[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638783":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":73,"collaborators":76,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":23,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":23,"enrollmentInfo":102,"targetDuration":23,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":23,"overallStatus":115,"whyStopped":23,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary HPV screen with management based on HPV types and VIA status","EXPERIMENTAL","All women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. WLWH who test hrHPV negative will exit the study. Women with hrHPV will return for speculum examination, cervical swab collection, VIA, and histology. Women with HPV 16\u002F18 will undergo immediate treatment. Women with non-16\u002F18 hrHPV will undergo immediate treatment only if cervical lesions are seen on VIA. Women who are not treated, but subsequently found to have cervical HSIL on histology, will return for cervical treatment. The choice of treatment modality (TA vs. LEEP\u002FLLETZ) will be determined by the extent of cervical lesions seen on VIA. Women with extensive lesions will undergo LEEP\u002FLLETZ treatment. All women who are enrolled (and therefore hrHPV positive) in the early months of the study will be asked to return for a visit 4-6 months later for repeat HPV testing and cervical histology.",[13,14,15,16],"Diagnostic Test: HPV DNA Testing (Abbott Alinity m HPV Assay)","Procedure: Visual Inspection with Acetic Acid","Procedure: Cervical Histology (Biopsy Procedures)","Procedure: Cervical Treatment (Thermal Ablation or LEEP\u002FLLETZ)",[18,24,31,35],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","HPV DNA Testing (Abbott Alinity m HPV Assay)","Women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. The Alinity m HR HPV assay is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of high-risk HPV DNA. The assay detects 14 hrHPV genotypes by targeting the conserved L1 region of HPV DNA and provides individual or group-level genotyping results, including separate readouts for HPV 16, HPV 18, and HPV 45, and grouped detection of other high-risk types. The assay also provides a proxy for HPV viral load as measured by the cycle threshold (CT) value for the type- or group-specific readout.",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Visual Inspection with Acetic Acid","Participants with hrHPV detected will undergo visual inspection with acetic acid (VIA) during a speculum examination. Standard acetic acid (3-5%) is applied to the cervix, and the provider will assess for the presence of cervical lesions, determine suitability for ablative treatment, and characterize the transformation zone (TZ1, TZ2, or TZ3). VIA findings will be used to guide participant management and treatment decisions.",[9],[30],"VIA",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":23},"Cervical Histology (Biopsy Procedures)","Cervical histology specimens will be obtained from participants with hrHPV detected. Biopsies may include lesion-directed cervical punch biopsies, endo- and ectocervical soft-brush biopsies, or endocervical curettage (ECC). At least two biopsies will be obtained even if no lesions are seen. For participants undergoing LEEP\u002FLLETZ, histology will be obtained through the excisional procedure. Cervical histology will be processed locally and interpreted according to the lower anogenital squamous terminology (LAST), including p16 testing where available to confirm morphologic-appearing CIN 2.",[9],{"type":25,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Cervical Treatment (Thermal Ablation or LEEP\u002FLLETZ)","Women with HPV 16 and\u002For 18 will undergo immediate treatment. Women with non-16\u002F18 hrHPV will undergo immediate treatment if cervical lesions are seen on VIA. Women who are not treated but are subsequently found to have cervical high-grade squamous intraepithelial lesions (hHSIL) on histology will return for cervical treatment. Treatment modality will be determined based on the extent of cervical lesions, with thermal ablation (TA) used for lesions appropriate for ablative therapy and LEEP\u002FLLETZ used for more extensive lesions.",[9],[40,41,42,43],"Thermal Ablation","LEEP\u002FLLETZ","LEEP","LLETZ",[45],{"name":46,"affiliation":5,"role":47},"Timothy J Wilkin, MD, MPH","STUDY_CHAIR",[49],{"name":50,"role":51,"phone":52,"phoneExt":23,"email":53},"Caique Mello, MPH","CONTACT","858-253-6394","camello@health.ucsd.edu",[55],{"facility":56,"status":23,"city":57,"state":58,"zip":23,"country":59,"countryCode":60,"cosmosGeoPoint":23,"geoPoint":23,"contacts":61},"Botswana Harvard Health Partnership","Gaborone","South-East District","Botswana","BW",[62,66,68,71],{"name":63,"role":51,"phone":64,"phoneExt":23,"email":65},"Scott L Dryden-Peterson, MD, MSc","617-732-8881","sldrydenpeterson@bwh.harvard.edu",{"name":63,"role":67,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"name":69,"role":70,"phone":23,"phoneExt":23,"email":23},"Rebecca G Luckett, MD, MPH","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":23,"phoneExt":23,"email":23},"Doreen Ramogola-Masire, MBBS, PhD, MPH",{"type":67,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Timothy Wilkin","Professor",[77,80,82,84,86,88,90],{"name":78,"class":79},"Frontier Science & Technology Research Foundation, Inc.","INDUSTRY",{"name":56,"class":81},"UNKNOWN",{"name":83,"class":6},"Brigham and Women's Hospital",{"name":85,"class":6},"Beth Israel Deaconess Medical Center",{"name":87,"class":6},"H. Lee Moffitt Cancer Center and Research Institute",{"name":89,"class":6},"University of North Carolina, Chapel Hill",{"name":91,"class":92},"National Cancer Institute (NCI)","NIH","100638783","testing-the-feasibility-of-different-hpv-screening-and-care-strategies-for-women-living-with-hiv-100638783",false,"NCT07576842","Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV","CASCADE: A Feasibility Study of HPV Screening and Management Strategies Utilizing Extended Molecular HPV DNA Genotyping and HPV Viral Load in Women Living With HIV","Inclusion Criteria:\n\n* HIV-1 infection, as documented by:\n\n  1. any FDA-approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA test kit, and confirmed by Western blot or other approved test), OR\n  2. a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and\u002For current management of HIV infection, OR\n  3. documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with participant identifiers affixed to the bottles or packages.\n* Aged 25 or older.\n* Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.\n* Have an intact cervix.\n\nExclusion Criteria:\n\n* Current symptoms or concern for cervical cancer.\n* History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.\n* Have undergone cervical hHSIL treatment in the past year.\n* Have a history of hysterectomy with removal of the cervix.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of AIDS and\u002For genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators.","FEMALE","25 Years",{"count":103,"type":104},750,"ESTIMATED","INTERVENTIONAL",[107],"NA","The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and\u002For 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16\u002F18) are not well defined.\n\nThis prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation.\n\nThe study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16\u002F18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).",[110,111,112,113,114],"Human Papillomavirus (HPV)","HPV Associated Cancers","Cervical Cancer","Human Immunodeficiency Virus (HIV)","Cervical Intraepithelial Neoplasia (CIN)","NOT_YET_RECRUITING","2026-05-04",{"date":118,"type":119},"2026-05-08","ACTUAL",{"date":121,"type":104},"2026-06-01",{"date":123,"type":104},"2027-06-01",{"name":5,"class":6},1]