N/A
N=658
HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM)
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03763942 ↗Enrolled (actual)
658
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: PrEP Uptake — 2.764; 2.116; 2.104; 1.837 events per 1000 person-months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HealthMindr App (Behavioral); Control App (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Uptake |
2.764; 2.116; 2.104; 1.837; 1.762; 1.509 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT03763942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.