ATN 141: MYCHOICES

ClinicalTrials.gov Number: NCT03179319

Study Summary:

MyChoices is an intervention development and feasibility and acceptability study of MyChoices, a theory-driven mobile app to increase HIV testing and PrEP uptake by young men who have sex with men (YMSM), ages 15-24. MyChoices app will be refined in theater testing and an open technical pilot, and will then the acceptability and feasibility of this integrated app will be evaluated in a pilot randomized controlled trial (RCT) among YMSM at risk for HIV acquisition in the US.

Study Details:

Study Duration:

Aim 1: single study visit (focus group) for theater testing
Aim 2: 2 months
Aim 3: 6 months

Sample Size:

Aim 1: Up to 40 YMSM
Aim 2: Up to 15 YMSM across two iTech SRVs
Aim 3: 60 YMSM across four iTech SRVs

Eligibility:

  • Between 15 and 24 years of age
  • Assigned male sex at birth and male-identified
  • Self-report being HIV uninfected or HIV status-unknown at screening
  • Self-report having not had an HIV test in the past 3 months (for Aims 2 and 3 only)
  • Able to understand, read, and speak English
  • Owns or leases a phone wiht Android platform (for Aims 2 and 3) or iOS platform (Aim 3 only), and has an active data plan
  • More information on eligibility and exclusion criteria available on ClinicalTrials.gov

Primary Objectives:

  1. To refine a mobile phone app, “MyChoices”, to promote HIV/STI testing and PrEP uptake among YMSM by conducting theater testing with up to 20 YMSM. Data will be used to make final app refinements.
  2. To conduct a technical pilot with up to 15 YMSM to optimize MyChoices app functionality, technical performance, and user satisfaction. Data will be used to finalize the pilot study methods, the mobile app functionalities, and measures for the pilot trial (Aim 3).
  3. To conduct a pilot randomized controlled trial (RCT) with up to 60 YMSM to evaluate the feasibility and acceptability of MyChoices to increase HIV/STI testing and PrEP uptake among YMSM. Every 3 months, participants will complete a brief quantitative assessment (in person at baseline and online at follow-up) and app usage patterns will be assessed. The primary outcomes will be acceptability (mean score on the System Usability Scale) and feasibility (participants utilizing the app at least once during follow-up) of the app.

Protocol Chairs:

Katie Biello, PhD, MPH
Kenneth Mayer, MD