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

NCT03763942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 658

Last updated 2024-06-04

Study results available
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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.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

HealthMindr App

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.

BEHAVIORAL

Control App

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Patrick Sullivan, DVM PhD · Emory University

  • Jeb Jones, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2023-03-17
Completion
2023-03-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763942 on ClinicalTrials.gov