Contextual analysis of cervical cancer prevention policies in Iran: A Leichter-based model

doi:10.21203/rs.3.rs-3918418/v1

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Research Article

Contextual analysis of cervical cancer prevention policies in Iran: A Leichter-based model

https://doi.org/10.21203/rs.3.rs-3918418/v1

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Background: Cervical cancer is considered the fourth most common type of cancer among women worldwide. The prevalence of this cancer is also increasing in Iran. This study aimed to conduct a context analysis of Iran's health policy concerning cervical cancer prevention.

Methods: In this qualitative study, data was collected through semi-structured interviews between July 2020 and September 2021. The sample consisted of 43 individuals, purposefully chosen to represent faculty members, researchers, policymakers, health insurance administrators, personnel of community health centers, and service users. The data underwent analysis using the framework analysis method, in accordance with the Leichter model, with the aid of MAXQDA2020 software.

Results: Due to the increasing incidence of cervical cancer and the growing international advocacy, a policy opportunity has arisen to focus policymakers' attention on preventing cervical cancer in Iran. The main challenges to implementing these policies are conflicts of interest, a poorly organized referral system, inadequate financial assistance for vulnerable groups, low public awareness, and inconsistent guidelines.

Conclusion: Overall, the findings highlight the need for comprehensive approaches to address cervical cancer in Iran. Such measures should emphasize elevating public awareness, encouraging human papillomavirus (HPV) vaccination, providing financial assistance for the cancer control plan, and supporting at-risk populations.

Context analysis

Health policy

Prevention

Cervical cancer

Cervical cancer is a major global health problem, and statistics highlight the disparity in the burden it places on low- and middle-income countries (LMICs). In 2020, there will be an estimated 604,000 new cases of cervical cancer worldwide, with 90% of these cases occurring in LMICs (1). In addition, the International Agency for Research on Cancer (IARC) has reported the age-standardized incidence rate, mortality and prevalence of cervical cancer in Iran 2.2, 1.5, and 7.1, respectively, per 100,000 women (2). These rates suggest that the burden of cervical cancer in Iran is relatively low compared with other countries. However, it is important to note that these rates may underestimate the true burden of the disease due to underreporting and limited access to health services, particularly in rural areas.

One worrying aspect highlighted by the statistics is the low uptake of cervical screening in Iran. Screening plays a critical role in the early detection and prevention of cervical cancer by identifying precancerous lesions or early-stage cancers that can be effectively treated. The reported screening coverage of 49.9% in Iran means that less than half of eligible women in the country are being screened for cervical cancer. In contrast, other countries have reported much higher screening coverage rates, ranging from 85% to 93%. This discrepancy suggests that increased efforts are needed to improve cervical cancer screening programs and access to health services in the country (3, 4).

Progress in the global initiative to reduce cervical cancer mortality is included as one of the targets of Sustainable Development Goal 3 (SDG 3). In response to the burden of cervical cancer, the World Health Organization (WHO) has formulated a comprehensive global strategy to accelerate the elimination of cervical cancer as a public health problem. This strategy recommends cost-effective interventions, including ensuring that 90% of girls receive the full HPV vaccine, that 70% of women are screened by age 35, with a repeat screening at age 45, and that 90% of women with cervical disease are treated promptly to achieve the targets set (5).

Widespread screening efforts in high-income countries (HICs) have led to significant reductions in cervical cancer mortality(6). Although cervical cancer is a relatively rare cause of death among women in Europe and North America, approximately 90% of cervical cancer deaths worldwide occur in LMICs, with sub-Saharan Africa bearing the greatest burden(7). These countries, known as LMICs, face the common challenge of establishing sustainable, integrated, timely and cost-effective health services that ensure equitable access and affordability while meeting the triple Millennium Development Goals (MDGs) targets set for 2030 (8). As a result, cervical cancer in these countries is often diagnosed at an advanced stage.

Context

In Iran, the 'Irapen' program, which includes cervical cancer screening as one of its key components, has been implemented in line with the Global Action Plan for 2013-2020. The National Cancer Control Program is the main national program focused on the control of Non-Communicable Diseases (NCDs). The comprehensive National Cervical Cancer Prevention (NCCP) includes four main processes: prevention, early detection, diagnosis and treatment, and supportive and palliative care. It also includes nine logistical processes: governance and policy-making; cancer research; development of facilities, equipment and service delivery networks; human resource management; financial resource management; management of cancer information systems and registries; and participation of nongovernmental organization (NGO), charities and the private sector. The objectives of the prevention and early detection sections of this plan are to identify cancer risk factors based on geographical area, education and personal health promotion. The aim is to reduce the burden of cancer and provide quality services (8, 9). -

Cervical cancer prevalence is increasing among Iranian women. Despite progress in cancer screening, it continues to be a major health challenge. Studies indicate that due to the COVID-19 pandemic, there has been an interruption in the supply of prevention and control services for NCDs, specifically screening and early detection of current cancers, at the PHC level (10, 11).

