Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,140
- 主要终点
- Human Papilloma Virus infection
研究概览
简要总结
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?
详细描述
Hypotheses:
- The prevalence of HPV infection (might be high) and Hep B immunity (might be low) is not documented and therefore unknown in this community, as there is no routine surveillance of these specific conditions
- Behavioral risk factors of High School students in Matabeleland South Province have not yet been assessed and remain unaddressed, hence the high rates of suicide, infection, and teen pregnancy, which predispose participants to Hep B and HPV related infection and consequently, cancers. Participants have not had access to the HPV preventing vaccine Gardasil 9. To provide answers to these concerns, investigators propose the activity described below.
Objectives
The objectives of this proposal are twofold:
1. Research- uses the Theory of Change and the quantitative epidemiologic descriptive survey method to gather, analyze, and interpret data and disseminate results. There is no sampling frame as this study is exploratory. True prevalences are not known.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the High school students' group:
- •All students aged 13 years and older, enrolled at the selected Mtshabezi and Matopo High Schools in the Gwanda and Matobo Rural Districts during the five years of the project, are eligible to participate in the study.
- •Ability to understand and respond to questions on the Youth Risk Behavior Survey questionnaire and PHQ-9 scale.
- •Relevant history of HPV vaccine administration. Ability to obtain parental/guardian consent for participation.
- •- For the women's group: All women and young female adults, thirteen to fifty years old, and requesting health services for prenatal, post-partum, family planning, and other care during the five-year project period are eligible to participate.
- •Can understand and respond to the PHQ-9 and Edinburgh Postnatal Depression scales.
- •Must have a valid consent for participation in the study.
排除标准
- •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.
- •Any potential participant who is unable to understand and respond to the questions being asked.
研究组 & 干预措施
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.
干预措施: Gardasil 9 vaccine (Biological)
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.
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Human Papilloma Virus infection
时间窗: Baseline and 10 years post vaccination
Women will be screened for HPV infection at baseline, and post vaccine with Gardasil 9
Hepatitis B immunity
时间窗: Baseline and six months to one year post vaccination.
Women will be screened for Hep B immunity before and after receiving a three-shot series of Hep B vaccine.
cancer of cervix
时间窗: Baseline assessment and 10 years post vaccination with Gardasil 9.
Patients will be assessed for malignancy on cervix
Cancer of the liver
时间窗: Baseline and six months to one year post vaccination with Hep B.
Patients will have a fibro scan to assess condition of liver at initial visit and post vaccination with Hep B.
次要结局
未报告次要终点
研究者
Eunice Dube
Project Director/Principal Investigator
Eunice Dube