[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649070":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":43,"studyPopulation":11,"armGroups":44,"interventions":65,"overallOfficials":11,"centralContacts":79,"locations":89,"responsibleParty":106,"collaborators":110,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":11,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":11,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":152,"whyStopped":11,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Vanderbilt University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,15,18,21],{"measure":10,"description":11,"timeFrame":12},"Self-reported engagement in partner concurrency",null,"Assessed at 3 months and 9 months after the intervention via follow-up survey.",{"measure":14,"description":11,"timeFrame":12},"Self-reported recent engagement in condomless sex",{"measure":16,"description":17,"timeFrame":12},"Self-reported engagement in alcohol use","Measured through the participant's self reported AUDIT-C score.",{"measure":19,"description":11,"timeFrame":20},"Self-reported HIV testing","Assessed at 3 months and 9 months after the intervention.",{"measure":22,"description":11,"timeFrame":12},"Self-reported alcohol\u002Fdrug use during sex",[24,26,28,30,32],{"measure":25,"description":11,"timeFrame":12},"Self-reported engagement in transactional sex",{"measure":27,"description":11,"timeFrame":12},"Self-reported PrEP willingness\u002Fstigma\u002Finterest",{"measure":29,"description":11,"timeFrame":12},"Self-reported engagement in other sexual behaviors",{"measure":31,"description":11,"timeFrame":12},"Self-reported perception of school-level rates of HIV\u002FSTI transmission and prevention behaviors and attitudes",{"measure":33,"description":11,"timeFrame":12},"Self-reported perception of school-level rates of engagement in alcohol use",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","FACTORIAL","PREVENTION",{"masking":39,"maskingDescription":11,"whoMasked":40},"DOUBLE",[41,42],"PARTICIPANT","OUTCOMES_ASSESSOR","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\u002FSTI 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\u002FSTI-transmission, alcohol misuse, and their intersection is to target misperceived norms, which are directly linked to personal health behavior.\n\nThis 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\u002FSTI 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\u002FSTI transmission behavior engagement rates were in their school and then receive accurate information about rates of HIV\u002FSTI 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\u002FSTI transmission behavior engagement rates were in their school and then receive both types of accurate normative information in their school.\n\nThe study assesses how providing this type of personalized normative feedback within cohort-based data collection affects alcohol use and engagement in HIV\u002FSTI transmission behaviors, such as condomless sex, transactional sex, and drug\u002Falcohol 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\u002FSTI transmission and prevention behavior engagement rates will decrease alcohol misuse, decrease engagement in HIV\u002FSTI-transmission behavior and increase prevention behavior (primary outcomes), and improve the accuracy of estimated school level rates of engagement in HIV\u002FSTI transmission behaviors and alcohol misuse in the future (secondary outcome).",[45,49,55,60],{"label":46,"type":47,"description":48,"interventionNames":11},"Arm 1: No normative feedback","NO_INTERVENTION","Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV\u002FSTI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV\u002FSTI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm.\n\nThis version does not provide any normative feedback information.",{"label":50,"type":51,"description":52,"interventionNames":53},"Arm 2: PNF-HIV norms only","EXPERIMENTAL","Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV\u002FSTI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV\u002FSTI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm.\n\nThis version provides personalized normative feedback with descriptive and injunctive norms information about school level rates of engagement in HIV-transmission and prevention behaviors.",[54],"Behavioral: PNF - HIV norms",{"label":56,"type":51,"description":57,"interventionNames":58},"Arm 3: PNF-Alcohol use norms only","Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV\u002FSTI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV\u002FSTI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm.\n\nThis version provides personalized normative feedback with descriptive and injunctive norms information about alcohol use.",[59],"Behavioral: PNF - Alcohol use norms",{"label":61,"type":51,"description":62,"interventionNames":63},"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\u002FSTI transmission behavior and perceived norms about other students' alcohol misuse and engagement in HIV\u002FSTI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm.\n\nThis version provides personalized normative feedback with both school level descriptive and injunctive norms surrounding alcohol use and engagement in HIV\u002FSTI transmission and prevention behaviors.",[64],"Behavioral: PNF - HIV and alcohol use norms",[66,71,75],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":11},"BEHAVIORAL","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.\n\nTwo follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV\u002FSTI transmission and prevention behaviors and alcohol misuse, which will be compared to baseline data collected before treatment.",[50],{"type":67,"name":72,"description":73,"armGroupLabels":74,"otherNames":11},"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.\n\nTwo follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV\u002FSTI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment.",[56],{"type":67,"name":76,"description":77,"armGroupLabels":78,"otherNames":11},"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.\n\nTwo follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV\u002FSTI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment.",[61],[80,85],{"name":81,"role":82,"phone":83,"phoneExt":11,"email":84},"Jessica M. Perkins, Ph.D.","CONTACT","585-750-6694","jessica.m.perkins@vanderbilt.edu",{"name":86,"role":82,"phone":87,"phoneExt":11,"email":88},"Sarah E Sowell, B.A.","982-832-8104","sarah.e.sowell@vanderbilt.edu",[90],{"facility":91,"status":11,"city":92,"state":93,"zip":11,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Mbarara University of Science and Technology","Mbarara","Uganda","UG",{"type":96,"coordinates":97},"Point",[98,99],30.64851,-0.60467,{"lat":99,"lon":98},[102],{"name":103,"role":82,"phone":104,"phoneExt":11,"email":105},"Charles Baguma, MPH","256-077-564-1558","Cbaguma@mustresearch.org",{"type":107,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jessica Perkins","Assistant Professor, Department of Human and Organizational Development",[111,112,114,116,118,120],{"name":91,"class":6},{"name":113,"class":6},"Vanderbilt University Medical Center",{"name":115,"class":6},"University of California, San Francisco",{"name":117,"class":6},"Massachusetts General Hospital",{"name":119,"class":6},"Brown University",{"name":121,"class":122},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100649070","pnf-rct-to-decrease-alcohol-use-and-increase-hiv-prevention-100649070",false,"NCT07731932","PNF RCT to Decrease Alcohol Use and Increase HIV Prevention","Personalized Normative Feedback to Decrease Unhealthy Alcohol Use and Increase HIV Prevention Behavior Among Youth and Young Adults in Rural Ugandan Schools","Inclusion Criteria:\n\n* All students enrolled in Kinoni High School, Kinoni Girls Secondary School, or Rugando Technical Institute, 13-25 years of age\n\nExclusion Criteria:\n\n* 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)",true,"ALL","13 Years","25 Years",{"count":135,"type":136},1350,"ESTIMATED","INTERVENTIONAL",[139],"NA","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\u002FSTI prevention among adolescents and young adults in Rwampara District, Uganda.",[142,143,144],"HIV (Human Immunodeficiency Virus)","Alcohol Misuse","STI",[146,147,148,149,150,151],"HIV transmission","sexually transmitted infections","personalized normative feedback","social norms","HIV prevention","alcohol use","NOT_YET_RECRUITING","2026-07-22",{"date":155,"type":156},"2026-07-28","ACTUAL",{"date":158,"type":136},"2026-09-01",{"date":160,"type":136},"2030-08-30",{"name":5,"class":6},1]