- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01142882
Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention
연구 개요
상세 설명
This trial will examine the comparative effectiveness and cost-effectiveness of a web-based HIV, hepatitis and STI prevention intervention when offered to youth in outpatient, community-based substance abuse treatment as directly compared to a traditional HIV (and infectious disease) prevention intervention. We will assess the comparative effectiveness and cost-effectiveness of these interventions by primarily examining changes from pre- to post-intervention in accurate HIV/disease prevention knowledge, intentions to engage in safer sex and HIV risk behavior. Additionally, we will examine the extent to which the interventions impact relevant skills acquisition (e.g., communication skills, negotiation skills and condom use skills), attitudes toward safer sex and self-reported substance use, as well as the acceptability of each intervention. We also plan to evaluate youth at both 1 and 3 month post-intervention to examine the durability of effects (including any differential durability of effects across intervention conditions). The web-delivered prevention intervention to be evaluated in this study has the potential to allow for a complex intervention to be delivered at a low cost, without increasing demands on staff time or training needs, and may thereby expand the reach of evidence-based prevention for youth in substance-abuse treatment.
This study will be conducted at three collaborating, community-based adolescent substance abuse treatment programs all of which are housed within the Daytop Village network of services and are located in New York City: (1) Daytop Village's Brooklyn Outreach Center; (2) Daytop Village's Bronx Outreach Center; and (3) Daytop Village's Queens Outreach Center. We expect to recruit approximately one third of the total number of participants from each site.
A total of up to 160 (no fewer than 120) adolescent participants will be enrolled in this study. Participants will be randomly assigned to one of the two study conditions in an intent-to-treat design (n=60-80 per group): (1) computer-delivered intervention or (2) traditional (person-delivered intervention). Participants in the traditional prevention intervention condition will complete two sessions (of approx. one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually. Participants in the computer-delivered intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program instead of the traditional, person-delivered prevention intervention. Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan. Participants will access this intervention using dedicated computer stations set up at their substance abuse treatment program.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New York
-
Bronx, New York, 미국, 10461
- 모병
- Daytop Village, Bronx Outreach Center
-
연락하다:
- Cassandra Melnikow, MA
- 전화번호: 2112 718-518-9007
- 이메일: melnikow@ndri.org
-
Brooklyn, New York, 미국, 11217
- 모병
- Daytop Village, Brooklyn Outreach Center
-
연락하다:
- Elaine Dillingham, B.A.
- 전화번호: 2811 718-625-1388
- 이메일: dillingham@ndri.org
-
Jamaica, New York, 미국, 11435
- 모병
- Daytop Village, Queens Outreach Center
-
연락하다:
- Cassandra Melnikow, M.A.
- 전화번호: 2252 718-523-4242
- 이메일: melnikow@ndri.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Enrolled in collaborating adolescent substance abuse treatment program (i.e., Daytop's Brooklyn Outreach Center, Bronx Outreach Center or Queens Outreach Center)
- 12-18 years of age
- Within first 30 days of substance abuse treatment (current treatment episode)
- Not yet received formal HIV prevention intervention during current treatment episode
Exclusion Criteria:
- Plans to move out of the area within the next 5 months
- Insufficient ability to understand and provide informed consent/assent to participate
- Insufficient ability to use English to participate in the consent process, the interventions and/or assessments
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Traditional Prevention
educator-delivered, small-group HIV & disease prevention education
|
Participants in the traditional prevention intervention condition will complete two sessions (of approx.
one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually.
|
|
실험적: Web-based Prevention
self-directed, interactive & customized web-based HIV & disease prevention education
|
Participants in the web-based intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program.
Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan.
Participants can choose to access this intervention using dedicated computer stations set up at their substance abuse treatment setting or can complete these sessions at their own home via the web.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HIV/disease prevention knowledge
기간: 3 months
|
3 months
|
|
|
behavioral intentions
기간: 3 months
|
intentions to engage in safer sex
|
3 months
|
|
HIV risk behavior
기간: 3 months
|
sexual risk behavior
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
skills acquisition
기간: 3 months
|
communication skills; negotiaion skills & condom use skills
|
3 months
|
|
self-reported substance use
기간: 3 months
|
as measured via Timeline Follow-back
|
3 months
|
|
intervention acceptability
기간: post-intervention
|
post-intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Lisa A. Marsch, Ph.D., National Development and Research Institutes, Inc.
- 연구 책임자: Honoria M. Guarino, Ph.D., National Development and Research Institutes, Inc.
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HIVPrev613
- 1RC1DA028415 (미국 NIH 보조금/계약)
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