Cervical Cancer Vaccine In Nigeria Health And Social Care Essay

Cervical cancer is a major public health issue, especially in developing countries where over 80% of cases are found. Current strategies in sub-Saharan Africa where the disease is the commonest female cancer are geared towards secondary prevention using screening strategies as a tool for early detection and treatment. However, with the discovery of cervical cancer vaccine against the Human Papilloma Virus (HPV), the hopes for primary prevention and possible eradication of the condition have been heightened. But these vaccines are unavailable in developing countries where the burden of CC is highest, probably due to high cost, lack of political will and absence of epidemiological data to serve as evidence for effectiveness of the vaccine.

This study seeks to use qualitative methods to examine the knowledge, attitudes and perceptions towards the possible introduction of the HPV vaccine in Nigeria. Its principle objectives will be to determine how much is known about cervical cancer and the HPV vaccine by women, assess their willingness to participate in a vaccination programme and how much money they are willing to spend to receive the vaccines. Participant recruitment will be purposive following a multi stage cluster sampling process. Women aged between 18-45 years attending hospital outpatient clinics will be targeted and asked to participate in focus groups discussions. Data will be collected using a grounded approach and analysed using constant comparative methods. The researcher seeks to use the results of the study to plan for an effective cervical cancer vaccination programme in Nigeria.

INTRODUCTION:

Cancer is responsible for more deaths globally than HIV/AIDS, malaria and tuberculosis combined (1). Cervical cancer (CC) is the seventh most common cancer worldwide accounting for about 5% of all cases*. It is the second most common female cancer after breast cancer (2,3) and is responsible for 15% of all female cancers(4). About half a million new cases of cervical cancer are diagnosed yearly, with over 80% of these cases occurring in developing and under-developed countries (5). The incidence of CC in Africa is nine times that of the United States of America, while the mortality of the condition in Africa is twenty four times that of the United States(1).

CC is a malignant neoplasm that occurs in the tissue of the cervix, the organ that connects the uterus to the vagina in the female reproductive system (6). The major causative agent for cervical cancer has been identified as the Human Papilloma Virus (HPV) associated with 99.7% of all cases (3, 7). However, women with HIV/AIDS have significantly increased risk of developing the condition, but it is unclear whether the HIV epidemic has had any effect on the incidence of in developing African countries, the reason being that CC incidence has remained unchanged from 1960-1990s in Nigeria and South Africa, but has increased in Zimbabwe, Kampala and Uganda within the same time frame (8). Other important causative factors include the presence of sexually transmitted infections like Herpes Simplex Virus-2 and Chlamydia Trachomatis. Smoking and prolonged use of oral contraceptives also increase the chances of developing the disease (9).

There are over 30 HPV genotypes that affect the female genital tract. HPV type 16 and HPV type 18 have been implicated in over 70% of cervical cancer (10). In sub-Saharan Africa, a study conducted in three countries, Mozambique, Nigeria and Uganda isolated HPV 16, 18,

33, 45 and 31 as the five most frequent types found in the region (11). HPV prevalence is estimated to be about 23.7% in Nigeria with about 9922 annual new cases of CC per year.

Pioneering work by Dr Harald zur Hausen in the early 1970's postulated the link between HPV and CC. Although these views were largely unpopular at that time, the facts were eventually recognized and given credence leading to the development of cervical cancer vaccine in the early part of the 21st century (12). There are currently two cervical cancer vaccines available, the bivalent vaccine Cervarix, and the quadrivalent Vaccine Gardasil. Both are effective principally against HPV -16 and HPV -18. As of 2009, Only Cervarix is licensed for use in Nigeria (4). The vaccines are usually delivered as three doses and cost approximately at a cost of approximately US$360 or N54, 000(Nigerian naira) for the full course. This makes it the most expensive vaccine in history. The high cost of the vaccine is also responsible for its delayed deployment in developing countries where it is most required (13).

BACKGROUND/RATIONALE:

CC is in essence a preventable disease. There are basically two modes of prevention, the primary preventive strategy which involves the use of vaccines against HPV, and the secondary preventive strategy which involves screening programmes directed towards early detection and treatment of the condition. Despite the current availability of HPV vaccines to prevent CC, its effectiveness will not be seen to manifest in developing countries until the vaccines become affordable and can be integrated into the national immunization programmes of developing countries (11, 14). It has been estimated that the future burden of CC in sub-Saharan Africa will rise to about 118,000 new cases in 2025, representing a massive 67% increase from the figures of 2002(11, 13).

The magnitude of the effect of cervical cancer on the health of women in developing countries has been largely underestimated, mostly due to the paucity of epidemiological data, low levels of awareness, absent cancer related health policies and lack of political will to tackle this problem (8, 11). Nigeria is estimated to have an incidence of 16.7/100,000 and a standardized mortality ratio (SMR) of 251/100, 000 (4).

