Clinical trial NCT03760211: A Mobile Gaming App to Improve ART Adherence for Youth
Official title: A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
HIV/AIDS
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
name: Boston Medical Center
name: Emory University
First posted: 2018-11-30
Enrollment: 107
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline HIV-1 Viral Load at 48 weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: Self-reported Medication Adherence
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Self-reported Missed ARV Doses (1 Month)
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Self-reported Missed ARV Doses (1 week)
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Other outcomes:
measure: HIV Treatment Knowledge Scale
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Antiretroviral Therapy Treatment Knowledge
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Motivation for Adherence
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Information-Motivation-Behavioral Skills ART Adherence Questionnaire - Behavioral Skills subscale
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Medication Adherence Barriers
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Social Support
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: HIV Treatment Self-Efficacy
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
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: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: University of Mississippi Medical Center
name: James B Brock, MD
role: STUDY_DIRECTOR
affiliation: Boston Medical Center
name: Rachel Epstein, MD
role: STUDY_DIRECTOR
affiliation: Boston Medical Center
name: Stephen Pelton, MD
role: STUDY_DIRECTOR
affiliation: Rhode Island Hospital
name: Larry K Brown, MD
role: STUDY_DIRECTOR
affiliation: Rhode Island Hospital
name: Laura Whiteley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Andres Camacho-Gonzalez, MD
role: STUDY_DIRECTOR
References:
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.