A Mobile Gaming App to Improve ART Adherence for Youth

Study Overview
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Brief Summary
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Despite the need for consistent adherence to medical care, youth living with HIV have low rates of adherence to medications and treatment. There are few interventions to improve adherence to HIV medications and treatment for youth, and there is a great need for novel approaches that are engaging for this age group. The investigators developed an intervention that includes a mobile gaming app that is integrated with a 7-day electronic medication device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small previous project found that the intervention helped youth who were newly starting medications for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This proposed project will test the intervention with larger number of youth (100) who are newly starting HIV treatment and medications in New England, Georgia, and in Mississippi. The investigators want to determine if adherence is improved and viral load is reduced in this larger sample.

Detailed Description
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Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have low rates of adherence and retention in care, and are at great risk for being lost to follow-up.(5,16-18) There is a great need for adherence interventions that are novel and appealing for YLWH.(7,8,14) The investigators developed, and preliminarily examined, a multi-level technology that integrates a 7-day smart medication device WITH an immersive and appealing smartphone app/game that is attractive and engaging for YLWH.(82,83) During gameplay, YLWH fight HIV in colorful and immersive organ systems, and receive adherence related text messages with game graphics. Electronic medication monitoring device openings guide game-related text messages. The investigators tested the Multilevel Gaming Intervention in a developmental trial. The impact of the intervention was greatest among those who had newly begun ART. In participants who had newly begun ART, the intervention decreased viral load and improved ART adherence. Those newly starting ART in the intervention, compared to those newly starting ART in the control, experienced a 0.96 log viral load greater decrease and evidenced a large effect size for improved adherence as measured by an electronic medication monitoring device (d=1.18, 71% vs. 48% adherence at post-test). These interactions between intervention and newly starting ART were significant in ANCOVAs, accounting for baseline values (viral load: F=4.33, p=0.04, adherence: F=3.20, p=0.05). For this next proposed stage of research, the investigators will further test the Multilevel Gaming Intervention with YLWH who are newly starting ART at clinical sites in New England, Georgia, and in Mississippi. A multisite randomized controlled study (48 weeks) among 100 YLWH newly starting ART will test the efficacy of the intervention compared to a control condition (who receive a non-HIV game and the electronic medication monitoring device) on behavioral and biological measures.

Official Title
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A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth

Conditions
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Medication Adherence, HIV/AIDS

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living with HIV English speaking Have started antiretroviral therapy (ART) in the last three months or restarted ART in the last three months after not taking ART for approximately six months Have access to a smartphone for the duration of the study Not involved with another HIV prevention or adherence related study Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment Detectable viral load Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 Battle Viro on their mobile phones, an electronic pill monitoring device, and, for 24 weeks, game-related text messages guided by medication adherence data (collected from an electronic pill monitoring device). | Behavioral: Multilevel Gaming Adherence Intervention<br>* Combination of electronic medication monitoring device with Information-Motivation-Behavior based mobile gaming application tailored for those living with HIV 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 and an electronic pill monitoring device. | Behavioral: Treatment as Usual +<br>* Combination of electronic medication monitoring device and non-HIV related mobile gaming application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HIV-1 Viral Load at 48 weeks | Assessing change from Baseline HIV-1 viral load (copies/mL) | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Medication Adherence | Proportion of doses taken correctly via electronic pill monitoring device. The proportion of days with correct openings each month will be calculated: (correct openings) / (total number of days in month) Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 
| Self-reported Missed ARV Doses (1 Month) | Proportion of days with missed doses via self-report: (reported missed doses in past month) / (total number of days in month) Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 
| Self-reported Missed ARV Doses (1 week) | Proportion of days with missed doses via self-report: (reported missed doses in past 7 days) / 7 Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |