HIV/AIDS, Medication Adherence
Conditions
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.
Interventions
BEHAVIORALMultilevel 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
BEHAVIORALTreatment as Usual +
Combination of electronic medication monitoring device and non-HIV related mobile gaming application
Sponsors
University of Mississippi Medical Center
Boston Medical Center
Emory University
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline HIV-1 Viral Load at 48 weeks | 48 weeks | Assessing change from Baseline HIV-1 viral load (copies/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Medication Adherence | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| Self-reported Missed ARV Doses (1 Month) | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| Self-reported Missed ARV Doses (1 week) | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Barriers | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| HIV Treatment Knowledge Scale | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| HIV Treatment Self-Efficacy | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| Social Support | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| Antiretroviral Therapy Treatment Knowledge | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| Motivation for Adherence | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
| Information-Motivation-Behavioral Skills ART Adherence Questionnaire - Behavioral Skills subscale | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks | 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 |
Countries
United States
Outcome results
None listed