[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576525":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":51,"locations":25,"responsibleParty":61,"collaborators":63,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":25,"overallStatus":91,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":25},{"fullName":5,"class":6},"Eunice Dube","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"High School Students","All high school students in study area are eligible, approximately 1000-1500 students.\n\nParticipants will complete a Youth Risk Behavior Screen (CDC), offer Cognitive Behavioral Therapy if indicated. Participants will be offered a 3-dose series of Gadarsil to protect against HPV.",[12,13],"Biological: Gardasil 9 vaccine","Behavioral: Cognitive Behavioral Therapy",{"label":15,"type":6,"description":16,"interventionNames":17},"Women of childbearing age and young adults","This group is at highest risk for having exposure to cervical and liver cancer, gall bladder issues, depression and anxiety. Participants are unlikely to have had vaccines of interest, Hep B. and HPV as status is unknown due to lack of screening and vaccination. Participants in this group with depressive\u002Fanxiety symptoms are likely to benefit from CBT intervention",[12,18,13],"Biological: Hepatitis B Virus Vaccine(HBV)",[20,26,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Gardasil 9 vaccine","Participants with a valid consent will be offered a three-dose Gardasil 9 series if eligible.",[9,15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Hepatitis B Virus Vaccine(HBV)","Participants who do not demonstrate immunity to Hep B antibody marker in their blood, HBsAb and not HBsAg will be offered a three-dose series of Hep B. vaccine. A blood test will be done six months later to assess vaccine take i.e. immunity. Patients who demonstrate infection with Hep B virus will be referred to their doctor for further management.",[15],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"BEHAVIORAL","Cognitive Behavioral Therapy","Participants who demonstrate signs and symptoms of depression and\u002For anxiety will be offered individual behavioral management services. This consists of weekly individual sessions by a trained therapist for 8 weeks with option for referral for further management depending on the outcome of the intervention. The positive outcome consists of a change in presenting symptoms determined after administration of the youth risk behavior screen for high school students, and PHQ-9, and Edinburgh post-natal depression screen for women respectively.",[9,15],[36,40,43,46,49],{"name":37,"affiliation":38,"role":39},"Elopy Sibanda, M.D","National University of Science and Technology, Zimbabwe","STUDY_DIRECTOR",{"name":41,"affiliation":5,"role":42},"Eunice Dube, DSc","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":42},"Jill Koshiol, Ph. D","National Cancer Institute (NCI)",{"name":47,"affiliation":48,"role":42},"Sodumisa Ngwenya, MD","Mtshabezi Mission Hospital",{"name":50,"affiliation":25,"role":42},"Desmond M Kaplan, MD",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":25,"email":56},"Eunice Dube, DSc.","CONTACT","4437106077","eunicedube@comcast.net",{"name":58,"role":54,"phone":59,"phoneExt":25,"email":60},"Jill Koshiol, Ph. D.","2402767178","koshiolj@mail.nih.gov",{"type":42,"investigatorFullName":5,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Project Director\u002FPrincipal Investigator",[64],{"name":38,"class":6},"100576525","phase-4-managing-hepatitis-b-hep-b-and-human-papilloma-virus-hpv-related-cancers-and-mental-health-100576525",false,"NCT06786429","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.","Inclusion Criteria:\n\n* For the High school students' group:\n\nAll students aged 13 years and older, enrolled at the selected Mtshabezi and Matopo High Schools in the Gwanda and Matobo Rural Districts during the five-year period of the project are eligible to participate in the study.\n\nAbility to understand and respond to questions on the Youth Risk Behavior Scree questionnaire and PHQ-9 scale.\n\nRelevant history of HPV vaccine administration. Ability to obtain parental\u002Fguardian consent for participation.\n\n\\- For the women group: All women and young female adults thirteen to forty-five years old and requesting health services for prenatal, post-partum, family planning and other care during the five-year project period are eligible to participate.\n\nMust not have received Hep B and HPV vaccine in the past and have no known contraindications to either of these two vaccines.\n\nAre able to understand and respond to the PHQ-9 and Edinburgh Postnatal Depression scales.\n\nMust have a valid consent for participation in the study.\n\nExclusion Criteria:\n\n* males who are not enrolled in these participating High Schools.\n* children below the age of thirteen who are not enrolled in high schools and are not seeking prenatal, post-partum and family planning services at these selected health facilities during the project period.\n* Any eligible potential participant without a valid consent.\n* Any potential participant who is excluded by a doctor or midwife for a known contraindicating medical condition that can lead to potential harm to the participant or staff.\n\nAny potential participant who is unable to understand and respond to the questions being asked.\n\nParticipants with proof of prior vaccination will be excluded from this part of the study.",true,"ALL","13 Years","45 Years",{"count":77,"type":78},1800,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Aim: The main goal of this observational study is to determine the prevalence of Human Papilloma Virus(HPV) infection, and Hepatitis B (Hep B) immunity amongst women of childbearing age 13 to 45 years) attending clinics at Mtshabezi Mission and Matobo clinic respectively; and assess behavioral risk factors of high school students at these catchment areas that can put them at risk for developing cancer of the cervix and liver.\n\nQuestion: Can screening for cancer, and vaccination against Hep B and HPV, and cognitive behavior intervention help in preventing related cancers amongst these groups of participants.",[84,85,86,87,88,89,90],"Hepatitis B","Human Papilloma Virus","Gall Stones (& [Calculus - Gall Bladder])","Mental Health Issue","Cancer Liver","Cancer of Cervix","Depression, Anxiety","NOT_YET_RECRUITING","2026-01-17",{"date":94,"type":95},"2026-01-21","ACTUAL",{"date":97,"type":78},"2026-08-30",{"date":99,"type":78},"2031-12-30",{"name":5,"class":6}]