KAP/WTP and HPV Prevalence Studies in a Developing World Setting (Bamako, Mali)

NCT01314404 | Unknown

• 2 other identifiers: HPV Study38433
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Human Papillomavirus

Keywords

Human papillomavirus; Prevalence; Knowledge Attitude and Practice; Willingness to Participate; Vaccine; HPV

Outcome Measures

Primary Outcomes (2)

• Prevalence of HPV subtypes associated with cervical cancer

  Blood and cervicovaginal samples will be collected, for Human Papillomavirus (HPV) serotyping (serum) and Polymerase Chain Reaction (PCR) (cervicovaginal samples).

  18 months

• Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV vaccine study

  Perform a survey evaluating KAP and WTP with regard to HPV and HPV vaccines in the proposed trials site.

  18 months

Secondary Outcomes (1)

• Determine usability of Gardasil in West Africa

  18 months

Study Arms (2)

KAP/WTP study population

The participants will range in age from 12 to 50 and will be selected randomly. The study population will be representative of the following categories: men, women, adolescent boys, and adolescent girls. As our study seeks to take a broad-based view of knowledge related to cervical cancer and HPV, our study population is necessarily wide-ranging. Adolescent boys and girls will 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.

Prevalence study population

We plan to identify and recruit women diagnosed with cervical cancer who are being treated by a doctor from the department of gynecology of the Hospital Gabriel Touré in Bamako, Mali. These patients will have been previously identified and diagnosed by clinical exam by an obstetrician-gynecologist at Gabriel Touré, and will have been identified as surgical candidates by a doctor. The subject has 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.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

(i) The KAP/WTP study will take place in Mékin-Sikoro, a peri-urban neighborhood of Bamako with a population of around 40,000. The study will comprise the six sectors of the district, enrolling a total of 300 participants. The participants will range in age from 12 to 50 and will be selected randomly. The study population will be representative of the following categories: men, women, adolescent boys, and adolescent girls. (ii) The Prevalence study subjects will be recruited among women diagnosed with cervical cancer who are attending a previously arranged appointment (i.e. not linked to the study) to have either a curative biopsy or a more extensive surgical procedure with the department of gynecology at Hôpital Gabriel Touré.

You may qualify if:

• (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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Global Alliance to Immunize Against AIDS Vaccine Foundation: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Community of Sikoro

Bamako, West Africa, Mali

RECRUITING

Gabriel Touré Hospital

Bamako, West Africa, Mali

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Two cervical scrapes and 2 blood samples will be collected from each of the 160 selected patients.

Study Officials

• Anne De Groot, M.D.

  Global Alliance to Immunize Against AIDS (GAIA) Vaccine Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne De Groot, M.D.

CONTACT

401-453-2068; gaiavfdirector@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

MA (2)