Knowledge, Attitudes, Practices and Willingness to Vaccinate in Preparation for the Introduction of HPV Vaccines in Bamako, Mali
Conditions: HPV, HPV-Related Cervical Carcinoma
Sponsor: Global Alliance to Immunize Against AIDS Vaccine Foundation

STI Knowledge and HPV Vaccine 
Acceptance in Bamako, Mali 
 
March 18, 2011 

Knowledge, Attitudes and Practices Study related to HPV and 
cervical cancer and Willingness to Participate in an HPV 
vaccine trial in the region of Bamako, Mali, West Africa 
 
  
 
 
 
 
 

 
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AMENDEMENT TO THE STUDY PROTOCOL # 11051 APPROVED BY IRC on March 18th 
2011 
In March-April 2011, the GAIA Vaccine Foundation did a pilot study in Sikoro, Mali West 
Africa. A team of interviewers, led by Dr. Tounkara Karamoko and Danielle Poole, completed 
50 interviews to better understand the knowledge and views of participants on vaccination 
and the link between HPV, cervical cancer, and mortality. 
This pilot study is currently in the analysis process and we found that gathering and 
analyzing data from four different questionnaires is very difficult. We want to compile all the 
questionnaires (Men - Women - Adolescent girls - Adolescent boys) in one single document 
using skip patterns. The content of the questionnaire remains the same. 
We also want to add a site to this study and have interviewers submit this questionnaire in 
an additional village named Djikoro also located near Bamako. Adding this site will allow us 
to get a better sense of people's knowledge, attitude, and practice related to HPV and 
cervical cancer in the region of Bamako. 
Below is the exact same protocol for the proposed study entitled “Knowledge, Attitudes and 
Practices Study related to HPV and cervical cancer and Willingness to participate in an HPV 
vaccine trial in the region of Bamako, Mali, West Africa”. Two major modifications were 
made: (1) Djikoro is listed as an additional site and (2) one single questionnaire is attached. 
 
I. OBJECTIVES OF THE PILOT STUDY AMENDMENT PROPOSED IN JULY 2010 
 
In Mali, the estimated 1,336 women who are diagnosed with cervical cancer each year face 
a mortality rate of over 80%.  Yet among Malian women ages 16 to 69, only 4.8% are tested 
for the disease.  The high death rate and low percentage of women tested can be attributed 
to a lack of information about cervical cancer. 
 
 
In July 2010, the Global Alliance to Immunize Against AIDS Vaccine Foundation (GAIA VF) 
carried out a study in the community of Sikoro-Mékin to determine the level of knowledge, 
attitudes, and practices (KAP study) related to HPV, cervical cancer, STIs, vaccines, and 
appropriate health services in these areas.  A questionnaire was distributed to 318 members 
of the community (67 men, 142 women, 29 adolescent boys, 74 adolescent girls, and 6 
people not specified) at the CSCOM in Sikoro.  After filling out this first questionnaire, each 
person surveyed attended an information and education session about the topics in the table 
below.  Participants then filled out the same questionnaire in order to measure the 
knowledge they had gained from the information-education session and to determine if their 
opinions had changed.  The results are in the following table: 
 
 
% before information 
session 
% after information 
session 
Participants who knew of the existence of 
cervical cancer 
46.1 % 
84.7 % 
Participants who knew that cervical cancer 
testing is free 
30.9 % 
60.9 % 
Participants who could identify at least one 
symptom of cervical cancer 
20.2 % 
41.3 % 
Participants who could identify at least one 
cause of cervical cancer 
18.1 % 
58.4 % 
 
Furthermore, 97.5% of participants indicated after the information session that they would be 
in favor of an HPV vaccine trial.  These results indicate that the residents of Sikoro were very 
receptive to the information sessions. 
 
Yet this study revealed that in general there is a great deal of confusion between HPV and 
cervical cancer, and that the relationship between the two is not well established.  The study 

 
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also showed us that certain questions in the questionnaire either were not appropriate or 
were not sufficiently clear. 
 
Thus we would like to repeat this study in order to disseminate more information about HPV 
and cervical cancer in the community of Sikoro. We would like to modify our approach so as 
to better sensitize the residents to these subjects and to reinforce their knowledge.  In order 
to do this, we propose an amendment to the pilot study conducted this summer.  The main 
modifications concern: 
 
- The questionnaire: Certain questions will be reformulated and clarified.  We would also like 
to collect more information about willingness to participate in a vaccine trial. 
- Approaching the community and education sessions: During the pilot study, the information 
sessions were done in groups of 20 to 40 people.  We would like to improve both outreach 
and the quality of the information collected by: 
(1) Reducing the size of the groups. 
(2) Contacting and informing people individually by going door to door. 
(3) Proposing information sessions in schools. 
- The duration of the study: We would like to conduct this study over a period of 12 to 18 
months (March 2011 – September 2012).  
 
We believe that spreading information about HPV and cervical cancer will both increase the 
number of people being tested and increase acceptance of an HPV vaccine trial. 
 
