Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 14, 2023
Date Accepted: Jul 21, 2023
Warning: This is an author submission that is not peer-reviewed or edited.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.
Evaluating the Feasibility and Acceptability of an Online PrEP Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth in Los Angeles County (PrEPresent): Protocol for a Pilot Randomized Controlled Trial
ABSTRACT
Background:
To end the HIV epidemic by 2030, we must double down on efforts to tailor prevention interventions to both YMSM and transgender and non-binary youth. There is an urgent need for interventions that specifically focus on PrEP uptake within sexual and gender minority youth populations. There are several factors that impact SGMY ability to successfully engage in the HIV prevention continuum, including uptake of PrEP. Patient activation, having the knowledge, skills, and self-efficacy to manage one’s health, is an important indicator of willingness and ability to manage one’s own health and care autonomously. Patient navigation also plays an important role in helping SGMY access PrEP and PrEP care, as navigators help guide patients through the healthcare system, set up medical appointments, and get financial, legal, and social support.
Objective:
This study aims to evaluate the feasibility and acceptability of an online PrEP navigation and activation intervention among a racially and ethnically diverse sample of SGM youth living in the Los Angeles area.
Methods:
In Phase 1, we will conduct formative research to inform the development of PrEPresent using qualitative data from Key Informant Interviews involving PrEP care providers and navigators and working groups with SGM youth. In Phase 2, we will complete two rounds of usability testing of PrEPresent with 8-10 SGM youth assessing both the intervention content and mHealth delivery platform to ensure features are usable and content is understood. In Phase 3, we will conduct a pilot RCT to evaluate the feasibility and acceptability of PrEPresent. We will randomize, 1:1, a racially and ethnically diverse sample of 150 SGM youth aged 16-26 years living in the Los Angeles area and follow participants for six months.
Results:
Phase 1 (formative work) was completed in April 2021. Usability testing was completed in December 2021. As of June 2023, 148 participants have been enrolled into the PrEPresent pilot RCT (Phase 3). Enrollment is expected to be completed in July 2023, with final results anticipated in December 2023.
Conclusions:
The PrEPresent intervention aims to bridge the gaps in PrEP eligibility and PrEP uptake among racially and ethnically diverse SGMY. By facilitating the delivery of PrEP navigation and focusing on improving patient activation, the PrEPresent intervention has the potential to positively impact the PrEP uptake cascade within the HIV care continuum as well as the serve as a model for the tailoring of PrEP interventions based on behavior-based qualifications for PrEP instead of generalized gender-based eligibility. Clinical Trial: ClinicalTrials.gov NCT05281393; https://clinicaltrials.gov/ct2/show/NCT05281393
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