[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634904":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":72,"collaborators":74,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":26,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":109,"overallStatus":114,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5% 5-fluorouracil","EXPERIMENTAL","Participants will receive 12 doses of intravaginal 5FU cream.",[13],"Drug: 5% 5-fluorouracil Topical Cream",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo cream","PLACEBO_COMPARATOR","Participants will receive 12 doses of intravaginal placebo cream.",[19],"Drug: Placebo Cream",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","5% 5-fluorouracil Topical Cream","Starting four weeks after thermal ablation, participants will self-administer 2 g of 5FU cream intravaginally once every two weeks for 12 doses.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Cream","Starting four weeks after thermal ablation, participants will self-administer 2g of placebo cream intravaginally once every two weeks for 12 doses.",[15],[32],{"name":33,"affiliation":5,"role":34},"Chemtai Mungo, MD, MPH","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Sorgi Kate","CONTACT","919-984-0000","kasorgi@email.unc.edu",[42,61],{"facility":43,"status":26,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Maseno University","Kisumu","614-40100","Kenya","KE",{"type":49,"coordinates":50},"Point",[51,52],34.76171,-0.10221,{"lat":52,"lon":51},[55,59],{"name":56,"role":38,"phone":57,"phoneExt":26,"email":58},"Jackton A Omoto, MBChB","254 733617503","jomoto@maseno.ac.ke",{"name":60,"role":34,"phone":26,"phoneExt":26,"email":26},"Jackton Omoto, MBChB",{"facility":62,"status":26,"city":44,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Nyanza Reproductive Health Society",{"type":49,"coordinates":64},[51,52],{"lat":52,"lon":51},[67,71],{"name":68,"role":38,"phone":69,"phoneExt":26,"email":70},"Fredrick Mak'Otieno","254 721759867","fotieno@nrhskenya.org",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":73,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[75,78],{"name":76,"class":77},"National Cancer Institute (NCI)","NIH",{"name":79,"class":80},"UNC Department of Obstetrics and Gynecology","UNKNOWN","100634904","phase-2-adjuvant-5-fluorouracil-following-thermal-ablation-to-improve-hpv-treatment-outcomes-in-women-with-hiv-in-kenya-100634904",false,"NCT07545746","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya : The ASCEND Trial","ASCEND","Inclusion Criteria\n\n* Women aged 25 years or older\n* Known HIV-positive status\n* On antiretroviral therapy (ART) for at least 60 days prior to enrollment\n* Positive HPV screening test screening result\n* Able to provide informed consent in English, Swahili, or Dholuo\n* Agree to use dual contraception during dosing phase if of childbearing potential\n* Planning to remain in study locale for duration of study (48 weeks) Exclusion Criteria\n* Current pregnancy or breastfeeding\n* History of anogenital cancer (cervical, vulvar, or anal)\n* Current use of immunosuppressive medications\n* History of total hysterectomy\n* Known allergy to 5FU\n* Medical comorbidity that would interfere with study participation\n* Unwilling or unable to use contraception during study participation","FEMALE","25 Years",{"count":92,"type":93},140,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks.\n\nIt is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.",[99,100,101,102,103,104,105,106,107,108],"HIV Infections","HPV Infection","Cervix Cancer","CIN2","CIN3","CIN1","CIN","Cervical Intraepithelial Neoplasia Grade 3","Cervical Intraepithelial Neoplasia Grade 1","Cervical Intraepithelial Neoplasia Grade 2\u002F3",[110,111,112,113],"5-fluorouracil (5FU)","thermal ablation (TA)","placebo","intravaginal topical","NOT_YET_RECRUITING","2026-06-01",{"date":117,"type":118},"2026-06-02","ACTUAL",{"date":120,"type":93},"2026-07",{"date":122,"type":93},"2028-03",{"name":5,"class":6},2]