 
II. INTRODUCTION 
 
Cervical cancer is the second most common cancer found in women globally. Though 
incidence and mortality rates have dropped appreciably in developed countries, cervical 
cancer is still the most common type of cancer among women in sub-Saharan Africa and is 
the main cause of cancer deaths among women in developing countries.  Notably, 83% of all 
new cases of cervical cancer diagnosed each year and 85% of all deaths from the disease 
occur in developing countries.   
 
Each year in Mali, an estimated 1,336 women are diagnosed with cervical cancer and 1,076 
women succumb to the disease, resulting in an 80% mortality rate.  Among the 16 countries 
of West Africa, Mali has the second highest rate of cervical cancer; in Mali alone, cervical 
cancer has the highest incidence rate of all cancers affecting women.  Over half of these 
cancer cases are the result of an infection with HPV types 16 and 18.  In Mali, the average 
age when people first begin a sexual relationship—and thus first risk contracting HPV—is 15 
years old.  Yet among women between the ages of 16 and 19, only 4.8% are tested for 
cervical cancer.   
 
Just four years ago, the first human HPV vaccine was approved by American medical 
services.  In the past four years, thousands of young women in Europe and the United 
States have been vaccinated against four strains of HPV.  Two of these strains are 
responsible for 70% of cervical cancers, and the two others for 90% of genital warts. 
 
In Mali, this disease is not well understood:  the mortality rate remains very high, and 
methods to prevent and treat cervical cancer are still largely insufficient.  Even the World 
Health Organization is currently debating how to collect necessary data for adopting 
vaccines in developing countries.  It is urgent that an information and communication 
strategy be developed to confront this disease. 
 

 
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British studies1 have shown that the individuals selected to receive the HPV vaccine are not 
interested in the scientific link between HPV and cervical cancer.  The relationship between 
HPV or an abnormal Pap smear and cancer was too technical, and consequently was 
difficult to understand.  This study thus concluded that the important message to emphasize 
was:  “This vaccine prevents cervical cancer.”  People were subsequently more inclined to 
accept the vaccine.  In Great Britain, young girls were the target population for vaccination, 
even though adolescent boys and young men transmit the HPV virus to girls.  Moreover, the 
vaccine protects against genital warts and cancers associated with HPV, both of which can 
affect men.  It is for these reasons that it is also important to vaccinate boys.  Thus in most 
countries, both boys and girls are now vaccinated against HPV. 
 
In conducting this study, we hope to measure the level of knowledge in the population of 
Sikoro and Djikoro and to inform the community about HPV and cervical cancer.  The data 
analysis and conclusions of this study will subsequently permit us to measure willingness to 
participate in a vaccine trial with Gardasil, which is already used in Europe and in the United 
States, in the hope that it would be distributed in Mali in the long run. 
 
 
III. INTRODUCTION TO GAIA 
 
The Global Alliance to Immunize Against AIDS Vaccine Foundation (GAIA VF) is a 
humanitarian organization based in Rhode Island that works in Bamako, Mali and in 
Providence, Rhode Island since 2002.  Our mission is to promote HIV prevention while 
working for the development of a global vaccine that would be distributed on a not-for-profit 
basis in developing countries.  The activities of GAIA VF are organized around four main 
themes:  education, prevention, access to care, and vaccines.  In collaborating with West 
African doctors and supporting clinical activities in the field of HIV, we strive to improve the 
health of children and their families while addressing the ethical aspects of a vaccine trial. 
 
 
WHY IS GAIA PROPOSING TO CONDUCT THIS STUDY? 
 
GAIA is focused on laying the groundwork for future vaccine trials in Mali.  The GAIA vaccine 
against HIV is still in the development phase, but in the meantime, we hope to reinforce 
preparations currently in place, from the scientific approach to the aspects of prevention and 
education. 
 
Dr. Tounkara Karamoko – Executive Director of GAIA VF – conducted a KAP study on HIV 
in 2008, which found that 78% of participants would be willing to participate in an HIV 
vaccine trial.  This study allowed us to put our HIV prevention and education programs in 
place and to establish a relationship of trust between the medical personnel at the clinic and 
the population of Mekin-Sikoro. 
 
The study that we are now proposing to conduct will allow us to measure the level of 
knowledge of the population of Sikoro and Djikoro, put in place an education program 
focusing on HPV and cervical cancer, and train our personnel.  The data collected on 
willingness to participate in a vaccine trial will allow us to elaborate on an appropriate 
approach for establishing a vaccine trial. 
 
Finally, we convey the data collected and analyzed to the MERCK laboratories – maker of 
Gardasil – in the hope that a vaccine will be introduced in the coming years. 
 
 
 
 
                                            
1 Bureau d’Immunisation de la Grande Bretagne (Bureau qui supervise les vaccins) 

 
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IV. GENERAL OBJECTIVES 
 
(1) Measure the level of knowledge of cervical cancer and HPV among the population of 
Mékin-Sikoro and Djikoro. 
 
(2) Measure the willingness to participate in an HPV vaccine trial.  
 
(3) Educate and inform the population of Sikoro and Djikoro.  
 
(4) Train GAIA VF personnel. 
 
