A Mobile Gaming App to Improve Adherence to PrEP
Recruiting · NCT05762705 · Interventional (participants receive a specific treatment) · Lead sponsor: Rhode Island Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.
Who can take part
Inclusion criteria
- 15-34 years old
- English speaking
- Initiated PrEP in the last 30 days or re-initiated PrEP after not taking PrEP for at least 1 month
- HIV negative as per clinician and clinical record
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
Exclusion criteria
- None
Where it is running
3 locations listed across 3 US states.
- Boston Medical Center - Boston, Massachusetts, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- Lifespan (The Miriam Hospital and Rhode Island Hospital) - Providence, Rhode Island, United States