What is Viral Combat studying for medication adherence?

Viral Combat is a mobile game being studied to see if it can improve how well people take their PrEP medication. The research compares this game to a non-HIV related game in young adults and adolescents receiving PrEP care. The study aims to understand if the game helps with medication use and clinic attendance, supported by Rhode Island Hospital.

Who may be eligible for this medication adherence clinical trial?

People aged 15 to 34 who speak English and have started or restarted PrEP within the last 30 days may be eligible. Participants must be HIV negative and able to provide consent without cognitive or medical limitations. Please review eligibility criteria for more details.

Is there any cost to participate in this medication adherence clinical trial?

Study-related care, including the study game and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered. Participants can expect to receive all study services without charge.

Actively Recruiting

Phase Not Applicable

Age: 15Years - 34Years

All Genders

Healthy Volunteers

ID05762705

A Multisite Randomized Trial of Viral Combat A Mobile Gaming App to Improve Adherence to PrEP

Led by Rhode Island Hospital · Updated on 2025-05-14

200

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the mobile game Viral Combat to see if it helps improve adherence to PrEP among diverse participants aged 15 to 34 years receiving PrEP care in clinical settings in New England and Mississippi. The study includes formative interviews with healthcare workers, clinic administrators, and patients to adapt the game for different populations and clinics. A randomized controlled trial will then compare Viral Combat to a non-PrEP related game to assess effects on biological and behavioral measures. Participants will be randomly assigned to one of two groups. One group will receive the Multilevel Gaming Adherence Intervention, which includes the Viral Combat mobile game and adherence-based text messages for 24 weeks. The other group will receive treatment as usual plus a non-HIV related mobile game. After the trial, additional interviews will evaluate factors that could affect future use of the game in clinical settings. Participants will complete assessments including biological tests measuring tenofovir blood levels at 24 and 48 weeks, self-reported medication adherence, and medical appointment adherence. The study will also collect data on knowledge, motivation, self-efficacy, and game metrics. The total participation includes a 24-week intervention period with follow-up assessments, along with interviews before and after the trial to inform game adaptation and implementation.

CONDITIONS

Brief Title

A Mobile Gaming App to Improve Adherence to PrEP

Who Can Participate

Age: 15Years - 34Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Between 15 and 34 years old
English speaking
Started or restarted PrEP within the last 30 days
HIV negative as confirmed by clinician and clinical record
Able to give consent and not impaired by cognitive or medical limitations as assessed clinically

You will not qualify if you...

Research Team

Laura Whiteley, MD

James B Brock, MD

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