Evidence map›Paper›PMID 31335588›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2019

Short- and Long-Term Pharmacologic Measures of HIV Pre-exposure Prophylaxis Use Among High-Risk Men Who Have Sex With Men in HPTN 067/ADAPT.

Jennifer Velloza, Peter Bacchetti, Craig W Hendrix, Pamela Murnane, James P Hughes, Maoji Li, Marcel E Curlin, Timothy H Holtz, Sharon Mannheimer, Mark A Marzinke and 8 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  7. A Cross-Biomeasure Study to Optimize Antiretroviral Adherence Estimation.Journal of acquired immune deficiency syndromes (1999) · 2025
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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

18 authors.

Jennifer VellozaDepartment of Global Health, University of Washington, Seattle, WA.
Peter BacchettiSchool of Medicine, University of California at San Francisco, San Francisco, CA.
Craig W HendrixDepartment of Medicine, Johns Hopkins University, Baltimore, MD.
Pamela MurnaneSchool of Medicine, University of California at San Francisco, San Francisco, CA.
James P HughesDepartment of Global Health, University of Washington, Seattle, WA.
Maoji LiFred Hutchinson Cancer Research Center, Seattle, WA.
Marcel E CurlinU.S. Centers for Disease Control and Prevention, Atlanta, GA.
Timothy H HoltzU.S. Centers for Disease Control and Prevention, Atlanta, GA.
Sharon MannheimerColumbia University, New York, NY.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University, Baltimore, MD.
K Rivet AmicoDepartment of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI.
Albert LiuSan Francisco Department of Public Health, San Francisco, CA.
Estelle Piwowar-ManningDepartment of Medicine, Johns Hopkins University, Baltimore, MD.
Susan H EshlemanDepartment of Medicine, Johns Hopkins University, Baltimore, MD.
Bonnie J DyeFHI 360, Durham, NC.
Monica GandhiSchool of Medicine, University of California at San Francisco, San Francisco, CA.
Robert M GrantSchool of Medicine, University of California at San Francisco, San Francisco, CA.
HPTN 067/ADAPT Study Team

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 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
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 1988 to 2026
$93.6M
Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Moises Arturo Huaman Joo, Colleen F Kelley · 2012 to 2026
$46.0M
TRAINEESHIPS IN AIDS PREVENTION STUDIEST32MH019105 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Carol Suzanne Camlin, Glenn-Milo Santos · 1989 to 2026
$15.3M
Plugging Hair ARV Levels as Adherence Biomarkers into HIV Prevention TrialsR01AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA · 2012 to 2021
$5.6M
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING-PUMA)R01AI143340 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2018 to 2026
$5.6M
“Hair Lengthening”: Using Hair Levels to Interpret Long-Acting PrEP Studies.R37AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2023 to 2026
$3.2M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
Depression and Pre-Exposure Prophylaxis Use among sub-Saharan African WomenF31MH113420 · NIMH · UNIVERSITY OF WASHINGTON · PI VELLOZA, JENNIFER · 2017 to 2018
$84k
NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI098472NIAID NIH HHS R01 AI118575NIAID NIH HHS R01 AI143340NIAID NIH HHS R37 AI098472NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069418NIMH NIH HHS F31 MH113420NIMH NIH HHS P30 MH062246NIMH NIH HHS T32 MH019105
6 · The paper itself

Abstract

backgroundThe effectiveness of oral emtricitabine (FTC)/tenofovir (TFV) disoproxil fumarate-based HIV pre-exposure prophylaxis (PrEP) depends on adherence. Pharmacologic measures help interpret patterns and predictors of PrEP adherence.

settingWe analyzed data from the subsample of men who have sex with men enrolled in HPTN 067/ADAPT in Bangkok, Thailand, and Harlem, NY, U.S.

methodsAfter a 5-week directly observed therapy period, participants were randomized to daily, time-driven, or event-driven PrEP. Follow-up occurred at weeks 4, 12, and 24 after randomization. Plasma and hair FTC/TFV levels indicated short- and long-term PrEP use, respectively. Electronic pill bottle data (Wisepill) were collected weekly. Pearson correlation coefficients between PrEP use measures were calculated; linear mixed models assessed predictors of plasma and hair drug concentrations.

resultsAmong 350 participants (median age: 31 years, interquartile range: 25-38), 49.7% were from Harlem, half had less than college education, and 21% reported heavy alcohol use. In multivariable models, being enrolled in Harlem, being in non-daily arms, and having less than college education were associated with lower hair FTC/TFV concentrations; heavy alcohol use was associated with higher concentrations. Similar results were found for plasma concentrations by site and arm, but older age and greater number of sex partners were associated with higher concentrations. Hair and plasma FTC/TFV concentrations were moderately correlated with Wisepill data (r ≥ 0.29) across visits.

conclusionsIn HPTN067, plasma, hair, and Wisepill data correlated with one another and served as complementary adherence measures. Site, arm, education, age, alcohol, and sexual behavior influenced patterns of adherence.

Indexed as

Homosexuality, MalePre-Exposure ProphylaxisAdultEmtricitabineHairHIV InfectionsHumansMaleMedication AdherenceTenofovirEmtricitabineTenofovir

Identifiers

PMID31335588
PMCPMC6749964

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.