A Mobile Gaming App to Improve Adherence to PrEP

A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV/AIDS; Medication Adherence
• Intervention / Treatment: Behavioral: Multilevel Gaming Adherence Intervention; Behavioral: Treatment as Usual +

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Whiteley, MD; Phone Number: (401)-455-6375; Email: laura_whiteley@brown.edu
• Study Contact Backup: Name: James B Brock, MD; Phone Number: 601-984-5560; Email: jbbrock@umc.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
      • Contact: Sharon Vuppula, MD; Email: sharon.vuppula@bmc.org
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
      • Contact: James B Brock, MD; Phone Number: 601-984-5560; Email: jbbrock@umc.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Lifespan (The Miriam Hospital and Rhode Island Hospital)
      • Contact: Larry K Brown, MD; Phone Number: 401-793-8808; Email: lkbrown@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 34 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Multilevel Gaming Adherence Intervention; Information-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages
Active Comparator: Treatment as Usual +; TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game.	Behavioral: Treatment as Usual +; non-PrEP related mobile gaming application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	48 weeks

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Study Director: Larry K Brock, MD, Rhode Island Hospital; Study Director: Sharon Vuppula, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: Pro00067477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No