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

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

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

• Brethren in Christ Church Health System

  collaborator UNKNOWN

• Abazukulu Health Research and Development Project

  collaborator UNKNOWN

• 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

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2027-01-30

Primary Completion

2032-12-15

Completion

2032-12-15