About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Multilevel Gaming Adherence Intervention
BehavioralInformation-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages
Treatment as Usual +
Behavioralnon-PrEP related mobile gaming application
Treatment groups
Trial outcomes
Primary outcomes
Tenofovir (TFV) blood concentration at 24 weeks
Tenofovir (TFV) concentration in blood from either venipuncture or dried blood spot labs immediately post-intervention (at 24 weeks follow-up).
Secondary outcomes
Tenofovir (TFV) blood concentration at 48 weeks
Tenofovir (TFV) concentration in blood from either venipuncture or dried blood spot labs at the end of study follow-up (at 48 weeks follow-up).
Self-reported Medication Adherence at 24 weeks
Proportion of days with missed doses via self-report: (reported missed doses in past month) / (total number of days in month) immediately post-intervention (at 24 weeks follow-up).
Self-reported Medication Adherence at 48 weeks
Proportion of days with missed doses via self-report: (reported missed doses in past month) / (total number of days in month) at the end of study follow-up (at 48 weeks follow-up).
Medical appointment adherence at 24 weeks
Number of PrEP-related medical visits kept in the past 3 months based on clinic records at 24 weeks follow-up.
Sponsors and contacts
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