An interventional study of IMB Gaming Adherence Intervention and Enhanced treatment as usual in Adherence to HIV Treatment and Medication, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 14 Years to 26 Years. Per ClinicalTrials.gov, last updated 2018-09-26.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention
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.
Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
Behavioral: IMB Gaming Adherence Intervention
Smart pill bottle cap and mobile phone but no game
Behavioral: Enhanced treatment as usual
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
Smart pill bottle cap and mobile phone but no game
Log10 HIV-1 Viral Load
Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
Time frame: 24 weeks
Electronically Measured Past 7-day Adherence
Past 7 day medication adherence as measured by electronic medication monitoring device.
Time frame: 24 weeks
Number of Kept Medical Appointments
Number of kept medical appointments since baseline.
Time frame: 24 weeks
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.
Time frame: 24 weeks
| Milestone | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual |
|---|---|---|
| Started | 33 | 33 |
| Completed | 32 | 29 |
| Not completed | 1 | 4 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
| Log10 copies/ml | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual |
|---|---|---|
| Log10 HIV-1 Viral Load | 1.48 ± 2.07 | 1.82 ± 2.14 |
Past 7 day medication adherence as measured by electronic medication monitoring device.
| proportion of adherence | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual |
|---|---|---|
| Electronically Measured Past 7-day Adherence | 0.29 ± 0.36 | 0.32 ± 0.36 |
Number of kept medical appointments since baseline.
| appointments kept since baseline | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual |
|---|---|---|
| Number of Kept Medical Appointments | 1.78 ± 1.24 | 1.74 ± 1.32 |
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.
| units on a scale | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual |
|---|---|---|
| Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale | 19.83 ± 4.68 | 19.48 ± 5.12 |
Collected over Up to 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IMB Gaming Adherence Intervention | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Enhanced Treatment as Usual | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
The baseline analysis population includes 61 participants. Participants that completed baseline and at least one follow-up assessment were included in the analytic sample.
| Age, Continuous(years) | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Mean | 22.5 ± 2.5 | 22.3 ± 2.5 | 22.4 ± 2.5 |
| Sex: Female, Male(Participants) | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 25 | 23 | 48 |
| Ethnicity (NIH/OMB)(Participants) | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 32 | 29 | 61 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 31 | 28 | 59 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Started ARV in past 3 months(Participants) | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Yes | 11 | 11 | 22 |
| No | 21 | 18 | 39 |
| Gaming Status(Participants) | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Daily or almost daily | 10 | 12 | 22 |
| Not everyday | 21 | 17 | 38 |
| Unknown or not reported | 1 | 0 | 1 |
| Sexual Orientation(Participants) | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Heterosexual | 9 | 7 | 16 |
| Homosexual | 17 | 18 | 35 |
| Bisexual | 5 | 2 | 7 |
| Undecided | 1 | 2 | 3 |
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Rhode Island Hospital