Given the impact of maternal and child mortality and disability on the Sustainable Development Goals (SDGs), which serve as a country's development indicators (12-14), and recognizing the effectiveness of screening programs (6), early detection of the disease should be a priority. Policy interventions aimed at preventing the disease's prevalence should also be analyzed.

Policy analysis entails a systematic study of numerous elements, as well as individuals and processes, which influence policy development, formulation, and implementation(15). Theoretical frameworks can be utilized to classify diverse contextual factors, which offers an understanding of how they impact actors and policymaking processes. Acknowledging the context is essential since it assists in identifying and engaging with these elements, scrutinizing data, and presenting findings. This facilitates the evaluation of how findings can be applied to various contexts (16).

Macro-level policymaking necessitates macro models for context analysis. Leichter's framework, alongside those formulated by Collins and Green, and Hunter, offer such models for classifying macro contexts (15, 17, 18). The Lichter context analysis model was selected because of its extensive range of factors for analyzing policy contexts (19). As the context plays a significant role in preventing cervical cancer, this study aimed to conduct a context analysis of Iran's health policy concerning cervical cancer prevention.

Study design

The study, which employed a policy analysis approach, was conducted from July 2020 to September 2021. The study explores the contextual factors affecting cervical cancer prevention policies in Iran using the Leichter model. The study refrains from subjective appraisals and uses clear, concise language with logical sentence structure and conventional academic formatting. This model incorporates four essential elements that affect policy-making: situational, structural-managerial, socio-economic, political-legal, and international factors. Within the Leichter model, additional elements are considered, such as the impact of changing conditions (a sub-factor of situational factors), the influence of executive management, the structure of inter-sectoral relationships, and the organizational structure itself (sub-factors of structural-managerial factors). Additionally, cultural, religious, traditional, and socio-economic factors are considered, along with the potential harm they may cause (a sub-factor of socio-economic factors). Furthermore, political factors, rules, and regulations are also included (sub-factors of political-legal factors), as well as international events, streams, and the role of international organizations (sub-factors of political-legal factors). All these factors collectively contribute to the analysis of the policy context in terms of cervical cancer prevention in Iran (18).

Data collection and study sampling

Data was gathered for this study through content analysis and semi-structured interviews as following steps:

Firstly, we conducted a content analysis of several national documents in order to collect data on the prevailing policies and interventions aimed at preventing cervical cancer, including the Iran Sixth Five-Year Economic, Cultural and Social Development Plan (2016-2021), the Health General Policies, Reported documents in the NCCP, and the National Cancer Care Network. In addition, an assessment was made of the "Irapen" system, which comprises basic interventions for NCDs within the PHC system.

As for participant selection, three in-depth interviews were conducted, utilizing a pre-test interview guide. The interviews were conducted by N.P in a semi-structured manner, with each interview lasting about an hour. They were held face-to-face with audio recordings made to ensure precise transcription.

The sample consisted of 43 participants, who were purposively selected following the WHO guidelines. Participants were selected from four different levels of the healthcare system, namely the policy level, regional level, clinical level, and community level (20). At least three participants were selected from each level. The inclusion criteria for participants were having a minimum of three years of experience in cancer-related fields.

Data analysis

Following the content analysis and interviews, the data was analyzed using the framework analysis method, specifically utilizing the Leichter model as the analytical framework. A comprehensive review of each interview transcript served as the first step in obtaining the overall meaning. The second step consisted of studying the content line by line and grouping sentences and phrases into initial sub-themes. Preliminary sub-themes and main sub-themes finally surfaced in all the interviews. Two of the researchers independently reviewed all the data to ensure the analysis's validity before getting together to discuss and agree on the final product. The quotations throughout this paper are illustrative of experiences reported by the wider sample. To assist in the analysis process, MAXQDA2020 software was employed. This software likely facilitated organizing, coding, and analyzing the data in a systematic and efficient manner.

The study's respondents had an average age of 35 and an average of 8 years of experience related to cervical cancer. The majority held doctoral, medical, or master's qualifications. The study consisted of a wide-ranging collection of participants, comprising of 4 faculty members, 3 researchers, 17 policy makers across varying levels of Iran's health system, 3 health insurance managers, 2 members of the Iranian Medical Council, 2 members of Iran's parliament, 1 faculty member from a Medical Sciences University, 8 staff members from community health centers, and 3 cervical health care service users.

Using the Leichter model and drawing on the opinions of participants in our study, we have identified five primary themes that influence the policy-making process for cervical cancer prevention in Iran. These themes include situational factors, structural-management factors, socio-economic factors, political-legal factors, and international factors. To provide greater detail and clarity, we have further subdivided each theme into relevant sub-themes and included select quotes in Table 1.

