HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study is a randomized controlled clinical trial of a theoretically based mobile app,
      HealthMindr, to increase pre-exposure prophylaxis (PrEP) uptake among men who have sex with
      men (MSM) to prevent human immunodeficiency virus (HIV). Participants in the intervention arm
      will receive access to the HealthMindr app, with information about PrEP and other HIV
      prevention methods in addition to provider locators. Participants randomized to the control
      arm will receive standard of care. The primary aim for this study is to assess PrEP uptake in
      the intervention arm compared to the control arm.
    

Detailed description: 
      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.
    

Intervention name(s): HealthMindr App; Control App
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home 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 information about obtaining health insurance coverage and paying for PrEP.; Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial will include 657 participants with 2:1 allocation for the intervention (438) and control (219) conditions. Recruitment strategies will be formulated to increase enrollment of MSM who identify as members of racial/ethnic minority groups.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Human Immunodeficiency Virus (HIV); Men who have sex with men (MSM); Pre-Exposure Prophylaxis (PrEP); HealthMindr