RECRUITING

A Mobile Gaming App to Improve Adherence to PrEP

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-21
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05762705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 34 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 15-34 years old
  2. * English speaking
  3. * Initiated PrEP in the last 30 days or re-initiated PrEP after not taking PrEP for at least 1 month
  4. * HIV negative as per clinician and clinical record
  5. * Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
  1. * None

Contacts and Locations

Study Contact

Laura Whiteley, MD
CONTACT
(401)-455-6375
laura_whiteley@brown.edu
James B Brock, MD
CONTACT
601-984-5560
jbbrock@umc.edu

Principal Investigator

Larry K Brock, MD
STUDY_DIRECTOR
Rhode Island Hospital
Sharon Vuppula, MD
STUDY_DIRECTOR
Boston Medical Center

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02118
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Lifespan (The Miriam Hospital and Rhode Island Hospital)
Providence, Rhode Island, 02904
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Larry K Brock, MD, STUDY_DIRECTOR, Rhode Island Hospital
  • Sharon Vuppula, MD, STUDY_DIRECTOR, Boston Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-21
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-06-21
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Medication Adherence
  • HIV/AIDS