Situational factors

The establishment of primary healthcare structure following the Alma-Ata Declaration in 1977 has had a significant impact on preventive measures. In 1989, Iran introduced a cervical cancer screening program. Women within the screening age range of 20 to 65 years are required to undergo Pap smear tests after their first sexual activity, at three-year intervals. In 1990, the cervical cancer screening program switched from a population-based approach to an opportunistic one due to cost-effectiveness concerns. As a result, individuals who receive the service are now responsible for paying for laboratory services associated with the Pap (Papanicolaou) Test. Additionally, referred cases will not receive follow-up, and any precancerous lesions that are diagnosed but not addressed by patients will go unnoticed. Noteworthy recent policy updates in the Iranian cervical cancer screening program consist of the 2014 Irapen program and the 2013 NCCP. Irapen is a comprehensive set of interventions for main NCDs within the primary healthcare system, which has been executed in cities with a population of 50,000 people as a component of the health system transformation plan. However, the Covid-19 pandemic disrupted the implementation of this program.

Alongside other influential upstream documents related to cervical cancer prevention in Iran, the "Best Buys" guidelines recommended by the WHO in 2017 have had a significant impact. These guidelines emphasize the most cost-effective interventions for NCDs prevention, including cervical cancer screening and elimination. In the same year, Iran implemented the cervical cancer prevention and early detection program based on Pap smear and HPV testing for women aged 30-59. However, economic challenges caused by sanctions and conflicts of interest have hindered the program's implementation.

Current reports from IARC project a rise in the incidence and mortality rates of cervical cancer in Iran between 2018 and 2040. These rates are expected to exceed two-thirds of the present figures, reaching 148.082 cases per 100,000 individuals. Regrettably, politicians in Iran exhibit reluctances in addressing matters associated with sexually transmitted diseases (STDs). A lack of comprehensive public awareness campaigns and preventive policies has contributed to challenges in detecting cervical cancer in the country at an early stage.

Structural-management factors

Although upstream documents delineate the importance of prevention and screening, there remain conspicuous inadequacies in the screening facilities in Iran. Such inadequacies encompass limited laboratory services coverage, deficiencies in standard operating procedures for patient referrals, and insufficient resources to introduce innovative sampling methods, such as self-sampling (e.g., Self-collection of a sample for cervical cancer screening by swabbing the vagina). The lack of a properly structured referral system results in deficiencies in the follow-up procedure, consequently leading to erroneous identification of cancer suspect cases. Furthermore, there is a structural problem with inadequate incorporation of data registration systems among the medical universities in the country. This lack of integration will result in contradictory indicators and escalate the staff's workload for data collection and entry. The absence of coordination and harmony can result in inefficiencies and difficulties in the accurate capture and management of data relating to cervical cancer prevention and screening initiatives. Moreover, the inadequate integration of information registration between private and public sectors represents a limitation of the inter-sectoral system.

The efficacy of educational schemes in improving screening coverage has been extensively documented. Iran's health system encounters difficulties when collaborating with other ministries, including the Ministry of Education, in setting up a holistic educational framework within schools for disease prevention and management. The absence of cohesion in the conception and implementation of directives to prevent and detect cervical cancer between the health and treatment departments of the Ministry of Health and Medical Education (MOHME) poses a significant managerial and structural obstacle.

The "Best Buys" recommendations regarding NCDs preventive measures specify that the most efficient and cost-effective approach to cervical cancer is a combination of Pap smear and HPV testing has been identified as the most cost-effective method for cervical cancer screening. However, the implementation of this directive in Iran has been postponed due to various challenges, including sanctions and limited financial resources. Another obstacle to the adoption of this guideline is the conflict of interest arising from opposition among pathologists. In simple terms, the new screening test is affordable and requires less screening interval. This has a detrimental impact on the income of gynecologists and pathologists.

One of the challenges faced in executive management is the failure to align job descriptions with the content of university training courses. This mismatch can lead to reduced efficiency and increased work-related risks. Additionally, the outbreak of the COVID-19 pandemic in recent years has disrupted the delivery of prevention and management services for NCDs, including the screening of common cancers. This disruption highlights the need for stronger strategic planning to address unanticipated circumstances and implement management measures for future events.

Socio-economic factors

Based on the interviewees' opinions, several social issues can contribute to increase in prevalence of HPV infection and subsequent cervical cancer. These include delayed age of marriage, the taboo surrounding HPV as a STD, low awareness of the public about HPV and its potential as a precancerous factor of cervical cancer, and cultural unacceptability of the vaccination. The interviews also highlighted challenges in collaboration between different stakeholders to plan for an HPV-based screening test and launch a surveillance and monitoring system. Thus, the first strategy is de-normalizing risky sexual behaviors and increasing the public awareness about HPV infection and then, cultural acceptability for the vaccination. The second strategy is implementing an HPV-based screening system for cervical cancer as well as launching a surveillance and monitoring system.

PHC is widely recognized as crucial in achieving the goal of "health for all." One of the global indicators used to monitor and evaluate progress towards this goal is the allocation of a reasonable percentage of a country's health budget to primary health care. However, in Iran, a larger proportion of the health budget is allocated to the treatment sector due to the prevalent treatment-oriented approach (21). This, combined with financial constraints resulting from sanctions and the relatively low incidence rate of cervical cancer compared to other types of cancer in Iran, has led to not including HPV vaccination program in the national immunization and vaccination program.

Cervical cancer prevention and early detection policies also face economic challenges, particularly in terms of inadequate financial support for vulnerable groups. These challenges are related to the financing functions within the health system, including revenue collection, pooling of resources, and purchasing of services, which play an essential role in achieving Universal Health Coverage (UHC). The identified challenges include difficulties in identifying financially vulnerable groups, weaknesses in the collection of insurance premiums through progressive financing mechanisms, insufficient integration of various insurance funds (such as Health Insurance Organization, Social Security Insurance Organization, Armed Forces Social Security Organization, Imam Khomeini Relief Foundation (IKRF) insurance, Welfare insurance coverage), and limited strategic purchasing of services. Addressing these challenges is crucial to ensure effective and fair cervical cancer prevention and early detection strategies.

Political-legal factors

Based on the viewpoints of key informants, the decision-making system in the country does not effectively utilize the capabilities of the private sector and NGOs. Furthermore, policies are formulated without adequate consideration of public preferences. Another issue is the top-down approach to policymaking, where program development, content, and implementation are influenced by the goals and concerns of higher authorities. The attitudes and political interests of stakeholders play a significant role in shaping, implementing, and potentially obstructing or distorting the policy-making process.

According to the interviewees, the primary challenge in cervical cancer prevention policy in Iran lies not in insufficient funds, but rather in the inadequate allocation and utilization of resources. Reluctance among politicians to address issues related to STDs is another problem stemming from political attitudes and interests. This factor, in turn, can impact the availability, accessibility, service utilization, and ultimately the coverage of screening facilities.

The findings from the examination of laws and rules pertaining to cervical cancer prevention and early detection policies in Iran indicate that these laws primarily focus on the guidelines and protocols set forth by MOHME. Additionally, the decisions regarding screening interventions in these procedures are based on international evidence rather than primary national studies that would confirm the cost-effectiveness of these interventions.

In the government's official approvals, organizations outside the healthcare sector have not given significant attention to the prevention of NCDs. While a few instances are mentioned in these documents, such as health general policies, enhancing the quality of life, welfare and social security, which fall under the umbrella of social affairs policies within Iran Sixth Five-Year Economic, Cultural and Social Development Plan. The focus of social harm reduction programs in these initiatives has primarily been on preventing drug addiction. Among the legal matters discussed in this context, one can mention the government's obligation to implement harm reduction programs among drug users and vulnerable groups, involving both individuals and non-governmental sectors. Despite these legal safeguards, there are challenges in providing prevention services for high-risk groups, particularly vulnerable women, in relation to cervical cancer.

Furthermore, the research examined the national response "program of the healthcare system in emergencies and disasters". This program encompasses various functions related to emergency response, hospital management, control of communicable diseases, management of NCDs, and more. However, the interview results indicate a delay in providing prevention services for NCDs within the primary healthcare system during the Covid-19 pandemic. Additionally, research conducted in Iran underscores the necessity to review and enhance this program's policies concerning the management of NCDs during pandemic and outbreaks.

International Factors

International events and trends can have a significant impact on policy formation, implementation, and sustainability. Table 1 and the 'Situational Factors' outline some of these influences. Furthermore, enhancing maternal health is a critical objective of SDGs and makes a substantial contribution to a country's development index. One reason for prioritizing maternal health in this research is the clear positive correlation between treating precancerous lesions of the cervix as well as childbearing and reducing risk of premature birth.

It is important to form a coalition with international organizations to successfully implement policies. Collaborating with organizations such as WHO, the Pan American Health Organization, the World Union for Vaccines and Immunization, the Global Fund, the International Union for Cancer Control, and the World Bank can be highly effective in financial and technical support to new cervical cancer prevention programs that include co-test and HPV vaccination. International organizations can provide valuable support and make a significant contribution to the success of initiatives such as HPV vaccination in cervical cancer prevention programs through advocacy. Advocacy efforts can raise awareness, mobilize resources, and generate political support at national and international levels.

In 2018, Iran joined the IARC Working Group on Cervical Screening Programs. This membership allowed IARC experts to visit and consult with Iran, and it provided access to the organization’s prevention program. However, due to the failure to pay membership fees, the cooperation was terminated.

The cancellation of this membership in Iran was due to several factors, including the failure of efficient communication with global organizations, which could be attributed to changes in leadership and advancements; insufficient follow-up with the International Vice-Chancellor to get the government board to credit membership fee, and not efficiently allocated financing for cervical cancer prevention program due to the poor statistics on the disease and its effects.

Although efforts were made to implement the program, it was ultimately halted due to internal organizational management changes. Furthermore, STDs caused by HPV, such as vulvar, oropharyngeal, and vaginal cancers, have a lower incidence and prevalence compared to other cancers that have established screening programs, such as breast and colorectal cancers. This presents challenges in advocating for prevention programs and early detection financing for these types of cancers from policymakers and high-level officials.

There is a prioritization of other cancer control programs, such as early detection of breast and colorectal cancers and tobacco control, over cervical cancer prevention. It is recommended that cervical cancer prevention be given equal priority to other cancer control programs. Despite the importance of cervical cancer and the availability of prevention strategies, there may be a need for increased public awareness and advocacy to highlight the significance of HPV infection and cervical cancer and ensures support for prevention programs and early detection efforts.

Table 1. The theme, sub-theme, and quote were derived from the context analysis of the prevention and early detection of cervical cancer in Iran based on Lichter's model

Theme

Sub theme

Quote

Situational Factors

Changing conditions and their effects

Increase in the incidence and prevalence of disease:

“The implementation of Pap smear tests as a screening program in small towns with religious and traditional contexts, cancer incidence and prevalence remain relatively high compared to other countries. Moreover, estimates suggest that the prevalence of HPV is even higher in big cities and is expected to increase in the future” (P 18).

Increasing the prevalence of high-risk sexual behaviors:

“The use of virtual networks has increased in society. This issue can increase the prevalence of high-risk behaviors such as the use of stimulant and psychoactive drugs. The use of these substances increases extreme sexual behaviors and ultimately increases the possibility of HPV infection transmission” (P 34).

The effect of HPV infection on the occurrence of several types of cancer:

"It is true that our incidence and prevalence are lower than some EMRO member countries, but these indicators only show one aspect of health issues. It is important to pay attention to the fact that this infection (HPV) is effective in the occurrence of several types of cancer, including vulva, vagina, and male penis, anus, and oropharynx area” (P 6).

Structural-managerial Factors

Organizational structure

Weakness of screening facilities:

"Pap smear test is a cytology test, so a pathologist puts this slide under a microscope and looks at it to see what the condition of this cell actually is. HPV is a molecular test, so a geneticist must do PCR in the laboratory." That means it needs a technician. These have their own considerations. If you are thinking about this, we have shortages” (P 42).

Weaknesses of standard operating procedures:

“One of the weaknesses of standard operating procedures is when specialists consider themselves superior to the protocol and do not necessarily follow it. This can lead to a break in the referral process and create challenges” (P 24). “Implementing cervical cancer screening based on HPV strategy and Pap smear may also encounter problems if this mindset persists” (P 30).

Weakness of health information registration system integration:

“Currently, we have several electronic health records, each of which does its job separately. The lack of a unified national registration system for communication between laboratories, the private sector, clinics, and comprehensive health service centers has caused the information is not properly communicated to the Ministry of Health” (P 20).

Inter-sectoral structure

Poor organization of the school-based educational program:

“In general, there is a serious lack of effort in educating young people about disease prevention. One of the reasons for this is the absence of a well-organized structure that can guide the activities of various organizations. Even if these organizations are willing to cooperate in this field, there is no coordinating structure to facilitate their collaboration. Another reason is that too much attention is given to treatment, overshadowing the importance of prevention” (P 16).

Insufficient inter- and intra-sectoral participation in developing cancer prevention and control programs:

"Within the Ministry of Health's structure, certain units like the Supreme Council of Health and Food Safety play a role in developing programs. However, outside the Ministry of Health, organizations such as the State Welfare Organization of Iran, the Ministry of Sport and Youth, and the Ministry of Science, Research and Technology have limited involvement in program development. Other organizations may have low participation due to their activities not being directly related to health affairs. Furthermore, certain organizations with the legal authority to attract the participation of executive bodies show limited interest in these matters” (P 32).

The low integrity within the departments of the Ministry of Health:

“Indeed, discrepancies exist in the instructions for cancer control between the Non-Communicable Disease Management Centers. These inconsistencies pose challenges when it comes to implementing the instructions effectively” (P 2).

Executive management

Financial conflict of interest:

When I mention a conflict of interest, I'm not solely referring to health managers or any specific profession. To provide a simpler example, let's say I work as a gynecologist or a laboratory specialist in the private sector. Up until now, I have conducted 10 pap smears successfully. However, there are two new tests that I encounter: one requires a sampling technique I am unfamiliar with, and the other necessitates specialized equipment that I don't possess. Coincidentally, a competing laboratory is also unable to afford the necessary device. In this situation, I might be tempted to compromise ethical standards and engage in unethical practices” (P 12).

Weak correlation between university education and community-oriented education:

"There seems to be a disconnect between education and implementation, with certain aspects appearing contradictory. Graduates often encounter challenges when they enter the workforce because the materials they have studied do not align with their practical responsibilities. This mismatch between theoretical knowledge and real-world application can create difficulties for individuals transitioning into their professional roles” (P 19).

Delays in screening and care caused by the effect of the Covid-19 pandemic:

“The surveys conducted in Iran and various other countries indicate a disruption in the provision of screening services, early diagnosis, and treatment for common cancers, such as cervical cancer. In response to this issue, it is crucial to develop a plan to compensate for the delay in these essential services” (P 43).

Socio-economic Factors

Culture, religion, tradition

Taboo of cervical cancer and sexual issues:

“There are several reasons contributing to the low coverage of screening services, such as women's limited knowledge about screening tests, concerns about stigma and discrimination, and challenges in accessing services, particularly for working individuals. Additionally, the stigma and taboo surrounding infections, specifically Human Papillomavirus (HPV), along with inappropriate behavior from some healthcare workers, can further discourage high-risk groups from seeking or being aware of available services” (P 25).

Accumulation of cultural deprivations:

“The accumulation of cultural deprivations can manifest in various ways, including the inability of teenage girls, middle school girls, and high school girls to have open conversations with their mothers. It is essential for health teachers to address this issue by designing appropriate educational plans that differentiate between discussing sex and addressing immoral or abnormal behavior. Unfortunately, our society often overlooks the importance of addressing both physical and mental health holistically, resulting in a lack of comprehensive plans to tackle these issues” (P 39).

Social and economic harm

Weakness of public awareness:

“If I want to do HPV, HPV pap smear or pap smear test in this situation, it is not covered by insurance at all, so I have to go to a private practice. Clinics claim that it is free, but it is not, well, the Ministry of Health does not give any explanation in this regard, for me, as a woman in this society, I need to be informed” (P 40).

Therapists' views on budget allocation:

“The health sector's focus on treatment has led to a situation where budget allocation to the health sector is not prioritized, and less funding is directed towards preventive measures. The predominant budget allocation to the treatment sector plays a central role in hospitalization and the acquisition of technology” (P 13).

Limitation of budget for implementation of new screening methods:

“A laboratory located within the country is responsible for providing services to various regions across the country. Initially, there were plans to establish laboratory centers in the polar provinces. However, these plans had to be halted due to sanctions and budget constraints” (P 5).

Weakness of financial support for vulnerable groups:

“In the insurance coverage for pap smear tests, the costs of laboratory services are typically borne by the individual, and there is no financial assistance provided to underprivileged groups. Unfortunately, there is no documented evidence regarding the number of people who may fall ill as a result of being denied screening or unable to afford it. Therefore, it is difficult to draw a definitive conclusion, but it is plausible that such cases could occur” (P 22).

Political-legal Factors

Political factors

Weakness of community participation in policy making and implementation:

“In our country, there is a perception that non-governmental organizations and the private sector pose a threat. Unfortunately, this perception has resulted in their capacity not being utilized in cancer control programs, including those related to cervical cancer” (P 17). “Consequently, policies are being formulated without taking into account the wishes of the people, and their values are being disregarded. However, it is crucial that this does not happen in the context of cervical cancer control, as comprehensive participation is the foundation of its prevention” (P 11).

Top-down policymaking:

“Policymaking from the bottom up, where experts in the field (line health workers) assess existing conditions and set priorities before seeking approval from higher levels, is often considered more effective than top-down policymaking. This approach involves communicating policies to departments and individuals and requiring their active participation in implementation. However, even in the absence of such a plan, the development, content, and implementation of individual plans are still influenced by the goals and concerns of higher levels” (P 21).

Political attitudes and interests:

“The primary issue in the domain of cancer prevention and screening does not lie in the budget itself, but rather in the inadequate allocation of credit and resources. Even if a sufficient budget is provided by higher authorities, a manager who is unwilling to invest in a particular area will not allocate funds accordingly” (P 41).

Denial of changes in the sexual behavior of society:

“In my opinion, the most important problem is the high policy levels and the main decision-makers who must be committed to the implementation of the programs, if they do not care about them and do not share their values, then the implementation of the program will not have the necessary effect” (P 3).

Rules and regulations

Insufficient attention to cancer prevention and early detection in upstream documents:

“Indeed, certain health issues face challenges in being effectively addressed due to their nature. Cervical cancer is one such topic, as it is primarily transmitted through sexual intercourse. Similarly, AIDS initially faced similar hurdles, but as its transmission was also associated with joint injection, efforts were made to accommodate and address the issue. Consequently, development programs now include harm reduction policies for AIDS as well” (P 6).

Weakness of policy-making based on health technology assessment:

“You raise an important point regarding the lack of systematic evaluation of the benefits and cost-effectiveness of certain medical services. Unlike the National Health Service in England, which conducts such assessments even for minor medical and surgical services, there seems to be a lack of clarity regarding the financial benefits to patients, the healthcare system, and health insurers when it comes to coverage for these services. Additionally, there appears to be a scarcity of pharmaceutical research and health technology assessment studies focused on evaluating these specific services” (P 36).

Weakness of policy based on strategic management in the pandemic:

“Even though we have a “National Health System Response Plan” in emergencies and disasters, it is unfortunate that the Covid-19 pandemic has had an impact on cervical cancer screening programs. The prioritization of resources and healthcare services towards managing and providing care for Covid-19 patients has understandably led to disruptions in other areas of healthcare, including cervical cancer screening. As a result, screening coverage has further declined during this challenging time” (P 8).

International Factors

International events and Streams

"Best Buy" programs recommended by the World Health Organization:

“The introduction of the World Health Organization's "Best Buys" initiatives in 2017 aimed to promote cost-effective interventions in healthcare. As part of these initiatives, the screening strategy for cervical cancer prevention guidelines was changed from Pap smear alone to a simultaneous HPV test and Pap smear, as it was considered more cost-effective. However, I understand that financial issues have prevented the implementation of this program in our context” (P 10).

