Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial
Authors: Stocks Jacob B , Calvetti Sam , Rosso Matthew T , Slay Lindsay , Kipke Michele , Puentes Manuel , Hightow-Weidman Lisa B 
Published: July 2023

Background
To end the HIV epidemic by 2030, we must double down on efforts to tailor prevention interventions to both young men who have sex with men and transgender and nonbinary youth. There is an urgent need for interventions that specifically focus on pre-exposure prophylaxis (PrEP) uptake in sexual and gender minority youth (SGMY) populations. There are several factors that impact the ability of SGMY 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 health care system, set up medical appointments, and get financial, legal, and social support.

Objective
This study aims to evaluate the feasibility and acceptability of a digital PrEP navigation and activation intervention among a racially and ethnically diverse sample of SGMY 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 SGMY. In phase 2, we will complete 2 rounds of usability testing of PrEPresent with 8-10 SGMY assessing both the intervention content and mobile health delivery platform to ensure features are usable and content is understood. In phase 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of PrEPresent. We will randomize, 1:1, a racially and ethnically diverse sample of 150 SGMY aged 16-26 years living in the Los Angeles area and follow participants for 6 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 randomized controlled trial (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 in the HIV care continuum as well as serve as a model for the tailoring of PrEP interventions based on behavior-based qualifications for PrEP instead of generalized gender-based eligibility.

Trial Registration
ClinicalTrials.gov NCT05281393; https://clinicaltrials.gov/ct2/show/NCT05281393

International Registered Report Identifier (IRRID)
DERR1-10.2196/50866