A Pilot Gaming Adherence Program for Youth Living With HIV

Study Overview
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Brief Summary
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This study will develop and test a novel, technology based intervention to improve treatment adherence among youth living with HIV who are taking antiretroviral medication. In the intervention youth will access an engaging and immersive app/game on their smartphone.Data about the opening of the smart pill bottle will be transferred from the bottle cap wirelessly and will trigger a text message about their adherence. While gaming, participants will gain information about their health, improve motivation for ARV and medical appointment adherence, and practice healthy behaviors. If the Intervention is found to be effective, it can be tested in a larger study and then disseminated to other youth on antiretroviral medications.

Detailed Description
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Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have suboptimal rates of retention in care and adherence to antiretroviral medication (ARV) treatment. There are few adherence studies with YLWH and the results are mixed, so there is a great need for the development of novel interventions. Results of adult HIV adherence studies indicate that participants are interested in using technology-based methods and are most receptive toward interventions that couple technological devices with motivational components. Pill taking monitoring devices have been found to be a sensitive measure of adherence to ARV medications, but do not lead to sustained improvements in adherence or intrinsic motivation when used alone. Building on this knowledge, this study will examine a multi-level technology that integrates a medication monitoring device WITH an interactive smartphone based app/game that is attractive and engaging to YLWH. This multi-level approach will integrate theory driven content with novel, but intuitive, technology to improve HIV treatment adherence. In this study, data on opening of the pill bottle will be transferred wirelessly from the bottle cap and a text on adherence sent to the phone. This developmental project will adapt and refine a smartphone app/game to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. Creation and adaptation will occur from in-depth interviews with YLWH on ART (n=25) and an open trial of the Intervention (n=20). While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about HIV treatment), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners). A small randomized controlled pilot study (24 weeks) among 60 YLWH will examine the preliminary efficacy of the IMB Gaming Adherence Intervention (integration of the smart cap with the IMB informed app/game) compared to a comparison group who receive the smart cap and smartphone but no IMB game, on adherence and biological measures.

Official Title
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A Pilot Gaming Adherence Program for Youth Living With HIV

Conditions
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Adherence to HIV Treatment and Medication

Intervention / Treatment
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* Behavioral: IMB Gaming Adherence Intervention
* Behavioral: Enhanced treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking in medical care for HIV and receiving antiretroviral treatment aware of their HIV status as per clinician and clinical record 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: 14 Years
Maximum Age: 26 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: IMB Gaming Adherence Intervention<br>Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV | Behavioral: IMB Gaming Adherence Intervention<br>* Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV<br>|
| Active Comparator: Enhanced treatment as usual<br>Smart pill bottle cap and mobile phone but no game | Behavioral: Enhanced treatment as usual<br>* Smart pill bottle cap and mobile phone but no game<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log10 HIV-1 Viral Load | Log viral load at end of study for participants with available viral load data (Log10 copies/ml) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electronically Measured Past 7-day Adherence | Past 7 day medication adherence as measured by electronic medication monitoring device. | 24 weeks | 
| Number of Kept Medical Appointments | Number of kept medical appointments since baseline. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, youth, medical adherence