Clinical trial NCT05762705: A Mobile Gaming App to Improve Adherence to PrEP
Official title: A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Adherence
HIV/AIDS
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Tenofovir (TFV) blood concentration at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Tenofovir (TFV) blood concentration at 48 weeks
timeFrame: 48 weeks
measure: Self-reported Medication Adherence at 24 weeks
timeFrame: 24 weeks
measure: Self-reported Medication Adherence at 48 weeks
timeFrame: 48 weeks
measure: Medical appointment adherence at 24 weeks
timeFrame: 24 weeks
measure: Medical appointment adherence at 48 weeks
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Providence
country: United States
facility: Lifespan (The Miriam Hospital and Rhode Island Hospital)
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Larry K Brock, MD
role: STUDY_DIRECTOR
affiliation: Boston Medical Center
name: Sharon Vuppula, MD
role: STUDY_DIRECTOR
References: