UnknownNot Applicable

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 range12 Years

SexALL

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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.

What they're measuring

Prevalence of HPV subtypes associated with cervical cancer

Timeframe: 18 months

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-03

Contact for this trial

Anne De Groot, M.D.

401-453-2068 gaiavfdirector@gmail.com