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

Sponsor
Eunice Dube
Study ID
NCT06786429
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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?

Key Dates

First listed
Jan 22, 2025
Start date
Jan 30, 2027
Status verified
Jul 2026
Primary completion
Dec 15, 2032
Completion
Dec 15, 2032

Study Design

Enrollment
2,140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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

Primary Outcome Measure

Human Papilloma Virus infection [ Time Frame: Baseline and 10 years post vaccination ]

Central Contacts

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