- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00103896
Connect to Protect Partnerships for Youth Prevention Interventions: Phase II
Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.
This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.
연구 개요
상태
정황
상세 설명
This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.
During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:
Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90054
- Childrens Hospital of Los Angeles
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San Diego, California, 미국, 92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco, California, 미국, 94143
- Univ of Califormia at San Francisco
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District of Columbia
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Washington, District of Columbia, 미국, 20010
- Children's Hospital National Medical Center
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Florida
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Ft. Lauderdale, Florida, 미국, 33301
- Children's Diag. and Treatment Center
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Miami, Florida, 미국, 33101
- University of Miami
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Tampa, Florida, 미국, 33606
- USF Peds Div. of Infectious Disease
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Illinois
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Chicago, Illinois, 미국, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Childrens' Hospital of Boston
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New York
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Bronx, New York, 미국, 10467
- Montefiore Medical Center, Adolescent AIDS Program
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New York, New York, 미국, 10128
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Children's Hopsital of Philadelphia
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San Juan, 푸에르토 리코, 00936
- University Pediatric Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Index Subjects:
- Documented HIV-infection
- Acquisition of HIV after age 9 years
- Verbal confirmation of 12-24 years of age
- Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
- Ability to understand and willingness to provide informed consent/assent
BVI subjects:
- Youths who appear to be 12-24 years old
HIV Serosurvey subjects at the venues:
- Verbal confirmation of 12-24 years of age
- Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
- Ability to understand and willingness to provide informed consent/assent
Exclusion Criteria:
- Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
- Visibly intoxicated or under the influence of psychoactive agents
- Clinically presents as acutely ill
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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HIV Infected Youth in Treatment/Care
HIV infected youth in treatment/care will be interviewed using Audio Computer-Assisted Self-Administered Interview ACASI technology to reveal possible venues where youth at high risk for acquiring the disease may be found (N = 20-30 individuals per ATN site).
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BVI Individuals
Additional data will be gathered on potential recruitment venues by administering a brief venue interview (BVI) to individuals who appear to be between 12 and 24 years old (N = unlimited individuals during 3-5 assessment periods per venue each lasting 5 hours).
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HIV Serosurvey Individuals
HIV Serosurvey Individuals Anonymous structured interview using ACASI technology and an anonymous HIV antibody assay will be administered to 20-30 young women at 2-3 targeted locations and 20-30 young men at 2-3 targeted locations whose HIV status is unknown (N = 160-360 individuals per ATN site)..
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study
기간: One time assessment at 10 months
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The outcome measure will be assessed using results from: (a) Phase I mapping; (b) Phase II interviews with HIV-infected youth; and (c) Phase II Brief Venue Interviews (BVIs).
Input from community partners and ethnographic procedures will add critical information.
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One time assessment at 10 months
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Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
기간: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Describe social networks of adolescents and young adults recruited from targeted venues
기간: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
기간: One time assessment at 10 months
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The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
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One time assessment at 10 months
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Assess the characteristics of the community-researcher partnerships
기간: One time assessment at 10 months
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The outcome measure will be assessed by conducting interviews with C2P staff and their community partners.
Questionnaires will be completed by both parties and detailed documentation kept.
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One time assessment at 10 months
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Assess quality of the community-researcher partnerships
기간: One time assessment at 10 months
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The outcome measure will be assessed by conducting interviews with C2P staff and their community partners.
Questionnaires will be completed by both parties and detailed documentation kept.
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One time assessment at 10 months
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Assess outcomes of the community-researcher partnerships
기간: One time assessment at 10 months
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The outcome measure will be assessed by conducting interviews with C2P staff and their community partners.
Questionnaires will be completed by both parties and detailed documentation kept.
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One time assessment at 10 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Donna Futterman, MD, Montefiore Medical Center
- 수석 연구원: Sue Ellen Abdalian, MD, Tulane Medical Center
- 연구 의자: Jonathan Ellen, MD, Johns Hopkins Medical Center
- 수석 연구원: Ligia Peralta, MD, Division of Adolescent & Young Adult Medicine University of MD, Medical School
- 수석 연구원: Marvin Belzer, MD, Childrens Hosp of Los Angeles, Division of Adolescent Medicine
- 수석 연구원: Bret Rudy, MD, Children's Hospital of Philadelphia
- 수석 연구원: Larry D'Angelo, MD, Children's National Research Institute
- 수석 연구원: Cathryn Samples, MD, Boston Children's Hospital
- 수석 연구원: Lisa Henry-Reid, MD, John H. Stroger Jr. Hospital and the CORE Center
- 수석 연구원: Ana Puga, MD, Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
- 수석 연구원: Lawrence Friedman, MD, University of Miami, School of Medicine, Div of Adolescent Medicine
- 수석 연구원: Patricia Emmanuel, MD, University of South Florida, Peds Div of Infectious Disease
- 수석 연구원: Linda Levin, MD, Mount Sinai Adolescent Health Center
- 수석 연구원: Irma Febo, MD, University of Puerto Rico Medical Sciences Campus
- 수석 연구원: Stephen A Spector, MD, UCSD Mother, Child, & Adolescent HIV Program
- 수석 연구원: Rolando M Viani, MD, UCSD Mother, Child, & Adolescent HIV Program
- 수석 연구원: Barbara Moscicki, MD, UCSF, Division of Adoles. Med
- 수석 연구원: Coco Auerswald, MD, UCSF, Division of Adoles. Med
간행물 및 유용한 링크
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ATN 016b
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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