NCT05762705Recruiting
A Mobile Gaming App to Improve Adherence to PrEP
A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 12 Feb 2023
- Start date
- 21 Jun 2024
- Primary completion date
- 3 Mar 2027
- Lead sponsor
- Rhode Island Hospital
- Diseases
- HIV
- NCT number
- NCT05762705
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 21 Jun 2024 to the primary completion date, 3 Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- 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.
Age in the registry: 15 years to 34 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Lifespan (The Miriam Hospital and Rhode Island Hospital) Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.