A Mobile Gaming App to Improve Adherence to PrEP

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rhode Island Hospital
Study ID
NCT05762705
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 34 Years
Healthy Volunteers
Accepted

Interventions

  • Multilevel Gaming Adherence Intervention — BEHAVIORAL
    Information-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages
  • Treatment as Usual + — BEHAVIORAL
    non-PrEP related mobile gaming application

Study Details

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.

Key Dates

Start date
Jun 21, 2024
Status verified
May 2025
Primary completion
Mar 3, 2027
Completion
Mar 3, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Multilevel Gaming Adherence
    Participants in the intervention arm will receive Multilevel Gaming Adherence Intervention. Participants receive Viral Combat on their mobile phones, and, for 24 weeks, game-related text messages guided by self-reported medication adherence.
  • Active Comparator: Treatment as Usual +
    TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game.

Primary Outcome Measure

Tenofovir (TFV) blood concentration at 24 weeks [ Time Frame: 24 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Sharon Vuppula, MD
[email protected]
University of Mississippi Medical CenterJacksonMississippi39216
James B Brock, MD
[email protected]
601-984-5560
Lifespan (The Miriam Hospital and Rhode Island Hospital)ProvidenceRhode Island02904
Larry K Brown, MD
[email protected]
401-793-8808

Find similar trials in Boston, MA

By condition
HIV
By specialty
Infectious disease
By research site
Boston Medical Center· Boston, MAUniversity of Mississippi Medical Center· Jackson, MSLifespan (The Miriam Hospital and Rhode Island Hospital)· Providence, RI

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