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

NCT06786429 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: EX8KG3L2Z649
• Study Type: interventional
• Target: 2,140
• Locations: 0 countries
• Sites: N/A

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?

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Human Papilloma Virus infection

  Women will be screened for HPV infection at baseline, and post vaccine with Gardasil 9

  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.

  Baseline and six months to one year post vaccination.

• cancer of cervix

  Patients will be assessed for malignancy on cervix

  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.

  Baseline and six months to one year post vaccination with Hep B.

Other Outcomes (1)

• A change in Depression and anxiety symptoms based on PHQ-9 and Edinburgh post-natal depression scale.

  Baseline and two to 12 months

Study Arms (2)

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.

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

Biological: Gardasil 9 vaccine; Biological: Hepatitis B Virus Vaccine(HBV); Behavioral: Cognitive Behavioral Therapy

Interventions

Gardasil 9 vaccine BIOLOGICAL

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

High School Students; Women of childbearing age and young adults (13-50years old)

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.

Women of childbearing age and young adults (13-50years old)

Cognitive Behavioral Therapy BEHAVIORAL

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.

High School Students; Women of childbearing age and young adults (13-50years old)

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Dube: lead
• National University of Science and Technology, Zimbabwe: collaborator
• Brethren in Christ Church Health System: collaborator
• Abazukulu Health Research and Development Project: collaborator

Related Links

• tba

MeSH Terms

Conditions

Hepatitis B; Carcinoma, Hepatocellular; Uterine Cervical Neoplasms; Depression; Anxiety Disorders

Interventions

Hepatitis B Vaccines; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elopy Sibanda, M.D

  National University of Science and Technology, Zimbabwe

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunice Dube, DSc.

CONTACT

4437106077; eunicedube@comcast.net

Jill Koshiol, Ph. D.

CONTACT

2402767178; koshiolj@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director/Principal Investigator

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

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 22, 2025
• Study Start (Estimated): January 30, 2027
• Primary Completion (Estimated): December 15, 2032
• Study Completion (Estimated): December 15, 2032
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.