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.
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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.
Parallel
Gardasil 9 vaccine
Biological/VaccineParticipants with a valid consent will be offered a three-dose Gardasil 9 series if eligible.
Hepatitis B Virus Vaccine(HBV)
Biological/VaccineParticipants 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
BehavioralParticipants 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.
Human Papilloma Virus infection
Women will be screened for HPV infection at baseline, and post vaccine with Gardasil 9
Hepatitis B immunity
Women will be screened for Hep B immunity before and after receiving a three-shot series of Hep B vaccine.
cancer of cervix
Patients will be assessed for malignancy on cervix
Cancer of the liver
Patients will have a fibro scan to assess condition of liver at initial visit and post vaccination with Hep B.
Number of women with gall stones expressed as a rate of total number women examined.
Women will be assessed for gallstones at the initial visit. They will have a onetime abdominal ultrasound to assess the condition of their gall bladder, an important component of the digestive system with close proximity to the liver. Labs reviewed. Poor nutrition is listed among the top ten behavior related causes of mortality in Zimbabwe. There does not appear to be any studies related to the prevalence of this problem in this community. Those with a positive screen will be referred for further management.
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
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Eunice Dube
Lead sponsor
National University of Science and Technology, Zimbabwe
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
