PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
Personalized Normative Feedback to Decrease Unhealthy Alcohol Use and Increase HIV Prevention Behavior Among Youth and Young Adults in Rural Ugandan Schools
調査の概要
状態
詳細な説明
New approaches to HIV prevention and treatment among young people in HIV-endemic African countries will be needed to meet the 95-95-95 UNAIDS targets. Several HIV/STI transmission-related behaviors are more likely to occur with heavy alcohol use including engaging in condomless sex, partner concurrency, and transactional sex. Heavy alcohol use is a prevalent and strong modifiable risk factor for HIV transmission risk behavior in Uganda. One way to target behaviors related to HIV/STI-transmission, alcohol misuse, and their intersection is to target misperceived norms, which are directly linked to personal health behavior.
This study employs a randomized controlled trial to evaluate how providing accurate information about local descriptive (i.e., behavioral) and injunctive (i.e., attitudinal) norms to adoloescents and young adults affect HIV/STI transmission behaviors and alcohol misuse. Participants are randomly assigned to one of four treatment arms: (1) a control condition without any normative information; (2) a treatment condition in which they are reminded of what they thought local HIV/STI transmission behavior engagement rates were in their school and then receive accurate information about rates of HIV/STI transmission behavior engagement and prevention in their school; (3) a treatment condition in which they are reminded of what they thought alcohol misuse rates were in their school and then receive accurate information about rates of alcohol misuse behavior in their school; or (4) a treatment condition in which they are reminded of what they thought alcohol misuse rates and local HIV/STI transmission behavior engagement rates were in their school and then receive both types of accurate normative information in their school.
The study assesses how providing this type of personalized normative feedback within cohort-based data collection affects alcohol use and engagement in HIV/STI transmission behaviors, such as condomless sex, transactional sex, and drug/alcohol use during sexual activity. Outcomes will be measured through self-reported data at two time points within 12 months through two follow-up survey waves, which will be compared to baseline self-reported data before exposure to the PNF treatment. We hypothesize that providing accurate information about alcohol misuse and HIV/STI transmission and prevention behavior engagement rates will decrease alcohol misuse, decrease engagement in HIV/STI-transmission behavior and increase prevention behavior (primary outcomes), and improve the accuracy of estimated school level rates of engagement in HIV/STI transmission behaviors and alcohol misuse in the future (secondary outcome).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jessica M. Perkins, Ph.D.
- 電話番号：585-750-6694
- メール：jessica.m.perkins@vanderbilt.edu
研究連絡先のバックアップ
- 名前：Sarah E Sowell, B.A.
- 電話番号：982-832-8104
- メール：sarah.e.sowell@vanderbilt.edu
研究場所
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Uganda
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Mbarara、Uganda、ウガンダ
- Mbarara University of Science and Technology
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コンタクト：
- Charles Baguma, MPH
- 電話番号：256-077-564-1558
- メール：Cbaguma@mustresearch.org
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- All students enrolled in Kinoni High School, Kinoni Girls Secondary School, or Rugando Technical Institute, 13-25 years of age
Exclusion Criteria:
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
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：階乗代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Arm 1: No normative feedback
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version does not provide any normative feedback information. |
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実験的：Arm 2: PNF-HIV norms only
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with descriptive and injunctive norms information about school level rates of engagement in HIV-transmission and prevention behaviors. |
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of engagement in HIV-transmission behavior engagement in their school. Participants are then provided with the true rates of HIV-transmission behavior engagement in their school, and notification that this is consistent across demographic groups. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol misuse, which will be compared to baseline data collected before treatment. |
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実験的：Arm 3: PNF-Alcohol use norms only
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with descriptive and injunctive norms information about alcohol use. |
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of rates of alcohol use in their school. Participants are then provided with information about the true rates of alcohol use in their school. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment. |
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実験的：Arm 4: PNF-HIV transmission and alcohol use norms
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with both school level descriptive and injunctive norms surrounding alcohol use and engagement in HIV/STI transmission and prevention behaviors. |
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The fourth treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of HIV transmission behavior engagement and alcohol use in their school. Participants are then provided with information about the true rates of both HIV transmission behavior engagement and alcohol use in their school. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment. |
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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Self-reported engagement in partner concurrency
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported recent engagement in condomless sex
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported engagement in alcohol use
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Measured through the participant's self reported AUDIT-C score.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported HIV testing
時間枠：Assessed at 3 months and 9 months after the intervention.
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Assessed at 3 months and 9 months after the intervention.
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Self-reported alcohol/drug use during sex
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Self-reported engagement in transactional sex
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported PrEP willingness/stigma/interest
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported engagement in other sexual behaviors
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported perception of school-level rates of HIV/STI transmission and prevention behaviors and attitudes
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported perception of school-level rates of engagement in alcohol use
時間枠：Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
- 250304
- R01AA031936 (米国 NIH グラント/契約)
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IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
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