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NCT Number: NCT07731932

PNF RCT to Decrease Alcohol Use and Increase HIV Prevention

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PNF - HIV norms

Behavioral

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.

PNF - Alcohol use norms

Behavioral

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.

PNF - HIV and alcohol use norms

Behavioral

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.

Primary outcomes

  1. Self-reported engagement in partner concurrency

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

  2. Self-reported recent engagement in condomless sex

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

  3. Self-reported engagement in alcohol use

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

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

  4. Self-reported HIV testing

    Time frame: Assessed at 3 months and 9 months after the intervention.

  5. Self-reported alcohol/drug use during sex

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

Secondary outcomes

  1. Self-reported engagement in transactional sex

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

  2. Self-reported PrEP willingness/stigma/interest

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

  3. Self-reported engagement in other sexual behaviors

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

  4. Self-reported perception of school-level rates of HIV/STI transmission and prevention behaviors and attitudes

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

  5. Self-reported perception of school-level rates of engagement in alcohol use

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica M. Perkins, Ph.D.

CONTACT

[email protected]

585-750-6694

Sarah E Sowell, B.A.

CONTACT

[email protected]

982-832-8104

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Brown University
  • Massachusetts General Hospital
  • Mbarara University of Science and Technology
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of California, San Francisco
  • Vanderbilt University Medical Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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