Evidence map›Paper›PMID 27129533›Full record

ArticleArchives of sexual behavior2017

Lessons for Rectal Microbicide Development From an Acceptability Trial of a Placebo Gel Applied Prior to Receptive Anal Intercourse.

Timothy Frasca, Rebecca Giguere, Mobolaji Ibitoye, Curtis Dolezal, Irma Febo, Ross D Cranston, Kenneth Mayer, Ian McGowan, Alex Carballo-Diéguez

Abstract readClinical Trial, Phase I
In one paragraph

Article in Archives of sexual behavior, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. 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
  7. Article
  8. Acceptability of a Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-033 Study).AIDS education and prevention : official publication of the International Society for AIDS Education · 2021
    Article
  9. Article
  10. Article
  11. 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

9 authors.

Timothy FrascaHIV Center for Clinical & Behavioral Studies, New York State Psychiatric Institute/Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. frascat@nyspi.columbia.edu.
Rebecca GiguereHIV Center for Clinical & Behavioral Studies, New York State Psychiatric Institute/Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.
Mobolaji IbitoyeDepartment of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.
Curtis DolezalHIV Center for Clinical & Behavioral Studies, New York State Psychiatric Institute/Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.
Irma FeboDepartment of Pediatrics, Medical Sciences Campus, University of Puerto Rico, San Juan, PR, USA.
Ross D CranstonDivision of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Kenneth MayerThe Fenway Institute, Fenway Health, Boston, MA, USA.
Ian McGowanDivision of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Alex Carballo-DiéguezHIV Center for Clinical & Behavioral Studies, New York State Psychiatric Institute/Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.

Funding

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 Puerto Rico Clinical Trials UnitUM1AI069415 · NIAID · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI FEBO, IRMA LUZ, SANTANA-BAGUR, JORGE L. · 2012 to 2021
$15.2M
Microbicide Safety and Acceptability in Young MenR01HD059533 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MCGOWAN, IAN MICHAEL · 2009 to 2012
$6.6M
Early Menarche and the Reproductive Health of Ghanaian Girls and Young WomenF31HD089592 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI IBITOYE, MOBOLAJI OMOWUMI · 2016 to 2018
$97k
NIAID NIH HHS UM1 AI069415NICHD NIH HHS F31 HD089592NICHD NIH HHS R01 HD059533NIMH NIH HHS P30 MH043520
6 · The paper itself

Abstract

Rectal microbicides, formulated as a gel to be applied before and/or after intercourse, are promising HIV prevention agents and are now in Phase II trials. However, both an optimal formulation and a practical delivery system are needed to ensure that the target population will use the product once efficacy is demonstrated. The precise dynamics of lubricant application by gay and bisexual men who practice anal sex and the qualities they seek in these products are underexplored. As part of a Phase I microbicide acceptability and adherence study conducted in one Puerto Rican and two continental U.S. cities, we recruited 124 young men who have sex with men (YMSM) with a history of unprotected receptive anal intercourse (RAI) and provided them with 40 rectal applicators containing a placebo gel to use prior to RAI during a 12-week period as a proxy for an eventual rectal microbicide. Ninety-five YMSM completed the trial. Their varied preferences as to product viscosity, durability, residue, and mode of application provide important lessons for the design of a product that will be satisfactory to users. Despite many reservations, the participants used the product frequently and found ways to overcome a range of obstacles. A successful rectal microbicide product may need to be presented in a range of viscosities to attract a broad client base.

Indexed as

Homosexuality, MaleSexual BehaviorAdolescentAdultAnti-Infective AgentsHumansLubricantsMalePatient Acceptance of Health CarePatient PreferenceYoung AdultAnti-Infective AgentsLubricantsAnal intercourseLubricantsMen who have sex with menMicrobicidesSexual orientation

Identifiers

PMID27129533
PMCPMC5086303

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.