Adherence to HIV Treatment and Medication
Conditions
Keywords
HIV, youth, medical adherence
Brief summary
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.
Detailed description
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
* English speaking * in medical care for HIV and receiving antiretroviral treatment * aware of their HIV status as per clinician and clinical record * 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 |
|---|---|---|
| Log10 HIV-1 Viral Load | 24 weeks | Log viral load at end of study for participants with available viral load data (Log10 copies/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electronically Measured Past 7-day Adherence | 24 weeks | Past 7 day medication adherence as measured by electronic medication monitoring device. |
| Number of Kept Medical Appointments | 24 weeks | Number of kept medical appointments since baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale | 24 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IMB Gaming Adherence Intervention Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV | 32 |
| Enhanced Treatment as Usual Smart pill bottle cap and mobile phone but no game | 29 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Total | IMB Gaming Adherence Intervention | Enhanced Treatment as Usual |
|---|---|---|---|
| Age, Continuous | 22.4 years STANDARD_DEVIATION 2.5 | 22.5 years STANDARD_DEVIATION 2.5 | 22.3 years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 32 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gaming Status Daily or almost daily | 22 Participants | 10 Participants | 12 Participants |
| Gaming Status Not everyday | 38 Participants | 21 Participants | 17 Participants |
| Gaming Status Unknown or not reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 59 Participants | 31 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 48 Participants | 25 Participants | 23 Participants |
| Sexual Orientation Bisexual | 7 Participants | 5 Participants | 2 Participants |
| Sexual Orientation Heterosexual | 16 Participants | 9 Participants | 7 Participants |
| Sexual Orientation Homosexual | 35 Participants | 17 Participants | 18 Participants |
| Sexual Orientation Undecided | 3 Participants | 1 Participants | 2 Participants |
| Started ARV in past 3 months No | 39 Participants | 21 Participants | 18 Participants |
| Started ARV in past 3 months Yes | 22 Participants | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
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
Population: Unable to extract viral load data from chart for 9 participants in IMB intervention and 1 in TAU+.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMB Gaming Adherence Intervention | Log10 HIV-1 Viral Load | 1.48 Log10 copies/ml | Standard Deviation 2.07 |
| Enhanced Treatment as Usual | Log10 HIV-1 Viral Load | 1.82 Log10 copies/ml | Standard Deviation 2.14 |
Electronically Measured Past 7-day Adherence
Past 7 day medication adherence as measured by electronic medication monitoring device.
Time frame: 24 weeks
Population: Missing data for n=1 from TAU+
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMB Gaming Adherence Intervention | Electronically Measured Past 7-day Adherence | 0.29 proportion of adherence | Standard Deviation 0.36 |
| Enhanced Treatment as Usual | Electronically Measured Past 7-day Adherence | 0.32 proportion of adherence | Standard Deviation 0.36 |
Number of Kept Medical Appointments
Number of kept medical appointments since baseline.
Time frame: 24 weeks
Population: Unable to pull information from chart for 9 participants in the IMB intervention and 6 in the TAU+ groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMB Gaming Adherence Intervention | Number of Kept Medical Appointments | 1.78 appointments kept since baseline | Standard Deviation 1.24 |
| Enhanced Treatment as Usual | Number of Kept Medical Appointments | 1.74 appointments kept since baseline | Standard Deviation 1.32 |
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
Population: Missing data for n=2 from IMB intervention, n=2 from TAU+
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMB Gaming Adherence Intervention | Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale | 19.83 units on a scale | Standard Deviation 4.68 |
| Enhanced Treatment as Usual | Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale | 19.48 units on a scale | Standard Deviation 5.12 |