[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628980":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":41,"locations":51,"responsibleParty":68,"collaborators":71,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":25,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":25,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":111,"whyStopped":25,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Fred Hutchinson Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (TA with 1 probe)","EXPERIMENTAL","Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 1 probe at month 0.",[13],"Procedure: Thermal ablation (TA) with 1 probe",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2 (TA with 2 probes)","Participants undergo a clinical exam, soft-brush endocervical and ectocervical biopsies, digital imaging, and visual assessment for TA, and if eligible undergo TA with 2 probes at month 0.",[18],"Procedure: Thermal ablation (TA) with 2 probes",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Thermal ablation (TA) with 1 probe","Undergo TA with 1 probe",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Thermal ablation (TA) with 2 probes","Undergo TA with 2 probes",[15],[31,35,38],{"name":32,"affiliation":33,"role":34},"Rachel L Winer, PhD, MPH","University of Washington","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Margaret M Madeleine, PhD, MPH","STUDY_CHAIR",{"name":39,"affiliation":40,"role":37},"Leeya Pinder, MD, MPH","University of Cincinnati",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},"Araceli Loera, MPH","CONTACT","+1 206-667-5816","aloera@fredhutch.org",{"name":48,"role":44,"phone":49,"phoneExt":25,"email":50},"Mark A Mounir","+254 768027841","mmounir@coptichospitals.org",[52],{"facility":53,"status":25,"city":54,"state":25,"zip":25,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Coptic Hope Center","Nairobi","Kenya","KE",{"type":58,"coordinates":59},"Point",[60,61],36.81667,-1.28333,{"lat":61,"lon":60},[64,66],{"name":65,"role":34,"phone":25,"phoneExt":25,"email":25},"Samah Rafie Sakr, MBChB, MRCS",{"name":67,"role":34,"phone":25,"phoneExt":25,"email":25},"Michael H Chung, MD, PhD, MPH, FRCP",{"type":34,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Margaret M. Madeleine, PhD","Professor",[72,73,76,77,80,82],{"name":33,"class":6},{"name":74,"class":75},"National Cancer Institute (NCI)","NIH",{"name":40,"class":6},{"name":78,"class":79},"Frontier Science & Technology Research Foundation, Inc.","INDUSTRY",{"name":81,"class":6},"Emory University",{"name":53,"class":83},"UNKNOWN","100628980","feasibility-study-comparing-use-of-one-or-two-probes-for-thermal-ablation-among-cervical-cancer-screen-positive-women-living-with-hiv-in-c1001p-cs2-kenya-100628980",false,"NCT07468695","Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS2 Kenya","Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV","Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled","FEMALE","25 Years","49 Years",{"count":95,"type":96},300,"ESTIMATED","INTERVENTIONAL",[99],"NA","Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. In Kenya, the estimated incidence rate of cervical cancer is 31-33 per 100,000 women per year among women without HIV and approximately 70-100 per 100,000 among WLWH.\n\nThe proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.",[102,103,104],"HIV (Human Immunodeficiency Virus)","HPV","Cervical Precancer",[106,107,108,109,110],"HIV","Cervical cancer screening","Treatment of Cervical Precancer","Thermal ablation","Human papillomavirus","NOT_YET_RECRUITING","2026-03-09",{"date":114,"type":115},"2026-03-12","ACTUAL",{"date":117,"type":96},"2026-03",{"date":119,"type":96},"2027-05-31",{"name":5,"class":6},1]