 
V. SPECIFIC OBJECTIVES 
 
(1) Measure the level of knowledge of cervical cancer and HPV among the population 
of Mékin-Sikoro and Djikoro. 
 
(2) Measure the willingness to participate in an HPV vaccine trial.  
 
- We want to gather KAP data that will allow us to measure: 
 
(A) Knowledge related to cervical cancer: 
(a) Places where one can be tested and receive care in Mali 
(b) Causes of cervical cancer 
(c) Symptoms of cervical cancer  
(d) How the disease is contracted 
(e) The link between HPV and cervical cancer 
 
(B) Knowledge related to HPV: 
(a) How the virus is contracted 
(b) Symptoms of HPV 
(c) Prevention methods 
(d) Places where one can be tested and receive care in Mali 
(e) The link between HPV and cervical cancer 
 
(C) The willingness to participate in an HPV vaccine trial:  
(a) Know the reasons of those in favor of participating in a vaccine trial 
(b) Know the reasons of those not in favor of participating in a vaccine trial 
(c) Evaluate the best way of contacting the public 
(d) Know who will give consent for receiving the vaccine 
 
(D) The framework needed in place for a vaccine trial : 
(a) Know where people would prefer to be vaccinated (schools, clinics, other) 
(b) Know the cost people would be willing to pay to receive the vaccine 
 
(3) Educate and inform the population of Sikoro and Djikoro.  
 
The study that we are proposing to do will be conducted over a period of 12 to 18 months.  
This extended period of time will allow us to put in place a cervical cancer education 
program.  As indicated before, the June 2010 pilot study revealed that the link between HPV 
and cancer was not evident among our study population.  Therefore we will strive to clarify 
this point. 
 
Other than the modes of transmission and the symptoms, we will emphasize methods of 
prevention and places where one can be tested in the Bamako region. 
 
(4) Train GAIA VF personnel. 

 
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The GAIA personnel will be trained so they will be capable of disseminating information 
about cervical cancer and HPV. 
 
VI. KEY PERSONNEL 
 
 
(1) Principal Investigators in Mali: 
Ousmane Koita, PhD: Head of the Laboratory of Applied Molecular Biology, Department of 
Biology, Faculty of Sciences and Techniques, University of Bamako, Bamako, MALI 
Karamoko Tounkara, MD: Director of GAIA in Mali 
 
(2) Principal Investigator in the United States: 
Anne De Groot, MD: Lecturer at the Brown University Medical School and at the University 
of Rhode Island; researcher and scientific director of GAIA VF. 
 
(3) Co-Investigateurs :  
Danielle Poole: Brown University, United States 
 
(4) Consultants: 
Kate Tracy : Professor – University of Maryland 
Dr Samba Sow: Centre pour le Developpment du Vaccin Bamako Mali 
Flabou Bougoudogo, PhD: INRSP, Bamako, Mali 
Yssouf Kone, MD: Head doctor of the CSCOM in Sikoro 
Tembely Fanta, MD: CSCOM de Sikoro 
Rokia: Vice president of the l’ASSACO 
Badialo: Person in charge of the CAFO 
 
(5) Other participants: 
Peer Educators 
Community leaders of Sikoro-Mékin and Djikoro 
Translators (if necessary) 
Mali Rochas: Management and finance (United States) 
Lauren Levitz: Translation – Literature review (United States) 
 
PERCENTAGE OF PARTICIPANTS’ INVOLVEMENT 
 
Principal Investigator: 
Karamoko Tounkara, MD 
 
 
 
 
50% 
 
GAIA Mali director 
Ousmane Koita, MD  
 
 
 
 
25% 
 
Co-investigators:  
- Anne de Groot, MD  
 
 
 
 
20% 
 
 
 
Student Investigators:  
Danielle Poole 
 
 
 
 
 
80% 
 
Study and training 
Mamadou Daou 
 
 
 
 
 
30% 
 
Translator 
 
Consultants: 
- Fanta Siby  
 
 
 
 
 
20% 
 
 
- Dr Moussa Hama Sankare  
 
 
 
25% 
 
 
- Flabou Bougoudogo, PhD, INRSP, Bamako, Mali  
25% 
 
- Kate Tracy  
 
 
 
 
 
25% 
- Samba Sow  
 
 
 
 
 
25% 
 
 
 
CSCOM Personnel Involved:  

 
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Kone Yssouf, MD 
 
 
 
 
 
15% 
 
Head doctor 
Tembely Fanta, MD  
 
 
 
 
15% 
 
Doctor 
 
Peer Educators (12)  
 
 
 
 
50% 
 
Peer Educators 
 
VII. METHODOLOGIE 
 
(1) Recruitment and getting in contact with the population 
 
We plan to contact the inhabitants of Sikoro and Djikoro with the help of community leaders 
and peer educators. 
 
(2) Sample size 
 
We want to interview around 300 people total, from ages 12 to 50.  These 300 people (150 
per study site) will be interviewed twice: with a first questionnaire, and then again with an 
identical questionnaire following the information and education session.  This study 
population must be representative of the following categories:  men, women, adolescent 
boys, and adolescent girls. 
 
