Addressing Psychosocial Needs and HIV Risk in Indian MSM
調査の概要
詳細な説明
MSM in India are at increased risk for HIV in a stigmatizing environment that includes discrimination and violence. There is a need for evidence-based MSM HIV prevention interventions that address HIV risk in the context of these psychosocial issues. This study consists of formative qualitative work followed by the development and testing of a pilot behavioral HIV prevention intervention for MSM in Chennai, India. Study goals are to maximize intervention feasibility and acceptability, estimate an effect size for a power analysis, and prepare for a full-scale trial to follow.
PHASE 1-Intervention Development. This phase involved the collection of formative data through MSM focus groups and key informant interviews to develop a subsequent pilot behavioral intervention.
PHASE 2-Open Pilot. Following Phase 1, the team conducted an open-phase non-randomized pilot of the intervention. Enrollment involved a baseline assessment that included an interviewer-administered behavioral assessment and voluntary counseling and testing for HIV and the STIs, syphilis, gonorrhea and chlamydia. Eleven MSM in Chennai then completed 6 group sessions and 4 individual sessions over 3 months. A follow-up behavioral assessment was administered upon completion of all sessions, and 6 months after baseline participants were again administered the questionnaire and HIV/STI testing.
PHASE 3-Pilot Randomized Controlled Trial. The study is currently in Phase 3, and the data articulated in this registry is for Phase 3. We are now conducting a pilot randomized controlled trial (RCT) of the intervention among 6 "batches" of 8 MSM in each group (n=48). Comparison groups (n=48) will receive the same baseline assessment and voluntary HIV/STI counseling and testing as the intervention groups. Based on Phase 2 findings, the intervention groups will meet for 4 group sessions and 4 individual sessions. Those assigned to receive the comparison condition will not receive these sessions. Participants complete the assessments approximately 3 months after randomization, and again 3 months after that.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
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
説明
Inclusion Criteria:
- Man who has had unprotected sex with another man in past 3 months
- Resident of Tamil Nadu state, India
- Identifies as Khothi or Double-decker
Exclusion Criteria:
- Does not identify as a man (i.e. Hijra/ Ali/Transgendered)
- Under age 18
- Unable to complete or understand informed consent procedures
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
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:HIV/STI voluntary counseling and testing
Participants enrolled in the control arm will receive study assessments only.
|
|
実験的:Behavioral intervention
Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months.
This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
|
The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months.
The overall focus is on psychosocial concerns and HIV risk.
他の名前:
|
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 |
---|---|---|
Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant
時間枠:up to 6 months
|
We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
|
up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Acquisition of STIs - Number of Participants That Acquired STIs
時間枠:6 months
|
We will test for locally relevant STIs at baseline and 6 months.
|
6 months
|
Changes in Psychosocial Mediators
時間枠:up to 6 months
|
We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
|
up to 6 months
|
協力者と研究者
協力者
捜査官
- 主任研究者:Steven A. Safren, PhD、Massachusetts General Hospital, Boston, Massachusetts, United States
- 主任研究者:Beena E. Thomas, PhD、Tuberculosis Research Centre, Chennai, India
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 (見積もり)
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
キーワード
その他の研究ID番号
- 5R21MH085314-02 (米国 NIH グラント/契約)
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/STI Riskの臨床試験
-
Institute of HIV Research and Innovation Foundation...amfAR, The Foundation for AIDS Research募集
-
The Miriam HospitalBoston University; National Institute of Allergy and Infectious Diseases (NIAID)積極的、募集していない
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Asociación Civil Impacta Salud y Educación, Peru完了
-
FHI 360United States Agency for International Development (USAID)完了
-
University of ZurichSwiss HIV Cohort Study募集
-
University of California, Los AngelesEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Tulane...完了
-
RTI InternationalDurham County Department of Public Health; Guilford County Department of Public Health; Wake County...終了しました
-
RTI InternationalMedical Research Council, South Africa完了ヒト免疫不全ウイルス (HIV) | コンドームなしのセックス | アルコールと薬物の使用 | 性感染症(STI) | 暴力と被害者 | 医療へのアクセスと連携 | 教育の進歩南アフリカ
-
ANRS, Emerging Infectious Diseases完了
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID)募集
Behavioral interventionの臨床試験
-
University of MichiganNational Institute on Drug Abuse (NIDA)募集
-
University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, 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
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
-
University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
-
Semra TUNCAY YILMAZSemra TUNCAY YILMAZ完了
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
-
Square2 Systems, Inc.National Institute on Drug Abuse (NIDA)募集