An interventional study of PNF - HIV norms and PNF - Alcohol use norms in HIV (Human Immunodeficiency Virus), Alcohol Misuse and STI, sponsored by Vanderbilt University. Not yet recruiting at 1 site in Uganda. Open to participants aged 13 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Prevention
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.
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 adolescents and young adults affects 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 participants 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 participants 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 participants 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 collected before exposure to the PNF treatment. The investigators 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 will improve the accuracy of participants' estimated school-level rates of engagement in HIV/STI transmission behaviors and alcohol misuse in the future (secondary outcome).
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's planned enrollment of 1,350 is above the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Vanderbilt University is the lead sponsor of 522 studies on the registry; 20 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Compared within Sexually Transmitted Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
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
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
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.
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.
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.
Recent engagement in partner concurrency
Self-reported yes vs. no
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Recent engagement in condomless sex
Self-reported yes vs no
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Recent engagement in alcohol use
Measured through self reported responses to the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) score. A higher AUDIT-C score is associated with alcohol misuse. Possible AUDIT-C scores range from 0 to 12 points.
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Recent HIV testing
Self-reported yes vs. no
Time frame: Assessed at 3 months and 9 months after the intervention.
Recent alcohol/drug use during sex
Self-reported yes vs. no
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Recent engagement in transactional sex
Self-reported yes vs. no
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
PrEP willingness/interest
Self-reported yes vs. no for willingness and interest.
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
PrEP stigma (personal)
Measure of personal stigma towards PrEP use based on the Young Women's PrEP Stigma Scale (Roberts et al, 2025; Journal of AIDS Patient Care and STDs). A higher score is associated with more PrEP stigma. Scores range from 0-5.
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
PrEP stigma (perceived)
Measure of perceived stigma towards PrEP use based on the Young Women's PrEP Stigma Scale (Roberts et al, 2025; Journal of AIDS Patient Care and STDs). A higher score is associated with more PrEP stigma. Scores range from 0-5.
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Recent engagement in other sexual behaviors
Self-reported yes vs. no
Time frame: 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
Time frame: 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
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
PrEP stigma (anticipated)
Measure of anticipated stigma towards PrEP use based on Giovenco et al, 2022, AIDS and Behavior. A higher score is associated with more PrEP stigma. Scores range from 1-5.
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Plan to share: Yes — De-identified data will be loaded into NIAAA data archive
Supporting information: 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
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Aug 2029, 31 months later.
Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's planned 31 months is close to that.
Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Jan 2027, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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