HIV Infections Clinical Trial
Official title:
Theoretically Based Mobile App to Increase PrEP Uptake Among MSM
Verified date | April 2023 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 658 |
Est. completion date | March 17, 2023 |
Est. primary completion date | March 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 34 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
United States,
Jones J, Dominguez K, Stephenson R, Stekler JD, Castel AD, Mena LA, Jenness SM, Siegler AJ, Sullivan PS. A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 21;9(2):e16231. doi: 10.2196/16231. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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