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

Summary

Aim: The main goal of this observational study is to determine the prevalence of Human Papilloma Virus(HPV) infection, and Hepatitis B (Hep B) immunity amongst women of childbearing age 13 to 45 years) attending clinics at Mtshabezi Mission and Matobo clinic respectively; and assess 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, and 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
• Gall Stones (& [Calculus - Gall Bladder])
• Mental Health Issue
• Cancer Liver
• Cancer of Cervix
• Depression, Anxiety

Interventions

BIOLOGICAL

Gardasil 9 vaccine

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

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.

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.

Sponsors & Collaborators

• National University of Science and Technology, Zimbabwe

  collaborator OTHER

• Eunice Dube

  lead OTHER

Principal Investigators

• Elopy Sibanda, M.D · National University of Science and Technology, Zimbabwe

• Eunice Dube, DSc · Eunice Dube

• Jill Koshiol, Ph. D · National Cancer Institute (NCI)

• Sodumisa Ngwenya, MD · Mtshabezi Mission Hospital

• Desmond M Kaplan, MD

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-30

Primary Completion

2031-09-30

Completion

2031-12-30