Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 19, 2020
Date Accepted: Jul 7, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission: Study Protocol for a Randomized Controlled Trial (TechStep)
ABSTRACT
Background:
Transgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender/gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. Additionally, transgender youth experience increased physical/sexual abuse, victimization, substance use, mental health disorder(s), incarceration, homelessness and engagement in sex work. Due to these syndemic health disparities, transgender youth are at substantially increased risk for HIV infection.
Objective:
In a 3-condition randomized controlled trial (N=250), ATN160 TechStep assesses the differential immediate and sustained effects of a text messaging stepped care intervention (Text plus step to eCoaching for participants with continued high risk) condition compared to a WebApp stepped care intervention (WebApp plus step to eCoaching for participants with continued high risk) condition compared to a low intensity information (“Info”) condition for reducing sexual risk behaviors and increasing PrEP uptake among high-risk, HIV-negative transgender youth and young adults (ages 15-24 years).
Methods:
Participants will be randomized into one of three conditions: 1) text messaging, 2) WebApp; or, 3) information-only control for 6 months. Assessments will occur at baseline and 3-, 6- and 9-months. Participants who do not evidence improvements in sexual risk and/or PrEP uptake at the 3-month assessment will be re-randomized to either receive weekly eCoaching sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for re-randomization.
Results:
Recruitment began in November 2018 for Phase 1, the formative phase. The data collection for Phase 2, the randomized controlled trial, is expected to be completed in April 2021. Final results are anticipated for May 2021.
Conclusions:
By providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in the 3-condition randomized controlled trial, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults. Clinical Trial: ClinicalTrials.gov Identifier: NCT04000724 https://clinicaltrials.gov/ct2/show/NCT04000724
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.