|Year : 2023 | Volume
| Issue : 2 | Page : 47-49
Gearing up for implementation of self-sampled HPV-DNA screening test for cervical cancer in India
Formerly at Division of Epidemiology and Communicable Diseases, Indian Council of Medical Research, New Delhi, India
|Date of Submission||14-Mar-2023|
|Date of Decision||07-Apr-2023|
|Date of Acceptance||15-Apr-2023|
|Date of Web Publication||28-Apr-2023|
Dr. Lalit Kant
B 95, Gulmohar Park, New Delhi - 110 049
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kant L. Gearing up for implementation of self-sampled HPV-DNA screening test for cervical cancer in India. Curr Med Res Pract 2023;13:47-9
In this issue of the Journal, a review on the acceptance, accuracy and feasibility of HPV self-sampling for cervical cancer screening is published. A large body of evidence has been cited, and a case is made for its incorporation in the National Screening Programme of India. I applaud the efforts of Oak et al. for a well-conducted and relevant review.
There are two take-home messages. India should opt for the HPV-DNA test as a screening tool, and self-sampling for HPV tests should be promoted in India.
Inter alia three implementation issues for India emerge from this review. One, the procurement of high-quality HPV-DNA tests. Second, the acceptability of self-sample in India. Third, follow-up visits of the women who have a positive screen test.
| Procurement and Testing of High-Quality HPV Assays|| |
By 2020, at least 254 distinct HPV assays and 425 assay variants were available on the global market. About 60% of these are without a single peer-reviewed publication, 82% lack any published analytical and/or clinical evaluation and over 90% have not undergone regulatory evaluation or have not been evaluated following a stringent clinical validation protocol. Such HPV tests are used globally with potentially serious consequences. By February 2023, assays of only three companies have received WHO pre-qualification.
In view of the mounting evidence in favour of the HPV-based screening test, as of February 2021, globally, 48 countries (24 low- and middle-income countries and 24 high-income countries) have already recommended primary HPV-based screening– either alone or in combination with other screening tests. As the demand for these screening tests has gone up, the prices have come down. For an order of 100,000 tests or more, presently, the unit price is <US$ 5 (about Rs 500).
In India, several imported HPV-DNA assays are available. Given India's women population between 35 and 44 years (UN estimates for 2021 is about 95 million), the requirement of the tests will be large. It is reported that a chip-based real-time polymerase chain reaction (PCR) for HPV with acceptable sensitivity and specificity is made and available in India; it also has marketing authorisation from the regulatory authority in India– making it an attractive preposition for India.
A silver lining of the COVID pandemic is that India has a network of 877 ICMR-accredited laboratories (524 perform the real-time reverse transcription PCR for COVID-19, 283 TrueNat test and 70 CBNAAT) for SARS-CoV-2 testing. These can be leveraged to facilitate HPV testing.
| Acceptability of Self-Sampling in High-Burden Countries|| |
Experiences of self-collection of samples for HPV-DNA tests published in 50 studies from 26 countries (19 from Sub-Saharan Africa and 18 from Latin America) indicate that HPV self-sampling is a well-performing test that shows promise in terms of expanding screening efforts for the prevention of cervical cancer-related deaths in low- and middle-income countries (LMICs).
This review covers studies from 26 of the 137 LMICs, including two studies from India. In one multicountry study (India, Nicaragua and Uganda), most women preferred clinic-based sampling. The other Indian study of over 5000 participants reported a sensitivity of 54% for self-sampling. Generalisations at times, blur country-specific differences.
A systematic review of studies done in India focussing on challenges in the implementation of HPV self-sampling highlights that most of the challenges were faced by women taking self-samples. Women's lack of knowledge leading to misconceptions fear and lack of motivation; low self-efficacy of the samples leading to poor quality of the sample collected; low socioeconomic status of the individual (having single-room houses without an indoor washroom) leading to lack of privacy and refusal for screening and further treatment.
Women have not come forward to be screened even when it is accessible– whether it is the fear of the unknown or they may need their husband's permission to participate in self-sampling programme. Studies also report about a section of women who prefer provider-collected samples over self-sampling for various reasons. Some fear hurting themselves, others feel comfortable when assistance is around.,
We still have gaping holes in our understanding of the role of sociocultural beliefs in women's preventive health-seeking behaviour.
