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Набор скоро начнётся NCT06786429

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

Фаза IV С лечением Hepatitis B Human Papilloma Virus Mental Health Issue Cancer Liver

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Gardasil 9 vaccine, Hepatitis B Virus Vaccine(HBV), Cognitive Behavioral Therapy.
Кому может быть актуально
Состояния в реестре: Hepatitis B, Human Papilloma Virus, Mental Health Issue, Cancer Liver. Базовые параметры: 13 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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.

Обзор

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?

Подробное описание

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.

1.1 Data collection, analysis, and interpretation to determine the burden of HPV infection; determine the HPV types that are prevalent in this community to assess the potential effectiveness of the available vaccine; assess the potential for developing a vaccine covering local Genotypes; determine the prevalence of immunity to Hep B, and depression prevalence among adult participants.1.2. Conduct a youth risk behavior screen to determine potential infection risk and mental health issues, and design intervention strategies.1.3 Disseminate preliminary findings after the first 6 months or year one and suggest intervention strategies that can be evaluated for effectiveness during the study period. Publish findings and scale project to other areas in Zimbabwe and internationally.1.4 Request collaboration with NIH/NCI/Global center/Behavioral health to strengthen research capabilities and service provision in this area.2. Intervention 2.1 Recruit 1140 consenting female participants attending prenatal, family planning, post-partum, and other clinics at these selected centers to perform a one-time comprehensive medical exam, pap smear (to detect abnormal cells, and HPV test (if eligible) to detect infection in the cervix); perform blood test to look for Hep. B. and cancer biomarkers' presence, perform a one-time fibro scan to assess the liver. 2.2 Administer the Youth Risk Behavior Screen (Centers for Disease Control and Prevention (CDC) to 1000 consenting students in the selected schools over a period of 5years to determine the types and significance of problem behavior and suggest appropriate interventions; Assess protective factors among boarders versus day scholars. offer the Gardasil 9 vaccine to 1000 eligible students with parental consent. 2.3 Refer participants with abnormal screens for further assessments and management, including behavioral health intervention as indicated. Assess potential for home visits, telehealth services, routine screening, and immunization to ease access to services. Create teen clinics at the school sites. Analyze data at three levels using the IBM Statistical Package for Social Sciences (SPSS) for significance testing and disseminate results. Solicit Ministry of Health and Childcare (MOHCC) buy-in for scaling to other Provinces.

* Investigators plan to follow up this cohort for ten years post-vaccination * Based on the data obtained, clinical trials will assess the probability of developing an HPV vaccine that is user and patient-friendly to Low to Middle Income Countries (LMIC); promote creation and use of screening tools suitable for rural communities. * Participants identified as having risk behaviors will be offered further assessment by a psychiatrist or /and/or psychologist to develop a viable framework to prevent and manage such behaviors, including medication, which is currently not available in Zimbabwe.

Recommendations regarding women's health, i.e., screening for cervical cancer and vaccination against HPV and Hep B, depression, and Intimate Partner Violence will be guided by the findings of this study.

Вмешательства

  • Биопрепарат Gardasil 9 vaccine
    Participants with a valid consent will be offered a three-dose Gardasil 9 series if eligible.
  • Биопрепарат 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.
  • Поведенческое 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-nata

Первичные конечные точки

  • Human Papilloma Virus infection [Срок оценки: Baseline and 10 years post vaccination]
  • Hepatitis B immunity [Срок оценки: Baseline and six months to one year post vaccination.]
  • cancer of cervix [Срок оценки: Baseline assessment and 10 years post vaccination with Gardasil 9.]
  • Cancer of the liver [Срок оценки: Baseline and six months to one year post vaccination with Hep B.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06786429 · EX8KG3L2Z649

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