck School of Medicine, Los Angeles, California, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Shapiro, David E" sort="Shapiro, David E" uniqKey="Shapiro D" first="David E." last="Shapiro">David E. Shapiro</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Tuomala, Ruth" sort="Tuomala, Ruth" uniqKey="Tuomala R" first="Ruth" last="Tuomala">Ruth Tuomala</name>
<affiliation>
<nlm:aff id="A1">Brigham and Women’s Hospital, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
<affiliation>
<nlm:aff id="A3">Harvard Medical School, Boston, Massachusetts, United States of America</nlm:aff>
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<idno type="doi">10.7326/M13-2005</idno>
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<title xml:lang="en" level="a" type="main">Factors Associated with Lack of Viral Suppression at Delivery among HAART-Naïve HIV-Positive Women in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study</title>
<author>
<name sortKey="Katz, Ingrid T" sort="Katz, Ingrid T" uniqKey="Katz I" first="Ingrid T." last="Katz">Ingrid T. Katz</name>
<affiliation>
<nlm:aff id="A1">Brigham and Women’s Hospital, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
<affiliation>
<nlm:aff id="A2">Massachusetts General Hospital Center for Global Health, Boston, Massachusetts, USA</nlm:aff>
</affiliation>
<affiliation>
<nlm:aff id="A3">Harvard Medical School, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Leister, Erin" sort="Leister, Erin" uniqKey="Leister E" first="Erin" last="Leister">Erin Leister</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Kacanek, Deborah" sort="Kacanek, Deborah" uniqKey="Kacanek D" first="Deborah" last="Kacanek">Deborah Kacanek</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Hughes, Michael D" sort="Hughes, Michael D" uniqKey="Hughes M" first="Michael D." last="Hughes">Michael D. Hughes</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Bardeguez, Arlene" sort="Bardeguez, Arlene" uniqKey="Bardeguez A" first="Arlene" last="Bardeguez">Arlene Bardeguez</name>
<affiliation>
<nlm:aff id="A5">University of Medicine and Dentistry of New Jersey, Newark, New Jersey, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Livingston, Elizabeth" sort="Livingston, Elizabeth" uniqKey="Livingston E" first="Elizabeth" last="Livingston">Elizabeth Livingston</name>
<affiliation>
<nlm:aff id="A6">Duke University School of Medicine, Durham, North Carolina, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Stek, Alice" sort="Stek, Alice" uniqKey="Stek A" first="Alice" last="Stek">Alice Stek</name>
<affiliation>
<nlm:aff id="A7">University of Southern California Keck School of Medicine, Los Angeles, California, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Shapiro, David E" sort="Shapiro, David E" uniqKey="Shapiro D" first="David E." last="Shapiro">David E. Shapiro</name>
<affiliation>
<nlm:aff id="A4">Harvard School of Public Health, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Tuomala, Ruth" sort="Tuomala, Ruth" uniqKey="Tuomala R" first="Ruth" last="Tuomala">Ruth Tuomala</name>
<affiliation>
<nlm:aff id="A1">Brigham and Women’s Hospital, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
<affiliation>
<nlm:aff id="A3">Harvard Medical School, Boston, Massachusetts, United States of America</nlm:aff>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Annals of internal medicine</title>
<idno type="ISSN">0003-4819</idno>
<idno type="eISSN">1539-3704</idno>
<imprint>
<date when="2015">2015</date>
</imprint>
</series>
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<div type="abstract" xml:lang="en">
<sec id="S1">
<title>Background</title>
<p id="P1">High delivery maternal plasma HIV-1 RNA level (viral load, VL) is a risk factor for mother to child transmission and poor maternal health.</p>
</sec>
<sec id="S2">
<title>Objective</title>
<p id="P2">To identify factors associated with detectable VL at delivery despite initiation of highly active antiretroviral therapy (HAART) during pregnancy.</p>
</sec>
<sec id="S3">
<title>Design</title>
<p id="P3">Multicenter observational study.</p>
</sec>
<sec id="S4">
<title>Setting</title>
<p id="P4">67 US AIDS clinical research sites.</p>
</sec>
<sec id="S5">
<title>Patients</title>
<p id="P5">HIV-1-positive pregnant women who initiated HAART during pregnancy.</p>
</sec>
<sec id="S6">
<title>Measurements</title>
<p id="P6">Descriptive summaries and associations between socio-demographic, HIV disease, treatment and pregnancy-related risk factors and detectable VL (>400copies/mL) at delivery.</p>
</sec>
<sec id="S7">
<title>Results</title>
<p id="P7">Between October 2002 and December 2011, 671 women met inclusion criteria and 13% had detectable VL at delivery. Factors associated with detectable VL included multiparity (16.4% vs 8% nulliparous, p=0.002), black non-Hispanic ethnicity (17.6% vs 6.6% Hispanic and 6.6% white/non-Hispanic, p<0.001), 11
<sup>th</sup>
