An interventional study of Multilevel Gaming Adherence Intervention and Treatment as Usual + in Medication Adherence and HIV/AIDS, sponsored by Rhode Island Hospital. Recruiting at 3 sites in United States. Open to participants aged 15 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention
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.
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.
Aim 1: To conduct formative evaluation interviews, guided by the i-PARHIS framework, with approximately 30 stakeholders (23 PrEP patients, 4 clinical staff, 3 clinic administrators) in order to adapt Viral Combat for diverse PrEP patient populations, and to identify individual, organizational, and structural factors associated with its implementation.
Aim 2: To evaluate, in a Hybrid Type 1 effectiveness-implementation randomized controlled trial with 200 participants taking PrEP (15-34 years of age), the effectiveness of Viral Combat compared to a control group that receives a non-PrEP related game.
The investigators will examine the impact of the intervention on:
2a: improving adherence to PrEP using a biological measure (tenofovir from DBS), clinic records, and self-report; 2b: the potential mediators of the intervention, such as knowledge, motivation, self-efficacy, and game metrics.
Aim 3: To conduct summative evaluation interviews, following the RCT phase, with an additional 30 stakeholders ((23 PrEP patients, 4 clinical staff, 3 clinic administrators). Interviews will assess and summarize the i-PARIHS constructs relevant to the intervention's future implementation success.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's planned enrollment of 200 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Multilevel Gaming Adherence Intervention
TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game.
Behavioral: Treatment as Usual +
Information-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages
non-PrEP related mobile gaming application
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
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
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
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
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
Medical appointment adherence at 48 weeks
Number of PrEP-related medical visits kept in the past 3 months based on clinic records at 48 weeks follow-up.
Time frame: 48 weeks
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Acquired Immunodeficiency Syndrome→
Rhode Island Hospital