Evidence map›Paper›PMID 30318905›Full record

Trial reportAIDS care2019

Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men.

Cheng-Shiun Leu, Rebecca Giguere, José A Bauermeister, Curtis Dolezal, William Brown, Ivan C Balán, Barbra A Richardson, Jeanna M Piper, Javier R Lama, Ross D Cranston and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in AIDS care, 2019. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. 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 at 7 institutions in 2 countries.

Cheng-Shiun Leua HIV Center for Clinical and Behavioral Studies , New York State Psychiatric Institute and Columbia University , New York , NY , USA.
Rebecca Giguerea HIV Center for Clinical and Behavioral Studies , New York State Psychiatric Institute and Columbia University , New York , NY , USA.ORCID 0000-0002-6529-0550
José A Bauermeisterb School of Nursing , University of Pennsylvania , Philadelphia , PA , USA.
Curtis Dolezala HIV Center for Clinical and Behavioral Studies , New York State Psychiatric Institute and Columbia University , New York , NY , USA.
William Browna HIV Center for Clinical and Behavioral Studies , New York State Psychiatric Institute and Columbia University , New York , NY , USA.
Ivan C Balána HIV Center for Clinical and Behavioral Studies , New York State Psychiatric Institute and Columbia University , New York , NY , USA.
Barbra A Richardsond Department of Biostatistics , University of Washington , Seattle , WA , USA.
Jeanna M Pipere Division of AIDS , National Institute of Allergy and Infectious Diseases , Rockville , MD , USA.
Javier R Lamaf Asociación Civil Impacta Salud y Educación , Lima , Peru.
Ross D Cranstong Department of Medicine , University of Pittsburgh , Pittsburgh , PA , USA.
Alex Carballo-Diégueza HIV Center for Clinical and Behavioral Studies , New York State Psychiatric Institute and Columbia University , New York , NY , USA.
New York Psychoanalytic Society and Institute · USAsociación Civil Impacta Salud y Educación · PENational Institute of Allergy and Infectious Diseases · USUniversity of California, San Francisco · USUniversity of Pennsylvania · USUniversity of Pittsburgh · USUniversity of Washington · 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
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
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
Social Interventions to address disparities In young adult tobacco useP60MD006902 · NIMHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BIBBINS-DOMINGO, KIRSTEN · 2012 to 2016
$6.4M
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
NIAID NIH HHS U01 AI068633NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI106707NIMHD NIH HHS P60 MD006902NIMH NIH HHS P30 MH043520NLM NIH HHS R01 LM012355NLM NIH HHS T15 LM007079
6 · The paper itself

Abstract

We examined product adherence among 187 men who have sex with men and transgender women enrolled in a phase II, crossover trial comparing safety and acceptability of an oral tablet and a rectal gel used daily for HIV prevention. Participants reported adherence via daily text messages during 8-week periods. Trajectory analysis identified weekly patterns. Polytomous logistic regression identified characteristics associated with higher probability of trajectory group membership. We identified 3 groups per product: high-adherers (72% daily oral, 70% daily gel); decreasing-adherers (20% daily oral, 22% daily gel); and low-adherers (8% daily oral, 9% daily gel). Daily oral high-adherers (compared with low-adherers) were more likely to self-identify as male (OR = 4.76, 95% CI:1.35-16.67), to have more sexual partners (OR = 1.67, 95% CI:1.04-2.63), and to find the tablet easy to swallow (OR = 2.22, 95% CI:1.08-4.76). Daily gel high-adherers (compared with low-adherers) were more likely to be older (OR = 1.16, 95% CI:1.05-1.28), to find gel application easier at the last few applications (OR = 2.27, 95% CI:1.01-5.00), and to report a change in routine if gel was not used (OR = 5.26, 95% CI:1.23-100.00). Characteristics of participants likely to be high-adherers to product use vary according to product. Evaluation of acceptability prior to phase II/III trials could identify participants likely to maintain high adherence.

Indexed as

Drug MonitoringSexual and Gender MinoritiesTransgender PersonsAdministration, OralAdministration, RectalAdolescentAdultAnti-HIV AgentsCross-Over StudiesFemaleGelsHIV InfectionsHumansMaleMiddle AgedSexual BehaviorAnti-HIV AgentsGelsTabletsadherencemicrobicidesPrEPSMStrajectory

Identifiers

PMID30318905
PMCPMC6382555
OpenAlexW2896970558

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.