C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation
연구 개요
상세 설명
Phase III's objective is to initiate and complete a community mobilization intervention aimed at reducing HIV incidence and prevalence among youth. The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. The effectiveness of the intervention will be evaluated by tracking venues where the population of interest congregates and trends in risk factors associated with HIV acquisition and transmission.
ATN 040b evaluates annual anonymous data collection of two cohorts per participating ATN/C2P site. Both cohorts will represent a site's population of focus, but will be recruited in different ways and for different activities.
Cohort #1 will be referred to the site via Official Community Partners and word of mouth. Each year of the study, 10 to 20 individuals will be recruited to complete venue-tracking surveys as described in Section 2.1 (N = 40-80 per site over four years). The results will either confirm that the population of focus can still be reached at previously identified congregation venues or reveal new ones that should be considered for further research activities. Each year, based on data from Cohort #1, ATN/C2P site staff will go to two to three of the confirmed and/or new congregation venues to recruit 20 to 30 participants per venue for Cohort #2. These participants will complete the HIV-related risk survey, with the addition of the HIV-Ab assay in the final year only (N = 160-360 per site over four years). Data will be used to evaluate the intervention within and across ATN/C2P sites.
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 Francisco, California, 미국, 94143
- University of California at San Francisco
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District of Columbia
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Washington, District of Columbia, 미국, 20010
- Childrens Hospital National Medical Center
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Florida
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Tampa, Florida, 미국, 33606
- University of South Florida
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Illinois
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Chicago, Illinois, 미국, 60612
- Stroger Hospital of Cook County
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland
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New York
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New York, New York, 미국, 10128
- Mount Sinai Medical Center
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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:
- An individual who provides verbal confirmation that his or her age falls within the range of the site's population of focus (which must be within 12 through 24 years, inclusive);
- Verbal confirmation of demographic and sexual orientation/experience profile reflective of the site's population of focus;
- Must report engaging in any voluntary sexual activity (vaginal, anal or oral sex) within the past 12 months, regardless of sexual abuse history; and
- Ability to understand and willingness to provide verbal informed consent/assent in English or Spanish.
Exclusion Criteria:
- Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood; exhibiting manic, suicidal, or violent behavior);*
- Visibly intoxicated or under the influence of psychoactive agents#; or
Presents as acutely ill.
Although it is very unlikely that an individual from the community will overtly show signs of suicidality, youth with any of these exclusion criteria may be approached at a later date if encountered again at the venue and earlier exclusionary conditions are resolved.
- For sites targeting drug users, this may pose challenges. Potential participants who are visibly under the influence are to be further assessed in terms of their level of alertness, coherency, and abilities to understand and respond to questions. This is to be done keeping staff and participant safety in mind, as well as follow-up procedures such as providing service referrals.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Cohort #1
Venue-tracking survey subjects recruited annually for 4 years: N= 320-640 (10-20 members of the population of focus per site, per year).
The purpose of this cohort is to identify and track venues at which the population of focus congregates.
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ATN 040b is the evaluation sub-study for ATN 040, Phase III of C2P.
Phase III is a community mobilization intervention aimed at reducing HIV rates among youth via community structural change.
ATN 040b involves annual anonymous data collection with two cohorts per participating ATN/C2P site.
Both cohorts will represent the site's target population, or "population of focus."
다른 이름들:
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Cohort #2
HIV-related risk survey subjects recruited annually for 4 years: N = 1280-2880 (20-30 members of the population of focus per 2-3 congregation venues, per site, per year).
These subjects will complete a survey designed to assess HIV-related risk.
In the fourth and final year only, HIV Antibody [Ab] assays will also be conducted with survey participants to assess HIV serostatus.
The survey and HIVAb assay data will be used to evaluate the intervention within and across sites.
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ATN 040b is the evaluation sub-study for ATN 040, Phase III of C2P.
Phase III is a community mobilization intervention aimed at reducing HIV rates among youth via community structural change.
ATN 040b involves annual anonymous data collection with two cohorts per participating ATN/C2P site.
Both cohorts will represent the site's target population, or "population of focus."
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention
기간: 4 years
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The aim of ATN 040b is to collect data that will be used to evaluate the overall efficacy of the community mobilization intervention and to assess changes in HIV-related risks over time.
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4 years
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Jonathan Ellen, MD, Johns Hopkins University
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 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. .
HIV 감염에 대한 임상 시험
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Duke UniversityGilead Sciences모병HIV 예방 | HIV 사전 노출 예방 | HIV 예방 프로그램 | HIV 예방 및 관리 | HIV 사전 노출 예방 사용미국
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Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)모병
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Massachusetts General HospitalNational Institute of Mental Health (NIMH)모병실행할 수 있음 | HIV 예방 | PrEP 흡수 | 수용 가능성 | HIV 자가 테스트 | HIV 음성 산후 여성의 남성 파트너남아프리카
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Johns Hopkins UniversityNational Institute of Mental Health (NIMH)모병
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State University of New York at BuffaloYale University Center for Interdisciplinary Research on AIDS아직 모집하지 않음HIV 예방 | HIV 테스트 | 성 및 생식 건강미국
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Hospital Clinic of Barcelona완전한
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Instituto Mexicano del Seguro Social모병체중 감량 | 에이즈 | HIV-1 감염 | 체중 변화 | HIV 관련 체중 감소 | 인테그라제 억제제, HIV; HIV 프로테아제 억제멕시코
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Thomas Aagaard RasmussenAarhus University Hospital; The Alfred; Germans Trias i Pujol Hospital; Walter and Eliza Hall...모병
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University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
Community Mobilization에 대한 임상 시험
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Alabama Physical Therapy & AcupunctureUniversidad Rey Juan Carlos모병
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Riphah International University아직 모집하지 않음
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Maastricht University Medical CenterErasmus Medical Center; Maxima Medical Center; The Netherlands Asthma Foundation; PICASSO:... 그리고 다른 협력자들완전한
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Natália Maria Oliveira Campelo완전한병리학적 과정 | 근골격계 질환 | 관절 질환 | 골관절염 고관절
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Cairo University완전한Lumbosacral Radiculopathy | 척수 신경 압박으로 인한 요추 신경근병증 | Radiculopathy를 동반한 요추 디스크 탈출증 | 요추 신경근병증이집트
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Charles Drew University of Medicine and ScienceNational Library of Medicine (NLM); Los Angeles County Department of Public Health모병