Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.

July 29, 2026 updated by: Eunice Dube

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Study Population

As of 2022, the population of Matabeleland South, Zimbabwe consisted of 760,345 persons, there being more women than men. The High schools enroll both malae and female boarders and day scholars, some of whom are orphans.

Study population: female participants= N 800. Highschool Student participants N 1000.

The population will be oversampled to allow for participants lost to follow up.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: High School Students

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
Participants with a valid consent will be offered a three-dose Gardasil 9 series if eligible.
Behavioral: Cognitive 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.
Other: Women of childbearing age and young adults (13-50years old)
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
Participants with a valid consent will be offered a three-dose Gardasil 9 series if eligible.
Behavioral: Cognitive 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.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 10 years post vaccination
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.
Baseline and six months to one year post vaccination.
cancer of cervix
Time Frame: Baseline assessment and 10 years post vaccination with Gardasil 9.
Patients will be assessed for malignancy on cervix
Baseline assessment and 10 years post vaccination with Gardasil 9.
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.
Baseline and six months to one year post vaccination with Hep B.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A change in Depression and anxiety symptoms based on PHQ-9 and Edinburgh post-natal depression scale.
Time Frame: Baseline and two to 12 months
Patients undergoing Cognitive Behavioral Therapy will be assessed for change in symptoms
Baseline and two to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eunice Dube

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National University of Science and Technology, Zimbabwe
Brethren in Christ Church Health System
Abazukulu Health Research and Development Project

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elopy Sibanda, M.D, National University of Science and Technology, Zimbabwe
  • Principal Investigator: Eunice Dube, DSc, Eunice Dube
  • Principal Investigator: Jill Koshiol, Ph. D, National Cancer Institute (NCI)
  • Principal Investigator: Sodumisa Ngwenya, MD, Mtshabezi Mission Hospital
  • Principal Investigator: Desmond M Kaplan, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EX8KG3L2Z649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only test results data with no participant identifying information will be shared.

IPD Sharing Time Frame

All selected study supporting information will be available from 01/30/2033 through 01/30/2040.

IPD Sharing Access Criteria

Selected IPD will be accessible to researchers at institutes of higher education, NIH, and non-profit organizations through the Zimbabwe data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Clinical Study Report
  2. Clinical Study Report
    Information identifier: tba

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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