HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM)

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.

Inclusion Criteria:

- Cisgender male

- 18-34 years of age (inclusive)

- Resides in one of the 3 study MSAs

- Intends to remain in study area for duration of the trial

- Owns a smartphone

- Able to read and understand English without assistance

- Reports having anal sex with a man in the past 6 months

- Reports being HIV negative or never tested for HIV

- Willingness to download mobile app

Exclusion Criteria:

- Cisgender female, transgender male, transgender female, gender non-conforming

- Currently on PrEP

- < 18 or >34 years of age

- Self-reported HIV positive

- Resides outside of the 3 MSAs or plans to move outside study MSA within 12 months

- Current participant in another HIV prevention study