A Mobile Gaming App to Improve ART Adherence for Youth

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03760211
• Other study ID #: 217318
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Medication Adherence

Intervention

Behavioral:
• Multilevel Gaming Adherence Intervention
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
• Treatment as Usual +
Combination of electronic medication monitoring device and non-HIV related mobile gaming application

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Rhode Island Hospital	Boston Medical Center, Emory University, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV Treatment Knowledge Scale	Balfour L, Kowal J, Tasca GA, et al. Development and psychometric validation of the HIV Treatment Knowledge Scale. AIDS Care. 2007;19(9):1141-1148.; The HIV Treatment Knowledge scale is a 21-item scale that assesses knowledge about complex HIV treatment issues such as co-occurring illnesses and drug resistance. Response options include "True", "False", and "Do not know". Cronbach's alpha was 0.90 in a population of HIV-infected adults. Higher scores indicate greater HIV treatment knowledge.; Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Other	Antiretroviral Therapy Treatment Knowledge	The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.; Antiretroviral therapy treatment knowledge will be assessed with the "Information" subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. The Information subscale includes 19 Likert-style items. Response options include "Strongly Disagree", "Somewhat Agree", "Neither Agree nor Disagree", "Somewhat Agree", and "Strongly Agree". Cronbach's alpha was 0.60 in a sample of youth living with HIV. Higher scores indicate greater knowledge of ART treatment.; Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Other	Motivation for Adherence	The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.; Motivation for adherence will be assessed with the "Motivation" subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. The "Motivation" subscale includes 10 Likert-style items that assess personal and social motivations for ART adherence. Cronbach's alpha was 0.75 in a sample of youth living with HIV. Higher scores indicate greater motivation towards adherence.; Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Other	Information-Motivation-Behavioral Skills ART Adherence Questionnaire - Behavioral Skills subscale	The LifeWindows Project Team. The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.; The "Behavioral Skills" subscale from the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire assesses perceived ability to perform necessary ART skills. This subscale includes 14 Likert-style items. Response options range from "Very Hard" to "Very Easy". Cronbach's alpha was 0.90 in a sample of youth living with HIV. Higher scores indicate greater motivation towards adherence.; Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Other	Medication Adherence Barriers	Simoni JM, Kurth AE, Pearson CR, Pantalone DW, Merrill JO, Frick PA. Self-report measures of antiretroviral therapy adherence: a review with recommendations for HIV research and clinical management. AIDS Behav. 2006; 10(3):227-245. doi: 10.1007/s10461-006-9078-6. PMID: 16783535. PMCID: PMC4083461.; This 26-item checklist was developed for use by the Adolescent AIDS Trials Network (ATN). This measure assesses common barriers to taking antiretrovirals (ARV) as prescribed and common reasons for stopping ARV.; Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Other	Social Support	Martinez J, Harper G, Carleton RA, et al. The Impact of Stigma on Medication Adherence Among HIV-Positive Adolescent and Young Adult Females and the Moderating Effects of Coping and Satisfaction with Health Care. AIDS Patient Care and STDs. 2012;26(2):108-115. doi:10.1089/apc.2011.0178.; Six Likert-style items assess social support for taking medications, going to medical appointments, and other tasks related to adherence. Responses options range from "Strongly disagree" to "Strongly agree". Cronbach's alpha for this scale is 0.91. Higher scores indicate greater perceived social support.; Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Other	HIV Treatment Self-Efficacy	MacDonell KE, Naar-King S, Murphy DA, Parsons JT, Harper GW. Predictors of Medication Adherence in High Risk Youth of Color Living with HIV. Journal of Pediatric Psychology. 2010;35(6):593-601. doi:10.1093/jpepsy/jsp080.; This six-item, Likert-style scale includes three items that assess self-efficacy for taking medication and three items that assess self-efficacy for adherence to medical appointments. Response options range from "Very Sure I Can" to "Very Sure I Cannot". Higher scores indicate greater self-efficacy for medication and appointment adherence. Cronbach's alpha is 0.92 for this scale.; Assessed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Primary	Change from Baseline HIV-1 Viral Load at 48 weeks	Assessing change from Baseline HIV-1 viral load (copies/mL)	48 weeks
Secondary	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
Secondary	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
Secondary	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