- Questionnaire(s) 
 
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. 
 
- Education 
 
The information and education sessions will take place after the first questionnaire, and will 
be followed by a second questionnaire to measure what was learned. 
 
As indicated before, 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. 
 
 
Study period: The study will take place from March 2011 to march 2012. Data analysis is 
planned to take place from March 2012 to September 2012. 
 
 
Study location: The study will take place in Mékin-Sikoro and Djikoro, two peri-urban 
communities located in the neighborhood of Bamako.   
  
 
Benefits:  
For the NGO: Measure the level of knowledge among the population of cervical cancer and 
evaluate the degree to which an HPV vaccine trial would be accepted. 
 
For the patients: Inform and sensitize the inhabitants of Mékin-Sikoro and Djikoro about 
cervical cancer and the possibility of a vaccine. 
 
 

 
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Risks: The study population will be comprised of adolescents.  This will require either the 
presence of parents or parental agreement to allow minors to respond to the questionnaire.  
 
Ethical considerations: The current study protocol will be submitted to the FMPOS 
committee in order to detect any human rights anomalies in form or content. 
 
We will conduct a study (see the attached questionnaires).  Before participating in this study, 
participants will complete a one-page consent form in French or in Bambara, which will 
define the objectives of this study.  Participants will be informed of the fact that the study is 
anonymous and that they do not have to give their name other than their signature on the 
consent form, which is separate from the study.  The consent form will be read out loud to 
participants, and careful attention will be paid while reading the consent form to illiterate 
participants.  A literate companion can verify the document if a participant wishes.  For all 
participants, a good understanding of consent will be established by checking off answers to 
questions at the end of the form.  
  
 
 Confidentiality: The confidentiality of participants will be respected.  We plan to collect and 
link information using a coding system. 
  
 
Compensation: 
Compensation for participating in the questionnaire: 2,000 CFA 
 
 
Data collection and analysis: Data collected from the questionnaires will be assembled 
into tables and analyzed.  All the information will be kept at GAIA headquarters and will 
remain confidential. 
 
 
VIII. CONCLUSION  
 
 
 
 
 
 
 
 
 
 
 
HPV has been identified as a cause of cervical cancer, of pre-cancer, of benign cervical 
lesions, and of genital warts. 
 
Setting up a simple test in certain European countries and in the United States resulted in an 
80% reduction in the incidence and mortality of cervical, much more than the vaccine and for 
a much lower cost. 
 
This study underlines the importance of adopting an information and communication strategy 
in order to give children of developing countries a chance against this disease. 
 
Finally, we hope that the collection and analysis of KAP data from this study will be used for 
the goal of promoting the introduction of the Gardasil vaccine in Mali. 
 
 
 
 
 
 
 
 
Bibliographic References: 

 
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1. 
Steben M, Louchini R and Duarte-Franco E. High risk of anal cancer in individuals 
treated for anal condyloma in a population-based transversal study in Quebec (Canada), 
1990-1999. In: Program and abstracts of the 18th International Society for Sexually 
Transmitted Disease Research, June 28– July 1, 2009. London, UK. 
2. 
Palefsky J, for the male quadrivalent HPV vaccine efficacy trial team. Efficacy of 
Gardasil in men aged 16-26 years naïve to vaccine HPV types at baseline: the latest data. 
In: Program and abstracts of the European Research Organization on Genital Infection and 
Neoplasia, 17-20 February 2010, Monte Carlo, Monaco. Abstract TC 4-2. 
3. 
Palefsky J, for the male quadrivalent HPV vaccine efficacy trial team. Quadrivalent 
HPV vaccine efficacy against anal intraepithelial neoplasia in men having sex with men. In: 
Program and abstracts of the European Research Organization on Genital Infection and 
Neoplasia, 17-20 February 2010, Monte Carlo, Monaco. Abstract SS 19-2. 
4. 
Wilkin T, Lee J, Goldstone S, et al. Safety and immunogenicity of the quadrivalent 
HPV vaccine in HIV-infected men: primary results of the AIDS Malignancy Consortium Trial 
052. In: Program and abstracts of the 17th Conference on Retroviruses and Opportunistic 
Infections, 16-19 February 2010, San Francisco, U.S. Abstract 1015. 
5. 
Smith JS, Moses S, Hudgens MG, et al. Increased risk of HIV acquisition among 
Kenyan men with human papillomavirus infection. Journal of Infectious Diseases. 2010 Jun 
1;201(11):1677-85. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CONSENT FORM 
Adult 
 

 
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Study title: Knowledge, Attitudes and Practices Study related to HPV and cervical cancer and 
Willingness to Participate in an HPV vaccine trial in the region of Bamako, Mali, West Africa 
 
Institution name: GAIA Foundation, Hippodrome, Rue 224 Porte 1803 Bamako Mali 
 
Principal Investigator: Dr. Karamoko Tounkara 
 
 
 
 Tel: 76495886 
 
 
 
 Email: tounkara.karamoko@gmail.com  
 
 
What are the implications of participating in this study?  
Your participation in this study is voluntary and anonymous.  No one other than the principal 
investigators will have access to your information.  You are not obligated to participate in this study.  
 
