- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02530645
Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults
연구 개요
상세 설명
Homeless young adults have high rates of substance abuse and HIV infection and, therefore, developing effective, acceptable, and sustainable interventions to reduce their substance abuse and sexual risk behaviors is of high public health significance.
HealthCall for Smartphone (HealthCall-S) is a smartphone application originally designed for self-monitoring of alcohol use and other HIV-related health behaviors, and receiving personalized feedback on these behaviors among urban substance-abusing HIV primary care patients. Building upon prior HealthCall-S studies, individual qualitative interviews were conducted with 10 homeless young adults (age 18-21 years) at Covenant House New York (CHNY), the largest provider of crisis shelter and services for homeless young adults (age 18-21 years) in NYC. The purpose of the individual interviews was to obtain reactions to various aspects of HealthCall-S and determine how it could be adapted to better suit the needs and interests of homeless young adults. HealthCall-S has since been adapted to target alcohol use, marijuana use, and sexual risk behaviors among homeless young adults and renamed 'OnTrack.' A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness of OnTrack plus a brief motivational intervention (BMI), in comparison to treatment as usual (TAU) at CHNY for those with substance abuse problems and who engage in risky sex. Following referral, screening, and eligibility determination, 60 participants will complete informed consent and be randomly assigned to one of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at baseline, 2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption, marijuana use, HIV sexual risk behaviors, and other relevant variables.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국
- Covenant House New York
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18-21 years of age
- Engaged in unprotected vaginal, anal, or oral sex in the past year
- Drank alcohol in the past year
- Used marijuana on 4 or more days in past month
Exclusion Criteria:
- Actively psychotic, suicidal, or homicidal
- Does not speak English
- Has a vision/hearing impairment that would preclude participation
- Has definite plans to leave the greater New York metropolitan area within the study period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: OnTrack + BMI
Brief motivational interview plus the use of a smartphone application to monitor alcohol and marijuana use and sexual risk behaviors.
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활성 비교기: Treatment as Usual
Treatment as usual involves substance use/HIV referral and treatment as regularly offered to all participants who report substance use and sexual risk behaviors at Covenant House New York.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Alcohol use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
기간: Baseline, 2, 4 (end of treatment), 6 weeks
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As measured by number of drinks per drinking day and percentage of days abstinent.
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Baseline, 2, 4 (end of treatment), 6 weeks
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Marijuana use in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
기간: Baseline, 2, 4 (end of treatment), 6 weeks
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As measured by times used marijuana per day.
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Baseline, 2, 4 (end of treatment), 6 weeks
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HIV sexual risk behavior in the last 2 weeks, assessed at baseline and repeatedly so that change can be analyzed
기간: Baseline, 2, 4 (end of treatment), 6 weeks
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As measured by the number of days the respondent engaged in unprotected sex.
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Baseline, 2, 4 (end of treatment), 6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ronald G Thompson, Ph.D., Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
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. .
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