A Mobile Gaming App to Improve Adherence to PrEP

NCT ID: NCT05762705

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2027-03-03

Brief Summary

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.

Detailed Description

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.

Conditions

Medication Adherence; HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multilevel Gaming Adherence Intervention

Intervention Type: BEHAVIORAL

Information-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages

Treatment as Usual +

TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual +

Intervention Type: BEHAVIORAL

non-PrEP related mobile gaming application

Interventions

Multilevel Gaming Adherence Intervention

Information-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages

Intervention Type: BEHAVIORAL

Treatment as Usual +

non-PrEP related mobile gaming application

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.

Exclusion Criteria

• None

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry K Brock, MD

Role: STUDY_DIRECTOR

Rhode Island Hospital

Sharon Vuppula, MD

Role: STUDY_DIRECTOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status: RECRUITING

Lifespan (The Miriam Hospital and Rhode Island Hospital)

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Whiteley, MD

Role: CONTACT

laura_whiteley@brown.edu

(401)-455-6375

James B Brock, MD

Role: CONTACT

jbbrock@umc.edu

601-984-5560

Facility Contacts

Sharon Vuppula, MD

Role: primary

sharon.vuppula@bmc.org

James B Brock, MD

Role: primary

jbbrock@umc.edu

601-984-5560

Larry K Brown, MD

Role: primary

lkbrown@lifespan.org

401-793-8808

Other Identifiers

Pro00067477

Identifier Type: -

Identifier Source: org_study_id