In signing your consent, you give us permission to use your responses for the collection, analysis, and 
processing of data in writing and publishing medical articles. 
 
Risks of your participation: The risks linked to your participation in this questionnaire are minor.  You 
are not obliged to respond to every question. 
 
The benefits of your participation are the following:  
Your responses and opinions will allow us to evaluate Knowledge, Attitudes, and Practices on the 
subject of cervical cancer, as well as willingness to participate in an HPV vaccine trial in the region of 
Bamako. 
 
For all questions or complaints, please contact the principal investigator, Dr. Tounkara Karamoko 
(Tel: 76495886).  You may also contact the president of the FMPOS Ethical Committee at Point G, 
Bamako (Tel: 20225277). 
 
Declaration of consent 
 
I the undersigned Mr/Mrs___________________________________, resident of _______________, 
confirm that the objectives and methods of the Knowledge, Attitudes, and Practices study on cervical 
cancer and perspectives on an HPV vaccine trial in the region of Bamako were explained to me and 
that I was given the chance to ask questions about the study. 
 
I have confidence that the investigator will guarantee that all sensitive information collected will 
remain confidential.  I was informed of the risks and benefits linked to my participation.  I have 
considered the time constraints that I may incur with participation.  I was informed that my 
participation does not involve payment either to me or to another member of my family.  I understand 
that participation is voluntary and that I have the right to remove myself from the study at any time. 
 
I voluntarily agree to participate in this study: 
/___/ Yes /___/ No. 
 
 
Signature/fingerprint: __________________________________ 
Date :_____________ 
 
 
Full name of the investigator:________________________________ 
 
 
Anne De Groot, MD 
 
 
 
 
 
Dr Tounkara Karamoko 
Fondatrice et Directrice Scientifique 
 
 
Directeur Executif 
 
 

 
10
CONSENT FORM 
Guardian 
 
Study title: Knowledge, Attitudes and Practices Study related to HPV and cervical cancer and 
Willingness to Participate in an HPV vaccine trial in the region of Bamako, Mali, West Africa 
 
 
Institution name: GAIA Foundation, Hippodrome, Rue 224 Porte 1803 Bamako Mali 
 
Principal Investigator: Dr. Karamoko Tounkara 
 
 
 
 Tel: 76495886 
 
 
 
 Email: tounkara.karamoko@gmail.com  
 
 
What are the implications of participating in this study?  
Participation in this study is voluntary and anonymous.  No one other than the principal investigators 
will have access to this information.  The adolescent you are accompanying is not obligated to 
participate in this study.  
 
In signing your consent, you give us permission to use the adolescent’s responses for the collection, 
analysis, and processing of data in writing and publishing medical articles. 
 
Risks of your participation: The risks linked to participation in this questionnaire are minor.  The 
adolescent is not obliged to respond to every question. 
 
The benefits of your participation are the following:  
The adolescent’s responses and opinions will allow us to evaluate Knowledge, Attitudes, and 
Practices on the subject of cervical cancer, as well as willingness to participate in an HPV vaccine trial 
in the region of Bamako. 
 
For all questions or complaints, please contact the principal investigator, Dr. Tounkara Karamoko 
(Tel: 76495886).  You may also contact the president of the FMPOS Ethical Committee at Point G, 
Bamako (Tel: 20225277). 
 
Declaration of consent 
 
I the undersigned Mr/Mrs___________________________________, resident of _______________, 
confirm that the objectives and methods of the Knowledge, Attitudes, and Practices study on cervical 
cancer and perspectives on an HPV vaccine trial in the region of Bamako were explained to me and 
that I was given the chance to ask questions about the study. 
 
I have confidence that the investigator will guarantee that all sensitive information collected will 
remain confidential.  I was informed of the risks and benefits linked to participation for the adolescent I 
am accompanying.  I have considered the time constraints that he/she may incur with participation.  I 
was informed that his/her participation does not involve payment either to him/her or to me.  I 
understand that participation is voluntary and that he/she has the right to remove him/herself from the 
study at any time. 
 
I voluntarily agree to the adolescent’s participation in this study:  
/___/ Yes /___/ No. 
 
Signature/fingerprint: __________________________________ 
Date:_____________ 
 
 
Full name of the investigator:________________________________ 
 
 
Anne De Groot, MD 
 
 
 
 
 
Dr Tounkara Karamoko 
Fondatrice et Directrice Scientifique 
 
 
Directeur Executif 
 
 

 
11
CONSENT FORM 
Adolescent 
 
Study title: Knowledge, Attitudes and Practices Study related to HPV and cervical cancer and 
Willingness to Participate in an HPV vaccine trial in the region of Bamako, Mali, West Africa 
 
Institution name: GAIA Foundation, Hippodrome, Rue 224 Porte 1803 Bamako Mali 
 
Principal Investigator: Dr. Karamoko Tounkara 
 
 
 
 Tel: 76495886 
 
 
 
 Email: tounkara.karamoko@gmail.com  
 
 
What are the implications of participating in this study?  
Your participation in this study is voluntary and anonymous.  No one other than the principal 
investigators will have access to your information.  You are not obligated to participate in this study.  
 