Evidence has shown that women in the United Kingdom are 50% less likely to get a diagnosis of cervical cancer these days, when compared to 1988, when the cervical cancer screening programme was introduced in 1988(1). Currently, the preventive strategy in sub-Saharan Africa where the disease is most prevalent focuses on secondary prevention using cervical cancer screening. Research is however lacking on the potential effectiveness of prevention using the HPV vaccine in the region.

A research paper investigating the key challenges towards HPV vaccine introduction in South Africa identified that there was poor knowledge among community respondents about cervical cancer and the availability of cervical cancer vaccines, but they showed willingness to be educated about the vaccine and its role in cervical cancer prevention. Regarding the cost of the vaccine, the researchers noted that most of the participants wanted the vaccine to be either free or delivered at a low cost (15).

Nonetheless, most existing literature on cervical cancer vaccine appears to be lacking information concerning vaccine deployment strategies in terms of; (a) community acceptability, (b) possible health channels for vaccine delivery, (c) vaccination strategies including age, sex and catch-up models and (d) cost effectiveness studies of the HPV vaccine(11).To a large extent, the success of any cervical cancer vaccination programme will be dependent on its acceptability by the target population(16).

This study proposes to address some of these gaps by exploring women's knowledge perceptions and attitudes towards cervical cancer vaccine in Nigeria. Specifically, the project will attempt to answer the following research questions:

How do Nigerian women view cervical cancer and the available preventive measures?

What are the attitudes of Nigerian women toward the HPV vaccine?

Are Nigerian women willing to participate in a HPV vaccination programme?

Will Nigerian women be willing to pay for the HPV vaccine?

AIMS:

To explore the knowledge of and attitude towards HPV vaccination by women in Nigeria, and to use this information to influence the nations health policy towards the institution of a primary cervical cancer prevention programme.

OBJECTIVES:

To explore women's knowledge of CC and the level of awareness of HPV vaccine.

Identify women's attitude and perception towards the HPV vaccine, and determine their willingness to participate in a vaccination programme.

Assess the extent of financial commitment women are willing to allow for vaccination against cervical cancer.

Use the data gathered to inform the planning of an effective CC primary prevention programme.

STUDY SETTING:

The study will be carried out in Nigeria, the most populous nation in Africa. It has an estimated population of 145 million (17), which is equivalent to approximately a quarter of Africa's total population. The country is located in the western part of sub-Saharan Africa on latitude 100North and Longitude 80East. It covers a total area of 923, 768 square kilometres (18).

Nigeria is a federation comprised of thirty six states. For the purpose of this study, Nigeria will be divided into three regions, the northern region, the south west and the south east, based on the regions created during British colonial rule*. The northern region has nineteen states, the south west has six states and the south east has eleven states.

The country has over 250 ethnic groups, but the three major ones are the Hausas located in the north, the Yorubas in the southwest and the Ibos in the southeast of the country respectively. The majority of ethnic groups in Nigeria speak different languages. However, the most common and widely understood languages in Nigeria are English and Pidgin English. The country has two major religions, with the southern population being mostly Christian and the northern population being mostly Muslim.

Nigeria's National health Policy (1998) stipulates Primary Health Care (PHC) as the cornerstone of the country's health system. It provides for a structured format with three levels of care, the primary, secondary and tertiary levels of care (19). There is a referral system for management of patients between the three levels of care. The average life expectancy for men is 48 years, and for women is 49years. About 55% of the country's population is aged between 15-64 years, the same age group where cervical cancer is most prevalent among women (11).

STUDY DESIGN AND DISCIPLINARY APPROACH:

The disciplinary approach for this project will be sociological, employing the use of qualitative methods. This method is suitable as the underlying process of the research is attempting to identify and understand the perceptions in a given situation by a particular group of people. The research is attempting to study a social process answering questions such as why and how. Thus enumerating the reasons behind human behaviour (20).Using a grounded theory approach (21), the principal qualitative method employed will be the use of focus groups (FG's). FG's have been referred to as the interaction between a group of individuals selected by researchers resulting in discussion and comments, usually from personal experience on the topic which forms the subject of the research (22,23)

FG's are best suited for this research, based on its characteristic ability to highlight participant's attitudes, feelings, beliefs, experiences and reactions which will be difficult to achieve if any other method is used (24). It also allows researchers to gather a large amount of information in a relatively short period of time (22). However, the method may be limited as respondents may feel peer pressure to give similar answers and it may be difficult to control group discussions (22, 23, 24).

SAMPLING:

The sampling strategy used will be a multi-stage cluster sampling. The three regions of Nigeria will serve as the initial clusters. One cluster will be randomly selected. This will be achieved with the aid of a random selection programme (Microsoft Excel). Within the selected cluster, one state will be randomly selected. Each state is divided into local governments. A local government in the chosen state that has the three levels of health care; a primary, secondary and tertiary health care centre will be chosen for inclusion in the study. Each of these centres will serve as the location for a FG discussion. In summary, there will be three locations for FG discussions in the designated local government area. The number of centres selected for sampling is an attempt by the researchers to get a snapshot of perspectives from a country with such a large and diverse population (15).

