Evidence map›Paper›PMID 28825142›Full record

Trial reportAIDS and behavior2018

Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial.

Rebecca Giguere, Christine Tagliaferri Rael, Alan Sheinfil, Ivan C Balán, William Brown, Titcha Ho, Curtis Dolezal, Cheng-Shiun Leu, Albert Liu, Kenneth H Mayer and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in AIDS and behavior, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01687218 (A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 36% 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.

NCT01687218 phase2completednot on this map

A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

TypeinterventionalSponsorCONRADRan2013 to 2015Enrolled195ConditionsHIVArmsOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet), Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel), Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 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
  5. Article
  6. Article
  7. Article
  8. 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

15 authors at 4 institutions in 2 countries.

Rebecca GiguereHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA. rebecca.giguere@nyspi.columbia.edu.ORCID 0000-0002-6529-0550
Christine Tagliaferri RaelHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Alan SheinfilHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Ivan C BalánHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
William BrownHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Titcha HoHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Curtis DolezalHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Cheng-Shiun LeuHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Albert LiuSan Francisco Department of Public Health, San Francisco, CA, USA.
Kenneth H MayerThe Fenway Institute, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Javier R LamaAsociación Civil Impacta Salud y Educación, Lima, Peru.
Ian McGowanUniversity of Pittsburgh, Pittsburgh, PA, USA.
Alex Carballo-DiéguezHIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
Ross D CranstonUniversity of Pittsburgh, Pittsburgh, PA, USA.
MTN-017 Protocol Team
New York Psychoanalytic Society and Institute · USUniversity of Pittsburgh · USBeth Israel Deaconess Medical Center · USUniversity of California, San Francisco · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
The Statistics, Data Science, and Data Management (SDM) CoreP30MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI Claude Ann Mellins · 2003 to 2026
$48.2M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
Training in Biomedical Informatics at Columbia UniversityT15LM007079 · NLM · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI NOEMIE ELHADAD, GEORGE M HRIPCSAK · 1992 to 2026
$28.9M
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
The Next Frontier in Diabetes Communication: Promoting Health Literacy in the Era of Secure MessagingR01LM012355 · NLM · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KARTER, ANDREW JOHN, SCHILLINGER, DEAN · 2015 to 2018
$2.8M
I3DEAL for HIV ResearchR03MH103957 · NIMH · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI BAKKEN, SUZANNE · 2014 to 2015
$160k
NIAID NIH HHS U01 AI068633NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI106707NIMH NIH HHS P30 MH043520NIMH NIH HHS P30 MH062246NIMH NIH HHS R03 MH103957NLM NIH HHS R01 LM012355NLM NIH HHS T15 LM007079
6 · The paper itself

Abstract

Adherence to product use in biomedical HIV prevention trials is essential to success. In MTN-017, a Phase 2 rectal microbicide gel trial, participants discussed applicator-inserted gel use in the context of receptive anal intercourse (RAI) with adherence counselors. We analyzed counseling session data to identify barriers to and facilitators of gel use for 26 participants in the United States who used gel with RAI as their first of three study regimens. The most common barriers were finding the gel application process cumbersome, physical discomfort after applying gel, difficulty with BAT-24 dosage regimen, and negative effects of gel on sex. The most common facilitators were incorporating gel use into routines, using gel in anticipation of sex, carrying gel when going out, reminders received via short message service, and ease of gel use. These findings can inform product development and future adherence counseling interventions for rectal gel trials to improve adherence outcomes.

Indexed as

Medication AdherencePersonal SatisfactionAdministration, RectalAdultAnti-Infective Agents, LocalBostonDrug Delivery SystemsFemaleGelsHIV InfectionsHomosexuality, MaleHumansMalePatient Acceptance of Health CarePhiladelphiaSan FranciscoAnti-Infective Agents, LocalGelsAdherenceCounselingHIVMicrobicideText messaging

Identifiers

PMID28825142
PMCPMC5818328
OpenAlexW2748792194

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.