Hepatitis BPhase 4NCT06786429
Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.
A Phase 4 study testing Gardasil 9 vaccine, Hepatitis B Virus Vaccine(HBV) and Cognitive Behavioral Therapy in people with Hepatitis B and Human Papilloma Virus, run by Eunice Dube.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Human Papilloma Virus, Mental Health Issue
- What is being tested?
- Gardasil 9 vaccine, Hepatitis B Virus Vaccine(HBV) and Cognitive Behavioral Therapy
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,140 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2027to 15 Dec 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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?
Read the 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:
- 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.
- Conditions
- Hepatitis B, Human Papilloma Virus, Mental Health Issue, Cancer Liver, Cancer of Cervix, Depression, Anxiety
- Being tested
- Gardasil 9 vaccine, Hepatitis B Virus Vaccine(HBV), Cognitive Behavioral Therapy
- Medical subject headings
- Hepatitis B, Carcinoma, Hepatocellular, Uterine Cervical Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil 9 vaccineBiological
Participants with a valid consent will be offered a three-dose Gardasil 9 series if eligible.
Hepatitis B Virus Vaccine(HBV)Biological
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.
Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High School Students | Other | 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. Receives: Biological: Gardasil 9 vaccine; Behavioral: Cognitive Behavioral Therapy |
| Women of childbearing age and young adults (13-50years old) | Other | 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 Receives: Biological: Gardasil 9 vaccine; Biological: Hepatitis B Virus Vaccine(HBV); Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papilloma Virus infection
Women will be screened for HPV infection at baseline, and post vaccine with Gardasil 9
Measured: 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.
Measured: Baseline and six months to one year post vaccination.
cancer of cervix
Patients will be assessed for malignancy on cervix
Measured: 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.
Measured: Baseline and six months to one year post vaccination with Hep B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start30 Jan 2027 (estimated)
- Primary completion15 Dec 2032 (estimated)
- Study completion15 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- High school students and women of childbearing age are participating concurrently as separate groups
- Masking
- None (open label)
- Enrolment
- 2,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Dube
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Science and Technology, Zimbabwe, Brethren in Christ Church Health System, Abazukulu Health Research and Development Project
- Responsible party
- Principal investigator, Eunice Dube, Eunice Dube
- Investigators
- Elopy Sibanda, M.D, Study director, National University of Science and Technology, ZimbabweEunice Dube, DSc, Principal investigator, Eunice DubeJill Koshiol, Ph. D, Principal investigator, National Cancer Institute (NCI)Sodumisa Ngwenya, MD, Principal investigator, Mtshabezi Mission HospitalDesmond M Kaplan, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786429
- Sponsor's protocol ID
- EX8KG3L2Z649
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only test results data with no participant identifying information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06786429
- Acronym / sponsor ID
- EX8KG3L2Z649
- Conditions
- Hepatitis B, Human Papilloma Virus, Mental Health Issue, Cancer Liver, Cancer of Cervix, Depression, Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,140 participants (estimated)
- Lead sponsor
- Eunice DubeUniversity, hospital or other
- Collaborators
- National University of Science and Technology, Zimbabwe, Brethren in Christ Church Health System, Abazukulu Health Research and Development Project
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 15 Dec 2032 (estimated)
- Study completion
- 15 Dec 2032 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- High school students and women of childbearing age are participating concurrently as separate groups
| Arm | Type | Receives |
|---|---|---|
| High School Students | Other | Biological: Gardasil 9 vaccine, Behavioral: Cognitive Behavioral TherapyAll 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. |
| Women of childbearing age and young adults (13-50years old) | Other | Biological: Gardasil 9 vaccine, Biological: Hepatitis B Virus Vaccine(HBV), Behavioral: Cognitive Behavioral TherapyThis 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 |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gardasil 9 vaccineParticipants with a valid consent will be offered a three-dose Gardasil 9 series if eligible. | Biological | High School Students, Women of childbearing age and young adults (13-50years old) |
| 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. | Biological | Women of childbearing age and young adults (13-50years old) |
| Cognitive Behavioral TherapyParticipants 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. | Behavioural | High School Students, Women of childbearing age and young adults (13-50years old) |
Primary outcome
Human Papilloma Virus infection
Time frame: Baseline and 10 years post vaccination
Women will be screened for HPV infection at baseline, and post vaccine with Gardasil 9
Hepatitis B immunity
Time frame: Baseline 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 cervix
Time frame: Baseline assessment and 10 years post vaccination with Gardasil 9.
Patients will be assessed for malignancy on cervix
Cancer of the liver
Time frame: Baseline 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- tbaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only test results data with no participant identifying information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elopy Sibanda, M.D study director
National University of Science and Technology, Zimbabwe
Eunice Dube, DSc principal investigator
Eunice Dube
Jill Koshiol, Ph. D principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gardasil 9 vaccine, Hepatitis B Virus Vaccine(HBV) and Cognitive Behavioral Therapy in people with Hepatitis B and Human Papilloma Virus, run by Eunice Dube.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunice Dube, DSc. (4437106077, eunicedube@comcast.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Papilloma Virus infection (time frame: Baseline and 10 years post vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.