Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: 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 or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection. Objective This protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years). Methods Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (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 rerandomization. Results Funding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in 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 a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults. Trial Registration ClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724 International Registered Report Identifier (IRRID) DERR1-10.2196/18326

mHealth for transgender and gender-expansive youth: harnessing gender-affirmative cross-disciplinary innovations to advance HIV prevention and care interventions

“…F o r m a n y T G E y o u t h , t e c h n o l o g y -m e d i a t e d interventions are situated within this rich, yet fractious, online milieu, in which TGE youth spend approximately 5 hours daily (29). Recent mHealth interventions, which aim to build upon evidence-based bio-behavioral HIV prevention strategies, intend to activate this online milieu to advance the health and wellbeing of these vulnerable communities (43). Notably, the field of HIV prevention is not alone in advancing genderaffirming mobile interventions for TGE communities.…”

“…messages, demonstrated significant outcomes for increased antiretroviral treatment (ART) uptake, excellent ART adherence, and viral suppression among trans-feminine young adults (ages 18-34) living with HIV (97). As of May 2020, TechStep, with its webapp, SMS, and eCoaching platforms (which we reviewed independently) are in the midst of a randomized controlled trial to determine their efficacy in reducing behavioral risk for HIV/STI acquisition and encouraging PrEP uptake and adherence (43). The they2ze app, developed by the nonprofit YTH [Youth + Tech + Health (98)], and the QueerDoc telehealth service ( 75), both include linkages to HIV services.…”

“…Among the 24 platforms, six described their theoretical groundings, which were mostly focused on HIV (n=5), with the exception of QueerViBE. The two SMS-enabled interventions reviewed, TechStep: SMS and Text Me, Girl!, were grounded in the Health Belief Model, Social Cognitive Theory, and Social Support Theory, aiming to identify health-protective behaviors and health threats, bolster individuals' self-efficacy, and embrace available instrumental, emotional, and informational supports, respectively (43,97). The TechStep: webapp intervention was developed based on the Information Motivation Behavioral Skills (IMB) model, which highlights the role of informational attainment and motivational drivers in the adoption of health-protective behaviors (91).…”

“…The TechStep: webapp intervention was developed based on the Information Motivation Behavioral Skills (IMB) model, which highlights the role of informational attainment and motivational drivers in the adoption of health-protective behaviors (91). Motivational interviewing (MI) guided both Project Moxie and TechStep: eCoaching; the latter of which employed a hybrid MI-Cognitive Behavioral Therapy (CBT) approach to empower TGE users through evoking their own capacities for selfdetermination and health-protective decision-making (6,43).…”

“…Each theory corresponds to 90 distinct messages along the HIV Prevention Continuum, for a total library of 270 messages. The text messages cover holistic understandings of health and wellness, linkage to HIV prevention services, and PrEP uptake and adherence(43).SMS/text message YesImmediate and sustained effects will be compared to those of the TechStep: webapp (see above) condition on the RCT's primary outcomes of interest(43).TechStep: eCoaching is an online counseling intervention tailored toward TechStep: webapp and TechStep: SMS users who could benefit from a more intensive model of care. At the trial's 3-month assessment, TechStep users engaging in refractory sexual risk behaviors may be re-randomized to the "eCoaching" intervention.…”