KAP/WTP and HPV Prevalence Studies in a Developing World Setting (Bamako, Mali) (NCT01314404) | Clinical Trial Compass
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KAP/WTP and HPV Prevalence Studies in a Developing World Setting (Bamako, Mali)
Mali460 participantsStarted 2011-03
Plain-language summary
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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
(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.
Exclusion Criteria:
\- 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of HPV subtypes associated with cervical cancer
Timeframe: 18 months
2
Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV vaccine study
Timeframe: 18 months
Trial details
NCT IDNCT01314404
SponsorGlobal Alliance to Immunize Against AIDS Vaccine Foundation