- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00183456
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Network HIV Prevention Intervention for Drug Users
연구 개요
상태
상세 설명
The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area.
Participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21231
- The Lighthouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for CBT or Peer Intervention Participants:
- Female
- Age 18-55
- Did not inject drugs in the past 6 months
- Self-reported sex with at least 1 male partner in the past 6 months
Had at least 1 of the following sexual risk factors:
- More than 2 sex partners in the past 6 months
- STI diagnosis in the past 6 months
- Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM)
Inclusion Criteria for Peer Network Participants:
- 18 years old or older
One of the following:
- Injected drugs
- Sex partner of index
- Social network member that the index felt comfortable talking to about HIV/STIs
Exclusion Criteria for All Participants:
- Currently enrolled in another HIV prevention intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention Condition: CHAT
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy.
Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
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The peer-oriented intervention program emphasized social identity and the goals of protecting family and community.
The peer program also trained participants to provide HIV/STD education to their peers.
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활성 비교기: Comparison Condition: Standard of Care
The comparison condition consisted of one group session.
The session focused on HIV and STIs transmission and risk reduction information.
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Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
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간섭 없음: Network Participants
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study.
These network participants completed study interviews but did not participate in the intervention.
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간섭 없음: Non-randomized Baseline index participants
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
기간: 6 months
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Number of participants that had 2 or more sex partners in the past 90 days.
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6 months
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Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
기간: 12 months
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12 months
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Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
기간: 18 month
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18 month
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Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
기간: 18 months
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18 months
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Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
기간: 18 months
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18 months
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Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
기간: 18 months
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18 months
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Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
기간: 18 months
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18 months
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2차 결과 측정
결과 측정 |
기간 |
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HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
기간: 6 months
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6 months
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HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
기간: 12 months
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12 months
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HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
기간: 18 months
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18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Carl A. Latkin, PhD, Johns Hopkins Bloomberg School of Public Health
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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Erasmus Medical Center모병
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Peer-oriented intervention에 대한 임상 시험
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MYnd AnalyticsUniversity of Ottawa; Canadian Forces Health Services Centre Ottawa알려지지 않은
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Monash University MalaysiaMinistry of Higher Education, Malaysia모병
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Mental Health Services in the Capital Region, DenmarkThe Peer partnership association완전한
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Washington University School of MedicineNational Institutes of Health (NIH)모병
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center초대로 등록