C2P (With Venues): Connect to Protect® Partnerships For Youth Prevention Interventions
Connect to Protect® Partnerships for Youth Prevention Interventions Phase III: Full Evaluation
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90054
- Childrens Hospital of Los Angeles
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San Francisco、California、アメリカ、94143
- University of California at San Francisco
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District of Columbia
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Washington、District of Columbia、アメリカ、20010
- Childrens Hospital National Medical Center
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Florida
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Tampa、Florida、アメリカ、33606
- University of South Florida
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Illinois
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Chicago、Illinois、アメリカ、60612
- Stroger Hospital of Cook County
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Maryland
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Baltimore、Maryland、アメリカ、21201
- University of Maryland
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New York
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New York、New York、アメリカ、10128
- Mount Sinai Medical Center
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San Juan、プエルトリコ、00936
- University Pediatric Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：断面図
コホートと介入
グループ/コホート |
介入・治療 |
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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."
他の名前：
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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."
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Collect data that will be used to evaluate the overall efficacy of the community mobilization intervention
時間枠：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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協力者と研究者
協力者
捜査官
- スタディチェア：Jonathan Ellen, MD、Johns Hopkins University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ATN 040b
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIV感染症の臨床試験
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Duke UniversityGilead Sciences募集HIV予防 | HIV曝露前予防 | HIV予防プログラム | HIV の予防とケア | HIV 曝露前予防の使用アメリカ
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Federal University of São PauloGilead Sciences完了
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Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)募集
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University of Alabama at BirminghamNational Institute of Mental Health (NIMH)募集
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University of PennsylvaniaNational Institute of Mental Health (NIMH); University of Botswana募集
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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Instituto Mexicano del Seguro Social募集減量 | HIV | HIV-1 感染症 | 体重変化 | HIV アソシエイト減量 | インテグラーゼ阻害剤、HIV; HIVプロテアーゼ阻害剤メキシコ
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Johns Hopkins UniversityNational Institute of Mental Health (NIMH)募集
Community Mobilizationの臨床試験
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Riphah International Universityまだ募集していません
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Riphah International Universityまだ募集していません
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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Cairo University完了腰仙神経根症 | 脊髄神経圧迫による腰椎神経根障害 | 神経根症を伴う腰椎椎間板脱出症 | 腰部神経根障害エジプト