grade or less education (17.6% vs.12.1% high school graduate and 6.7% some college or higher, p=0.013), and initiation of HAART in third trimester (23.9% vs 12.3% second and 8.6% first, p=0.002), timing of HIV diagnosis prior to current pregnancy (16.1% vs 11% during current pregnancy, p=0.051), and timing of first prenatal visit in 3
<sup>rd</sup>
trimester (33.3% vs 14.3% second and 10.5% first, p=0.002). Women who experienced treatment interruptions or reported poor medication adherence during pregnancy were more likely to have detectable VL at delivery than women with no interruptions or who reported better adherence.</p>
</sec>
<sec id="S8">
<title>Limitations</title>
<p id="P8">Women entered the study at varying times during pregnancy and for this and other reasons there was incomplete data on many covariates.</p>
</sec>
<sec id="S9">
<title>Conclusions</title>
<p id="P9">In this large U.S.-based cohort of HIV-1 positive women, 13% of women who initiated HAART during pregnancy had detectable VL at delivery. The timing of HAART initiation and prenatal care along with medication adherence during pregnancy appear to be modifiable factors associated with detectable VL at delivery. Social factors such as Black/non-Hispanic ethnicity and less than high school education may help to identify women at highest risk who may benefit from focused efforts to promote early treatment initiation and adherence to HAART.</p>
</sec>
<sec id="S10">
<title>Clinical Trial Registration Number</title>
<p id="P10">NCT00028145</p>
</sec>
</div>
</front>
</TEI>
<pmc article-type="research-article">
<pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-journal-id">0372351</journal-id>
<journal-id journal-id-type="pubmed-jr-id">596</journal-id>
<journal-id journal-id-type="nlm-ta">Ann Intern Med</journal-id>
<journal-id journal-id-type="iso-abbrev">Ann. Intern. Med.</journal-id>
<journal-title-group>
<journal-title>Annals of internal medicine</journal-title>
</journal-title-group>
<issn pub-type="ppub">0003-4819</issn>
<issn pub-type="epub">1539-3704</issn>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">25599347</article-id>
<article-id pub-id-type="pmc">4299931</article-id>
<article-id pub-id-type="doi">10.7326/M13-2005</article-id>
<article-id pub-id-type="manuscript">NIHMS630717</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Article</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Factors Associated with Lack of Viral Suppression at Delivery among HAART-Naïve HIV-Positive Women in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Katz</surname>
<given-names>Ingrid T.</given-names>
</name>
<degrees>MD, MHS</degrees>
<xref rid="FN1" ref-type="author-notes">*</xref>
<xref ref-type="aff" rid="A1">a</xref>
<xref ref-type="aff" rid="A2">b</xref>
<xref ref-type="aff" rid="A3">c</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Leister</surname>
<given-names>Erin</given-names>
</name>
<degrees>MS</degrees>
<xref ref-type="aff" rid="A4">d</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Kacanek</surname>
<given-names>Deborah</given-names>
</name>
<degrees>ScD</degrees>
<xref ref-type="aff" rid="A4">d</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hughes</surname>
<given-names>Michael D.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="A4">d</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Bardeguez</surname>
<given-names>Arlene</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A5">e</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Livingston</surname>
<given-names>Elizabeth</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A6">f</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Stek</surname>
<given-names>Alice</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A7">g</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Shapiro</surname>
<given-names>David E.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="A4">d</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Tuomala</surname>
<given-names>Ruth</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">a</xref>
<xref ref-type="aff" rid="A3">c</xref>
</contrib>
</contrib-group>
<aff id="A1">
<label>a</label>
Brigham and Women’s Hospital, Boston, Massachusetts, United States of America</aff>
<aff id="A2">
<label>b</label>
Massachusetts General Hospital Center for Global Health, Boston, Massachusetts, USA</aff>
<aff id="A3">
<label>c</label>
Harvard Medical School, Boston, Massachusetts, United States of America</aff>
<aff id="A4">
<label>d</label>
Harvard School of Public Health, Boston, Massachusetts, United States of America</aff>
<aff id="A5">
<label>e</label>
University of Medicine and Dentistry of New Jersey, Newark, New Jersey, United States of America</aff>
<aff id="A6">
<label>f</label>
Duke University School of Medicine, Durham, North Carolina, United States of America</aff>
<aff id="A7">
<label>g</label>
University of Southern California Keck School of Medicine, Los Angeles, California, United States of America</aff>
