A Phase 4 interventional study of Gardasil 9 vaccine and Hepatitis B Virus Vaccine(HBV) in Hepatitis B, Human Papilloma Virus and Mental Health Issue, sponsored by Eunice Dube. Not yet recruiting. Open to participants aged 13 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Eunice Dube · Phase 4, Interventional, and Health services research
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?
Hypotheses:
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.
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 2,140 is above the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →This is the only study on the registry with Eunice Dube as lead sponsor.
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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:
Any potential participant who is unable to understand and respond to the questions being asked.
All high school students in the study area are eligible, approximately 1000 students. Consenting participants will complete a one-time Youth Risk Behavior Survey (CDC) and receive Cognitive Behavioral Therapy if indicated. Eligible and consenting participants will be offered a 3-dose series of Gardasil 9 to protect against HPV.
Biological: Gardasil 9 vaccine · Behavioral: Cognitive Behavioral Therapy
This group is at highest risk for having exposure to cervical and liver cancer, depression and anxiety. Participants are unlikely to have had vaccines of interest, Hep B, and HPV, as their status is unknown due to a lack of screening and vaccination. Participants in this group with depressive/anxiety symptoms are likely to benefit from CBT intervention
Biological: Gardasil 9 vaccine · Biological: Hepatitis B Virus Vaccine(HBV) · Behavioral: Cognitive Behavioral Therapy
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.
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.
Human Papilloma Virus infection
Women will be screened for HPV infection at baseline, and post vaccine with Gardasil 9
Time frame: Baseline and 10 years post vaccination
Hepatitis B immunity
Women will be screened for Hep B immunity before and after receiving a three-shot series of Hep B vaccine.
Time frame: Baseline and six months to one year post vaccination.
cancer of cervix
Patients will be assessed for malignancy on cervix
Time frame: Baseline assessment and 10 years post vaccination with Gardasil 9.
Cancer of the liver
Patients will have a fibro scan to assess condition of liver at initial visit and post vaccination with Hep B.
Time frame: Baseline and six months to one year post vaccination with Hep B.
A change in Depression and anxiety symptoms based on PHQ-9 and Edinburgh post-natal depression scale.
Patients undergoing Cognitive Behavioral Therapy will be assessed for change in symptoms
Time frame: Baseline and two to 12 months
No study locations are listed for this record.
Plan to share: Yes — Only test results data with no participant identifying information will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: All selected study supporting information will be available from 01/30/2033 through 01/30/2040.
Access criteria: Selected IPD will be accessible to researchers at institutes of higher education, NIH, and non-profit organizations through the Zimbabwe data repository.
Data sharing details ↗ · www.nust.ac.zw
Start is estimated for Jan 2027; primary completion for Dec 2032, 70 months later.
Of 47 non-industry phase 4 interventional studies under Hepatitis B, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 70 months is above that.
Counting every sponsor, half of 63 studies reached it within 35 months; a quarter within 12 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hepatitis B Surface Antigens