Clinical trial NCT01887210: A Pilot Gaming Adherence Program for Youth Living With HIV
Official title: A Pilot Gaming Adherence Program for Youth Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence to HIV Treatment and Medication
Keywords: HIV
youth
medical adherence
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 66
Sex: ALL
Minimum age (years): 14
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Log10 HIV-1 Viral Load
timeFrame: 24 weeks
Secondary outcomes:
measure: Electronically Measured Past 7-day Adherence
timeFrame: 24 weeks
measure: Number of Kept Medical Appointments
timeFrame: 24 weeks
Other outcomes:
measure: Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale
timeFrame: 24 weeks
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Larry K Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Laura Whiteley, MD
role: STUDY_DIRECTOR
References:
citation: Whiteley L, Brown L, Lally M, Heck N, van den Berg JJ. A Mobile Gaming Intervention to Increase Adherence to Antiretroviral Treatment for Youth Living With HIV: Development Guided by the Information, Motivation, and Behavioral Skills Model. JMIR Mhealth Uhealth. 2018 Apr 23;6(4):e96. doi: 10.2196/mhealth.8155.