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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06786429
Enrollment
2140
Registered
2025-01-22
Start date
2027-01-30
Completion date
2032-12-15
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Liver, Cancer of Cervix, Depression, Anxiety, Hepatitis B, Human Papilloma Virus, Mental Health Issue

Brief summary

Aim: The main goal of this quantitative epidemiological observational study is to determine the prevalence of Human Papilloma Virus (HPV) infection and Hepatitis B (Hep B) immunity amongst women of childbearing age. attending clinics at Mtshabezi Mission and Matobo clinic respectively, and assessing 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. Question: Can screening for cancer, vaccination against Hep B and HPV, and cognitive behavior intervention help in preventing related cancers amongst these groups of participants?

Detailed description

Hypotheses: * The prevalence of HPV infection (might be high) and Hep B immunity (might be low) is not documented and therefore unknown in this community, as there is no routine surveillance of these specific conditions * Behavioral risk factors of High School students in Matabeleland South Province have not yet been assessed and remain unaddressed, hence the high rates of suicide, infection, and teen pregnancy, which predispose participants to Hep B and HPV related infection and consequently, cancers. Participants have not had access to the HPV preventing vaccine Gardasil 9. To provide answers to these concerns, investigators propose the activity described below. Objectives The objectives of this proposal are twofold: 1\. Research- uses the Theory of Change and the quantitative epidemiologic descriptive survey method to gather, analyze, and interpret data and disseminate results. There is no sampling frame as this study is exploratory. True prevalences are not known. 1.1 Data collection, analysis, and interpretation to determine the burden of HPV infection; determine the HPV types that are prevalent in this community to assess the potential effectiveness of the available vaccine; assess the potential for developing a vaccine covering local Genotypes; determine the prevalence of immunity to Hep B, and depression prevalence among adult participants.1.2. Conduct a youth risk behavior screen to determine potential infection risk and mental health issues, and design intervention strategies.1.3 Disseminate preliminary findings after the first 6 months or year one and suggest intervention strategies that can be evaluated for effectiveness during the study period. Publish findings and scale project to other areas in Zimbabwe and internationally.1.4 Request collaboration with NIH/NCI/Global center/Behavioral health to strengthen research capabilities and service provision in this area.2. Intervention 2.1 Recruit 1140 consenting female participants attending prenatal, family planning, post-partum, and other clinics at these selected centers to perform a one-time comprehensive medical exam, pap smear (to detect abnormal cells, and HPV test (if eligible) to detect infection in the cervix); perform blood test to look for Hep. B. and cancer biomarkers' presence, perform a one-time fibro scan to assess the liver. 2.2 Administer the Youth Risk Behavior Screen (Centers for Disease Control and Prevention (CDC) to 1000 consenting students in the selected schools over a period of 5years to determine the types and significance of problem behavior and suggest appropriate interventions; Assess protective factors among boarders versus day scholars. offer the Gardasil 9 vaccine to 1000 eligible students with parental consent. 2.3 Refer participants with abnormal screens for further assessments and management, including behavioral health intervention as indicated. Assess potential for home visits, telehealth services, routine screening, and immunization to ease access to services. Create teen clinics at the school sites. Analyze data at three levels using the IBM Statistical Package for Social Sciences (SPSS) for significance testing and disseminate results. Solicit Ministry of Health and Childcare (MOHCC) buy-in for scaling to other Provinces. * Investigators plan to follow up this cohort for ten years post-vaccination * Based on the data obtained, clinical trials will assess the probability of developing an HPV vaccine that is user and patient-friendly to Low to Middle Income Countries (LMIC); promote creation and use of screening tools suitable for rural communities. * Participants identified as having risk behaviors will be offered further assessment by a psychiatrist or /and/or psychologist to develop a viable framework to prevent and manage such behaviors, including medication, which is currently not available in Zimbabwe. Recommendations regarding women's health, i.e., screening for cervical cancer and vaccination against HPV and Hep B, depression, and Intimate Partner Violence will be guided by the findings of this study.

Interventions

BIOLOGICALGardasil 9 vaccine

Participants with a valid consent will be offered a three-dose Gardasil 9 series if eligible.

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.

BEHAVIORALCognitive Behavioral Therapy

Participants who demonstrate signs and symptoms of depression and/or 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.

Sponsors

Eunice Dube
Lead SponsorOTHER
National University of Science and Technology, Zimbabwe
CollaboratorOTHER
Brethren in Christ Church Health System
CollaboratorUNKNOWN
Abazukulu Health Research and Development Project
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

High school students and women of childbearing age are participating concurrently as separate groups

Eligibility

Sex/Gender
ALL
Age
13 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* For the High school students' group: All 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 years of the project, are eligible to participate in the study. Ability to understand and respond to questions on the Youth Risk Behavior Survey questionnaire and PHQ-9 scale. Relevant history of HPV vaccine administration. Ability to obtain parental/guardian consent for participation. \- For the women's group: All women and young female adults, thirteen to fifty 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. Can understand and respond to the PHQ-9 and Edinburgh Postnatal Depression scales. Must have a valid consent for participation in the study.

Exclusion criteria

* males who are not enrolled in these participating High Schools. * 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. * Any eligible potential participant without a valid consent. * 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. Any potential participant who is unable to understand and respond to the questions being asked.

Design outcomes

Primary

MeasureTime frameDescription
Human Papilloma Virus infectionBaseline and 10 years post vaccinationWomen will be screened for HPV infection at baseline, and post vaccine with Gardasil 9
Hepatitis B immunityBaseline and six months to one year post vaccination.Women will be screened for Hep B immunity before and after receiving a three-shot series of Hep B vaccine.
cancer of cervixBaseline assessment and 10 years post vaccination with Gardasil 9.Patients will be assessed for malignancy on cervix
Cancer of the liverBaseline and six months to one year post vaccination with Hep B.Patients will have a fibro scan to assess condition of liver at initial visit and post vaccination with Hep B.

Contacts

CONTACTEunice Dube, DSc.
eunicedube@comcast.net4437106077
CONTACTJill Koshiol, Ph. D.
koshiolj@mail.nih.gov2402767178
STUDY_DIRECTORElopy Sibanda, M.D

National University of Science and Technology, Zimbabwe

PRINCIPAL_INVESTIGATOREunice Dube, DSc

Eunice Dube

PRINCIPAL_INVESTIGATORJill Koshiol, Ph. D

National Cancer Institute (NCI)

PRINCIPAL_INVESTIGATORSodumisa Ngwenya, MD

Mtshabezi Mission Hospital

PRINCIPAL_INVESTIGATORDesmond M Kaplan, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026