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PNF RCT to Decrease Alcohol Use and Increase HIV Prevention

22 juli 2026 bijgewerkt door: Jessica Perkins, Vanderbilt University

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

1350

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Oeganda
    • Uganda
      • Mbarara, Uganda, Oeganda
        • Mbarara University of Science and Technology
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.
Gedragsmatig: PNF - HIV norms

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.
Experimenteel: 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.
Gedragsmatig: PNF - Alcohol use norms

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.
Experimenteel: 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.
Gedragsmatig: PNF - HIV and alcohol use norms

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-reported engagement in partner concurrency
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported recent engagement in condomless sex
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported engagement in alcohol use
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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
Tijdsspanne: Assessed at 3 months and 9 months after the intervention.
Assessed at 3 months and 9 months after the intervention.
Self-reported alcohol/drug use during sex
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Assessed at 3 months and 9 months after the intervention via follow-up survey.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Self-reported engagement in transactional sex
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported PrEP willingness/stigma/interest
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported engagement in other sexual behaviors
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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
Tijdsspanne: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Assessed at 3 months and 9 months after the intervention via follow-up survey.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt University

Medewerkers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

30 augustus 2029

Studie voltooiing (Geschat)

30 augustus 2030

Studieregistratiedata

Eerst ingediend

22 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juli 2026

Eerst geplaatst (Werkelijk)

28 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 250304
  • R01AA031936 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified data will be loaded into NIAAA data archive

IPD-tijdsbestek voor delen

IPD will be deposited in the NIAAA data archive on an ongoing basis, generally every 6 months until data collection is complete.

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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