A Mobile Gaming App to Improve Adherence to PrEP

Study Overview
=================
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.

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

Conditions
-----------------
Medication Adherence, HIV/AIDS

Intervention / Treatment
-----------------
* Behavioral: Multilevel Gaming Adherence Intervention
* Behavioral: Treatment as Usual +


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 |