MSM are disproportionately impacted in terms of HIV prevalence and incidence. Electronically delivered or supported prevention services are effective, are acceptable to MSM, and will likely reach heavily impacted men. The study is based on the premise that providing, through a mobile phone app, self-directed PrEP information; periodic behavioral screenings to identify HIV risk and PrEP indication objectively; referral to PrEP providers with directions; and related prevention services will increase the uptake of PrEP among at risk, HIV negative MSM to a greater extent than standard of care referrals to existing resources.
The study will examine the effectiveness of the HealthMindr app to increase uptake of PrEP among MSM. The study will enroll 657 men across the three sites - the metropolitan statistical areas (MSA) of Atlanta, Georgia (GA), Jackson, Mississippi (MS), and Washington, D.C. - into a randomized controlled trial. Participants in the intervention arm will receive access to the HealthMindr app and men in the control arm will receive standard of care HIV prevention information. PrEP uptake will be assessed during follow-up by self-report at months 3, 6, 9, and 12. Self-report will be confirmed by laboratory testing for the presence of tenofovir diphosphate (TFV-DP) and/or photograph of PrEP prescription or bottle.
At the beginning of the study, all participants will download a study mobile app. After completing a baseline survey, participants will be randomized to the intervention or control arm. For participants assigned to the intervention arm, additional app content will become available. This content will include information about basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home sexually transmitted infection (STI) specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides links to health insurance exchanges, where men can seek health insurance or assistance to help cover PrEP costs. The control arm will be referred to existing online PrEP and HIV prevention information. Participants in the control arm will access the control version of the app that contains elements pertinent to their participation in the research study.
Additional follow-up surveys will be conducted at 3, 6, 9, and 12 months and participants will also complete monthly assessments. The monthly assessments will assess indications for PrEP and PrEP uptake (intervention arm) and other health-related behaviors (control arm). Participants reporting PrEP initiation will be asked to submit a dried blood spot self-collection kit to allow for measurement of tenofovir diphosphate (TFV-DP) levels and/or upload a photo of their PrEP prescription bottle to verify PrEP uptake.
Participants will primarily be recruited online from the main study sites in Atlanta, Georgia, Jackson, Mississippi, and Washington, District of Columbia (DC). Online recruitment will expand to other areas of the United States, as needed to meet recruitment targets.
