RESUMO
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.
RESUMO
BACKGROUND: On-demand dosing of preexposure prophylaxis (PrEP) requires accurate prediction of sex; however, prediction abilities among young men who have sex with men (YMSM) have not been characterized. SETTING: A nationally recruited prospective cohort of YMSM ages 16-24 years. METHODS: We followed 120 YMSM for 8 weeks using digital daily surveys (DDSs) to measure engagement in and prediction of anal sex over 24 hours, along with condom use and other encounter-level circumstances. Our main outcome, an "unpredicted spontaneous encounter," was defined as an anal sex encounter that occurred without sufficient prior knowledge to (hypothetically) enable protective on-demand PrEP use according to dosing guidelines. We operationalized this outcome as an anal sex encounter for which a participant indicated: (1) on the prior day's DDS that there was a low likelihood of sex occurring in the subsequent 24 hours (unpredicted) and (2) on the current day's DDS that he knew ≤2 hours in advance that the encounter would occur (spontaneous). RESULTS: Approximately one-third of all anal sex encounters during the study period were unpredicted and spontaneous and would not have been protected (hypothetically) by on-demand dosing. More than two-thirds of participants experienced such an encounter and almost three-quarters of all acts were condomless. CONCLUSIONS: On-demand PrEP to prevent HIV acquisition may be challenging for many YMSM. Clinical and public health approaches that account for patients' predictive abilities alongside their dosing preferences may help to optimize selection of and adherence to PrEP dosing strategies.