- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00267436
Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE PLUS
Adopting and Demonstrating the Adaptation of Prevention Techniques: Community PROMISE Positives Leading and Utilizing Strategies (ADAPT CP PLUS)
연구 개요
상세 설명
During the ADAPT project both sites will adapt the original Community Promise intervention to specifically address the HIV prevention needs of sero-positive, African American men who have sex with men (HIV+ AAMSM) in either Boston, MA or Minneapolis/St. Paul (MSP), MN. The adapted intervention will be referred to as Community PROMISE, Positives Leading and Utilizing Strategies (CP PLUS).
In the first two months of the ADAPT project, the Boston and MSP sites will conduct formative evaluation activities (i.e., a comprehensive literature review, focus groups, and individual interviews) to assess the needs of the target population and organizational capacities to serve them. Results will be used to inform the adaptation of the original intervention to ensure that CP PLUS meet the expressed needs of the target population.
Process data will also be collected from various sources throughout the life of the project. Process data will be collected through staff meetings, interviews with staff, focus groups with peer advocates, and an expert panel consultation. Process data will be extremely useful for ensuring program objectives are met, improving CP PLUS, and providing information for providers in other locales who may be interested in adapting this intervention to serve this target population.
The Boston and MSP sites will also conduct outcome monitoring through collection of data concerning risk behaviors pre- and post-intervention implementation (follow-up at 6-8 months post and 11-13 months post [Boston only]) to determine if the adapted intervention has met its outcome objectives. Outcome monitoring will also be conducted for the "parent" intervention at both sites for HIV- or unknown status men who have sex with men.
In addition to the project activities, the organization will be examining the utility of the CDC draft guidance. The Boston and MSP sites are two of five case studies throughout the United States that will detail the challenges, successes and lessons learned from adapting an intervention packaged by CDC's Replicating Effective Programs (REP) and disseminated by Diffusing Effective Behavioral Interventions (DEBI) to a specific population. These findings will help other community-based organizations and Health Departments effectively adapt and tailor group, individual and community-level interventions.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- AIDS Action Committee
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Minneapolis Urban League
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
HIV+ cohort
- Self-reports as HIV+ (for CP PLUS cohort)
- Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
- Self-reports as a resident of the identified geographic areas.
- Identifies as African American
- 18 years of age, or older.
HIV- cohort
- HIV- or unknown status only, has engaged in risky sexual contact (defined as those who self-report engaging in unprotected anal or vaginal intercourse within the past year)
- Self-report that they had sex with men in the past 3 years (MSP) or 1 year (Boston)
- Identifies as African American (MSP); No racial/ethnic criteria however AA will be over-sampled and will be at least 20% of sample
- 18 years of age, or older.
- Self-reports as a resident of the identified geographic areas.
- Engage in risky sex (defined as individuals who self-report engaging in unprotected anal or vaginal intercourse within the past year.
Exclusion Criteria:
- Inability to complete informed consent process due to (a) substantial cognitive impairment. (b) non-English speaking; (c) under the influence of drugs or alcohol
- Under 18 years of age
- Plans to relocate within 12 months after baseline interview
- Anyone who does not meet inclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Sexual activities with main and casual partners in past 30 days to 6 months (i.e., unprotected insertive and receptive anal/vaginal sex and protected insertive and receptive anal/vaginal sex)
기간: 7/2006-2/2007
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7/2006-2/2007
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Behavioral intentions and attitudes for condom use; disclosure of HIV status; self reported STD diagnosis; medication adherence; links to care.
기간: 7/2006-2/2007
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7/2006-2/2007
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Jennifer S Galbraith, Centers for Disease Control and Prevention
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 Center모집하지 않고 적극적으로
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USDA Food and Nutrition ServiceMathematica Policy Research, Inc.완전한
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University of Wisconsin, MadisonNational Institute on Aging (NIA)완전한