Establishing the structure of primary health care:

“You're correct in highlighting the shift in society's view of health before and after the year 2000. Prior to that, the focus was primarily on treatment and curative care. However, significant changes occurred following the Alma-Ata meeting, which emphasized the importance of primary healthcare and its role in achieving health for all. This shift was further reinforced with the establishment of the Millennium Development Goals and later the Sustainable Development Goals” (P 15).

The importance of improving maternal health in SDGs:

“The findings of several studies have established a connection between a lower weight at birth and the medical intervention for precancerous cells. Given the significance of these matters, coupled with the aim to decrease non-communicable disease-related premature deaths, including cervical cancer, by one-third by 2030, this issue carries particular importance (P 7).

The role of international organizations

Forming a coalition and advocacy at the international level:

“Iran's cooperation in cervical cancer prevention was terminated due to the Covid-19 pandemic and non-payment of membership fees. It's unfortunate that the lack of funding, changes in management, and unavailability of accurate statistics hindered Iran's ability to seek support for financing the membership fee (P 17).

Preventing and reducing the risk of cervical cancer is crucial because it can be detected and treated early. Therefore, it is essential to implement effective policies in Iran. The purpose of this study was to analyze the prevention and early diagnosis of cervical cancer in Iran using the Leichter model. The findings show challenges associated with early prevention and diagnosis of cervical cancer in Iran include situational, structural, financial, human resource, strategic, socio-cultural, political-legal, and international factors.

The analysis of the healthcare system's role in cervical cancer prevention shows that, despite the implementation of various programs aimed at controlling the disease, the incidence and prevalence of cervical cancer in Iran are projected to exceed two-thirds of the current statistics by 2040 (22). Despite the presence of initiatives such as the national cervical cancer screening program, the Irapen program, evaluation programs, Pap smear tests, and awareness and education campaigns regarding cervical cancer and prevention methods, the expected rise in cervical cancer cases suggests that additional efforts are required to address the underlying factors contributing to this trend.

One of the potential reasons contributing to this issue is the presence of structural-management challenges. Additionally, findings from various studies have indicated governance challenges in the implementation of policies related to cervical cancer screening (23-26). The weak organization of disease case follow-up and insufficient inter- and intra-sectoral collaboration in formulating and implementing screening strategies are indeed notable structural challenges identified in Iran. These challenges pose obstacles to the successful implementation of cervical cancer screening programs. Moreover, conflicts of interest have been commonly identified as managerial-executive issues in various health programs in Iran. These conflicts can impede decision-making processes and undermine the effective execution of preventive measures. In other words, the presence of policy makers who also hold executive-level responsibilities can create challenges in the decision-making and implementation of new cervical screening programs in Iran. Indeed, the weakness of school-based and community-based education is another management problem that hinders effective cervical cancer prevention efforts. Studies have shown that inadequate public awareness plays a significant role in reducing the coverage of screening services (24, 25, 27-36).

Challenges related to accessing cervical screening services have been identified in Iranian screening programs, particularly in terms of time and location. Difficulties in accessing screening services can negatively impact participation rates and the overall effectiveness of the programs. Furthermore, the monitoring and evaluation of these programs often focuses more on the process rather than the outcomes or results achieved. Focusing on result-oriented monitoring and evaluation can improve understanding of the program's impact and identify areas for improvement. A qualitative study conducted in Iran identified limitations of Pap smear tests, confirming issues with accessing these services (37). It is crucial to acknowledge the weaknesses in registration, monitoring, and evaluation systems identified by Duches et al. in their study (36).

From an economic-social perspective, the primary economic challenges in Iran include the impact of sanctions and embargoes, as well as economic difficulties faced in implementing new screening methods such as HPV vaccination and HPV testing. Additionally, ensuring access to screening services for vulnerable groups is another significant economic challenge. Indeed, weaknesses in financial and cost mechanisms have been highlighted as management and policy challenges in various studies, including research conducted by WHO (20, 25, 35, 38, 39). Furthermore, the weakness of insurance coverage for Pap smear diagnostic services, coupled with Iran's middle-to-low-income status, presents a challenge in implementing widespread Pap smear screening programs. Given these circumstances, the implementation of VIA (Visual Inspection with Acetic Acid) as part of an opportunistic screening program seems to be a suitable strategy for cervical cancer screening in Iran. VIA is a cost-effective and accessible screening method that can be performed by trained healthcare providers in various healthcare settings. This approach can help overcome the financial barriers associated with Pap smear tests and improve the overall accessibility and affordability of cervical cancer screening services in Iran. Indeed, it is true that the VIA test has certain advantages despite its lower sensitivity compared to the Pap smear. One of the most significant benefits of VIA is the immediate and quick results it provides. Unlike the Pap smear, which requires laboratory processing and subsequent follow-up, VIA allows for the identification of potential precancerous lesions during the initial visit itself. This immediate feedback enables timely interventions, such as further diagnostic evaluation or treatment, if necessary. Additionally, VIA can be performed using simple equipment and does not require specialized laboratory facilities, making it more accessible in resource-limited settings (40). The study conducted by Moore and colleagues demonstrated that economic development plays a significant role in controlling cancer risk factors (41).

