European Journal of Cardiovascular Medicine

Globally, the fourth most prevalent type of cancer among women is carcinoma cervix.(1) The incidence of cervical cancer worldwide was estimated to be 604000 cases along with 342000 deaths in 2020 (2). 90% of new cases and deaths occurred in low and middle-income countries. Cervical cancer is linked to high-risk subtypes of human papillomavirus (HPV) in 99% of cases. (3)Majority of these cases are seen in nations whose programmes fall short of quality requirements or where women are not routinely screened. Cases in well-established, effective programmes are mostly the consequence of women choosing not to actively engage in screening. (3,4)Cervical cancer cannot be prevented without HPV vaccination, screening, and treatment of precancerous lesions. HPV testing for cervical screening can be done in three ways: cytology, visual examination using acetic acid, and HPV testing. In the screen-and-treat strategy, the WHO advises using HPV DNA testing as the primary screening method. (5) Although every nation has its screening standards and procedures, most women do not get checked. It could be brought on by a lack of access to screening services, embarrassment or fear, or cultural or religious beliefs.  In comparison to pap tests, HPV testing is a more sensitive primary screening method.

Self-sampling is a secure and simple method that makes it easier to contact women who would not otherwise take part in a clinician-based screening or make a screening test more accessible to them. (5) Self-sampling is thought to get around some of these issues and has made screening more popular. Because of its comfort, simplicity of use, privacy, and convenience, it is seen as quite acceptable. The WHO has also recommended primary HPV-based screening and included self-sampling in the recently released guidelines on self-intervention for health and as part of the cervical cancer screening guidelines (5). As a result, the International Agency for Research on Cancer has updated its assessment of the efficacy and effectiveness of cervical cancer screening methods, and it supports the recommendation that primary HPV-based screening be done. (6)

The rationale for conducting this research lies in the transformative potential of self-sampling in the realm of cervical cancer prevention. In recent years, self-sampling for HPV testing has garnered attention as a promising alternative to conventional clinician-administered methods. This innovative approach not only provides women with a more convenient and accessible means of participating in cervical cancer screening but also holds the potential to increase screening uptake, particularly in populations facing barriers to traditional screening methods. Understanding the factors that influence women's experiences with self-sampling is crucial for tailoring interventions that align with cultural, contextual, and individual preferences. Furthermore, insights gained from this study may contribute to the optimization of cervical cancer screening programs, not only within the confines of the specific medical institute under investigation but also in broader public health contexts across South India.

By focusing on this specific population, the study aims aim to assess the degree to which the self-sampling method has reduced the discomfort and barriers towards cervical cancer screening and to determine if the development of more patient-centered screening programs can improve screening participation rates and reduce the incidence of cervical cancer.

This is a cross sectional study that was conducted at a tertiary care hospital in South India.

Study Population:

The study involved female employees working at the PSG Institute of Medical Sciences and Research, Coimbatore in South India. There were around 1284 females employed in this institution who were above 30 years of age. This research study was carried out over the period between May 2021 to April 2022.

Eligibility criteria:

All female employees aged between 30-65 years who participated in the self-sampling for HPV testing were included in the study. Pregnant women and women with already diagnosed cervical cancer were excluded from the study.

Sample size calculation:

The research conducted by Sultana et al. (7), showed 14% women had stated not having time as reason for not taking up cervical screening. With 95% confidence level and precision of 5%, the sample size required for the current study was calculated using OpenEpi v3.01. (8) The calculated sample size came out to be 185 female study participants.

Study procedure:

The details of women including their phone numbers who participated in the self-sampling cervical cancer screening were obtained from the hospitalemployee database. The participants were interviewed over the phone by administering a semi-structured questionnaire. This wascarried out by a trained investigator. Verbal consent was obtained at the start of the interview. The questionnaire consisted of socio-demographic details such as age, educational status, occupation, and questions regarding their previous screening history and reasons for not having done a pap smear in the past. Questions regarding their experience in self-sampling, their future screening options, and recommendations to others were also included.

Statistical analysis:

The collected data were entered into Epidata version 3.1, and subsequent data analysis was conducted using STATA version 12.0. (9,10) Descriptive statistics were used to summarize the sociodemographic and screening profile of the study population. Continuous variables were summarized as mean (SD), while categorical variables were presented as frequency (Proportions). Chi square test was used to find the difference in proportions among the groups. P-value of less than 0.05 was considered to be statistical significant.

Ethical Considerations:

This study received approval from the Institutional Ethics Committee and adhered to the principles outlined in the Declaration of Helsinki, which provides ethical guidelines for medical research involving human subjects.

