A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

Jeb Jones, Karen Dominguez, Rob Stephenson, Joanne D Stekler, Amanda D Castel, Leandro A Mena, Samuel M Jenness, Aaron J Siegler, Patrick S Sullivan, Jeb Jones, Karen Dominguez, Rob Stephenson, Joanne D Stekler, Amanda D Castel, Leandro A Mena, Samuel M Jenness, Aaron J Siegler, Patrick S Sullivan

Abstract

Background: HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low.

Objective: The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States.

Methods: In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription.

Results: Participant recruitment began in January 2020.

Conclusions: This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States.

Trial registration: ClinicalTrials.gov NCT03763942; https://ichgcp.net/clinical-trials-registry/NCT03763942.

International registered report identifier (irrid): PRR1-10.2196/16231.

Keywords: HIV; electronic health; men who have sex with men; mobile health; pre-exposure prophylaxis.

Conflict of interest statement

Conflicts of Interest: JDS reports involvement in HPTN 069/ACTG A5305 in which Gilead and ViiV contributed study medications and attending a Gilead Latinx Advisory Board Meeting in 2018. LAM reports funding from Gilead Sciences, Merck, ViiV Healthcare, and Roche.

©Jeb Jones, Karen Dominguez, Rob Stephenson, Joanne D Stekler, Amanda D Castel, Leandro A Mena, Samuel M Jenness, Aaron J Siegler, Patrick S Sullivan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.02.2020.

Figures

Figure 1
Figure 1
Study schema depicting planned enrollment in each arm and the schedule of surveys and monthly self-assessments. PrEP: pre-exposure prophylaxis.
Figure 2
Figure 2
Screenshots of the splash screen, home page, and all about PrEP screen of the HealthMindr app. FAQ: frequently asked questions; PrEP: pre-exposure prophylaxis; STI: sexually transmitted infection.

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