Evidence map›Paper›PMID 38066471›Full record

Trial reportBMC public health2023

A latent trajectory analysis of young sexual and gender minorities' adherence to three rectal microbicide placebo formulations (MTN-035; a randomized crossover trial).

Seul Ki Choi, José Bauermeister, Ryan C Tingler, Sherri Johnson, Nicole Macagna, Ken Ho, Craig Hoesley, Albert Liu, Noel Kayange, Thesla Palanee-Phillips and 4 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03671239 (Acceptability, Tolerability, and Adherence of Three Rectal Microbicide Placebo Formulations Among HIV Seronegative Cisgender Men, Transgender Men and Transgender Women Who Engage in Receptive Anal Intercourse), which is not on this map. Not yet cited in PubMed.

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

NCT03671239 nacompletednot on this map

Acceptability, Tolerability, and Adherence of Three Rectal Microbicide Placebo Formulations Among HIV Seronegative Cisgender Men, Transgender Men and Transgender Women Who Engage in Receptive Anal Intercourse

TypeinterventionalSponsorMicrobicide Trials NetworkRan2019 to 2020Enrolled217ConditionsHIV PreventionArmsPlacebo rectal insert, Placebo rectal suppository, Placebo rectal douche
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Seul Ki ChoiDepartment of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA. skchoi@nursing.upenn.edu.
José BauermeisterDepartment of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA.
Ryan C TinglerDepartment of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA.
Sherri Johnson, FHI 360, Durham, NC, USA.
Nicole Macagna, FHI 360, Durham, NC, USA.
Ken HoMagee-Women's Research Institute, Pittsburgh, PA, USA.
Craig HoesleyUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Albert LiuSan Francisco Department of Public Health, San Francisco, CA, USA.
Noel KayangeJohns Hopkins University Research Project, Blantyre, Malawi.
Thesla Palanee-PhillipsFaculty of Health Sciences, School of Public Health, Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.
Suwat ChariyalertsakFaculty of Public Health, Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.
Pedro GonzalesIMPACTA, San Miguel, Peru.
Jeanna M PiperDivision of AIDS/NIAID/NIH, Bethesda, MD, USA.
MTN-035 Protocol Team

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
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Sharon L. Hillier, JONATHAN KARN · 1994 to 2026
$50.0M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
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
Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU)UM1AI069399 · NIAID · CHIANG MAI UNIVERSITY · PI Kiat Ruxrungtham, Khuanchai Supparatpinyo · 2012 to 2026
$25.0M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
San Francisco Vaccine and Prevention UnitU01AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI BUCHBINDER, SUSAN · 2007 to 2011
$7.3M
NIAID NIH HHS P30 AI036219NIAID NIH HHS U01 AI068633NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069496NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069399NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

backgroundRectal microbicides (RM) are biomedical HIV prevention products that aim to prevent or reduce the transmission of HIV and other sexually transmitted infections (STIs). RM modalities may be beneficial for populations who have complex lifestyles, difficulties adhering to pre-exposure prophylaxis (PrEP) regimens, and/or have limited access to care. MTN-035 (DESIRE; Developing and Evaluating Short-Acting Innovations for Rectal Use), a randomized crossover trial, aimed to evaluate the safety and acceptability of, and adherence to, three placebo RM modalities (douche, insert, and suppository) prior to receptive anal intercourse.

methodsWe conducted latent trajectory analysis to identify clusters of individuals who shared similar trajectories in acceptability and adherence for each product (douche, insert, and suppository) over time. We analyzed weekly short messaging service (SMS) use reports for each modality as reported by enrolled sexual and gender minority (SGM) participants.

resultsTwo trajectories for each product were identified: a "protocol compliant" trajectory (i.e., at least one product use occasion per week) and "high use" trajectory (i.e., more than three product use occasions per week). Participants with high use were more likely to lack access to PrEP and have higher intentions to utilize RM modalities compared to those who were protocol compliant.

conclusionsThis study highlighted high adherence to RM modalities among SGM. As research into viable HIV prevention modalities continues to evolve, tailored intervention strategies are needed to support the uptake of and adherence to alternative prevention modalities that are behaviorally congruent with targeted users.

trial registrationNCT03671239 (14/09/2018).

Indexed as

Anti-HIV AgentsAnti-Infective AgentsHIV InfectionsPre-Exposure ProphylaxisSexual and Gender MinoritiesCross-Over StudiesHomosexuality, MaleHumansMaleSexual BehaviorAnti-HIV AgentsAnti-Infective AgentsHIV preventionPre-exposure prophylaxisRectal microbicideSexual and gender minoritiesSMSYouth

Identifiers

PMID38066471
PMCPMC10709877

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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.