Evidence map›Paper›PMID 24135734›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2013

The acceptability and feasibility of an HIV preexposure prophylaxis (PrEP) trial with young men who have sex with men.

Sybil G Hosek, George Siberry, Margo Bell, Michelle Lally, Bill Kapogiannis, Keith Green, M Isabel Fernandez, Brandy Rutledge, Jaime Martinez, Robert Garofalo and 2 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 109 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 13 pooled it
6.4field-weighted citation impact, top 2% 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.

NCT02611362 nacompletednot on this mapstarted 2015, after this paper: background citation

A Multilevel Gaming Intervention for Persons on PrEP

TypeinterventionalSponsorRhode Island HospitalRan2015 to 2019Enrolled82ConditionsMSM, PrEP, HIV RiskArmsIMB Gaming Intervention
NCT03617874 nacompletednot on this mapstarted 2020, after this paper: background citation

PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care

TypeinterventionalSponsorAlbert Einstein College of MedicineRan2020 to 2022Enrolled22ConditionsHuman Immunodeficiency Virus TransmissionArmsPC4PrEP- Intervention Clinics, Standard of Care Clinics
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 13 syntheses or guidelines pooled it, 177 citations in OpenAlex.

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  19. Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
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49 more citing papers are in PubMed but not listed here.

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

12 authors at 6 institutions in 1 country.

Sybil G Hosek*Department of Psychiatry, John Stroger Hospital of Cook County, Chicago, IL †Maternal and Pediatric Infectious Disease Branch, NICHD/PAMAB, Bethesda, MD ‡Department of Pediatrics, John Stroger Hospital of Cook County, Chicago, IL §Department of Medicine, Alpert Medical School of Brown University, Providence, RI ‖Department of Osteopathic Medicine, Nova Southeastern University, Ft. Lauderdale, FL ¶Westat, Rockville, MD #Department of Pediatrics, Children's Memorial Hospital, Chicago, IL **Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL.
George Siberry
Margo Bell
Michelle Lally
Bill Kapogiannis
Keith Green
M Isabel Fernandez
Brandy Rutledge
Jaime Martinez
Robert Garofalo
Craig M Wilson
Adolescent Trials Network for HIVAIDS Interventions (ATN)
John H. Stroger, Jr. Hospital of Cook County · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USBrown University · USLurie Children's Hospital · USNova Southeastern University · USWestat (United States) · US

Funding

LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
Stroger/CORE Chicago Adolescent Trials Unit (ATU)U01HD040515 · NICHD · HEKTOEN INSTITUTE FOR MEDICAL RESEARCH · PI HENRY-REID, LISA MICHELLE · 2001 to 2015
$9.4M
NICHD NIH HHS U01 HD040515NICHD NIH HHS U01 HD040533NICHD NIH HHS U01 HD040533-06
6 · The paper itself

Abstract

backgroundThis study examined the feasibility of a combination prevention intervention for young men who have sex with men (YMSM), an anticipated target population for HIV preexposure prophylaxis (PrEP).

methodsProject PrEPare, a pilot study using a randomized 3-arm design, compared an efficacious behavioral HIV prevention intervention (Many Men, Many Voices-3 MV) alone, 3 MV combined with PrEP (tenofovir/emtricitabine), and 3 MV combined with placebo. Eligible participants were 18- to 22-year-old HIV-uninfected men who reported unprotected anal intercourse in the past year. Participants were screened for preliminary eligibility at youth venues and community organizations and were also referred through social networks. Laboratory screening determined final eligibility. Behavioral and biomedical data were collected at baseline and every 4 weeks thereafter for 24 weeks.

resultsSixty-eight youth (mean age = 19.97 years; 53% African American, 40% Latino) were enrolled; 58 were randomized. Self-reported medication adherence averaged 62% (range, 43%-83%), whereas rates of detectable tenofovir in plasma of participants in the emtricitabine/tenofovir disoproxil fumarate arm ranged from 63.2% (week 4) to 20% (week 24). There were 5 ≥ grade 2 adverse events possibly/probably related to the study medication. Sexual risk behavior declined from baseline to week 24 in all study arms.

conclusionsThe feasibility of enrolling at-risk youth, particularly young men who have sex with men of color, into Project PrEPare has been demonstrated. The acceptability of the group intervention along with counseling and testing was high. Self-reported medication adherence and corresponding plasma drug concentrations were low indicating the need for enhanced adherence counseling. Exploration of PrEP use among youth in nonrandomized open label trials is warranted.

Indexed as

AdolescentAdultFeasibility StudiesHIV InfectionsHumansMalePilot ProjectsRisk FactorsYoung Adult

Identifiers

PMID24135734
PMCPMC3656981
OpenAlexW2051929758

What OpenQuestion holds

Textmetadata
LicenceTDM
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.