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

3

Research Sites

N/A

Total Duration

On this page

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

Eligible

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 24 weeks

Participants use a mobile gaming app designed to improve adherence to PrEP, receiving game-related text messages tailored to self-reported medication adherence.

Regular interaction with the mobile app; follow-up visits may occur as part of PrEP care

Follow-up

Duration - 24 weeks

Participants are monitored to assess long-term adherence and health outcomes after the intervention period.

Follow-up visits coinciding with 48-week assessments

Trial Site Locations

Total: 3 locations

1

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

2

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Actively Recruiting

3

Lifespan (The Miriam Hospital and Rhode Island Hospital)

Providence, Rhode Island, United States, 02904

Actively Recruiting

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Research Team

L

Laura Whiteley, MD

J

James B Brock, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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