Evidence map›Paper›PMID 39237135›Full record

ArticleSexually transmitted infections2025

Acceptability of a rectal microbicide douche for HIV prevention: a mixed-methods analysis of a first-in-human formulation pilot study.

Rebecca Giguere, Iván C Balán, Cody Lentz, Curtis Dolezal, Alex Carballo-Diéguez, Edward J Fuchs, Peter Anton, Ian McGowan, Ken Ho, Ethel Weld and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Sexually transmitted infections, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02750540 (DREAM-01), which is not on this 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.

NCT02750540 phase1completednot on this map

DREAM-01: Optimization of a Tenofovir Enema for HIV Prevention

TypeinterventionalSponsorJohns Hopkins UniversityRan2016 to 2019Enrolled21ConditionsHIV PreventionArmsTenofovir enema, Saline enema
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  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.

Rebecca GiguereCenter for Translational Behavioral Science, College of Medicine, Florida State University, Tallahassee, Florida, USA rebecca.giguere@med.fsu.edu.ORCID 0000-0002-6529-0550
Iván C BalánCenter for Translational Behavioral Science, College of Medicine, Florida State University, Tallahassee, Florida, USA.
Cody LentzHealth Disparities and Prevention Science Lab, Department of Clinical Psychology, Temple University, Philadelphia, Pennsylvania, USA.
Curtis DolezalCenter for Translational Behavioral Science, College of Medicine, Florida State University, Tallahassee, Florida, USA.
Alex Carballo-DiéguezHIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Edward J FuchsDivision of Clinical Pharmacology, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Peter AntonDivision of Digestive Disease, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA.
Ian McGowanOrion Biotechnology, Barcelona, Spain.
Ken HoDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Ethel WeldDivision of Clinical Pharmacology, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Craig W HendrixDivision of Clinical Pharmacology, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Anna Palmer Durbin · 2012 to 2026
$67.0M
The Statistics, Data Science, and Data Management (SDM) CoreP30MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI MILTON L WAINBERG · 2003 to 2026
$48.2M
Tissue pharmacology imaging and modelingU19AI113127 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MCGOWAN, IAN MICHAEL · 2014 to 2018
$20.7M
Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
NIAID NIH HHS P30 AI094189NIAID NIH HHS U19 AI113127NIGMS NIH HHS T32 GM066691NIMH NIH HHS P30 MH043520
6 · The paper itself

Abstract

objectivesDREAM-01 was an open label, dose-escalation and variable osmolarity study to identify a tenofovir HIV-prevention douche/enema that could achieve protective colon tissue cell concentrations and high acceptability. To assess impact on sexual enjoyment, iso-osmolar and hypo-osmolar placebo douches were provided for at-home use before receptive anal sex (RAS).

methodsEighteen HIV-uninfected men who have RAS were administered three tenofovir douches at the research clinic: Product A, an iso-osmolar dose; Product B, an iso-osmolar escalation dose; and Product C, a hypo-osmolar escalation dose. Following Products A and C, participants were given a saline douche of matching osmolarity to use at home before RAS. Participants reported acceptability via a computer-assisted self-interview and in-depth interview in this mixed-methods study.

resultsAll three products were rated acceptable by 17 (95%) of the participants. A majority (94%) would be likely or very likely to use any of the three products before RAS. Of those who used the saline douches before RAS and then rated their sexual enjoyment, most reported that their sexual enjoyment was not affected. Interview data revealed that participants found the product easy to incorporate into their regular routine, but would prefer to use more liquid for cleansing.

conclusionsThese findings indicate that the hypo-osmolar Product C, which also provides the most rapid delivery of tenofovir for HIV prevention, is acceptable for future safety trials and that our sample reports high likelihood of using a rectal microbicide douche for HIV prevention. Our findings support continued pursuit of a tenofovir rectal microbicide douche. TRIAL REGISTRATION NUMBER: NCT02750540.

Indexed as

AdenineAnti-HIV AgentsHIV InfectionsPatient Acceptance of Health CareTenofovirAdministration, RectalAdultEnemaHumansMaleMiddle AgedPilot ProjectsSexual BehaviorYoung AdultAdenineAnti-HIV AgentsTenofovirBehavioral SciencesHIVPre-Exposure ProphylaxisSexual and Gender MinoritiesSEXUAL HEALTH

Identifiers

PMID39237135
PMCPMC11779595

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.