RECRUITMENT:

At this stage, sampling will be purposive to ensure participants are of different ages, socio-economic and educational backgrounds. The researchers will aim for a heterogeneous group of participants, seeking to utilize exploration of diverse perspectives within a group setting (25). All women recruited into the study will be directly contacted while attending out-patient hospital clinics at designated centres and their consent will be sought for participation in the study. This is in contrast to the snowballing technique employed by Waller et al (2006), where one participant was contacted and made responsible for recruiting other members of the focus group from among friends and acquaintances (16). Women will be approached while waiting to see a doctor, and given a letter of invitation to participate in the study.

INCLUSION CRITERIA: Women between the ages of 18 and 45 years attending out-patient clinics in Nigerian hospitals.

EXCLUSION CRITERIA:

Insufficient understanding of English or Pidgin English to participate effectively in the focussed group discussion;

Refusal to give consent for participation

DATA COLLECTION:

FG's will be organized in a relaxed and comfortable setting, with refreshments provided for the participants (25). Each group will consist of about 6 to 10 participant and will be scheduled to last between forty five to ninety minutes. Focus groups will be moderated by a principal facilitator and an assistant. As researchers will employ a grounded approach to sampling with the aim of achieving theoretical saturation, it is uncertain at this time how many focus groups will take place in each designated centre, or the eventual sample size of participant (21, 26), however it is anticipated that at least ten FG's will be conducted in each centre. Theoretical saturation is said to occur when no new data seems to emerge on a particular subject, the subject matter has been extensively developed in terms of its properties and dimension, and the relationship between different categories are well defined(21,22). Essentially, the data collection will follow an iterative process where the researchers will keep increasing the sample size and the number of focus groups until no apparent new data is generated (27, 28).

DATA ANALYSIS:

Data analysis will be done using the Nvivo 8. FG's will be transcribed verbatim. Using the grounded approach, constant comparison will form the basis of the analysis, allowing for an inductive pattern where categories are generated from the data, rather than being superimposed from preconceived theoretical notions. This method according to Patton (1990) involves "grouping of answers to common questions and analyzing different perspectives on central issues."(29) Constant comparative analysis as described by Glaser and Strauss (1967) involves four stages including: Comparing incidents applicable to each category; integrating categories and their properties; delimiting the theory; writing the theory (21, 30, 31).Data analysis will follow these guidelines closely. Hypothesis generation will commence with analysis of initial observations which will undergo continuous refinement throughout the data collection exercise. The benefits of this process will ensure that new dimensions and relationships previously not considered will be detected (31).

ETHICAL CONSIDERATIONS:

Ethical issues will be the same as other social research methods (32). Ethical clearance for this project will be sought from the National Health Research Ethics Committee, Nigeria (33).

During the recruitment process, full disclosure of the purpose of and use of each participant's contribution will be made known to those involved. Signed consent will be sought from them, and confidentiality will be assured.

ANTICIPATED PROBLEMS:

There are numerous problems that are associated with carrying out research of this nature. Some of the problems anticipated by the researchers and how we intend to minimize their effects are listed below;

Religion and traditional barriers: in parts of the country, certain religious and cultural values may prohibit the participation of women in such programmes. The researches will avoid such conflicts of interest by ensuring that approval is granted by local authorities (traditional rulers and religious leaders) before embarking on data collection in every designated centre.

Financial Implications: A project of this scale will require huge financial commitments. The researchers will seek for funding from the government of Nigeria and non-governmental organizations with strong interest in public health.

Language barrier: this may not be very significant since the official language in Nigeria is English. However, to overcome this potential problem, the researchers have widened the inclusion criteria to encompass participant who understand English and the widely spoken local dialect Pidgin English. There will be recruitment and training of local translators for the project.

Rigours of qualitative research: Qualitative research is very demanding and requires a great deal of skill to undertake effectively. Bearing this in mind, the project team will consist of multidisciplinary resource personnel including;

Interviewers experienced in social research, especially running focused groups.

Qualitative data analyst to handle the large amount of information expected to be generated.

Programme evaluation and monitoring experts, among others.

Anticipated Outcomes:

It is foreseen that the results of our research will be made available to policy makers in the federal Ministry of health Nigeria. Our results will also be published in major public health and medical journals, adding to the available literature on cervical cancer and its prevention strategies. These findings will inform policy changes towards the introduction of HPV vaccine in the country. At the end of the study, there will also be heightened awareness of cervical cancer among the population following dissemination of the results of the study. It is also anticipated that the study will be replicated in other developing countries in Africa leading to the same outcome and eventually improving the health status of the region.

Anticipated Time Table for Project completion

June - July 2010

Anticipated provision of ethical approval by NHREC, Nigeria

Recruitment and training of Project team and

August - September 2010

Commencement of Project

Sampling / Participant recruitment

October 2010 - February 2011

Collection of Data using focus groups

Concurrent data analysis

March - May 2011

Compilation of results

Report Writing

June 2011

Submission of report/Dissemination of project findings