Evidence map›Paper›PMID 29420695›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018

Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study.

Robert M Grant, Sharon Mannheimer, James P Hughes, Yael Hirsch-Moverman, Avelino Loquere, Anupong Chitwarakorn, Marcel E Curlin, Maoji Li, K Rivet Amico, Craig W Hendrix and 12 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01327651 (The ADAPT Study), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 4% 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.

NCT01327651 phase2completednot on this map

The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP)

TypeinterventionalSponsorHIV Prevention Trials NetworkRan2011 to 2014Enrolled622ConditionsHIV InfectionsArmsDaily dosing, Time-driven dosing, Event-driven dosing
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Access of transgender people and transvestites to pre-exposure prophylaxis for HIV in Brazil: a descriptive study, 2018-2023.Epidemiologia e servicos de saude : revista do Sistema Unico de Saude do Brasil · 2025
    Article
  12. Review
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Observational
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

22 authors at 13 institutions in 2 countries.

Robert M GrantGladstone Institutes, University of California, San Francisco AIDS Foundation.
Sharon MannheimerHarlem Hospital and Mailman School of Public Health, Columbia University, New York, New York.
James P HughesUniversity of Washington, Seattle, Washington.
Yael Hirsch-MovermanICAP, Mailman School of Public Health, Columbia University, New York, New York.
Avelino LoquereICAP, Mailman School of Public Health, Columbia University, New York, New York.
Anupong ChitwarakornThailand Ministry of Public Health, Nonthaburi.
Marcel E CurlinThailand Ministry of Public Health, Nonthaburi.
Maoji LiFred Hutchinson Cancer Research Center, Seattle, Washington.
K Rivet AmicoUniversity of Michigan, Ann Arbor.
Craig W HendrixJohns Hopkins University, Baltimore, Maryl.
Peter L AndersonUniversity of Colorado Anschutz Medical Campus, Aurora.
Bonnie J DyeFHI 360, Durham, North Carolina.
Mark A MarzinkeJohns Hopkins University, Baltimore, Maryl.
Estelle Piwowar-ManningJohns Hopkins University, Baltimore, Maryl.
Laura McKinstryFred Hutchinson Cancer Research Center, Seattle, Washington.
Vanessa ElharrarNational Institutes of Health, Bethesda, Maryl.
Michael StirrattNational Institutes of Health, Bethesda, Maryl.
James F RooneyGilead Sciences, Foster City, California.
Susan H EshlemanJohns Hopkins University, Baltimore, Maryl.
Janet M McNichollThailand Ministry of Public Health, Nonthaburi.
Frits van GriensvenThai Red Cross AIDS Research Center, Bangkok.
Timothy H HoltzThailand Ministry of Public Health, Nonthaburi.
Johns Hopkins University · USColumbia University · USMinistry of Public Health · THFred Hutch Cancer Center · USNational Institutes of Health · USCenters for Disease Control and Prevention · USFamily Health International 360 · USGilead Sciences (United States) · USSan Francisco AIDS Foundation · USUniversity of California, San Francisco · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Michigan–Ann Arbor · USUniversity of Washington · US

Funding

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
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
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
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
NIAID NIH HHS P30 AI094189NIAID NIH HHS R01 AI118575NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI069470
6 · The paper itself

Abstract

Background: Nondaily dosing of oral preexposure prophylaxis (PrEP) may provide equivalent coverage of sex events compared with daily dosing. Methods: At-risk men and transgender women who have sex with men were randomly assigned to 1 of 3 dosing regimens: 1 tablet daily, 1 tablet twice weekly with a postsex dose (time-driven), or 1 tablet before and after sex (event-driven), and were followed for coverage of sex events with pre- and postsex dosing measured by weekly self-report, drug concentrations, and electronic drug monitoring. Results: From July 2012 to May 2014, 357 participants were randomized. In Bangkok, the coverage of sex events was 85% for the daily arm compared with 84% for the time-driven arm (P = .79) and 74% for the event-driven arm (P = .02). In Harlem, coverage was 66%, 47% (P = .01), and 52% (P = .01) for these groups. In Bangkok, PrEP medication concentrations in blood were consistent with use of ≥2 tablets per week in >95% of visits when sex was reported in the prior week, while in Harlem, such medication concentrations occurred in 48.5% in the daily arm, 30.9% in the time-driven arm, and 16.7% in the event-driven arm (P < .0001). Creatinine elevations were more common in the daily arm (P = .050), although they were not dose limiting. Conclusions: Daily dosing recommendations increased coverage and protective drug concentrations in the Harlem cohort, while daily and nondaily regimens led to comparably favorable outcomes in Bangkok, where participants had higher levels of education and employment. Clinical Trials Registration: NCT01327651.

Indexed as

Medication AdherencePre-Exposure ProphylaxisTransgender PersonsAdolescentAdultAnti-HIV AgentsDrug Administration ScheduleEmtricitabineFemaleHIV InfectionsHomosexuality, MaleHumansMaleTenofovirYoung AdultAnti-HIV AgentsEmtricitabineTenofovir

Identifiers

PMID29420695
PMCPMC5961078
OpenAlexW2789391634

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.