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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jessica M. Perkins, Ph.D.
- 전화번호: 585-750-6694
- 이메일: jessica.m.perkins@vanderbilt.edu
연구 연락처 백업
- 이름: Sarah E Sowell, B.A.
- 전화번호: 982-832-8104
- 이메일: sarah.e.sowell@vanderbilt.edu
연구 장소
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Uganda
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Mbarara, Uganda, 우간다
- Mbarara University of Science and Technology
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연락하다:
- Charles Baguma, MPH
- 전화번호: 256-077-564-1558
- 이메일: Cbaguma@mustresearch.org
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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간섭 없음: 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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실험적: 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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실험적: 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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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-reported engagement in partner concurrency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Self-reported engagement in transactional sex
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 250304
- R01AA031936 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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