NCT05762705 A Mobile Gaming App to Improve Adherence to PrEP
| NCT ID | NCT05762705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhode Island Hospital |
| Condition | Medication Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-21 |
| Primary Completion | 2027-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-06-21 with a primary completion date of 2027-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Larry K Brock, MD
STUDY DIRECTOR
Rhode Island Hospital
Frequently Asked Questions
Who can join the NCT05762705 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 34 Years, studying Medication Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05762705 currently recruiting?
Yes, NCT05762705 is actively recruiting participants. Contact the research team at laura_whiteley@brown.edu for enrollment information.
Where is the NCT05762705 trial being conducted?
This trial is being conducted at Boston, United States, Jackson, United States, Providence, United States.
Who is sponsoring the NCT05762705 clinical trial?
NCT05762705 is sponsored by Rhode Island Hospital. The principal investigator is Larry K Brock, MD at Rhode Island Hospital. The trial plans to enroll 200 participants.