跳至主要内容
临床试验/NCT07731932
NCT07731932尚未招募不适用

Personalized Normative Feedback to Decrease Unhealthy Alcohol Use and Increase HIV Prevention Behavior Among Youth and Young Adults in Rural Ugandan Schools

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 1,350 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,350
试验地点
1
主要终点
Self-reported engagement in partner concurrency

研究概览

简要总结

Randomized controlled trial to test the preliminary efficacy and mediating mechanism of a personalized normative feedback intervention on behavioral intentions, heavy alcohol use, and HIV/STI prevention among adolescents and young adults in Rwampara District, Uganda.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All students enrolled in Kinoni High School, Kinoni Girls Secondary School, or Rugando Technical Institute, 13-25 years of age

排除标准

  • 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)

结局指标

主要结局

Self-reported engagement in partner concurrency

时间窗: Assessed at 3 months and 9 months after the intervention via follow-up survey.

Self-reported recent engagement in condomless sex

时间窗: Assessed at 3 months and 9 months after the intervention via follow-up survey.

Self-reported engagement in alcohol use

时间窗: Assessed at 3 months and 9 months after the intervention via follow-up survey.

Measured through the participant's self reported AUDIT-C score.

Self-reported HIV testing

时间窗: Assessed at 3 months and 9 months after the intervention.

Self-reported alcohol/drug use during sex

时间窗: Assessed at 3 months and 9 months after the intervention via follow-up survey.

次要结局

  • Self-reported engagement in transactional sex(Assessed at 3 months and 9 months after the intervention via follow-up survey.)
  • Self-reported PrEP willingness/stigma/interest(Assessed at 3 months and 9 months after the intervention via follow-up survey.)
  • Self-reported engagement in other sexual behaviors(Assessed at 3 months and 9 months after the intervention via follow-up survey.)
  • Self-reported perception of school-level rates of HIV/STI transmission and prevention behaviors and attitudes(Assessed at 3 months and 9 months after the intervention via follow-up survey.)
  • Self-reported perception of school-level rates of engagement in alcohol use(Assessed at 3 months and 9 months after the intervention via follow-up survey.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Perkins

Assistant Professor, Department of Human and Organizational Development

Vanderbilt University

研究点 (1)

Loading locations...

相似试验