KAP/WTP and HPV Prevalence Studies in Preparation for a Phase IV Trial of the Gardasil HPV Vaccine in a Developing World Setting (Bamako, Mali)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV vaccine study
研究概览
简要总结
The Global Alliance to Immunize Against AIDS Vaccine Foundation (GAIA Vaccine Foundation or GAIA VF) proposes to carry out a Knowledge, Attitudes, and Practices (KAP) study in conjunction with a Willingness To Participate (WTP) evaluation to establish the prevalence of cervical dysplasia, to and perform Human Papillomavirus (HPV) subtyping studies in Bamako and in Sikoro-Mekin, a village within the perimeter of Bamako, the capital of Mali, West Africa. Working with experienced collaborators, we propose to carry out an HPV prevalence study (among women diagnosed with cervical cancer at Hôpital Touré), coupled with a study of Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV vaccine study among individuals living in Sikoro-Mekin. These studies will lay the groundwork for a phase IV study of Gardasil® at the same site, which would be an important step forward for West Africa.
详细描述
Hypothesis:
Human Papillomavirus (HPV) vaccination with the Gardasil vaccine has the potential to eradicate cervical cancer worldwide. However, the impact of quadrivalent Gardasil vaccination in developing world settings, where HPV subtype prevalence may differ, is unknown. Prior to conducting a Phase IV trial, HPV subtyping should be studied. Furthermore, few data are available on vaccine acceptability, health systems preparedness and vaccine cost-effectiveness and long-term impact in this region of the world.
We propose to:
(i) Evaluate, in a sample of 160 women diagnosed with cervical cancer recruited from the hospital Hôpital Touré, the prevalence of HPV subtypes associated with cervical cancer. Hôpital Touré is the referral center for cervical cancer patients from the entire city of Bamako (>1.8M inhabitants).
(ii) Train local clinical staff to implement good clinical protocols and good clinical laboratory practices for cervical cancer screening, and establish HPV sub-typing methodology at the affiliated laboratory sites [Sikoro, Bamako, Mali and the National Institute for Research on Public Health (INRSP), Bamako].
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) For the KAP/WTP study:
- •Adolescent boys and girls must be between the ages of 12 and 18; men and women will be older than 18, with at least one child that falls within the adolescent age range. All must be residents of one of the six sectors of Mékin-Sikoro.
- •(ii) For the Prevalence study:
- •The major eligibility criteria are that the subject is a woman who has been positively diagnosed with cervical cancer, has voluntarily expressed a willingness to have a biopsy or other gynecological operation and have a doctor collect tissue samples during a "standard" medical appointment, has agreed to have blood drawn, was older than 18, and has the capacity to give informed consent.
排除标准
- •For the KAP/WTP study: Unwilling or unable to provide consent. Under 12 years old.
- •For the Prevalence study: Male gender Women not diagnosed with cervical cancer. Under 18 years old. Unwilling or unable to provide consent.
结局指标
主要结局
Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV vaccine study
时间窗: 18 months
Perform a survey evaluating KAP and WTP with regard to HPV and HPV vaccines in the proposed trials site.
Prevalence of HPV subtypes associated with cervical cancer
时间窗: 18 months
Blood and cervicovaginal samples will be collected, for Human Papillomavirus (HPV) serotyping (serum) and Polymerase Chain Reaction (PCR) (cervicovaginal samples).
次要结局
- Determine usability of Gardasil in West Africa(18 months)