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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Global Alliance to Immunize Against AIDS Vaccine Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Global Alliance to Immunize Against AIDS Vaccine Foundation
ClinicalTrials.gov Identifier:
NCT01314404
First received: March 11, 2011
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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.


Condition
Human Papillomavirus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Global Alliance to Immunize Against AIDS Vaccine Foundation:

Primary Outcome Measures:
  • Prevalence of HPV subtypes associated with cervical cancer [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Blood and cervicovaginal samples will be collected, for Human Papillomavirus (HPV) serotyping (serum) and Polymerase Chain Reaction (PCR) (cervicovaginal samples).

  • Knowledge, Attitudes and Practices (KAP) and Willingness To Participate (WTP) in an HPV vaccine study [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Perform a survey evaluating KAP and WTP with regard to HPV and HPV vaccines in the proposed trials site.


Secondary Outcome Measures:
  • Determine usability of Gardasil in West Africa [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 460
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314404

Contacts
Contact: Anne De Groot, M.D. 401-453-2068 gaiavfdirector@gmail.com

Locations
Mali
Community of Sikoro Recruiting
Bamako, West Africa, Mali
Contact: Karamoko Tounkara, M.D.    223-7649-5886    tounkara.karamoko@gmail.com   
Principal Investigator: Ousmane Koita, Ph.D.         
Gabriel Touré Hospital Not yet recruiting
Bamako, West Africa, Mali
Contact: Youssouf Traoré, M.D.       drtraorey@yahoo.fr   
Principal Investigator: Ousmane Koita, Ph.D.         
Sponsors and Collaborators
Global Alliance to Immunize Against AIDS Vaccine Foundation
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Anne De Groot, M.D. Global Alliance to Immunize Against AIDS (GAIA) Vaccine Foundation
  More Information

No publications provided

Responsible Party: Dr Anne De Groot Scientific Director, Global Alliance to Immunize Against AIDS Vaccine Foundation
ClinicalTrials.gov Identifier: NCT01314404     History of Changes
Other Study ID Numbers: HPV Study, 38433
Study First Received: March 11, 2011
Last Updated: July 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Global Alliance to Immunize Against AIDS Vaccine Foundation:
Human papillomavirus
Prevalence
Knowledge Attitude and Practice
Willingness to Participate
Vaccine
HPV

ClinicalTrials.gov processed this record on November 20, 2014