Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 1, 2022
Date Accepted: Mar 22, 2022
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Optimizing an mHealth intervention to improve uptake and adherence of the HIV pre-exposure prophylaxis (PrEP) in vulnerable adolescents and emerging adults: Protocol for a multi-phase trial
ABSTRACT
Background:
Vulnerable adolescents and emerging adults (ages 18-29), particularly young transgender women (hereafter called vulnerable youth), are among the fastest growing HIV+ populations worldwide. Thailand has the highest adult HIV seroprevalence in Asia, with rates of infection among this population of 18%. Widespread technology offers opportunities for innovative mHealth interventions. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for at-risk individuals. PrEP is highly effective when taken as prescribed, but uptake and adherence have been low, with high discontinuation rates among youth.
Objective:
We propose to develop and pilot a multi-component, technology-based intervention to promote PrEP usage. We will adapt an existing two-session, technology-delivered, Motivational Interviewing intervention to focus on PrEP use in vulnerable youth in Thailand, resulting in the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also refine and enhance “YaCool,” a mobile app with integrated text messaging developed and used clinically by our Thai team, to develop “enhanced YaCool” for self-management of gender/sexual health (including PrEP). Our primary aim is to develop and assess preliminary efficacy of the resulting mHealth intervention.
Methods:
We will utilize a Multiphase Optimization Strategy (MOST) to identify the most effective intervention component or combination of components to address PrEP usage in this population. The study includes 2 phases. Phase I (R21) includes qualitative interviews with key stakeholders to explore barriers and facilitators of PrEP usage through thematic analysis to inform intervention adaptation. Following this, we will adapt and beta-test MES-PrEP and enhanced YaCool for functionality and feasibility using a community advisory board of HIV-negative Thai vulnerable youth. In Phase II (R33), we will conduct a MOST design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and YaCool. Eighty HIV-negative youth who are on PrEP and 80 youth who are not starting PrEP will be randomized to four conditions: 1) Standard PrEP Counseling (SPC, control), 2) MES-PrEP + SPC, 3) enhanced YaCool + SPC, and 4) MES-PrEP + enhanced YaCool + SPC. Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of PrEP initiation and level of adherence to PrEP. Assessments will be at baseline and 1, 3, 6, 9, and 12 months post-intervention. Biomarkers of adherence to PrEP and HIV/STI will be collected.
Results:
Upon project completion, we will have an optimized mHealth intervention to support vulnerable youth using PrEP which will be ready for testing in a larger efficacy trial.
Conclusions:
Despite facing increasing risk for HIV, few interventions have targeted Thailand’s most vulnerable youth. Effective developmentally- and culturally-tailored interventions are needed to prevent HIV transmission in this high-risk population. Clinical Trial: Clinicaltrials.gov NCT05262426.
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