One of the significant social challenges in Iran is the existence of taboos surrounding HPV infection. This issue has resulted in a lack of appropriate communication between children and families regarding sexual matters, as well as limited interaction between healthcare professionals and individuals utilizing Pap smear screening services. The MOHME reported that the cytology coverage rate for cervical cancer screening and early detection services among middle-aged women (30-49 years old) in Iran was only 46% (95% CI) in 2019 (42). However, the screening coverage rate in the Behavioral Diseases Counseling Center for vulnerable women in Iran has been reported as 28% (43). This low coverage rate may be attributed to economic and social challenges. Fallahi et al. conducted research to identify predictors of cervical cancer screening in Iran. The study results indicate that several factors are crucial in the prevention, detection, and treatment of cervical cancer. These factors include behavior, attitude, enabling factors, misconceptions about the disease, laws and policies, interactions between service users and healthcare providers, inter-departmental and intra-departmental cooperation, educational interventions, and feelings of guilt, embarrassment, and fear (44).

The VIA test may address the limitations of low screening coverage and limited financial access for vulnerable groups who are not covered by the Pap smear test. This method can be useful in increasing screening coverage, regardless of the screening program type.

The taboo surrounding cervical cancer as a sexual issue in Iran has impacted the formulation of prevention policies and early detection strategies. However, studies have highlighted the crucial role of public awareness in increasing the coverage of screening services (24, 25, 27-36). Indeed, there is a well-established relationship between low coverage of screening services and reduced cost-effectiveness of interventions. When the coverage of screening services is low, it leads to missed opportunities for early detection and intervention, resulting in higher healthcare costs and poorer health outcomes (45, 46).

Despite the international focus on addressing cervical cancer through primary healthcare development, policy-making and implementation in this area still encounter challenges. According to Lichter model, international factors play a significant role in cervical cancer prevention and control policy. These factors include events and the involvement of international organizations, which are listed in Table 1. Considering the link between managing precancerous cervical lesions and childbearing and premature birth, as well as the impact of maternal and child health indicators on a country's level of development as per SDGs, it is essential to prioritize the implementation of an HPV vaccination program. Given the correlation between HPV infection and the development of various cancers, it is advisable to establish a coalition with international organizations. This collaboration would enable the utilization of financial and technical support for new cervical cancer screening interventions.

The findings present significant challenges in health policy for prevention and early detection of cervical cancer. It requires collaboration between governments, MOHME, and various health organizations to effectively address these challenges. This includes improving access to healthcare services, promoting research, and raising public awareness about cervical cancer symptoms, causes, and prevention methods. In addition, governments can play a crucial role in facilitating access to preventive measures by providing financial support. By involving multiple stakeholders, improving the patient referral system, and addressing potential conflicts of interest among stakeholders, these challenges can be effectively addressed. By formulating and implementing a comprehensive prevention program, it is possible to exert full control over this disease and ensure its effective management.

Limitations

During the research, we faced limitations in accessing policymakers and high-level managers of organizations. However, we were able to address this issue through the collaboration of university professors, who facilitated the interview process. Additionally, we encountered challenges in accessing complete texts of certain upstream and electronic documents, which unfortunately could not be overcome. To address the challenge of accessing information related to advocacy from international organizations, which falls under the category of international factors, we contacted the Central Library Publications Unit. Additionally, we made efforts to obtain necessary information by communicating with the authors of relevant articles via email. However, it should be noted that despite these efforts, some parties did not cooperate in providing the necessary information.

HICs: high-income countries; HPV: Human papillomavirus; IARC: International Agency for Research on Cancer; IKRF insurance: Imam Khomeini Relief Foundation insurance; LMICs: low- and middle-income countries; MDGs: Millennium Development Goals; MOHME: Ministry of Health and Medical Education; NCCP: National Cervical Cancer Prevention; NCDs: Non-Communicable Diseases; NGO: Non-governmental Organization; Pap test: Papanicolaou test; PHC: Primary Health Care; SDGs: Sustainable Development Goals; STDs: sexually transmitted diseases; UHC: Universal Health Coverage; VIA: Visual Inspection with Acetic Acid; WHO: World Health Organization.

Acknowledgements

Not applicable.

Author contributions

NP and MJ are the principal investigators and developed the original idea for the study. The study design was developed by NP, MJ, LD, HS, FEFA, HP, and FA. Data Analysis and interpretation was carried out by NP and LD, and results were discussed by all of the authors. NP wrote the manuscript. LD has read and corrected the draft and all the authors have approved the final version of this paper.

Funding

There was no financial support in the design of the study, data collection, and analysis.

Availability of data and materials

The data supporting the results of this study consist of audio and transcripts of interview meetings and are not publicly available due to the conditions set out in the consent given by participants; however, they are available upon reasonable request to the corresponding author.

The study was done after holding the ethical code of IUMS /1402-1-74-25417 from deputy of research and technology/ Iran University of Medical Sciences. Written informed consent was obtained from all study participants and all methods were performed in accordance with the relevant guidelines and regulations.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Contextual analysis of cervical cancer prevention policies in Iran: A Leichter-based model

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