In signing your consent, you give us permission to use your responses for the collection, analysis, and 
processing of data in writing and publishing medical articles. 
 
Risks of your participation: The risks linked to your participation in this questionnaire are minor.  You 
are not obliged to respond to every question. 
 
The benefits of your participation are the following:  
Your responses and opinions will allow us to evaluate Knowledge, Attitudes, and Practices on the 
subject of cervical cancer, as well as willingness to participate in an HPV vaccine trial in the region of 
Bamako. 
 
For all questions or complaints, please contact the principal investigator, Dr. Tounkara Karamoko 
(Tel: 76495886).  You may also contact the president of the FMPOS Ethical Committee at Point G, 
Bamako (Tel: 20225277). 
 
Declaration of consent 
 
 
I the undersigned ___________________________________, resident of _______________, 
confirm that I was accompanied by a guardian who gave his/her agreement for my participation in this 
study.  I also confirm that the objectives and methods of the Knowledge, Attitudes, and Practices 
study on cervical cancer and perspectives on an HPV vaccine trial in the region of Bamako were 
explained to me and that I was given the chance to ask questions about the study. 
 
I have confidence that the investigator will guarantee that all sensitive information collected will 
remain confidential.  I was informed of the risks and benefits linked to my participation.  I have 
considered the time constraints that I may incur with participation.  I was informed that my 
participation does not involve payment either to me or to another member of my family.  I understand 
that participation is voluntary and that I have the right to remove myself from the study at any time. 
 
I voluntarily agree to participate in this study: 
/___/ Yes /___/ No. 
 
 
Signature/fingerprint: __________________________________ 
Date :_____________ 
 
 
Full name of the investigator:________________________________ 
 
 
Anne De Groot, MD 
 
 
 
 
 
Dr Tounkara Karamoko 
Fondatrice et Directrice Scientifique 
 
 
Directeur Executif 
 
 
 

 
12
GAIA  
Global Alliance to Immunize against AIDS 
146 Clifford Street  
(401) 453-2068 
  Providence, RI 02903 USA www.GAIAvaccine.org 
 
 
Knowledge, Attitudes and Practices Study related to HPV and cervical cancer and Willingness to 
Participate in an HPV vaccine trial in the region of Bamako, Mali, West Africa 
 
 
Date :  
 
 
 
 
ID Code : 
 
 
 
 
 
Part I : Background information about the participant 
 
1. How old are you?:  
 
 
______years  
 Prefer not to answer 
2. Marital status: Are you: 
 Married 
 
 Married in a polygamous family 
If yes: How many wives are there?  
 
 Cohabiting 
 Single 
 
 
 Prefer not to answer 
 
3. (a) Did you go to school? : 
 
 Yes  
 
 No (Go directly to Part II) 
 
3. (b) If yes, until what age? : 
 
 
 
3. (c) or what grade?: 
 
 
 
 
 Part II: Sexual history 
 
4. Are you circumcised? 
 Yes  
 
 No  
 
 Prefer not to answer 
 Don’t know 
 
5. (a) Have you ever had a sexual relationship? 
 Yes  
 
 No (For men and adolescent boys go directly to Part IV) 
 
(For women and adolescent girls go directly to Part III) 
 Prefer not to answer 
 Don’t know 
 
5. (b) How old were you when you had your first sexual relationship? :  
   
  
 
Years old 
 
 Prefer not to answer  
 
 Don’t know 
 
6. How many sexual partners have you had? :  

 
13
  
 
Partners 
 
 Prefer not to answer  
 
 Don’t know 
 
7. Have you ever been forced to have sexual relations? 
 Yes  
 No  
 Prefer not to answer 
 
8. Have you had sexual relations in exchange for something? 
 Yes for money 
 Yes for food 
 Yes for shelter 
 Yes for other reasons,(please elaborate): _______________________ 
 
 
 No 
 Prefer not to answer 
 
If the person is married: 
9. How many sexual partners did you have before getting married? :  
  
 
Partners 
 Prefer not to answer  
 Don’t know 
 
10. Do you have – or did you have - any sexual partners other than your husband? 
 
 Yes  
 
 No 
 
 
 Prefer not to answer 
 
FOR MEN AND TEENAGE BOYS GO DIRECTLY TO PART 4 
 
Part III - Gynecological information 
FOR WOMEN AND TEENAGE GIRLS ONLY 
 
11. (a) Are you menstruated? 
 Yes  
 
 No 
 (Go directly to Q14) 
 Prefer not to answer 
 Don’t know (Go directly to Q12) 
 
11. (b) How old were you when you began menstruating? 
 
 
 Prefer not to answer  
 
 Don’t know 
 
12. (a) Do you have children? :   
 
 Yes  
 
 No (Go directly to Q13) 
 Prefer not to answer (Go directly to Q13) 
 Don’t know (Go directly to Q13) 
 
12. (b) How many children do you have? 
  
children 
 Prefer not to answer  
 Don’t know 
 
13.  (a) How many pregnancies have you had? 

