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A Pilot Gaming Adherence Program for Youth Living With HIV

A Pilot Gaming Adherence Program for Youth Living With HIV

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01887210
Enrollment
66
Registered
2013-06-26
Start date
2012-09-30
Completion date
2017-08-31
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence to HIV Treatment and Medication

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

BEHAVIORALIMB Gaming Adherence Intervention

Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV

BEHAVIORALEnhanced treatment as usual

Smart pill bottle cap and mobile phone but no game

Sponsors

Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 26 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Log10 HIV-1 Viral Load24 weeksLog viral load at end of study for participants with available viral load data (Log10 copies/ml)

Secondary

MeasureTime frameDescription
Electronically Measured Past 7-day Adherence24 weeksPast 7 day medication adherence as measured by electronic medication monitoring device.
Number of Kept Medical Appointments24 weeksNumber of kept medical appointments since baseline.

Other

MeasureTime frameDescription
Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale24 weeksBehavioral 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

ArmCount
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
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up01
Overall StudyWithdrawal by Subject13

Baseline characteristics

CharacteristicTotalIMB Gaming Adherence InterventionEnhanced Treatment as Usual
Age, Continuous22.4 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 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
61 Participants32 Participants29 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gaming Status
Daily or almost daily
22 Participants10 Participants12 Participants
Gaming Status
Not everyday
38 Participants21 Participants17 Participants
Gaming Status
Unknown or not reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
59 Participants31 Participants28 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants1 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
13 Participants7 Participants6 Participants
Sex: Female, Male
Male
48 Participants25 Participants23 Participants
Sexual Orientation
Bisexual
7 Participants5 Participants2 Participants
Sexual Orientation
Heterosexual
16 Participants9 Participants7 Participants
Sexual Orientation
Homosexual
35 Participants17 Participants18 Participants
Sexual Orientation
Undecided
3 Participants1 Participants2 Participants
Started ARV in past 3 months
No
39 Participants21 Participants18 Participants
Started ARV in past 3 months
Yes
22 Participants11 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 33
other
Total, other adverse events
0 / 330 / 33
serious
Total, serious adverse events
0 / 330 / 33

Outcome results

Primary

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+.

ArmMeasureValue (MEAN)Dispersion
IMB Gaming Adherence InterventionLog10 HIV-1 Viral Load1.48 Log10 copies/mlStandard Deviation 2.07
Enhanced Treatment as UsualLog10 HIV-1 Viral Load1.82 Log10 copies/mlStandard Deviation 2.14
Secondary

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+

ArmMeasureValue (MEAN)Dispersion
IMB Gaming Adherence InterventionElectronically Measured Past 7-day Adherence0.29 proportion of adherenceStandard Deviation 0.36
Enhanced Treatment as UsualElectronically Measured Past 7-day Adherence0.32 proportion of adherenceStandard Deviation 0.36
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
IMB Gaming Adherence InterventionNumber of Kept Medical Appointments1.78 appointments kept since baselineStandard Deviation 1.24
Enhanced Treatment as UsualNumber of Kept Medical Appointments1.74 appointments kept since baselineStandard Deviation 1.32
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.

Time frame: 24 weeks

Population: Missing data for n=2 from IMB intervention, n=2 from TAU+

ArmMeasureValue (MEAN)Dispersion
IMB Gaming Adherence InterventionInformation-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale19.83 units on a scaleStandard Deviation 4.68
Enhanced Treatment as UsualInformation-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale19.48 units on a scaleStandard Deviation 5.12

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026