A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China
A Cluster-Randomized Trail to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life (QOL) For HIV-Positive Villagers in Rural China
調査の概要
詳細な説明
Over the past decade, the rates of HIV infection and death due to HIV/AIDS have been steadily increasing in China. The China Comprehensive AIDS Response (China CARES) program was developed in 2003 in order to help poor counties and those with severe epidemic problems increase public awareness and improve knowledge about epidemic diseases such as HIV. Currently, behavioral interventions focusing on individual skills training and self-efficacy building for HIV infected individuals are not included in China CARES. Fuyang, Anhui Province, China has a high rate of HIV infected individuals, many of whom were former plasma donors (FPDs) and would benefit from HIV skills training.
In 2004, CIPRA conducted a study (CIPRA CH 002A), entitled "A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China," which provided insight into HIV infected individuals in Fuyang, Anhui Province, China. According to the results of CIRPA CH 002A, most HIV infected individuals described their QOL as poor. The factors affecting their poor QOL include poverty, poor health, stigma and discrimination. Participants in the CIPRA CH 002A study showed interest in learning more about HIV/AIDS disease and treatment. This study will last 18 months. HIV infected participants and their families will attend eight 2-hour group skills training sessions during Weeks 1 through 8, and booster sessions every two months during Months 3 through 15. Popular Opinion Leaders (POL) participants will attend 4 weeks of 2-hour training sessions about anti-stigma and anti-discrimination, followed by support meetings every 2 months during Months 2 through 13. Some participants will complete cross-sectional surveys evaluating the levels of stigma and discrimination in the community at study entry and at Months 6 and 12 following completion of POL training. All participants will complete follow-up visits at Months 6 and 12.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Beijing、中国、100050
- Fuyang CDC Office
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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
説明
Inclusion Criteria for HIV Infected Individuals:
- HIV infected
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Willing to provide location information
Inclusion Criteria for Family members of HIV Infected Individuals:
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Family member of HIV infected participant
Inclusion Criteria for POLs:
- Identified as an influential member of the community
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Willing to attend training and follow-up meetings Note: Both HIV infected and non HIV infected individuals may participate as POLs
Inclusion Criteria for Cross-Sectional Survey Participants:
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Randomly selected and invited to participate in study
Exclusion Criteria for HIV Infected Individuals:
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Has not made contact with study staff after three attempts
Exclusion Criteria for Family Members of HIV Infected Individuals:
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
Exclusion Criteria for POLs:
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
Exclusion Criteria for Cross-Sectional Survey Participants:
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Has not made contact with study staff after three attempts
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
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：1
HIV infected participants and their families
|
Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15
|
|
実験的：2
Popular Opinion Leaders (POL) participants
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Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.
|
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 |
時間枠 |
|---|---|
|
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants
時間枠：Throughout study
|
Throughout study
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Level of stigma among community members, including HIV knowledge
時間枠：Throughout study
|
Throughout study
|
協力者と研究者
捜査官
- スタディチェア：Zunyou Wu, MD, PhD、Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
- スタディチェア：Jie Xu, MD, MS, MPH、Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
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
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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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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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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Helios SaludViiV Healthcareわからない
HIV skills trainingの臨床試験
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Queens College, The City University of New York完了
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VA Office of Research and Development募集
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Semra TUNCAY YILMAZSemra TUNCAY YILMAZ完了