PNF RCT to Decrease Alcohol Use and Increase HIV Prevention

NCT07731932 | Not Yet Recruiting DMC

• 2 other identifiers: 250304R01AA031936
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV (Human Immunodeficiency Virus); Alcohol Misuse; STI

Keywords

HIV transmission; sexually transmitted infections; personalized normative feedback; social norms; HIV prevention; alcohol use

Outcome Measures

Primary Outcomes (5)

• Self-reported engagement in partner concurrency

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

• Self-reported recent engagement in condomless sex

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

• Self-reported engagement in alcohol use

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

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

• Self-reported HIV testing

  Assessed at 3 months and 9 months after the intervention.

• Self-reported alcohol/drug use during sex

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

Secondary Outcomes (5)

• 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.

Study Arms (4)

Arm 1: No normative feedback

NO INTERVENTION

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.

Arm 2: PNF-HIV norms only

EXPERIMENTAL

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.

Behavioral: PNF - HIV norms

Arm 3: PNF-Alcohol use norms only

EXPERIMENTAL

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.

Behavioral: PNF - Alcohol use norms

Arm 4: PNF-HIV transmission and alcohol use norms

EXPERIMENTAL

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.

Behavioral: PNF - HIV and alcohol use norms

Interventions

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.

Arm 2: PNF-HIV norms only

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.

Arm 3: PNF-Alcohol use norms only

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.

Arm 4: PNF-HIV transmission and alcohol use norms

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Jessica M. Perkins, Ph.D.

CONTACT

585-750-6694; jessica.m.perkins@vanderbilt.edu

Sarah E Sowell, B.A.

CONTACT

982-832-8104; sarah.e.sowell@vanderbilt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Human and Organizational Development

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): August 30, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be deposited in the NIAAA data archive on an ongoing basis, generally every 6 months until data collection is complete.
• Access Criteria: Data is made available to the general research community at the time of an associated primary publication or the end of the award period, whichever comes first

Locations

UG (1)