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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMB Gaming Adherence Intervention | Experimental | Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV |
|
| Enhanced treatment as usual | Active Comparator | Smart pill bottle cap and mobile phone but no game |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMB Gaming Adherence Intervention | Behavioral | Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log10 HIV-1 Viral Load | Log viral load at end of study for participants with available viral load data (Log10 copies/ml) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Electronically Measured Past 7-day Adherence | Past 7 day medication adherence as measured by electronic medication monitoring device. | 24 weeks |
| Number of Kept Medical Appointments | Number of kept medical appointments since baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale | Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale. This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment. Five items were summed to get a total Behavioral Skills subscale score. Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry K Brown, MD | Rhode Island Hospital | Principal Investigator |
| Laura Whiteley, MD | Rhode Island Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29685863 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMB Gaming Adherence Intervention | Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV |
| FG001 | Enhanced Treatment as Usual | Smart pill bottle cap and mobile phone but no game |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population includes 61 participants. Participants that completed baseline and at least one follow-up assessment were included in the analytic sample.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMB Gaming Adherence Intervention | Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV |
| BG001 | Enhanced Treatment as Usual | Smart pill bottle cap and mobile phone but no game |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Log10 HIV-1 Viral Load | Log viral load at end of study for participants with available viral load data (Log10 copies/ml) | Unable to extract viral load data from chart for 9 participants in IMB intervention and 1 in TAU+. | Posted | Mean | Standard Deviation | Log10 copies/ml | 24 weeks |
|
Up to 24 weeks
Adverse events as described in the study protocol were reported by study staff to the principle investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMB Gaming Adherence Intervention | Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV |
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This study had a small sample. Participants were recruited from Jackson, MS, so this sample is not nationally representative. There is no perfect measure of adherence. Self-report and electronic monitoring devices assessments differed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Larry Brown | Rhode Island Hospital | 401-793-8808 | lkbrown@lifespan.org |
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| Enhanced treatment as usual | Behavioral | Smart pill bottle cap and mobile phone but no game |
|
| 24 weeks |
| 24 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Started ARV in past 3 months | Count of Participants | Participants |
|
| Gaming Status | Participants were asked about how often they played video games. | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Electronically Measured Past 7-day Adherence | Past 7 day medication adherence as measured by electronic medication monitoring device. | Missing data for n=1 from TAU+ | Posted | Mean | Standard Deviation | proportion of adherence | 24 weeks |
|
|
|
| Secondary | Number of Kept Medical Appointments | Number of kept medical appointments since baseline. | Unable to pull information from chart for 9 participants in the IMB intervention and 6 in the TAU+ groups. | Posted | Mean | Standard Deviation | appointments kept since baseline | 24 weeks |
|
|
|
| Other Pre-specified | Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale | Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale. This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment. Five items were summed to get a total Behavioral Skills subscale score. Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment. | Missing data for n=2 from IMB intervention, n=2 from TAU+ | Posted | Mean | Standard Deviation | units on a scale | 24 weeks |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Enhanced Treatment as Usual | Smart pill bottle cap and mobile phone but no game | 0 | 33 | 0 | 33 | 0 | 33 |
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