A Mobile Gaming App to Improve Adherence to PrEP

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05762705
• Other study ID #: Pro00067477
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: Rhode Island Hospital
• Contact: Laura Whiteley, MD
• Phone: (401)-455-6375
• Email: laura_whiteley[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Medication Adherence

Intervention

Behavioral:
• Multilevel Gaming Adherence Intervention
Information-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages
• Treatment as Usual +
non-PrEP related mobile gaming application

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Lifespan (The Miriam Hospital and Rhode Island Hospital)	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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