A Mobile Gaming App to Improve Adherence to PrEP

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-34
SponsorRhode Island Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Multilevel Gaming AdherenceExperimental treatment 1 intervention
Group B: Treatment as Usual +Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
24 weeks

Secondary outcomes

1

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).

Time frame
48 weeks
2

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).

Time frame
24 weeks
3

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).

Time frame
48 weeks
4

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.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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