An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

Aaron J Siegler, James B Brock, Christopher B Hurt, Lauren Ahlschlager, Karen Dominguez, Colleen F Kelley, Samuel M Jenness, Gretchen Wilde, Samuel B Jameson, Gina Bailey-Herring, Leandro A Mena, Aaron J Siegler, James B Brock, Christopher B Hurt, Lauren Ahlschlager, Karen Dominguez, Colleen F Kelley, Samuel M Jenness, Gretchen Wilde, Samuel B Jameson, Gina Bailey-Herring, Leandro A Mena

Abstract

Background: Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored mobile phone app, specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care.

Objective: The goal of this study is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (electronic PrEP, ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up.

Methods: This 2-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged between 18 and 24 years from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of black or Latino men who have sex with men. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate in dried blood spots).

Results: Enrollment will begin in May 2019, with study completion in 2022.

Conclusions: This trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small-town areas of the United States.

Trial registration: ClinicalTrials.gov NCT03729570; https://ichgcp.net/clinical-trials-registry/NCT03729570 (Archived by WebCite at http://www.webcitation.org/78RE2Qizf).

International registered report identifier (irrid): PRR1-10.2196/13982.

Keywords: mHealth; mobile apps; pre-exposure prophylaxis; prevention; sexual and gender minorities; smartphone; telehealth; telemedicine.

Conflict of interest statement

Conflicts of Interest: AJS is an investigator on a grant from the Gilead Foundation, which is paid to his institution. He is an investigator on a study for which Gilead Sciences has donated the study drug. CBH is the University of North Carolina site investigator of record for an industry-sponsored clinical trial of PrEP (DISCOVER; NCT02842086), under an interinstitutional contract between the UNC and Gilead Sciences. LAM has received an honorarium from Gilead Science as consultant and member of their Speakers Bureau.

©Aaron J Siegler, James B Brock, Christopher B Hurt, Lauren Ahlschlager, Karen Dominguez, Colleen F Kelley, Samuel M Jenness, Gretchen Wilde, Samuel B Jameson, Gina Bailey-Herring, Leandro A Mena. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.06.2019.

Figures

Figure 1
Figure 1
Electronic pre-exposure prophylaxis (ePrEP) study flow chart. DBS: dried blood spot; M: month; TFV-DP: tenofovir diphosphate.
Figure 2
Figure 2
Electronic pre-exposure prophylaxis (ePrEP) intervention and study measures in Andersen behavioral model.
Figure 3
Figure 3
Screenshots of the eP app.

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