Out of 1284 female employees in the age group of 30-65 years working in the tertiary care institution, only 200 women participated in the self-sampling camp conducted in the institution premises. The participation rate was 15.5%. Among those who participated, 177 (88.5%) women responded to the phone call, while 23 (11.5%) women did not answer the phone call.

The majority of the participants were between the age group 46 -55 years(46.3%). Moreover, 78 (44%) women were unskilled workers,49(27.7%) were semi-skilled workers, 24(13.6%) women were clerks and 26(14.5%) were professionals. Education status and whether they live in a nuclear or joint family did not significantly influence participation in the self-sampling screening. (Table 1)

Table 1: Comparison of Demographic Characteristics among different age groups. (N=177)

Table 2: Previous screening history and reason for not screening among the study participants (N=177)

Table 3: Comparison among occupational groups based on previous screening history among the study participants (N=177)

Table 4: Experience of women in taking self-sampling among the study participants (N=177)

Table 5:Options for future screening among the study participants (N=177)

Table 6: Comparison among the occupational groups based on options on future screening (N=177)

Previous screening:

Despite pap smear being part of the annual health checkup for all employees done free of cost, only 45 women (25.4%) had previous pap screening tests. 23(13%) women were from the age group of 46-55 years. In the age group of 30-35 years, only one woman had a previous pap screening done. (Table 2)On comparing the occupations, 12 out of 26 professionals (46%) had previous screening, while among unskilled workers only 10 out of 78 (12.8%) had previous screening done.(Table 3)

Of 177 women who responded to the phone call,132(74.5%) of them had no previous screening. (Table 2)The most common reason stated for not having a pap smear done was – "I don't think I need a pap test”, while52% women stated, “they had no symptoms” as the reason. 54 (41%) women said “they didn't know about the pap test”. A few participants especially professionals said that “they were embarrassed” or “didn't have time to go to the doctor”. None mentioned that “the test was expensive” as a reason for not having a pap smear test done. 87.2 % of women in the unskilled group had no previous screening while 54 % of professionals had no previous screening history.

Experience in self-sampling:

Table 4 compares the experience of women in self-sampling among the various age groups. All the participants expressed that the instructions given for taking the sample was clear and easily understandable. The swab provided to take the sample was felt easy to use by most of the people in all the age groups (97%) and the p-value was significant at 0.007. 88.7% of women expressed they were not embarrassed to take the sample by themselves. The p-value was significant at 0.0421. 11.3% study participants said that they were embarrassed. 50% among them were from the age group 36-45 years. Regarding, pain while taking the sample 77.9% of women said they had no pain while 22% of women experienced pain while taking the sample. Most of the women who said they had pain were from the age group 36-55 years. 90.3% of women said that the test was convenient for them. 79.6% of women were confident in taking the sample, while 20.3% of women were not confident about taking the sample On comparing the experience of women in different occupational groups there was no significant difference elicited in the current study.

Future screening:

Regarding future screening, 49.1% women said that they would opt for self-screening while 24.8% expressed their preference tovisit clinician to take the sample. 25.9% of women were not able to decide at the moment.(Table 5) Among the occupational groups, 46 out of 78 (58%) unskilled workers,18 out of 49(36%), and 10 out of 24(41.6%) clerks said that they would opt for self-sampling. In the professional group, 13 out of 26 (50%) said that they would go for self-sampling, while10 out of 26(38%) would prefer clinician sampling in the future.87% of women said that they would recommend this self-sampling method to their friends and relatives. (Table 6)

Though there are many screening methods and screening strategies available, most women are not screened at least once in a lifetime. Cancer screening services and uptake is less in rural areas when compared to suburban and urban areas. In a study done by Laia Bruni et al, the estimated worldwide cancer screening coverage for aged 30-49years in 2019 was 15% in the previous year,28% in the previous 3 years, and 32% in the previous 5 years. (11) A study done by Sultana et al., shows that 64% of women in age group 30-49years had not been screened at all at least once in a lifetime. (7)  The screening rate is higher in the high-income group compared to the low-income group. In our study, most of the women 74.5% had no previous screening at all. Most of the women were in age groups between 30-45 years. In comparing the occupational group87.5% of women in the unskilled group did not have previous screening, while in the professional group, 54% did not have previous screening.

There are many barriers to cervical cancer screening including lack of access to screening services, cost, travel, and time(12). Apart from this, there are also personal reasons like shame, fear of cancer(13,14,15), embarrassment for pelvic examination(15), lack of knowledge(16, 17), discomfort and pain while taking the sample. (7). Even though there are free screening programs conducted in many of the low-income countries women do not come forward for screening. (12)In our study we found the reason for not screening is that they don’t have any symptoms or complaints to go for screening. Many of them said they didn't know about the pap smear test. The above two reasons were given by most of the women from the unskilled and semiskilled groups. Studies have shown that going to the doctor and the embarrassment of getting a pelvic examination is the most common barrier. (13) This best suits developed countries but in developing countries, like India, lack of proper knowledge regarding screening for asymptomatic remains a big obstacle to attaining the screening coverage. It is necessary to improve the knowledge of the people about cervical screening and this will help in increasing the coverage rate in many low and middle-income countries. This study will provide valuable insights as there are limited Indian studies on the experience of women with self-sampling.

HPV testing as a screening tool has brought a big change in screening strategy as it can be done in aself-collected sample. HPV testing is the only test which can be done by using a vaginal sample. (12) There are many doubts on the reliability of the test but it is important to know that HPV not only affects the cervical epithelium but also infects the vagina, vulva, and anal region. The cells collected from vaginal fluid are sufficient to find whether HPV infection is present or not. (12) Self-sampling is more effective than sending the remainder letter for a pap smear in increasing the participation in women who are never or under-screened. (7,19,20) In our study, 74.5 % who had not even screened at least once participated in the self-sampling screening method. HPV test sensitivity and specificity using a vaginal sample taken by the patient is similar to that by the health care provider. (12)Moreover, it has the advantage that health workers can go door to door and distribute the kit so the women can take the sample with privacy at their home and can take back the sample or the sample can be mailed to the lab. By this we can involve many women in screening and the dropout out will be less.

Self-sampling helps in overcoming the barriers like pain, discomfort, embarrassment, and time. (14) This is evident from our study also as many women said that the swab was easy to use, sampling was convenient, and less painful. Many women were not embarrassed (88.7%) to take the sample by themselves and many were confident(90.3%) in taking the sample. This was similar to the study conducted by Farhana Sultana et al where 81% of women were confident(7) and in another study conducted by Virtanan A et al in Finland 88% of women were confident in taking the sample. (22) All women could easily understand the instructions given to take the sample.  In a study conducted by Virtana A et al 83% trusted the result. (22) Similarly in our study 98.3% said that they rely on the test. Studies showed that self-sampling is highly acceptable by women in all age groups and can increase the participation rate. (12) There are still a few women who reject the self-sampling and prefer the sampling done by the clinician. The reason for this is fear of hurting themselves while taking the sample, fear that the sample might not be of good quality, and resistance to touching their genitals. (12) In our study 22% of women experienced pain and 20.3% were not confident in taking the sample. Proper counseling to remove the fear and proper training in taking the sample will help the women. Women should be informed clearly about the benefits of self-sampling. By this, we can increase the participation rate in self-sampling.

Many countries are now adopting the self-sampling method for screening. WHO recommends that HPV self-sampling should be made available as an additional approach to sampling in the cervical cancer screening services, for women aged 30-60 years. Many developed countries are now using HPV as a primary screening test and sampling method they are moving towards self-sampling. But in low-resource settings doing HPV tests remains a question because of the cost and resources required. Attention towards cost-effectiveness even in low resource settings will improve the coverage rate. This is evident from our study even the unskilled and less educated women were satisfied with this method and they came forward to doing the self-sampling method.

The main concern is the cost of the self-sampling kit. This is justified that if we do cytology we have to do it once in three years but HPV is done once in 5years only. The global strategy encourages a minimum of two-lifetime screens with a high-performance HPV test by age 35 and again by age 45 years. (23)In a study done by Riina Aarnio et al, it was found that HPV testing done by the self-sampling method is more effective and less costly than the sample collected by health workers for cytology in primary cervical screening. (24) 87% of the women in our study said that they would recommend this method to their friends and relatives. This is very important as it would bring many women into the screening services. It is already a proven fact that the impact will be more if they learn from their peers rather than from some unknown person. The referral chain among the women will increase the uptake of screening services and the sampling method will help in this context.

Although screening at least once in a lifetime reduces the incidence of cervical cancer screening at regular intervals will help us in eliminating the occurrence of cervical cancer. It is very important that the women should be compliant and the screening method we use should meet this criterion. If it is painful, uncomfortable, and inaccessible then many women will not utilize it. Patient compliance will be improved by self -the sampling method which is evident from our study. 49.1% of women said that they would opt for the self-sampling method in their future screening and the p-value was found to be significant (0.05). 25% of women said they were not sure which method to choose at present. Among the unskilled workers, 58% of them said they would choose this method. This shows that the self-sampling method has reached even the women who are less educated and of low socioeconomic status. By utilization of this method screening rates in low and middle-income countries can be increased.

Self-sampling helps to overcome the obstacles and barriers and increases the screening participation rates. The findings are encouraging as many women not yet screened have at least participated. Increasing the knowledge and awareness about cervical screening and promoting more self-sampling will help in achieving the WHO target of a 70 % coverage rate by 2030.

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