 
14
  
pregnancies (if none, Go directly to Q14) 
 Prefer not to answer  
 Don’t know 
 
13. (b) How old were you when you had your first pregnancy?  
 
 years 
 Prefer not to answer  
 Don’t know 
 
14. (a) Have you ever gone to a gynecologist? for reasons other than pregnancy care? 
 
 Yes  
 
 No 
 (Go directly to Q15) 
 Prefer not to answer (Go directly to Q15) 
 Don’t know  (Go directly to Q15) 
 
14. (b) How many times have you gone to a gynecologist? 
        Times 
 Prefer not to answer  
 Don’t know  
 
14. (c) For what reasons? 
 Pain 
 Itching 
 Abnormal bleeding 
 Vaginal discharge 
 Loss of menstrual periods 
 Others: _____________________ 
 Prefer not to answer  
 Don’t know 
 
15. Do you know what a Pap smear is?  
 Yes  
 
 No 
 Prefer not to answer  
 
If no, explain what a Pap smear is:  A gynecological Pap smear is a procedure that uses an 
instrument (a spatula) to collect and examine cervical cells for health reasons. 
 
16. (a) Have you ever gotten a Pap smear?  
 
 Yes  
 
 No (Go directly to Q17) 
 Prefer not to answer (Go directly to Q17) 
 Don’t know (Go directly to Q17) 
 
16. (b) How old were you when you got your first Pap smear? 
  
 
years 
 Prefer not to answer  
 
 Don’t know 
 
16. (c) If yes  Where did you have the Pap smear done? 
 At the hospital 
 At the CSCOM 
 At a free testing center 
 At home 
 Prefer not to answer  

 
15
 Don’t know 
 
16. (d) Who performed this Pap smear? 
 
 A gynecologist 
 
 A midwife 
 
 Other: Explain: 
 Prefer not to answer  
 Don’t know 
 
17. Do you know what contraception means? 
 Yes  
 No (Go directly to Q19) 
 Prefer not to answer (Go directly to Q19) 
 
18. Do you use a method of contraception?  
 
 
 Yes Which one(s)? : 
 
 
 
 
 
 
 No 
 Prefer not to answer  
 Don’t know 
 
19. How frequently do you wash your genitals? 
 Never (Go directly to Part IV) 
 Once a day 
 Less than once a day 
 More than once a day 
 Prefer not to answer (Go directly to Part IV) 
 Don’t know (Go directly to Part IV) 
 
20. (a) Do you use any feminine hygiene products? 
 
 Yes  
 
 No 
 
 
 Prefer not to answer 
 Don’t know 
 
20. (b) If yes to question:  Which product(s) do you use? 
 Soap  
 Other (Explain:  
 
 
 
 
) 
 Prefer not to answer 
 Don’t know 
 
 If no to question :  What do you use? 
 
 Water 
 
 Other (Explain:  
 
 
 
 
) 
 Prefer not to answer 
 Don’t know 
 
Part IV – STIs and HPV 
 
21. Do you know what an STI is? 
 
 
 
 
 Yes 
 No (Go directly to Q26) 
 Prefer not to answer 
 
22. Do you know how to protect yourself against STIs?  
 
 Yes (Explain:  
 
 
 
 
) 

 
16
 No 
 
 
 Prefer not to answer 
 
23. Do you know where to go to get tested for STIs? 
 Yes (Where :                      ) 
 
 No 
 
24. Have you ever had an STI?   
 Yes: Which one (s)?: 
 
 No (Go directly to Q26) 
 Prefer not to answer (Go directly to Q26) 
 Don’t know (Go directly to Q26) 
 
25. How many times have you had an STI?: 
     
times 
 Prefer not to answer 
 Don’t know 
 
26. Do you know what HPV is? 
 Yes: Please elaborate: 
 
 
 
 
 
 No (Go directly to part V) 
 Prefer not to answer 
 
HPV is the human papilloma virus.  It is an STI that is common among sexually active people. 
  
27. Do you know one or more of the symptoms of HPV? 
 
 Yes : Which ones :  
 
 
 
 
 No 
 
28. HPV affects: 
 Women? 
 Men? 
 Adolescent girls? 
 Adolescent boys? 
 Prefer not to answer 
 Don’t know 
 
29. Is HPV related to cervical cancer? 
 Yes 
 No  
 Prefer not to answer 
 Don’t know 
 
30. Is HPV one of the main causes of cervical cancer?  
 
 Yes  
 
 No 
 Prefer not to answer 
 Don’t know 
 
31. (a) Can cervical cancer be avoided if one is vaccinated against HPV?  
 
 Yes  
 
 No 
 Prefer not to answer 
 Don’t know 
 

 
17
    (b) Among women, is HPV one of the main causes of cervical cancer?  
 
