[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659567":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":33,"interventions":44,"overallOfficials":50,"centralContacts":54,"locations":63,"responsibleParty":77,"collaborators":25,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":25,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":25,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":101,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Miami","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"PreP Uptake","PrEP uptake is a binary composite endpoint defined as attendance at a PrEP initiation appointment and\u002For receipt of a PrEP prescription.","1 month post-intervention, 3 months post-intervention",{"measure":14,"description":15,"timeFrame":16},"Intention to Initiate PrEP","Intention to initiate PrEP will be assessed using the 3-item PrEP Intention Scale. Scores range from 1 (Very unlikely) to 5 (Very likely), with higher scores indicating a greater intention to initiate PrEP.","Baseline, 1 month post-intervention, and 3 months post-intervention",[18,22],{"measure":19,"description":20,"timeFrame":21},"Safe Sex Behavior Questionnaire (SSBQ) Total Score","Sexual HIV risk behaviors will be assessed using the 27-item Safe Sex Behavior Questionnaire (SSBQ), a validated self-report measure of HIV risk-reduction and safer sex behaviors. Items are scored from 1 (Never) to 5 (Always), with higher scores indicating greater engagement in safer sexual behaviors and lower sexual HIV risk.","Baseline, 1 month post-intervention, and 3 months post-intervention.",{"measure":23,"description":24,"timeFrame":21},"PrEP Knowledge Scale Total score","PrEP knowledge will be measured using the 13-item PrEP Knowledge Questionnaire. Scores range from 0 to 13, with higher scores indicating greater knowledge of PrEP.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to either the SEPA+PrEP-Women intervention or a delayed-intervention control group. The intervention group will receive the intervention immediately after baseline assessment. The control group will receive the intervention after completion of the 3-month follow-up interview.","PREVENTION",{"masking":32,"maskingDescription":25,"whoMasked":25},"NONE",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"SEPA+PrEP-Women Intervention","EXPERIMENTAL","Participants will receive the the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. Each session lasting approximately 2 hours.",[39],"Behavioral: SEPA+PrEP Women",{"label":41,"type":42,"description":43,"interventionNames":25},"Delayed SEPA+PrEP-Women Intervention (Wait-List Control)","NO_INTERVENTION","Participants assigned to this arm will complete baseline, 1-month, and 3-month follow-up assessments and will not receive the SEPA+PrEP-Women intervention during the 3-month study period. After completing the 3-month follow-up assessment, participants will be offered the SEPA+PrEP-Women intervention, which consists of three weekly group sessions delivered via Zoom, with each session lasting approximately 2 hours.",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":25},"BEHAVIORAL","SEPA+PrEP Women","Participants will receive the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. The intervention focuses on HIV testing, PrEP awareness, PrEP decision-making, partner communication, HIV risk perception, stigma, relationship dynamics, intimate partner violence and safety considerations, substance use, and navigation of healthcare and community resources. Sessions include facilitated discussion, skills-building activities, role-play, interactive exercises, and peer support.",[35],[51],{"name":52,"affiliation":5,"role":53},"Joseph De Santis, PhD","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":25,"email":59},"Rosina Cianelli, PhD","CONTACT","305 284 2147","rcianelli@miami.edu",{"name":52,"role":57,"phone":61,"phoneExt":25,"email":62},"305 284 5039","jdesantis@miami.edu",[64],{"facility":65,"status":25,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":25},"University of Miami School of Nursing and Health Studies","Coral Gables","Florida","33147","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-80.26838,25.72149,{"lat":75,"lon":74},{"type":53,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Rosina Cianelli","Professor","100659567","sepaprep-women-pilot-trial-for-hiv-prevention-among-women-at-risk-for-hiv-100659567",false,"NCT07864766","SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV","Pilot Testing the Efficacy and Implementation of SEPA+PrEP-Women Intervention for Women at Risk of HIV","Inclusion Criteria:\n\n* Self-identify as a woman\n* Age 18 years or older\n* HIV-negative or unknown HIV status\n* Report vaginal or anal sex with a male partner within the past 6 months\n* Report at least one HIV risk factor\n* Not currently using PrEP\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Does not meet the applicable inclusion criteria\n* Currently using PrEP\n* Unable to provide informed consent",true,"FEMALE","18 Years",{"count":91,"type":92},70,"ESTIMATED","INTERVENTIONAL",[95],"NA","The purpose of this study is to evaluate the preliminary efficacy of SEPA (SEPA (Salud\u002FHealth, Educación\u002FEducation, Prevención\u002FPrevention, Autocuidado\u002FSelf-Care) +PrEP (Pre-Exposure Prophylaxis) -Women in a randomized pilot trial (N=70 women at risk for HIV; 35 intervention, 35 control). The primary outcome is PrEP uptake (attendance at a PrEP initiation appointment and\u002For receipt of a PrEP prescription, and intention to use PrEP), measured at baseline, 1-month post-intervention, and 3 months post-intervention. The control group will receive SEPA+PrEP-Women after the 3-month assessment (delayed intervention). We hypothesize that women assigned to SEPA+PrEP-Women will demonstrate higher PrEP uptake than controls, yielding initial effect size estimates to power a future definitive trial. Secondary outcomes include changes in sexual HIV risk behaviors, PrEP knowledge, and PrEP intentions.",[98],"HIV Infections",[100],"women primary disease prevention, online intervention","NOT_YET_RECRUITING","2026-10-02",{"date":104,"type":105},"2026-10-08","ACTUAL",{"date":107,"type":92},"2026-11",{"date":109,"type":92},"2027-05",{"name":5,"class":6},1]