A Mobile Gaming App to Improve Adherence to PrEP

NCT05762705 | Recruiting

• 1 other identifier: Pro00067477
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Medication Adherence; HIV/AIDS

Outcome Measures

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).

  24 weeks

Secondary Outcomes (5)

• Tenofovir (TFV) blood concentration at 48 weeks

  48 weeks

• Self-reported Medication Adherence at 24 weeks

  24 weeks

• Self-reported Medication Adherence at 48 weeks

  48 weeks

• Medical appointment adherence at 24 weeks

  24 weeks

• Medical appointment adherence at 48 weeks

  48 weeks

Study Arms (2)

Multilevel Gaming Adherence

EXPERIMENTAL

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

Treatment as Usual +

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual +

Interventions

Multilevel Gaming Adherence Intervention BEHAVIORAL

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

Multilevel Gaming Adherence

Treatment as Usual + BEHAVIORAL

non-PrEP related mobile gaming application

Treatment as Usual +

Eligibility Criteria

• Age: 15 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (3)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Lifespan (The Miriam Hospital and Rhode Island Hospital)

Providence, Rhode Island, 02904, United States

RECRUITING

MeSH Terms

Conditions

Medication Adherence; Acquired Immunodeficiency Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Larry K Brock, MD

  Rhode Island Hospital

  STUDY DIRECTOR

• Sharon Vuppula, MD

  Boston Medical Center

  STUDY DIRECTOR

Central Study Contacts

Laura Whiteley, MD

CONTACT

(401)-455-6375; laura_whiteley@brown.edu

James B Brock, MD

CONTACT

601-984-5560; jbbrock@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 10, 2023
• Study Start: June 21, 2024
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (3)