 Yes  
 
 No 
 Prefer not to answer 
 Don’t know 
 
FOR MEN AND ADOLESCENT BOYS GO TO PART VI 
 
PART V – Cervical cancer 
FOR WOMEN AND ADOLESCENT GIRLS ONLY 
 
32. Have you heard of cervical cancer? 
 Yes  
 
 No 
 Prefer not to answer 
 Don’t know 
 
33. Do you know one or more of the symptoms or signs of cervical cancer? 
 
 Yes: Which ones?  
 No 
 Prefer not to answer 
 Don’t know 
 
34. Have you heard that there is free testing for cervical cancer in Mali? 
 Yes  
 
 No 
 Prefer not to answer 
 
35. Do you know where to go to get tested (i.e. get a cervical exam)? 
 Yes : Where ?; 
 No 
 Prefer not to answer 
 
36. Have you ever been tested (i.e. gotten a cervical exam)? 
 Yes: Where? 
 
 
 
 
How many times?  
 
 
 No (Go directly to Q37) 
 Prefer not to answer 
 
37. Do you know what happens during a cervical exam? 
 Yes  
 
 No 
 Prefer not to answer 
 
38. True/False: A screening test tells you if you have cervical cancer?  
 True  
 
 False 
 
 
 Don’t know 
 Prefer not to answer 
 
39. True or False:  Cervical cancer is a cause of death among women? 
 True  
 
 False 
 
 
 Don’t know 
 Prefer not to answer 
 

 
18
40. Do you know one or more of the causes of cervical cancer?  
 Yes: Which ones?:  
 
 
 
 
 
 No 
 
 Don’t know 
 Prefer not to answer 
 
Part VI – Vaccines and vaccine trials 
 
41. Have you ever been vaccinated? 
 
 Yes: list the names of the vaccines you received: 
 No 
 
 
 Prefer not to answer 
 Don’t know 
 
41.  If the HPV vaccine were available in Mali, to whom should it be given?  (Mark your 
response for each of the following groups.) 
 
 
(a) To young adolescent girls before their first sexual relationships?  
 
 
 Yes  
 No 
 
 Prefer not to answer 
 Don’t know 
 
 
(b) To young adolescent boys before their first sexual relationships?  
 
 Yes  
 No 
 
 Prefer not to answer 
 Don’t know 
 
 
(c) To women?  
 Yes  
 No 
 
 Prefer not to answer 
 Don’t know 
 
 
(d) To men?   
 Yes  
 No 
 
 Prefer not to answer 
 Don’t know 
 
42. 
If you were going to be vaccinated, who would make this decision or give their 
permission? 
- Your husband: 
 
 Yes  
 No 
 
 Prefer not to answer 
- You:  
 
 
 Yes  
 No 
 
 Prefer not to answer 
- Your father:  
 
 Yes  
 No 
 
 Prefer not to answer 
- Your mother: 
 
 Yes  
 No 
 
 Prefer not to answer 
 
43. 
If you were going to vaccinate your child(ren), who would make this decision or give their 
permission?  
- Your husband: 
 
 Yes  
 No 
 
 Prefer not to answer 
- You:  
 
 
 Yes  
 No 
 
 Prefer not to answer 
- Your father:  
 
 Yes  
 No 
 
 Prefer not to answer 
- Your mother  
 
 Yes  
 No 
 
 Prefer not to answer 
 

 
19
44. The vaccine against HPV (to prevent cervical cancer) is given by: 
 An injection into the cervix 
 An injection into the arm 
 Prefer not to answer 
 Don’t know 
 
45. You can protect yourself against HPV by: 
 
 Using condoms 
 
 Being vaccinated 
 
 Both 
 Prefer not to answer 
 Don’t know 
 
46. The vaccine against HPV (to prevent cervical cancer) is already available in Europe 
and in the United States.  Would you want it to be available in Mali, as well?  
 Yes  
 
 No 
 
 
 Prefer not to answer 
 Don’t know 
 
47. Would you want to participate in a vaccine trial to get the vaccine approved for use in 
Mali? 
 Yes: For what reason?: 
 
 
 
 
 
 
 
 
 No: For what reason?: 
 
 
 
 
 
 
 
 
 Prefer not to answer 
 Don’t know 
 
48. Would you want your child(ren) to participate in a vaccine trial? 
 Yes: For what reason?: 
 
 
 
 
 
 No: For what reason?: 
 
 
 
 
 
 
 Prefer not to answer 
 Don’t know 
 
 
 
(a) If the vaccine is approved in Mali, would you want to get vaccinated? 
 Yes  
 No 
(Directly go to Q 50)  
 Prefer not to answer 
 
(b) Where would you want to be vaccinated?  (Keep in mind that there are three shots, 
given at three separate appointments.)  
 At the hospital 
 At the CSCOM 
 At school 
 At home 
 Other:  
 
 
 
 
 
49. How would you like to be contacted for these three appointments? 
 By phone call 
 By text message 
 By a visit to my house 
 Other  
 Prefer not to answer 
 Don’t know 
 
50. I would get vaccinated/I would vaccinate my child(ren) against cervical cancer: 

 
20
 If the vaccine were free. 
 If the vaccine were less expensive than  ____. 
 I would not get vaccinated or vaccinate my children against cervical cancer.