Connecting Youth and Young Adults to Optimize ART Adherence (YouTHrive): Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Youth account for a disproportionately high rates of new HIV infections in the United States (US). Despite intensive efforts to engage people living with HIV (PLWH) in the US, less than half of 13-24 years old achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. OBJECTIVE There are three phases of this project. Phase 1 involves conducting focus groups in three cities (New York City, Chicago, and Houston) to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YouTHrive intervention among youth living with HIV (YLWH) in 6 US cities (Atlanta, New York City, Chicago, Houston, Philadelphia, and Tampa). METHODS In Phase 1, we will conduct six focus groups with approximately 8 youths (15-19 years old) and young adults (20-24 years old) each in three US cities to obtain: 1) feedback from YLWH about the “look and feel” and content of an existing adult-focused web-based ART adherence intervention; and 2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve collaboration with our technology development partner to update the existing intervention to include features and functionality recommended by YLWH in Phase 1. Phase 2 will conclude with beta testing with 12 participants to ensure that all features are working properly and function in a way that users can easily navigate. For Phase 3, we will enroll 300 YLWH in 6 US cities into a two-arm prospective randomized controlled trial (RCT). Participants randomized to the control condition will view a weekly newsletter for 20 weeks. The newsletter will be delivered via e-mail and will contain information on topics related to HIV, with the exception of ART adherence. Participants randomized to the YT intervention condition will be given access to the YT site for 20 weeks. Study assessments will occur at enrollment and 5, 8, and 11 months postenrollment. RESULTS Participant recruitment began in May 2017 for Phase 1 of the study. The data collection for Aim 3 is anticipated to end in April 2020. CONCLUSIONS The efficacy trial of the YT intervention will help to fill gaps in understanding about the efficacy of mobile interventions to improve ART adherence among at-risk populations. Other important questions remain to be addressed, including how best to incorporate virtual ART interventions into clinical care and when they are most effectively delivered. CLINICALTRIAL ClinicalTrials.gov (NCT03149757); University of North Carolina at Chapel Hill Institutional Review Board (16-3136).

Pregnancy in an Urban Cohort of Adolescents Living with Human Immunodeficiency Virus: Characteristics and Outcomes in Comparison to Adults

“…[17][18][19][20] Several additional studies investigating novel approaches for ALHIV engagement in care are ongoing. [21][22][23][24] These interventions should be studied in pregnancy as well.…”