Know Cancer

or
forgot password

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)


N/A
12 Years
N/A
Open (Enrolling)
Both
Human Papillomavirus

Thank you

Trial Information

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)


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].

(iii) Perform a survey evaluating the Knowledge Attitude and Practice (KAP) and Willingness
To Participate (WTP) with regard to HPV and HPV vaccines in the proposed trials site (300
individuals will be asked to complete surveys with trained surveyors; minimum of 100
adolescents and their 200 parents). Use focus groups and house-by-house interviews as means
of collecting data. Obtain information on preferred consenting, screening and notification
practices.

Methodology:

(i) We plan to identify and recruit a sample of 160 women diagnosed with cervical cancer
within 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. Recruitment will be done during appointments either for a curative
biopsy or for a more extensive surgical procedure. No biopsy will be done just for the sake
of the study. During the study, each participant will sign a consent form and undergo an
interview with a nurse. The nurse will be in charge of briefly presenting the proposed study
protocol and ensuring that the patient (a) had been positively diagnosed with cervical
cancer (diagnoses are established from a clinical case and/or based on the patient's
history), (b) voluntarily expressed a willingness to have a biopsy or other gynecological
operations and have a doctor collect tissue samples during a "standard" medical appointment
(i.e. not linked to the study), (c) agreed to have blood drawn, (d) was older than 18, and
(e) had the capacity to give informed consent.

In order to collect the necessary data for this study, the following procedures will be
used:

- Blood draws: Blood samples will be collected in order to measure antibodies against a
panel of HPV types, including HPV 16 and 18. Blood samples will be sent to the
laboratory for Applied Molecular Biology (LAMB/LBMA) located in Bamako, for
centrifugation and serum aliquoting. The serum samples will be stored at -20°C and will
be sent to the United States every four months for serological testing in the Merck
laboratories.

- Serology: The serum samples will be sent to the Merck research laboratories in the
United States (Wayne Laboratories) and will be tested using the Luminex immunological
assay. This assay will allow for the detection of HPV types 6, 11, 16, and 18.

- Rapid test: A rapid test will be conducted on the cells from the tissue samples. This
test will allow for the detection of 14 types of HPV (16, 18, 31, 33, 35, 39, 45, 51,
52, 56, 58, 59, 66, and 68) in two and a half hours.

- Tissue collection: Two cervical scrapes will be collected from each patient. One
sample will be taken of the cells on the outer opening of the cervix and the other
sample will be taken of the cells inside the cervical canal. Cervical scrapes will be
stored in liquid nitrogen for maximum preservation and will be sent to the Merck
laboratories to be analyzed by a laboratory technician.

- HPV Polymerase Chain Reaction (PCR): PCR assays will be conducted at the Laboratory for
Applied Molecular Biology (LBMA) with adherence to strict standards of good laboratory
practices. HPV sub-typing will be conducted with the cells from the cervical scrapes.

In order to protect the identity and confidentiality of each patient, a unique
identification number will be used. Only the study personnel - and the patient, if requested
- will have access to the study results.

(ii) We will be identifying and training the experts necessary for this study. We plan to
recruit and train local medical personnel in clinical and laboratory practices. We want to
develop necessary protocols for this study, put an infrastructure in place, and train
medical personnel. This step is necessary not only for this study, but also for preparing
for a vaccine trial (if possible). The goal is to lay the groundwork for all clinical
studies to come, and to improve the conditions of vaccine research in Mali.

(iii) In order to assess KAP and WTP with regard to HPV and HPV vaccines, we plan to contact
the inhabitants of Sikoro-Mekin with the help of community leaders and peer educators.
Sikoro is a peri-urban neighborhood of Bamako with a population of around 40,000. The study
will comprise the six sectors of the neighborhood. We want to interview around 300 people
total.

Two questionnaires will be given. The participant will be given the first questionnaire,
which will be followed by an information and education session. This will be followed by a
second, identical questionnaire that will permit us to measure information retention and
comprehension from the information session. The information sessions will be conducted
either in small groups or individually in order to improve the quality of information
provided, as well as the contact and communication with the person being surveyed.

Data collection and analysis:

Data will be collected and analyzed according to (i) Interview and questionnaire responses
(ii) HPV subtypes and (iii) serology, Polymerase Chain Reaction (PCR), and rapid test
results.

Conclusion:

Conducting this study will allow us to collect information that could help bolster the fight
against the spread of HPV and cervical cancer in Mali. With the development of protocols and
the training of medical personnel, we are striving to reinforce human capacity, improve
research conditions, and lay the groundwork for all clinical studies to come in Mali. We
hope that the collection and analysis of KAP/WTP data will be used for the goal of promoting
the introduction of the Gardasil vaccine in Mali. Finally in the coming years we hope to
obtain approval for the use of Gardasil and to plan for an HPV vaccine trial in Mali.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Prevalence of HPV subtypes associated with cervical cancer

Outcome Description:

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

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Anne De Groot, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Global Alliance to Immunize Against AIDS (GAIA) Vaccine Foundation

Authority:

United States: Food and Drug Administration

Study ID:

HPV Study

NCT ID:

NCT01314404

Start Date:

March 2011

Completion Date:

September 2012

Related Keywords:

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

Name

Location