A Mobile Gaming App to Improve ART Adherence for Youth
| Status: | Not yet recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 15 - 26 |
| Updated: | 12/8/2018 |
| Start Date: | April 2020 |
| End Date: | August 2023 |
| Contact: | Laura Whiteley, MD |
| Email: | laura_whiteley@brown.edu |
| Phone: | (401)-455-6375 |
A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth
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 and in Mississippi. The investigators
want to determine if adherence is improved and viral load is reduced in this larger sample.
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 and in Mississippi. The investigators
want to determine if adherence is improved and viral load is reduced in this larger sample.
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 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.
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 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.
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:
We found this trial at
3
sites
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
Phone: 401-793-8808
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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