Health Trials

PNF RCT to Decrease Alcohol Use and Increase HIV Prevention

ConditionsHIV (Human Immunodeficiency Virus)Alcohol MisuseSTI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-25
SponsorVanderbilt University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

1,350 Participants
are divided into 4 treatment groups
Group A: Arm 1: No normative feedbackNo intervention 0 interventions
Group B: Arm 2: PNF-HIV norms onlyExperimental treatment 1 intervention
Group C: Arm 3: PNF-Alcohol use norms onlyExperimental treatment 1 intervention
Group D: Arm 4: PNF-HIV transmission and alcohol use normsExperimental treatment 1 intervention

Trial outcomes

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

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

Time frame
Assessed at 3 months and 9 months after the intervention via follow-up survey.
4

Self-reported HIV testing

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

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University

Lead sponsor

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

Source ClinicalTrials.gov

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