Evidence map›Paper›PMID 40439767›Full record

ArticleAIDS and behavior2025

Assessing the Acceptability of a Tenofovir-Based Rectal Microbicide Douche among Young Men who Have Sex with Men: Results from ATN-DREAM (ATN 163).

José A Bauermeister, Willey Lin, Jessica Webster, Louis L Listerud, Tyler Burgese, Allison Agwu, Jessica Coleman Lewis, Thuy Anderson, Lisa Hightow-Weidman, Craig Hendrix and 1 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in AIDS and behavior, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04686279 (Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04686279 phase1completednot on this map

Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men (DREAM)

TypeinterventionalSponsorUniversity of PennsylvaniaRan2021 to 2022Enrolled8ConditionsHIV/AIDS, HIV PreventionArmsTenofovir Douche
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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.

José A BauermeisterUniversity of Pennsylvania, Philadelphia, PA, USA. bjose@upenn.edu.ORCID http://orcid.org/0000-0002-9276-2306
Willey LinUniversity of Pennsylvania, Philadelphia, PA, USA.
Jessica WebsterUniversity of Pennsylvania, Philadelphia, PA, USA.
Louis L ListerudUniversity of Pennsylvania, Philadelphia, PA, USA.
Tyler BurgeseUniversity of Pennsylvania, Philadelphia, PA, USA.
Allison AgwuJohns Hopkins University, Baltimore, MD, USA.
Jessica Coleman LewisJohns Hopkins University, Baltimore, MD, USA.
Thuy AndersonJohns Hopkins University, Baltimore, MD, USA.
Lisa Hightow-WeidmanFlorida State University, Tallahassee, FL, USA.
Craig HendrixJohns Hopkins University, Baltimore, MD, USA.
Renata Arrington-SandersChildren's Hospital of Philadelphia, Philadelphia, PA, USA.

Funding

Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ronald G Collman · 1999 to 2026
$78.6M
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Ann M Chahroudi, Colleen F Kelley · 2002 to 2026
$74.0M
The UNC/Emory Center for Innovative Technology (iTech) across the prevention and care continuumU19HD089881 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HIGHTOW-WEIDMAN, LISA B, SULLIVAN, PATRICK SEAN · 2016 to 2022
$35.8M
National Institute of Allergy and Infectious Diseases P30 AI 045008National Institute of Allergy and Infectious Diseases P30AI050409National Institute of Child Health and Human Development U19HD089881NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI050409NICHD NIH HHS U19 HD089881
6 · The paper itself

Abstract

Young men who have sex with men (YMSM) remain disproportionately affected by HIV, yet adherence to daily oral pre-exposure prophylaxis (PrEP) remains suboptimal. Rectal microbicides formulated as douches offer a behaviorally congruent alternative by leveraging existing douching practices. This study assessed the acceptability of a tenofovir-based rectal microbicide douche among YMSM. Eight YMSM (M = 20.9 years; range 18-24 years) participated in a Phase I, open-label, single-arm trial evaluating the safety, pharmacokinetics, and tolerability of a single 600 mg dose of tenofovir delivered in a 125mL rectal douche (NCT04686279). This mixed-methods study included post-dosing behavioral surveys and qualitative in-depth interviews (IDIs) to assess acceptability, tolerability, and perceptions of the product's usability. Interviews were transcribed, coded, and analyzed thematically. Descriptive statistics summarized participant characteristics, douching behaviors, and willingness to use the product in different contexts. Participants reported high acceptability of the rectal microbicide douche, particularly its ease of use and integration into existing sexual health routines. Most (87.5%) indicated they would find the product acceptable for HIV prevention, and 75% reported they would likely use it before every receptive anal intercourse (RAI) event. The episodic dosing regimen was perceived as a benefit, especially for casual sexual encounters. Barriers included product design concerns, privacy, and cost. A rectal microbicide douche was highly acceptable among YMSM, supporting its potential as a novel HIV prevention strategy. Findings underscore the importance of behaviorally congruent interventions and highlight key considerations for future product development, including improved packaging, affordability, and accessibility.Trials Registration: NCT04686279.

Indexed as

Anti-HIV AgentsHIV InfectionsHomosexuality, MalePatient Acceptance of Health CarePre-Exposure ProphylaxisTenofovirAdministration, RectalAdolescentHumansInterviews as TopicMaleYoung AdultAnti-HIV AgentsTenofovirAdolescent healthPre-exposure prophylaxis (PrEP)PreventionReceptive anal intercourse

Identifiers

PMID40439767
PMCPMC12484309

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.