Actively Recruiting

Phase Not Applicable
Age: 15Years - 34Years
All Genders
Healthy Volunteers
NCT05762705

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

140 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official 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...

  • Participants aged 15 to 34 years
  • English speaking
  • Initiated PrEP in the last 30 days or restarted PrEP after not taking it for at least 1 month
  • Confirmed HIV negative status by clinician and clinical record
  • Able to give consent or assent and not impaired by cognitive or medical limitations as per clinical assessment
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

J

James B Brock, MD

CONTACT

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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A Mobile Gaming App to Improve Adherence to PrEP | DecenTrialz