<author-notes>
<corresp id="FN1">
<label>*</label>
Correspondence: Ingrid T. Katz, Address: 1620 Tremont Street, 3rd Floor BWH, Division of Women’s Health, Boston, MA 02120. Tel: +617 525 8194/617 447 4982; fax: +617 525 7746;
<email>ikatz2@partners.org</email>
</corresp>
<fn id="FN2">
<p>
<bold>Address for reprint requests:</bold>
Ingrid T. Katz, Address: 1620 Tremont Street, 3rd Floor BWH, Division of Women’s Health, Boston, MA 02120.</p>
</fn>
<fn id="FN3">
<p>
<bold>Current mailing addresses for additional authors:</bold>
<list list-type="order" id="L1">
<list-item>
<p>Erin Leister: 651 Huntington Avenue, FXB 619, Boston, Massachusetts 02115</p>
</list-item>
<list-item>
<p>Deborah Kacanek: 651 Huntington Avenue, FXB 505, Boston, Massachusetts 02115</p>
</list-item>
<list-item>
<p>Michael D. Hughes: 655 Huntington Avenue, Building II, Room 439A, Boston, Massachusetts 02115</p>
</list-item>
<list-item>
<p>Arlene Bardeguez: MSB E-506,185 S Orange Ave, Newark, NJ 07103</p>
</list-item>
<list-item>
<p>Elizabeth Livingston: DUMC 3967, Durham, NC 27710</p>
</list-item>
<list-item>
<p>Alice Stek: 1240 N Mission Rd, Los Angeles, CA 90033</p>
</list-item>
<list-item>
<p>David E. Shapiro: 651 Huntington Avenue, FXB 643B, Boston, Massachusetts 02115</p>
</list-item>
<list-item>
<p>Ruth Tuomala: 75 Francis St, Boston, MA 02115</p>
</list-item>
</list>
</p>
</fn>
</author-notes>
<pub-date pub-type="nihms-submitted">
<day>26</day>
<month>9</month>
<year>2014</year>
</pub-date>
<pub-date pub-type="ppub">
<day>20</day>
<month>1</month>
<year>2015</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>20</day>
<month>7</month>
<year>2015</year>
</pub-date>
<volume>162</volume>
<issue>2</issue>
<fpage>90</fpage>
<lpage>99</lpage>
<pmc-comment>elocation-id from pubmed: 10.7326/M13-2005</pmc-comment>
<abstract>
<sec id="S1">
<title>Background</title>
<p id="P1">High delivery maternal plasma HIV-1 RNA level (viral load, VL) is a risk factor for mother to child transmission and poor maternal health.</p>
</sec>
<sec id="S2">
<title>Objective</title>
<p id="P2">To identify factors associated with detectable VL at delivery despite initiation of highly active antiretroviral therapy (HAART) during pregnancy.</p>
</sec>
<sec id="S3">
<title>Design</title>
<p id="P3">Multicenter observational study.</p>
</sec>
<sec id="S4">
<title>Setting</title>
<p id="P4">67 US AIDS clinical research sites.</p>
</sec>
<sec id="S5">
<title>Patients</title>
<p id="P5">HIV-1-positive pregnant women who initiated HAART during pregnancy.</p>
</sec>
<sec id="S6">
<title>Measurements</title>
<p id="P6">Descriptive summaries and associations between socio-demographic, HIV disease, treatment and pregnancy-related risk factors and detectable VL (>400copies/mL) at delivery.</p>
</sec>
<sec id="S7">
<title>Results</title>
<p id="P7">Between October 2002 and December 2011, 671 women met inclusion criteria and 13% had detectable VL at delivery. Factors associated with detectable VL included multiparity (16.4% vs 8% nulliparous, p=0.002), black non-Hispanic ethnicity (17.6% vs 6.6% Hispanic and 6.6% white/non-Hispanic, p<0.001), 11
<sup>th</sup>
grade or less education (17.6% vs.12.1% high school graduate and 6.7% some college or higher, p=0.013), and initiation of HAART in third trimester (23.9% vs 12.3% second and 8.6% first, p=0.002), timing of HIV diagnosis prior to current pregnancy (16.1% vs 11% during current pregnancy, p=0.051), and timing of first prenatal visit in 3
<sup>rd</sup>
trimester (33.3% vs 14.3% second and 10.5% first, p=0.002). Women who experienced treatment interruptions or reported poor medication adherence during pregnancy were more likely to have detectable VL at delivery than women with no interruptions or who reported better adherence.</p>
</sec>
<sec id="S8">
<title>Limitations</title>
<p id="P8">Women entered the study at varying times during pregnancy and for this and other reasons there was incomplete data on many covariates.</p>
</sec>
<sec id="S9">
<title>Conclusions</title>
<p id="P9">In this large U.S.-based cohort of HIV-1 positive women, 13% of women who initiated HAART during pregnancy had detectable VL at delivery. The timing of HAART initiation and prenatal care along with medication adherence during pregnancy appear to be modifiable factors associated with detectable VL at delivery. Social factors such as Black/non-Hispanic ethnicity and less than high school education may help to identify women at highest risk who may benefit from focused efforts to promote early treatment initiation and adherence to HAART.</p>
</sec>
<sec id="S10">
<title>Clinical Trial Registration Number</title>
<p id="P10">NCT00028145</p>
</sec>
</abstract>
<kwd-group>
<kwd>Antiretroviral therapy</kwd>
<kwd>pregnancy</kwd>
<kwd>maternal to child transmission</kwd>
<kwd>HIV</kwd>
<kwd>women</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>

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