[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497164":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"RTI International","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard: mHealth-Women's CoOp","ACTIVE_COMPARATOR","Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young women. The app will be installed on each participant's smartphone by study staff after randomization.",[13],"Behavioral: mHealth-Women's CoOp",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced: mHealth-Women's CoOp+Group","EXPERIMENTAL","Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young women, in addition to a virtual peer group component. The app with a link to the virtual group will be installed on each participant's smartphone by study staff after randomization.",[13,19],"Behavioral: Virtual Group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","mHealth-Women's CoOp","The mHealth-Women's CoOp, was developed and tested in a previous randomized trial, is a human immunodeficiency virus (HIV) risk-reduction intervention that addresses the intersection of substance use, sexual risk and violence through education, skills-building, and role-play and rehearsal via a mobile app. The mHealth-Women's CoOp app is also used to help participants monitor progress toward their goals throughout the study period. Specifically, the app is programmed to prompt the user, to visit the app and participate in several activities, including health and behavior check-in and revisiting aspects of the mHealth-Women's CoOp educational content to sustain risk reduction.",[15,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Virtual Group","The enhanced online group component will be available to be accessed using the mHealth-Women's CoOp platform for participants in the enhanced arm. The purpose of this component is to allow for young women who use alcohol to interact with young women like them and also discuss issues related to substance use and sexual risk-taking via a guided conversation to allow for motivational and informational support. The virtual group component will include online live discussions moderated and monitored by a trained online facilitator.",[15],[32],{"name":33,"affiliation":5,"role":34},"Felicia A Browne, ScD, MPH","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","9195416596","fbrowne@rti.org",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Durham","North Carolina","27707","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-78.89862,35.99403,{"lat":52,"lon":51},[55],{"name":33,"role":37,"phone":56,"phoneExt":26,"email":39},"919-541-6596",{"type":34,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Felicia A. Browne, ScD, MPH","Senior Research Social Epidemiologist",[61],{"name":62,"class":63},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100497164","gathering-online-for-dialogue-and-discussion-to-enhance-social-support-100497164",false,"NCT05753683","Gathering Online for Dialogue and Discussion to Enhance Social Support","GODDESS (Gathering Online for Dialogue and Discussion to Enhance Social Support): Engaging Young African American Women in a Virtual Group App to Address Alcohol Misuse, Sexual Risk, and Pre-exposure Prophylaxis (PrEP) in North Carolina (NC)","GODDESS","Selected Inclusion Criteria:\n\n* identify as Black\u002FAfrican American\n* identify as female\n* be between 18 and 30 years old\n* recent substance use\n* HIV negative and not currently on PrEP\n* have an Android or iOS-based smartphone\n\nSelected Exclusion Criteria:\n\n* test positive for HIV\n* participated in the previous study activities of the current study or previous related studies",true,"ALL","18 Years","30 Years",{"count":77,"type":78},500,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol.\n\nThe expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation.\n\nParticipants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3- and 6-months post-enrollment.",[84,85,86,87],"Alcohol Misuse","HIV","Sexually Transmitted Infections","Pre-exposure Prophylaxis","2026-05-15",{"date":90,"type":91},"2026-05-19","ACTUAL",{"date":93,"type":91},"2025-04-07",{"date":95,"type":78},"2027-11",{"name":5,"class":6},1]