Evidence map›Paper›PMID 34657218›Full record

ArticleAIDS and behavior2022

Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

José A Bauermeister, Ryan C Tingler, Clara Dominguez, Eileen F Dunne, Craig Hoesley, Ken Ho, Sherri Johnson, Jonathan Lucas, Nicole Macagna, Elizabeth Brown and 15 more

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

Article in AIDS and behavior, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03239483 (A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03239483 phase1completednot on this map

A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2018Enrolled28ConditionsHIV InfectionsArmsDapivirine gel, Placebo gel
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Acceptability of PC-1005 Gel Administered Rectally to HIV-1 Seronegative Adults at Three Different Volume Levels (MTN-037).AIDS education and prevention : official publication of the International Society for AIDS Education · 2022
    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

25 authors.

José A BauermeisterUniversity of Pennsylvania, 418 Curie Blvd, Room 222L, Philadelphia, PA, 19104, USA. bjose@upenn.edu.ORCID http://orcid.org/0000-0002-9276-2306
Ryan C TinglerUniversity of Pennsylvania, 418 Curie Blvd, Room 222L, Philadelphia, PA, 19104, USA.
Clara DominguezStatistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Eileen F Dunneivision of HIV/AIDS Prevention, D, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Craig HoesleyUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Ken HoUniversity of Pittsburgh, Pittsburgh, PA, USA.
Sherri Johnson, FHI 360, Durham, NC, USA.
Jonathan Lucas, FHI 360, Durham, NC, USA.
Nicole Macagna, FHI 360, Durham, NC, USA.
Elizabeth BrownStatistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Holly GundackerStatistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Melissa PedaStatistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Cindy E JacobsonMicrobicide Trials Network, Pittsburgh, PA, USA.
Lindsay KramzerMicrobicide Trials Network, Pittsburgh, PA, USA.
Devika SinghMicrobicide Trials Network, Pittsburgh, PA, USA.
Charlene S DezzuttiMicrobicide Trials Network, Pittsburgh, PA, USA.
Ratiya Pamela Kunjara Na AyudhyaMicrobicide Trials Network, Pittsburgh, PA, USA.
Mark A MarzinkeJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Jeanna PiperDivision of AIDS/NIAID/NIH, Bethesda, MD, USA.
Bríd DevlinInternational Partnership for Microbicides, Silver Spring, MD, USA.
Jeremy NuttallInternational Partnership for Microbicides, Silver Spring, MD, USA.
Ian McGowanUniversity of Pittsburgh, Pittsburgh, PA, USA.
Craig W HendrixMicrobicide Trials Network, Pittsburgh, PA, USA.
Ross D CranstonUniversity of Barcelona, Barcelona, Spain.
MTN 026 team

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Alan David Levine · 1994 to 2026
$50.0M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
NIAID NIH HHS P30 AI036219NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI106707NIH HHS UM1AI068615NIH HHS UM1AI068633NIH HHS UM1AI106707
6 · The paper itself

Abstract

This study describes the acceptability of a rectal microbicide gel formulation using dapivirine (DPV) among men and women from two countries (United States and Thailand) participating in the Microbicide Trials Network-026 trial. We evaluated participants' acceptability of a rectal DPV/placebo gel as part of a Phase I trial (N = 26; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n = 14; 53.8%) or more (n = 11; 42.4%) than when they started the trial. Over half of participants noted that they would prefer the gel over condoms (n = 13; 50%) or that they liked condoms and the gel equally (n = 8; 30.8%). Side effects across products included leakage (n = 8; 30.8%), diarrhea (n = 4; 15.4%), or soiling (n = 1; 3.8%). The high acceptability of a rectal gel underscores its promise as a short-acting biomedical prevention, warranting future research for HIV prevention.Trial Registration: NCT03239483.

Indexed as

Anti-Infective AgentsHIV-1HIV InfectionsAdultFemaleGelsHumansMalePyrimidinesUnited StatesAnti-Infective AgentsDapivirineGelsPyrimidinesDapivirineHIVHIV preventionMicrobicidesRectal

Identifiers

PMID34657218
PMCPMC9024063

What OpenQuestion holds

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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.