To get a holistic view of the areas that will need strengthening a Prevention and Screening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC) is being conducted in four countries including India. It aims to study the feasibility of implementing the latest WHO recommendations for cervical cancer screening in addition to existing community-based cervical cancer screening programmes and provide evidence regarding HPV self-testing. The project will apply a community-based approach, in which eligible women will be visited in their homes and/or mobilised through outreach efforts and will be offered a self-test for HPV screening. In case of a positive HPV result, the women will be invited for a follow-up examination in a screen, triage and treat approach. Women aged 35–63 will be targeted in rural, urban, urban slum and hilly regions in Udupi, Sikkim, Kolkata, Bangalore and Mumbai.
It is hoped that the results of the study will plug some of the gaps in our knowledge and provide decision-makers with insights into the economic aspects of implementing HPV self-testing.
| Follow-Up Visits of Screen Test Positives|| |
Any screening programme without linkage to care does not save lives and is a wasteful expenditure. The rates of follow-up in some of the studies have varied widely from 13.7% to 90%. Some investigators have observed that by engaging community health workers, participation rates and follow-up rates improved significantly. An updated review of the current global evidence on HPV-based self-sampling also highlights sub-optimal follow-up post-self-sampling.
A programme acronymed Removing Obstacles to cervical ScrEening in Malaysia has gained the attention of countries which are looking for models that link every woman who has provided self-collected samples for HPV testing to care. Moreover, the results prove it-of the over 4000 screened, 99.7% had a valid HPV test result, almost 99% of the HPV-positive women confirmed receipt of the test results and 90% of them attended colposcopy follow-up. This vital connection to care is facilitated using digital registries. It should be kept in mind that about 60% of Malaysian population is Muslim, with Islam as the official religion.
Notwithstanding the potential benefits of introducing HPV-DNA tests and self-sampling, studies have shown that their implementation has challenges. Recently, the results of implementation research on introducing primary HPV-DNA testing on self-collected samples in partnership with the State Government were shared. There are learnings for every stage.
Each state in India would need to address the implementation challenges as they are context specific. India has an uphill task to reach the elimination targets by 2030. HPV testing either self-sampled and/or provider-assisted has the best chance to succeed in accelerating the progress towards elimination, provided we address the challenges.
| References|| |
Oak A, Sivaranjini K, Pathak R, Dikshit R. Human papillomavirus self-sampling for cervical cancer screening: Review on the acceptance, accuracy, feasibility and incorporation in the National Screening Programme of India. Curr Med Res Pract 2023;13:74-80. [Full text]
Poljak M, Oštrbenk Valenčak A, Gimpelj Domjanič G, Xu L, Arbyn M. Commercially available molecular tests for human papillomaviruses: A global overview. Clin Microbiol Infect 2020;26:1144-50.
Serrano B, Ibáñez R, Robles C, Peremiquel-Trillas P, de Sanjosé S, Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening. Prev Med 2022;154:106900.
Inturrisi F, Berkhof J. Pricing of HPV tests in Italian tender-based settings. J Med Econ 2022;25:762-8.
Kamath Mulki A, Withers M. Human papilloma virus self-sampling performance in low- and middle-income countries. BMC Womens Health 2021;21:12.
Hariprasad R, John A, Abdulkader RS. Challenges in the implementation of human papillomavirus self-sampling for cervical cancer screening in India: A systematic review. JCO Glob Oncol 2023;9:e2200401.
Adsul P, Srinivas V, Gowda S, Nayaka S, Pramathesh R, Chandrappa K, et al
. A community-based, cross-sectional study of hrHPV DNA self-sampling-based cervical cancer screening in rural Karnataka, India. Int J Gynaecol Obstet 2019;146:170-6.
Sultanov M, Zeeuw J, Koot J, der Schans JV, Beltman JJ, Fouw M, et al
. Investigating feasibility of 2021 WHO protocol for cervical cancer screening in underscreened populations: PREvention and SCReening innovation project toward elimination of cervical cancer (PRESCRIP-TEC). BMC Public Health 2022;22:1356.
Di Gennaro G, Licata F, Trovato A, Bianco A. Does self-sampling for human papilloma virus testing have the potential to increase cervical cancer screening? An updated meta-analysis of observational studies and randomized clinical trials. Front Public Health 2022;10:1003461. https://doi.org/10.3389/fpubh.2022.1003461
Woo YL, Khoo SP, Gravitt P, Hawkes D, Rajasuriar R, Saville M. The implementation of a primary HPV self-testing cervical screening program in Malaysia through program ROSE-lessons learnt and moving forward. Curr Oncol 2022;29:7379-87.
Dhanasekaran K, Tamang H, Pradhan S, Lhamu R, Hariprasad R. Challenges in setting up a primary human papillomavirus-DNA testing facility in a lower and middle income country: Lessons learned from a pilot programme. Ecancermedicalscience 2022;16:1492.