Evidence map›Paper›PMID 28328548›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2017

Characterization of HIV Seroconverters in a TDF/FTC PrEP Study: HPTN 067/ADAPT.

Mariya V Sivay, Maoji Li, Estelle Piwowar-Manning, Yinfeng Zhang, Sarah E Hudelson, Mark A Marzinke, Rivet K Amico, Andrew Redd, Craig W Hendrix, Peter L Anderson and 8 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 5% 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

33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV - CDC Recommendations, United States, 2025.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2025
    Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Suppressed HIV antibody responses following exposure to antiretrovirals-evidence from PrEP randomized trials and early antiretroviral treatment initiation studies.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2024
    Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. The demographic features and outcome indicators of the Barbados HIV Pre-exposure Prophylaxis Program, 2018-2019.Revista panamericana de salud publica = Pan American journal of public health · 2021
    Article
  16. Review
  17. Article
  18. Article
  19. Article
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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 at 11 institutions in 2 countries.

Mariya V Sivay*Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; †Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ‡Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI; §Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; ‖Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institute of Health, Bethesda, MD; ¶Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, MD; #Department of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO; **FHI 360, Durham, NC; ††Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; ‡‡Department of Epidemiology and Biostatistics, University of California San Francisco School of Medicine, San Francisco, CA; §§Departments of Medicine and Epidemiology, Columbia University Affiliation at Harlem Hospital, New York, NY; ‖‖Columbia University Mailman School of Public Health, New York, NY; ¶¶Department of Biostatistics, University of Washington, Seattle, WA; and ##University of California, San Francisco Gladstone Institutes, San Francisco, CA.
Maoji Li
Estelle Piwowar-Manning
Yinfeng Zhang
Sarah E Hudelson
Mark A Marzinke
Rivet K Amico
Andrew Redd
Craig W Hendrix
Peter L Anderson
Kevin Bokoch
Linda-Gail Bekker
Frits van Griensven
Sharon Mannheimer
James P Hughes
Robert Grant
Susan H Eshleman
HPTN 067/ADAPT Study Team
Johns Hopkins Medicine · USColumbia University · USFamily Health International 360 · USInfectious Disease Research Institute · USJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · USUniversity of California, San Francisco · USUniversity of Cape Town · ZAUniversity of Colorado Anschutz Medical Campus · USUniversity of Michigan–Ann Arbor · USUniversity of Washington · US

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
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
International Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8M
Laboratory and Statistical Development of Cross-Sectional HIV Incidence AssaysR01AI095068 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ESHLEMAN, SUSAN H · 2011 to 2021
$6.6M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
NIAID NIH HHS R01 AI095068NIAID NIH HHS R01 AI118575NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069470
6 · The paper itself

Abstract

backgroundHIV Prevention Trials Network (HPTN) 067/ADAPT evaluated tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) in women (South Africa) and men who have sex with men (Thailand, US). Participants received once-weekly directly observed therapy (DOT) of TDF/FTC, and were then randomized to daily, time-driven, or event-driven PrEP. This report describes characterization of 12 HIV seroconversion events in this trial.

methodsHIV rapid testing was performed at study sites. Retrospective testing included fourth generation assays, HIV RNA testing, Western blot, an HIV-1/2 discriminatory assay, resistance testing, and antiretroviral drug testing.

resultsSix of the 12 seroconverters received TDF/FTC in the DOT phase, but were not randomized (3 were acutely infected at enrollment; 2 were infected during the DOT phase; 1 was not randomized because of pregnancy). One of the 6 randomized participants had acute infection at randomization but was not diagnosed for 3-4 months because HIV rapid tests were nonreactive; continued daily PrEP use was associated with false-negative antibody tests and low HIV RNA levels. The 5 participants infected after randomization included 4 with low adherence to the PrEP regimen, and one who reported a 7-day period without dosing before infection. Three participants had TDF/FTC resistance (M184I, K65R), including 2 who received only 4 once-weekly TDF/FTC doses; most TDF/FTC mutations were detected by next generation sequencing only.

conclusionsIn HPTN 067/ADAPT, participants who acquired HIV infection had infrequent PrEP dosing or low/suboptimal adherence. Sensitive assays improved detection of HIV infection and drug resistance. Drug resistance was observed with limited PrEP exposure.

Indexed as

Directly Observed TherapyPre-Exposure ProphylaxisAdultAnti-HIV AgentsDrug Resistance, ViralEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFemaleHIV SeropositivityHumansMalePredictive Value of TestsRetrospective StudiesSouth AfricaThailandAnti-HIV AgentsEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Identifiers

PMID28328548
PMCPMC5472493
OpenAlexW2602409846

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.