Evidence map›Paper›PMID 39083151›Full record

Trial reportAIDS and behavior2024

Pharmacologic Drug Detection and Self-Reported Adherence in the HPTN069/ACTG5305 Phase II PrEP Trial.

Stanley E Cooper, Shuaiqi Zhang, Daniel Haines, Kenneth H Mayer, K Rivet Amico, Raphael J Landovitz, Craig W Hendrix, Mark A Marzinke, Wairimu Chege, Marybeth McCauley and 1 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in AIDS and behavior, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. Article
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

11 authors.

Stanley E CooperDivision of Infectious Diseases, Weill Cornell Medicine, 525 East 68th Street, Baker 24, New York, NY, 10065, USA. sec9059@med.cornell.edu.ORCID http://orcid.org/0000-0003-3371-0845
Shuaiqi ZhangFred Hutchison Cancer Center, Seattle, WA, USA.
Daniel HainesFred Hutchison Cancer Center, Seattle, WA, USA.
Kenneth H MayerFenway Health, Harvard Medical School, Boston, MA, USA.
K Rivet AmicoUniversity of Michigan, Ann Arbor, MI, USA.
Raphael J LandovitzUniversity of California, Los Angeles, CA, USA.
Craig W HendrixJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Mark A MarzinkeJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Wairimu ChegeDAIDS, NIAID, NIH, Bethesda, MD, USA.
Marybeth McCauley, Durham, NC, FHI 360, USA.
Roy M GulickDivision of Infectious Diseases, Weill Cornell Medicine, 525 East 68th Street, Baker 24, New York, NY, 10065, USA.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
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
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 2012 to 2026
$44.6M
T32: Pathogenesis of Infectious Diseases Training ProgramT32AI007613 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 1999 to 2026
$8.8M
Division of Intramural Research, National Institute of Allergy and Infectious Diseases T32AI007613NIAID NIH HHS T32 AI007613NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069424
6 · The paper itself

Abstract

Adherence drives efficacy in PrEP clinical trials. We compared drug concentrations and self-reported adherence in HPTN069/ACTG5305, a double-blinded, randomized trial of the safety and tolerability of candidate PrEP regimens that included maraviroc (MVC), tenofovir (TDF), and emtricitabine (FTC). Plasma drug concentrations and self-reported adherence by computer-assisted self-interview (CASI) were assessed at study weeks 24 and 48. Descriptive statistics and a generalized linear model were used to assess the association between selected demographic factors, self-report of daily medication adherence and plasma drug concentrations consistent with daily adherence. Among 718 paired observations from 370 participants, 43% (306/718) reported daily adherence by CASI, 65% (467/718) had drug concentrations consistent with daily adherence and 11% (81/718) had CASI responses that reported daily adherence despite having drug concentrations consistent with less-than-daily adherence. In adjusted analyses, participants who were assigned male at birth (aOR 1.42 [95% CI 1.02, 1.97]), older (5-year increments aOR 1.10 [95% CI 1.09, 1.11]), White (aOR 2.2 [95% CI 1.88, 2.56]), had advanced education (aOR 3.89 [95% CI 2.97, 5.09]), were employed (aOR 1.89 [95% CI 1.50, 2.40]), or partnered/married (aOR 2 [95% CI 1.72, 2.32]) were more likely to have drug concentrations consistent with daily adherence. Participants who were not employed (aOR 2.7 [95% CI 1.31, 5.55]) or who were single/not partnered (aOR 2.33 [CI 95% 1.25, 4.34]) were more likely to have drug concentrations that did not reflect daily adherence despite self-reported PrEP adherence. These findings support the need for ongoing adherence counseling in clinical trials of new PrEP regimens.

Indexed as

Anti-HIV AgentsDrug MonitoringEmtricitabineHIV InfectionsMaravirocPre-Exposure ProphylaxisSelf ReportTenofovirAdultCyclohexanesDouble-Blind MethodFemaleHumansMaleMiddle AgedAnti-HIV AgentsCyclohexanesEmtricitabineMaravirocTenofovir(6/6): AdherenceCASIHIV preventionMaravirocPrEPTenofovir

Identifiers

PMID39083151
PMCPMC11471692

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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.