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Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa

BACKGROUND: Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the im...

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Autores principales: Haberer, Jessica E., Baeten, Jared M., Campbell, James, Wangisi, Jonathan, Katabira, Elly, Ronald, Allan, Tumwesigye, Elioda, Psaros, Christina, Safren, Steven A., Ware, Norma C., Thomas, Katherine K., Donnell, Deborah, Krows, Meighan, Kidoguchi, Lara, Celum, Connie, Bangsberg, David R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769210/
https://www.ncbi.nlm.nih.gov/pubmed/24058300
http://dx.doi.org/10.1371/journal.pmed.1001511
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author Haberer, Jessica E.
Baeten, Jared M.
Campbell, James
Wangisi, Jonathan
Katabira, Elly
Ronald, Allan
Tumwesigye, Elioda
Psaros, Christina
Safren, Steven A.
Ware, Norma C.
Thomas, Katherine K.
Donnell, Deborah
Krows, Meighan
Kidoguchi, Lara
Celum, Connie
Bangsberg, David R.
author_facet Haberer, Jessica E.
Baeten, Jared M.
Campbell, James
Wangisi, Jonathan
Katabira, Elly
Ronald, Allan
Tumwesigye, Elioda
Psaros, Christina
Safren, Steven A.
Ware, Norma C.
Thomas, Katherine K.
Donnell, Deborah
Krows, Meighan
Kidoguchi, Lara
Celum, Connie
Bangsberg, David R.
author_sort Haberer, Jessica E.
collection PubMed
description BACKGROUND: Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation. METHODS AND FINDINGS: Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to <80%. Participants were followed monthly to provide study medication, adherence counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants—all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%–100%, p<0.001). Median adherence was 99.1% (interquartile range [IQR] 96.9%–100%) by unannounced pill counts and 97.2% (90.6%–100%) by electronic monitoring over 807 person-years. Report of no sex or sex with another person besides the study partner, younger age, and heavy alcohol use were associated with <80% adherence; the first 6 months of PrEP use and polygamous marriage were associated with >80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort. CONCLUSIONS: The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary
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spelling pubmed-37692102013-09-20 Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa Haberer, Jessica E. Baeten, Jared M. Campbell, James Wangisi, Jonathan Katabira, Elly Ronald, Allan Tumwesigye, Elioda Psaros, Christina Safren, Steven A. Ware, Norma C. Thomas, Katherine K. Donnell, Deborah Krows, Meighan Kidoguchi, Lara Celum, Connie Bangsberg, David R. PLoS Med Research Article BACKGROUND: Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation. METHODS AND FINDINGS: Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to <80%. Participants were followed monthly to provide study medication, adherence counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants—all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%–100%, p<0.001). Median adherence was 99.1% (interquartile range [IQR] 96.9%–100%) by unannounced pill counts and 97.2% (90.6%–100%) by electronic monitoring over 807 person-years. Report of no sex or sex with another person besides the study partner, younger age, and heavy alcohol use were associated with <80% adherence; the first 6 months of PrEP use and polygamous marriage were associated with >80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort. CONCLUSIONS: The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary Public Library of Science 2013-09-10 /pmc/articles/PMC3769210/ /pubmed/24058300 http://dx.doi.org/10.1371/journal.pmed.1001511 Text en © 2013 Haberer et al http://creativecommons.org/licenses/by/4.0/ 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.
spellingShingle Research Article
Haberer, Jessica E.
Baeten, Jared M.
Campbell, James
Wangisi, Jonathan
Katabira, Elly
Ronald, Allan
Tumwesigye, Elioda
Psaros, Christina
Safren, Steven A.
Ware, Norma C.
Thomas, Katherine K.
Donnell, Deborah
Krows, Meighan
Kidoguchi, Lara
Celum, Connie
Bangsberg, David R.
Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa
title Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa
title_full Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa
title_fullStr Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa
title_full_unstemmed Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa
title_short Adherence to Antiretroviral Prophylaxis for HIV Prevention: A Substudy Cohort within a Clinical Trial of Serodiscordant Couples in East Africa
title_sort adherence to antiretroviral prophylaxis for hiv prevention: a substudy cohort within a clinical trial of serodiscordant couples in east africa
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769210/
https://www.ncbi.nlm.nih.gov/pubmed/24058300
http://dx.doi.org/10.1371/journal.pmed.1001511
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