Evidence map›Paper›PMID 26009832›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2015

Adherence to Early Antiretroviral Therapy: Results From HPTN 052, a Phase III, Multinational Randomized Trial of ART to Prevent HIV-1 Sexual Transmission in Serodiscordant Couples.

Steven A Safren, Kenneth H Mayer, San-San Ou, Marybeth McCauley, Beatriz Grinsztejn, Mina C Hosseinipour, Nagalingeswaran Kumarasamy, Theresa Gamble, Irving Hoffman, David Celentano and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
5.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Risk of sexual transmission of human immunodeficiency virus with antiretroviral therapy, suppressed viral load and condom use: a systematic review.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
    Pooled it
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  9. National HIV programme testing recommendations.Singapore medical journal · 2025
    Article
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  18. PMTCT Adherence in Pregnant South African Women: The Role of Depression, Social Support, Stigma, and Structural Barriers to Care.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2020
    Article
  19. A clinical practice guide: What HIV care providers need to know about HIV pregnancy planning to optimize preconception care for their patients.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 4 countries.

Steven A Safren*Department of Psychiatry, Massachusetts General Hospital, Boston, MA; †Department of Medicine, Harvard Medical School, Boston, MA; ‡Department of Medicine, Fenway Health, Boston, MA; §Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA; ‖Vaccine and Infectious Disease Division, Statistical Center for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ¶Science Facilitation Department, FHI 360, Washington, DC; #HIV/AIDS Clinical Trials Unit, Instituto de Pesquisa Clinica Evandro Chagas, Rio de Janeiro, Brazil; **Division of Infectious Diseases, University of North Carolina at Chapel Hill, Institute for Global Health and Infectious Diseases, Lilongwe, Malawi; ††CART CRS, YRGCARE Medical Centre, YRG CARE Medical Center, VHS Chennai CRS, Chennai, India; ‡‡Science Facilitation Department, FHI 360, Durham, NC; §§Department of Medicine, Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, NC; and ‖‖Department of Epidemiology, John Hopkins University, Bloomberg School of Public Health, Baltimore, MD.
Kenneth H Mayer
San-San Ou
Marybeth McCauley
Beatriz Grinsztejn
Mina C Hosseinipour
Nagalingeswaran Kumarasamy
Theresa Gamble
Irving Hoffman
David Celentano
Ying Qing Chen
Myron S Cohen
HPTN 052 Study Team
University of North Carolina at Chapel Hill · USFamily Health International 360 · USFred Hutch Cancer Center · USBeth Israel Deaconess Medical Center · USHarvard University Press · USInstituto Evandro Chagas · BRJohns Hopkins University · USYR Gaitonde Centre for AIDS Research and Education · IN

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI MYRON Scott COHEN, Sinead Delany-Moretlwe · 2011 to 2026
$779.5M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
HIV Prevention trials Network (HPTN) Coordinating and Operations CenterU01AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI VERMUND, STEN H. · 2006 to 2010
$72.7M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
Leadership for HIV/AIDS Clinical Trials Networks; HIV Prevention Trials NetworkU01AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DONNELL, DEBORAH J · 2006 to 2010
$28.8M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
HIV Prevention Trials Network: Network LaboratoryU01AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ESHLEMAN, SUSAN H · 2006 to 2010
$16.5M
Harvard Medical School Vaccine Clinical Trials UnitU01AI069412 · NIAID · HARVARD MEDICAL SCHOOL · PI DOLIN, RAPHAEL · 2007 to 2011
$5.4M
Statistical Methods for Adherence Issues in HIV Prevention ResearchR01AI121259 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI CHEN, YING QING · 2015 to 2018
$2.5M
NCI NIH HHS NIH/NCI R01 CA172415NCI NIH HHS R01 CA172415NIAID NIH HHS 1P30AI094189NIAID NIH HHS P30 AI094189NIAID NIH HHS R01 AI089341NIAID NIH HHS R01 AI121259NIAID NIH HHS U01 AI068613NIAID NIH HHS U01 AI068617NIAID NIH HHS U01 AI068619NIAID NIH HHS U01 AI069412NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1AI068619NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069476NIMH NIH HHS 5K24MH094214NIMH NIH HHS K24 MH094214PHS HHS NIH/NIAID R01 AI089341
6 · The paper itself

Abstract

backgroundCombination antiretroviral therapy (ART) for HIV-1-infected individuals prevents sexual transmission if viral load is suppressed.

methodsParticipants were HIV-1-infected partners randomized to early ART (CD4 350-550) in HPTN052 (n = 886, median follow-up = 2.1 years), a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries. Adherence was assessed through pill count (dichotomized at <95%) and through self-report items. Predictors of adherence were mental health and general health perceptions, substance use, binge drinking, social support, sexual behaviors, and demographics. Viral suppression was defined as HIV plasma viral load <400 copies per milliliter. Adherence counseling and couples' counseling about safer sex were provided. Logistic and linear regression models using generalized estimating equation for repeated measurements were used.

findingsThrough pill count, 82% of participants were adherent at 1 month and 83.3% at 1 year. Mental health was the only psychosocial variable associated with adherence [pill count, odds ratios (OR) = 1.05, 95% confidence intervals (CIs): 1.00 to 1.11; self-report parameter estimate, OR = 0.02, 95% CI: 0.01 to 0.04], although regional differences emerged. Pill count (OR = 1.19, 95% CI: 1.10 to 1.30) and self-report (OR = 1.42, 95% CI: 1.14 to 1.77) adherence were associated with viral suppression.

interpretationAlthough adherence was high among individuals in stable relationships taking ART for prevention, mental health and adherence covaried. Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored. Adherence and couples' counseling, feedback about viral suppression, and/or altruism may also help explain the magnitude of adherence observed.

Indexed as

Medication AdherenceAdolescentAdultAnti-Retroviral AgentsAntiretroviral Therapy, Highly ActiveCounselingDisease Transmission, InfectiousFamily CharacteristicsFemaleHIV-1HIV InfectionsHumansMaleMental HealthSexual BehaviorSexual PartnersAnti-Retroviral Agents

Identifiers

PMID26009832
PMCPMC4445420
OpenAlexW2005592438

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.