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

Study Overview
=================
Brief 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.

Official Title
-----------------
Theoretically Based Mobile App to Increase PrEP Uptake Among MSM

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: HealthMindr App
* Behavioral: Control App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cisgender male 18-34 years of age (inclusive) Resides in one of the study MSAs Intends to remain in study area for duration of the trial Owns an Android or Apple operating system (iOS) smartphone and willing to download study app 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 Exclusion Criteria: Cisgender female, transgender male, transgender female, gender non-conforming Currently on PrEP < 18 or >34 years of age Reports being HIV positive Resides outside of the MSAs or plans to move outside study MSA within 12 months Current participant in another HIV prevention study Unable to download study app

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HealthMindr App<br>Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area. | Behavioral: HealthMindr App<br>* 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.<br>|
| Placebo Comparator: Control App<br>Participants in the control arm will be directed to download a study app that allows study staff to interact with them. | Behavioral: Control App<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PrEP Uptake | PrEP uptake will be assessed at each follow-up timepoint (3, 6, 9, and 12 months) in the intervention and control groups. The primary measure of PrEP uptake will be self-report. Validation will occur through submission of a dried blood spot self-collection kit to detect tenofovir diphosphate (TFV-DP) and/or upload of a photo of a PrEP prescription bottle. | 3, 6, 9, and 12 months post-randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Immunodeficiency Virus (HIV), Men who have sex with men (MSM), Pre-Exposure Prophylaxis (PrEP), HealthMindr