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PNF RCT to Decrease Alcohol Use and Increase HIV Prevention

22 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

1350

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição fatorial
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Self-reported engagement in partner concurrency
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Prazo
Self-reported engagement in transactional sex
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

30 de agosto de 2029

Conclusão do estudo (Estimado)

30 de agosto de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

22 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de julho de 2026

Primeira postagem (Real)

28 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 250304
  • R01AA031936 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified data will be loaded into NIAAA data archive

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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