Evidence map›Paper›PMID 39521970›Full record

ArticleAddiction science & clinical practice2024

Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services Knowledge-PrEP (A.S.K.-PrEP).

Cathy J Reback, Raphael J Landovitz, David Benkeser, Ali Jalali, Steven Shoptaw, Michael J Li, Raymond P Mata, Danielle Ryan, Philip J Jeng, Sean M Murphy

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Addiction science & clinical practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05934877 (Optimizing PrEP Implementation and Cost-effectiveness Among Sexual and Gender Minority Individuals With a Substance Use Disorder), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT05934877 naterminatednot on this map

Optimizing PrEP Implementation and Cost-effectiveness Among Sexual and Gender Minority Individuals With a Substance Use Disorder

TypeinterventionalSponsorFriends Research Institute, Inc.Ran2023 to 2025Enrolled152ConditionsSubstance Use Disorders, HIVArmsPrEP navigation + text messaging, Standard of Care, Contingency Management
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

10 authors.

Cathy J RebackFriends Research Institute, Inc, Los Angeles, CA, USA.
Raphael J LandovitzCenter for HIV Identification, Prevention and Treatment Services, Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Ali JalaliDepartment of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Steven ShoptawCenter for HIV Identification, Prevention and Treatment Services, Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
Michael J LiCenter for HIV Identification, Prevention and Treatment Services, Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
Raymond P MataFriends Research Institute, Inc, Los Angeles, CA, USA.
Danielle RyanDepartment of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Philip J JengDepartment of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Sean M MurphyDepartment of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA. smm2010@med.cornell.edu.ORCID 0000-0001-9104-0670

Funding

UCLA Rapid, Relevant, Rigorous Implementation Science HubP30MH058107 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Sung-Jae Lee · 1997 to 2026
$53.5M
Utilization of health services after engagement with opioid use disorder (OUD) treatment provider by individuals with and without post-traumatic stress disorderP30DA040500 · NIDA · WEILL MEDICAL COLL OF CORNELL UNIV · PI Bruce R Schackman · 2015 to 2026
$20.7M
Optimizing PrEP Implementation and Cost-effectiveness among Sexual and Gender Minority Individuals with a Substance Use DisorderR01DA056888 · NIDA · FRIENDS RESEARCH INSTITUTE, INC. · PI MURPHY, SEAN M., REBACK, CATHY J · 2022 to 2025
$3.3M
Trajectories of socially regulated gene expression, methamphetamine use, and viral load among HIV-positive men who have sex with men (MSM) receiving contingency managementK01DA051329 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LI, MICHAEL JONATHAN · 2021 to 2025
$947k
NIDA NIH HHS K01 DA051329NIDA NIH HHS K01DA051329NIDA NIH HHS P30 DA040500NIDA NIH HHS P30DA040500NIDA NIH HHS R01 DA056888NIDA NIH HHS R01DA056888NIMH NIH HHS P30 MH058107NIMH NIH HHS P30MH58107
6 · The paper itself

Abstract

backgroundIn the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration.

objectiveTo determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD.

methodsThis study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone).

resultsRecruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027. DISCUSSION: Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances.

trial registrationThis trial has been registered at ClinicalTrials.gov under the number NCT05934877.

Indexed as

HIV InfectionsPre-Exposure ProphylaxisSexual and Gender MinoritiesSubstance-Related DisordersTransgender PersonsAdultAnti-HIV AgentsFemaleHumansMalePatient NavigationRandomized Controlled Trials as TopicUnited StatesAnti-HIV AgentsHIVPrEP care ContinuumSexual minority menSubstance Use DisorderTransgender women

Identifiers

PMID39521970
PMCPMC11549772

What OpenQuestion holds

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LicenceCC BY
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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.