[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611410":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":32,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":91,"whyStopped":32,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Kenyan women","Up to 500 adult women will undergo cervical cancer screening.",[12,13],"Diagnostic Test: High Risk HPV DNA Testing","Procedure: Visual Inspection with acetic acid (VIA) and possible cervical biopsy",{"label":15,"type":6,"description":16,"interventionNames":17},"Kenyan daughters","Up to an additional 2000 girls (daughters of participants in the Kenyan women arm) will be immunized against HPV using the 9-valent HPV vaccine (Gardasil-9).",[18],"Biological: Gardisil-9",[20,27,33],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Gardisil-9","The 9 valent vaccine will be offfered to 2000 adolescent girls. The 9 valent vaccine will be offered to 2000 adolescent girls. The first vaccination dose will be administered at a community meeting, after parental consent has been obtained. The second vaccination dose will be administered at a subsequent community meeting, 6 to 12 months after the first dose.",[15],[26],"9-valent HPV vaccine",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","High Risk HPV DNA Testing","Self-collected cervical swabs will be tested for high-risk HPV using the Roche Cobas Assay. This assay provides specific HPV 16 or 18 detection, as well as detection of any of 12 additional oncogenic types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"PROCEDURE","Visual Inspection with acetic acid (VIA) and possible cervical biopsy","Cervical screening in Kenya is usually done through pelvic examination and VIA. Cervical biopsy will additionally be performed for all HIV-infected women, and for HIV-uninfected women with abnormal VIA results.",[9],[39],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Phillip Tonui, MD","CONTACT","0722 609132","tonui46@yahoo.co.uk",[45],{"facility":46,"status":32,"city":47,"state":32,"zip":32,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Moi University","Eldoret","Kenya","KE",{"type":51,"coordinates":52},"Point",[53,54],35.26993,0.52036,{"lat":54,"lon":53},[57,58],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},{"name":59,"role":41,"phone":60,"phoneExt":32,"email":61},"Darron R Brown, MD","317-407-9034","darbrow@iu.edu",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Darron Brown MD, MPH","Professor of Microbiology","100611410","the-mother-daughter-project-merck-4-100611410",false,"NCT07240220","The Mother-Daughter Project: Merck-4","The Mother-Daughter Project: Inclusion of Difficult-to-reach Kenyan Families, and Studies of Factors Influencing the Immune Response to HPV Vaccination (Merck-4)","Merck-4","Kenyan Adult Women\n\nInclusion Criteria:\n\n* ages 25 through 49 years\n* able\u002Fwilling to sign informed consent\n* willing to participate in the community meetings\n\nExclusion Criteria:\n\n• pregnant\n\nKenyan Girls\n\nInclusion Criteria:\n\n* ages 9 through 14 years\n* have mother that is able\u002Fwilling to sign informed consent for vaccination\n* can return for the second HPV vaccine dose in 6 - 12 months\n\nExclusion Criteria:\n\n• girls who are not willing or unable to return for the second HPV vaccine dose",true,"FEMALE","9 Years","49 Years",{"count":79,"type":80},2500,"ESTIMATED","INTERVENTIONAL",[83],"NA","This project serves to continue a community-based initiative, known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), in the Webuye region of Western Kenya. The MDP project, since its initiation in 2018, has sought to develop a framework for the eradication of cervical cancer through effective screening of adult women and through the vaccination of female children.\n\nThis project specifically aims to collect additional data on the ability for HR-HPV testing to detect premalignant lesions of the cervix, especially in HIV-infected women, to investigate and identify barriers leading to non-participation in previous MDP efforts, and to examine factors associated with the immune response to HPV vaccination among rural Kenyan girls.",[86],"Cervical Dysplasia",[88,89,90],"cervical dysplasia","cervical cancer screening","HPV infection","NOT_YET_RECRUITING","2026-01-14",{"date":94,"type":95},"2026-01-15","ACTUAL",{"date":97,"type":80},"2026-02-01",{"date":99,"type":80},"2028-08-01",{"name":5,"class":6},1]