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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age13-50
SponsorEunice Dube

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gardasil 9 vaccine

    Biological/Vaccine

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

  • Hepatitis B Virus Vaccine(HBV)

    Biological/Vaccine

    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 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.

Treatment groups

2,140 Participants
are divided into 2 treatment groups
Group A: High School StudentsOther 2 interventions
Group B: Women of childbearing age and young adults (13-50years old)Other 3 interventions

Trial outcomes

Primary outcomes

1

Human Papilloma Virus infection

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

Time frame
Baseline and 10 years post vaccination
2

Hepatitis B immunity

Women will be screened for Hep B immunity before and after receiving a three-shot series of Hep B vaccine.

Time frame
Baseline and six months to one year post vaccination.
3

cancer of cervix

Patients will be assessed for malignancy on cervix

Time frame
Baseline assessment and 10 years post vaccination with Gardasil 9.
4

Cancer of the liver

Patients will have a fibro scan to assess condition of liver at initial visit and post vaccination with Hep B.

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

Secondary outcomes

Other outcomes

1

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

Patients undergoing Cognitive Behavioral Therapy will be assessed for change in symptoms

Time frame
Baseline and two to 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eunice Dube

Lead sponsor

National University of Science and Technology, Zimbabwe

Collaborator

Brethren in Christ Church Health System

Collaborator

Abazukulu Health Research and Development Project

Collaborator

This trial is not recruiting at the moment. You can still explore other options: