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PNF RCT to Decrease Alcohol Use and Increase HIV Prevention

22 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1350

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Uganda
    • Uganda
      • Mbarara, Uganda, Uganda
        • Mbarara University of Science and Technology
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.
Experimental: 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.
Conductual: 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.
Experimental: 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.
Conductual: 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.
Experimental: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-reported engagement in partner concurrency
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Self-reported engagement in transactional sex
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Vanderbilt University

Colaboradores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de agosto de 2029

Finalización del estudio (Estimado)

30 de agosto de 2030

Fechas de registro del estudio

Enviado por primera vez

22 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de julio de 2026

Publicado por primera vez (Actual)

28 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 250304
  • R01AA031936 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified data will be loaded into NIAAA data archive

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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