- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01887210
A Pilot Gaming Adherence Program for Youth Living With HIV
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: IMB Gaming Adherence Intervention
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
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Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
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|
활성 비교기: Enhanced treatment as usual
Smart pill bottle cap and mobile phone but no game
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Smart pill bottle cap and mobile phone but no game
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Log10 HIV-1 Viral Load
기간: 24 weeks
|
Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
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24 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Electronically Measured Past 7-day Adherence
기간: 24 weeks
|
Past 7 day medication adherence as measured by electronic medication monitoring device.
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24 weeks
|
|
Number of Kept Medical Appointments
기간: 24 weeks
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Number of kept medical appointments since baseline.
|
24 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale
기간: 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.
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24 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Larry K Brown, MD, Rhode Island Hospital
- 연구 책임자: Laura Whiteley, MD, Rhode Island Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .