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Abstract

Background: The World Health Organization (WHO) aims to eliminate cervical cancer by 2030 through a global strategy, centred on high-risk Human papillomavirus (hrHPV)-based screening and treatment. Implementing these strategies in low-resource settings remains challenging, due to barriers associated with limited healthcare infrastructure and patient awareness. Self-sampling for hrHPV has shown higher acceptability and similar diagnostic accuracy compared to clinician-taken samples. This study proposes a protocol to evaluate the clinical efficacy of a cervical cancer screening program utilising hrHPV self-sampling in Ghana.

Methods and Analysis: 1000 non-pregnant women aged 30-65 years will be invited to self-collect hrHPV samples. Those testing hrHPV positive will undergo visual inspection with acetic acid. Those diagnosed with high-grade squamous intraepithelial lesions will be offered ablation. In any case where there is a suspicion of invasion, or equivocal diagnosis, biopsies will be taken. Follow-up for women who are test positive for hrHPV and/or undergo treatment, will involve hrHPV self-sampling after 6 months. HrHPV-negative women will rescreen after 3 years. Biopsies will be taken where immediate treatment is not suitable, and women with confirmed or suspected invasive cervical carcinoma will be referred for surgical and/or oncological care. The primary outcome will be the proportion of women successfully screened, defined as the proportion of women with a valid HPV test result out of those invited to attend cervical screening. Secondary outcomes include screening uptake, disease detection rate, hrHPV genotype prevalence, treatment acceptance rate, successful treatment response, missed disease during treatment, number lost to follow-up, and disease recurrence.

Discussion: In low-resource settings, hrHPV self-sampling offers an accessible method to increase screening uptake. This study will inform strategies for broader implementation of cervical cancer screening and contribute to achieving the WHO’s goal of elimination by 2030.

Trial Registration: Ethical approval for this study was obtained from the Kintampo Health Research Centre Institutional Ethics Committee (IEC), Bono East, Ghana, West Africa, on 24 May 2024 (IEC IRB Registration No. 0004854; Study ID: KHRCIEC/2024-03).

Plain Language Summary

Background: The World Health Organization (WHO) aims to eliminate cervical cancer by 2030, focusing on testing for high-risk human papillomavirus (hrHPV) and providing treatment. However, many low-resource countries face challenges like limited healthcare facilities and low awareness among women. Self-testing for hrHPV has proven to be a reliable and more acceptable method than tests done by healthcare professionals. This study aims to test the effectiveness of an hrHPV self-testing program for cervical cancer screening in Ghana. Study Plan: We will invite 1,000 women aged 30-65 to collect their own hrHPV samples. Women who test positive will have a follow-up test using a simple method that examines the cervix with vinegar (visual inspection with acetic acid). If pre-cancerous changes are found, they will be treated with a quick and simple procedure (ablation). If more serious disease is suspected, small tissue samples (biopsies) will be taken. Women who test positive and/or receive treatment will be asked to self-test again after six months. Women who test negative will be screened again after three years. Any women needing advanced care, such as surgery or cancer treatment, will be referred to specialists. What We’re Measuring: The main goal is to measure how many women participate in the program and successfully provide self-collected samples. We will also track the number of cases detected, treatment acceptance, treatment success, missed cases, follow-up rates, and disease recurrence. Why This Matters: Self-testing for hrHPV is a simple and accessible way to improve cervical cancer screening in low-resource settings. This study will guide the expansion of screening programs in Ghana and similar countries, helping achieve the WHO’s goal to eliminate cervical cancer by 2030.

Keywords

human papillomavirus cervical cancer screening self-sampling low-income countries

Background

Cervical cancer (CC) is the fourth most common cancer among women globally, with a disproportionate burden in low- and middle- income countries (LMICs), in part due to limited access to established preventative healthcare services. In 2020, there were an estimated 604 127 new cases and 341 831 deaths worldwide,¹ with over 85% of cases occurring in LMICs, where financial, infrastructural, and cultural barriers limit access to screening and treatment.² This highlights the critical need for effective primary and secondary prevention strategies to reduce cervical cancer incidence in these regions.

The World Health Organization (WHO) aims to eliminate cervical cancer by 2030 by adopting the “90-70-90” strategy. This strategy focuses on ensuring that 90% of girls are fully vaccinated against high-risk Human Papillomavirus (HPV) by age 15, 70% of women are screened with a high-performance test by ages 35 and again by 45 years of age, and 90% of women diagnosed with cervical disease receive adequate treatment.^3-5 The lower target for screening (70%) reflects the substantial barriers in LMICs, such as inadequate healthcare infrastructure, limited availability of trained healthcare workers, and low awareness of screening programs.^6-10

HPVs are a group of more than 200 related viruses, which are classified into low-risk and high-risk types based on their potential to cause disease.¹¹ Low-risk HPVs are associated with benign conditions such as warts, while high-risk HPVs, particularly types 16 and 18 are linked to the development of cervical cancer.¹¹ Persistent infection with high-risk HPV types is the primary cause of cervical cancer, making HPV screening a critical tool in cancer prevention. The virus is primarily transmitted through sexual contact, and most infections are asymptomatic and resolve spontaneously. However, persistent infections can lead to precancerous lesions and, if untreated, to invasive cancers.¹¹

Ghana exemplifies these challenges. Despite cervical cancer being the second most common cancer among women in the country, with approximately 2800 new cases and 1700 deaths each year,¹² the country currently lacks a national CC screening program. This leaves many women without access to routine screening and early detection services, contributing to the late-stage diagnosis and high mortality rates.¹³ Additionally, women in Ghana often face significant barriers to healthcare, including upfront costs and travelling long distances to health facilities, further complicating their access to preventive care or definitive treatment.¹⁴

High risk Human Papillomavirus (hr-HPV) is responsible for over 99% of cervical cancer cases, with types 16 and 18 accounting for the majority of cases.¹⁵ Although vaccines against these hrHPV types are highly effective, vaccination coverage remains low in many LMICs, including Ghana, due to the absence of national vaccination programs.^6-9 Even if a robust and well-established vaccination program were to be implemented, screening initiatives remain essential to identify cases until vaccines achieve full effectiveness in reducing disease incidence. Estimates suggest that HPV 16 and 18 contribute to 38.5% of high-grade squamous intraepithelial lesions (HSIL) and 59.2% of CC cases in Ghana.^13,16,17 HPV 45 has been reported to contribute to 8% of CC cases worldwide with a geographic clustering in West Africa.¹⁸

Existing literature points to hrHPV self-sampling as a promising strategy for implementing a practical screening program and increasing screening uptake, particularly in LMICs. By eliminating the need for a physician to perform the pelvic examination during screening, women can maintain greater privacy, and self-screening offers the convenience of being conducted outside regular physician working hours, thereby minimising disruptions to their daily activities. Studies show that self-sampling has similar accuracy to clinician-collected samples and is generally more acceptable to women, especially in settings where cultural or logistical barriers may prevent them from attending clinic-based screenings.^14,19-23 Arbyn et al. (2018) demonstrated in a meta-analysis that HPV testing on self-collected samples is an acceptable screening tool.²³ Other studies further confirm that self-collected samples provide accuracy comparable to clinician-collected ones, making self-sampling a practical alternative, especially in resource-limited settings.^24,25 A recent United Kingdom (UK) based study demonstrated that opportunistically offering self-sampling kits in primary care significantly increased screening participation among non-attenders, particularly in underserved and ethnically diverse populations, with a 22% increase in screening in this cohort per month; this may also apply to women in LMICs.¹⁹ Additionally, self-sampling offers a cost-effective, scalable solution, particularly crucial in resource-constrained settings where traditional screening methods can be financially and logistically challenging. The relatively low cost per sample, especially when compared to clinician-administered tests, makes it a feasible option for large-scale implementation. This affordability not only allows for broader population coverage but also eases pressures on healthcare systems by reducing the need for multiple specialised clinic visits, rendering self-screening a resource-efficient strategy for increasing screening uptake in LMICs.^14,21-23

The study will be conducted in Holy Family Hospital (HFH) located in Techiman, the capital of the Bono East region of Ghana. Techiman has a population exceeding 204 000, with approximately 60% of the population living in urban areas and 40% in rural localities. Furthermore, 52% of the population are female. Established in 1953 as a maternity health post, HFH is now a 303-bed capacity hospital with secondary level accreditation. In recent years, the number of females aged 25-65 years presenting at the outpatient clinic has increased, with 52 737, 65 184, and 69 868 women attending in 2020, 2021, and 2022, respectively. Although there are several other health facilities in the Techiman municipality that provide gynaecological services, HFH was selected for this study due to its status as the largest facility in terms of the number of women attending the outpatient clinic annually.

Given the challenges to CC screening and the potential benefits of self-sampling, this study aims to evaluate the clinical efficacy of a hrHPV self-sampling program in Techiman, Ghana. By introducing an accessible and scalable screening method, this study seeks to improve early detection rates and reduce the incidence of CC in the region. Moreover, the findings from this could inform future strategies for the development of a national screening program, contributing to the WHO’s global elimination goal. In doing so, it will provide valuable insights into how self-sampling could be integrated into sustainable, long-term CC prevention strategies in Ghana and other LMICs worldwide.

Methods

Ethics

Ethical approval for this study was obtained from the Kintampo Health Research Centre Institutional Ethics Committee (IEC), Bono East, Ghana, West Africa, on 24 May 2024 (IEC IRB Registration No. 0004854; Study ID: KHRCIEC/2024-03).

Patient and Public Involvement (PPI)

The study protocol was developed collaboratively with local women, primarily patients attending the outpatient gynaecology department at HFH, as well as members of the local Obstetrics & Gynaecology Department and Public Health Department. Engaging patients through focus group discussions and community meetings provided valuable insights into various aspects of the study. Feedback from focus group participants influenced the wording of patient information leaflets and emphasised the importance of culturally sensitive communication regarding cervical cancer screening and treatment options. Additionally, participants suggested incorporating visual diagrams into educational materials to enhance understanding and accessibility for a broader audience.

Patients involved in the development of the study protocol provided input voluntarily and were not required to provide formal consent, as their contributions were part of general discussions and consultations. However, verbal consent was obtained for their views to be used anonymously in the development of the protocol. All participants recruited into the study itself will provide informed consent prior to participation.

Study Design and Timeline

We plan to employ a cross-sectional design combined with a prospective cohort study to evaluate the clinical efficacy of an hrHPV self-sampling screening program. Participant recruitment has started, and data collection is projected to conclude by December 2025. Interim results from the hrHPV-positive cohort are expected to be available by January 2026, with full results from all participants anticipated for release by January 2029.

Sampling will be performed by participants using the COPAN FLOQswab (Type 552C.80), a validated self-sampling device designed for HPV detection.^24,25 Prior to enrolment, written informed consent will be obtained from each participant. Outcome reporting will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines to ensure that key outcomes, including participant safety, data collection, and trial processes, are comprehensively addressed and reported in line with best practices for clinical research.²⁶

Characteristics of Participants

The target population consists of 1000 non-pregnant women aged 30 to 65 years who will be invited to use hrHPV self-sampling kits. This is consistent with WHO guidance on cervical cancer screening.²⁷ Inclusion criteria specify that participants must be non-pregnant women aged 30 to 65 years. Women with current pregnancies, prior total hysterectomies, or those who have previously undergone treatment for cervical intraepithelial neoplasia or cervical carcinoma will be excluded.

Intervention

Participants will receive tailored visual and written information about cervical cancer screening and the self-sampling procedure from trained healthcare providers. They will first undergo comprehensive training, which will include clear instructions on the proper use of hrHPV self-sampling kits, emphasising the importance of collecting a high-quality sample. The COPAN FLOQswab Self Sampling Swab (Type 552C.80) will be used for the procedure. Participants will be asked to take a pregnancy test prior to the procedure. Any participants found to be pregnant will be excluded from the study. Participants will be instructed to insert the swab into the vagina until the red line is at the level of the vaginal fourchette/hymen and is then rotated 360° ten times to collect the sample. Anatomical education will utilise visual aids to illustrate relevant female anatomy, ensuring participants feel comfortable and confident in performing the self-sampling. The self-sampling process will take place in a designated area within the clinic to ensure privacy and promote a supportive environment. The self-sampling kit will include the swab and all necessary materials for sample collection and transport.

After completing the self-sampling, samples will be processed for hrHPV testing. Samples will be tested for hrHPV genotypes 16, 18 and 45. Women who test positive for hrHPV types 16, 18, or 45 will be invited for further evaluation through colposcopy with visual inspection of the cervix with acetic acid for treatment (VAT) with thermocoagulation. The colposcopy assessment will use the nomenclature established by the International Federation of Cervical Pathology and Colposcopy 2011. During colposcopy, areas identified as “major changes” indicating high-grade squamous intraepithelial lesions (HSIL) will be documented and treated using a Liger thermocoagulator, allowing for precise ablation of abnormal cervical tissue. For participants unsuitable for immediate ablative treatment or who decline ablative treatment, a punch biopsy of the abnormal area will be offered, and further management will be guided by the histological result. Biopsy results demonstrating histologically confirmed invasive carcinoma will be referred for appropriate surgical and/or oncological care. In women who are hrHPV positive but do not have any colposcopic evidence of HSIL at VIA, repeat colposcopy and VIA will be offered in 12 months; if there is persistent colposcopic evidence of low-grade squamous intraepithelial lesions (LSIL) at repeat VIA, treatment with thermal ablation to the abnormal cervical epithelium will be considered and they will then return to routine 3 yearly screening (Figure 1).

Figure 1.

Cervical Screening and Treatment Pathway High-Risk Human Papillomavirus (hrHPV); Visual Assessment for Treatment (VAT); High-Grade Squamous Intraepithelial Lesions (HSIL); Low-Grade Squamous Intraepithelial Lesions (LSIL).

Follow-Up Care

Participants will return for follow-up 6 months post-treatment, during which hrHPV self-sampling will be conducted to monitor treatment effectiveness. Women who test hrHPV-negative will be advised to re-screen after 3 years (Figure 1). This 3-year interval was chosen in agreement with protocol developers and local women to address the potential risk of missing less oncogenic hrHPV types, as our study tests only for HPV types 16, 18, and 45. A 3-year interval is also routine practice in many countries, including the UK, and may be particularly important in unvaccinated populations. Additionally, as screening is voluntary, this approach ensures that women are not precluded from attending until 5 years later, reducing missed opportunities for early detection. The shorter interval also helps improve patient retention, particularly in low- and middle-income countries, where compliance with follow-up care may be lower.

Study Aims and Outcomes

The aim of this study is to evaluate the clinical efficacy of a hrHPV self-sampling screening program in a low resource setting.

The primary outcome will be the percentage of women successfully screened, defined as:

The proportion of women successfully screened, defined as the proportion of women with a valid* HPV test result out of those invited to attend cervical screening (*A valid result is defined as one that is not classified as ‘invalid.’).

Secondary outcomes will include screening uptake rate, disease detection rate, hrHPV prevalence including genotype distribution, number of participants lost to follow-up, number accepting ablative treatments for cervical lesions, successful treatment response rates, and disease recurrence rates at 3 years follow up.

Laboratory Methods

For genotyping, the Agilent AriaMx 4-channel HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) machine will be utilized. PCR results will be available within approximately two hours, with the capacity to process 90 samples per run. The hrHPV self-sampling kit used in this study is the CarciScan HPV PCR Assay (catalogue no. 8684808726007) manufactured by eDNA Teknoloji, Ltd. Turkey, which employs multiplex PCR for HPV detection. The Karolinska Institute, Sweden, WHO HPV reference centre report that the CarciScan HPV Kit demonstrates high sensitivity (≥95% detection rate) and specificity (no significant cross-reactivity or false negatives) for detecting high-risk HPV types, including 16, 18, and 45 [Supplementary material 1].

Data Analysis

Data analysis will be conducted using R statistical software. Descriptive statistics will summarise participant demographics, including age, smoking status, past medical history, knowledge about cervical cancer screening, and menopausal status. Continuous variables will be presented as means with standard deviations, while categorical variables will be expressed as frequencies and percentages.

The primary outcome of the study will be the proportion of women who are successfully screened, defined as the proportion of women successfully screened, defined as the proportion of women with a valid* HPV test result out of those invited to attend cervical screening (*A valid result is defined as one that is not classified as ‘invalid.’).

The secondary outcomes will be defined as follows:

• Screening uptake: The proportion of women who attend cervical screening out of the total number of women invited to participate in the study.

• Disease detection rate: The number of women diagnosed with HSIL/CIN2+ or invasive cervical cancer out of the number of women successfully screened.

• HPV genotype prevalence: The prevalence of hr HPV types 16, 18 and 45 will be calculated as a percentage, along with the distribution of these genotypes.

• Lost to follow up: the percentage of hrHPV-positive women who do not attend follow up treatment or screening out of the total number of women successfully screened. In the longer term, we will also collect data on the number of hrHPV test negative women who did not attend the next screening appointment in 3 years.

• Treatment acceptance rate: The proportion of women who accept ablative treatment out of those for whom it is recommended.

• Successful treatment response: The proportion of women testing hrHPV-negative 6 months post-ablative therapy.

• Missed disease during treatment: The number of screened women who present with cervical cancer within the 3-year screening interval, as a proportion of the total screened.

• Disease recurrence: The number of recurrent cases of HSIL, CIN2+, or invasive cervical cancer detected at the 3-year follow-up following an initial successful treatment response.

Each outcome will be analysed using descriptive statistics, proportions, and regression analyses where appropriate to determine predictors and associations. Proportions will be calculated with 95% confidence intervals to assess treatment success, follow-up adherence, and recurrence or missed disease within the screening intervals.

Discussion

This study aims to evaluate the clinical efficacy of a high-risk human papillomavirus (hrHPV) self-sampling screening program for cervical cancer (CC) in Techiman, Ghana. Given the absence of a national screening program in Ghana and the growing burden of CC, this project seeks to increase screening coverage through a patient friendly and scalable self-sampling method. The study will assess the program’s impact on screening uptake, hrHPV detection rates, and treatment success rates. These findings will inform the development of a sustainable national screening strategy, in a low resource setting, aligned with the WHO’s global CC elimination goals.^3,28,30

CC ranks as the second most prevalent cancer among women in Ghana.¹⁶ Ghana currently lacks a national CC screening program, with only a few hospitals offering any screening services. The lack of a national screening policy, coupled with logistical and financial barriers, leads to a low uptake of available screening services and a high rate of late-stage diagnoses.^3,28,29 Holy Family Hospital (HFH) in Techiman, with its high patient volume, was selected as the study site for this self-sampling approach, addressing the critical need for scalable and accessible screening options. By evaluating this approach in a real-world setting, the study will be the largest study evaluating CC self-sampling screening in Ghana and aims to bridge gaps in CC prevention for these underserved populations.

Conventional cytology-based screening faces numerous operational challenges in low- and middle-income countries (LMICs) due to insufficient resources, shortage of trained staff, and delays in returning test results, which contribute to low screening coverage.³¹ Crucially, studies indicate that self-sampling maintains comparable accuracy to clinician-administered tests and offers a more flexible, cost-effective screening option.¹⁹ Limited studies on HPV self-sampling in Ghana suggest its acceptability and feasibility, they have involved only small sample sizes of 52 and 105 participants.^14,21,22 These studies indicate that self-sampling could overcome existing barriers and increase screening uptake, especially in settings where traditional clinician-led methods have not been effective.

In other LMICs, hrHPV self-sampling has shown promising results. Countries such as Myanmar, Kenya, Rwanda, and Uganda report acceptance rates exceeding 90% among women participating in HPV self-sampling programs.^14,21,22,32 Furthermore, studies demonstrate that women are twice as likely to participate in HPV self-sampling programs as compared to clinician-administered testing in both LMIC and high-income contexts.^14,33 Nigeria’s Cervical Cancer Prevention Program, involving over 83 000 women, highlighted the benefits of timely intervention,³⁴ where nearly all eligible participants received treatment on the same day as screening, primarily through visual inspection with acetic acid (VIA).³⁵ This model, combining HPV self-sampling with VIA and colposcopy, has proven effective in increasing screening accessibility and rapid intervention, crucial for the success of screening programs in resource-limited settings. Additionally, studies from Cameroon and Nigeria indicate that education about cervical cancer screening significantly enhances uptake of HPV self-sampling compared to clinician-based testing.^36,37 Based on these findings, our study includes structured patient information leaflets explaining cervical cancer, the HPV self-sampling method, and the importance of routine screening. Culturally sensitive communication is crucial in improving engagement with cervical cancer screening, particularly in diverse populations. Feedback from focus group participants highlighted the need for clear, accessible information and led to modifications in patient information leaflets to ensure inclusivity. Additionally, the incorporation of visual diagrams was suggested to enhance comprehension and overcome literacy barriers. Previous studies have demonstrated that interventions such as visual aids to support shared decision making can improve patient understanding and decision-making in healthcare settings.³⁸ By integrating these elements into educational materials, we aim to facilitate informed participation and improve screening uptake. Providing comprehensive information on cervical anatomy and self-sampling kit usage is a critical factor in enhancing community engagement and participation.^39-41

This study has several strengths. Firstly, it represents the largest hrHPV self-sampling project in Ghana, providing valuable data on hrHPV prevalence among women attending HFH’s outpatient clinic. Given the limited published data on hrHPV genotype prevalence in Ghana, our study also aims to provide evidence on genotype distribution, addressing a significant gap in the epidemiological understanding of hrHPV in this region. Secondly, the centralisation of at HFH offers cost-effective access to a large patient base while ensuring privacy and continuity in patient care. Conducting screenings at a central location aims to minimise the logistical and financial challenges associated with deploying mobile health units, which can be prohibitively expensive in resource-limited settings such as Ghana. The HFH setting allows for a consistent, secure environment where trained staff can educate patients, guide them through the self-sampling process, and address any immediate concerns, aiming to foster patient trust and improving adherence to follow-up care. Additionally, centralisation enables streamlined management of patient data, facilitating timely reporting of results and targeted follow-up, which is critical to minimise patients lost to follow up and maximise the scalability of a national screening program.

We recognise there are several limitations to this study. Firstly, the self-sampling kits used in this study detect only hrHPV types 16, 18, and 45. Although these types are commonly associated with cervical cancer in Ghana, the limited detection range could result in missed cases involving other high-risk HPV strains, impacting overall detection rates.¹⁵ The decision to focus on HPV types 16, 18, and 45 was made in collaboration with the study team and local women, prioritising the most oncogenic types for women who currently have no access to hrHPV testing. Future expansion of testing to include additional hrHPV types will be considered as further funding becomes available. Women who test negative for these types will be advised to rescreen after 3 years to minimise the risk of undetected disease from other HPV genotypes. Additionally, our program’s centralisation at HFH may unintentionally exclude women who face travel barriers. Although mobile clinics delivering self-sampling kits to homes have proven effective in other LMICs, the associated costs make this strategy impractical for our study.^20,42 Instead, conducting screenings at HFH offers a sustainable compromise, ensuring structured patient education, follow up and treatment. However, this approach may result in limited representation of remote populations, highlighting the need for future interventions aimed at extending reach and inclusivity as the program scales.

This study will provide real-world data on the efficacy of a hrHPV self-sampling CC screening program in the Bono East Region of Ghana. By implementing the screening program at HFH, we aim to gather foundational data, which will provide valuable insights into developing a sustainable CC screening program in a low-resource setting. Based on our results, we aim to refine and scale the program, ultimately integrating it into Ghana’s national health system to enhance CC prevention efforts across the country, crucially improving the health outcomes of women from this preventable disease and contributing to the WHO’s 2030 goals for CC elimination.

Supplemental Material

Supplemental Material - Implementing High-Risk Human Papillomavirus Self-Sampling for Cervical Cancer Screening in Ghana: A Study (CarciSCAN) Protocol

Supplemental Material for Implementing High-Risk Human Papillomavirus Self-Sampling for Cervical Cancer Screening in Ghana: A Study (CarciSCAN) Protocol by Nadja Taumberger, Ibrahim Friko, Vera Mwinbe-Ere Der, Laura Burney Ellis, Amy MacDonald Shearer, Sarah J Bowden, Maria Kyrgiou, Teresa L. Pan, Verena Lessiak, Neli Hofer, Elisabeth Rogatsch, Manurishi Nanda, Isabella Pfniss, Elmar Joura, Alper Cinar, Yalin Kilic, and Murat Gultekin in Cancer Control.

Supplemental Material

Supplemental Material - Implementing High-Risk Human Papillomavirus Self-Sampling for Cervical Cancer Screening in Ghana: A Study (CarciSCAN) Protocol

Footnotes

Acknowledgments

Thank you to the German Doctors registered association, a German Non-Governmental Organisation (NGO), for their long-standing commitment and collaboration in improving the health of women in Ghana. Thank you to the members of the European Society of Gynaecological Oncology (ESGO) prevention committee for their guidance and support, as well as to Yalin Kilic, Alper Cinar and Murat Gultekin for overseeing equipment procurement. Finally, we extend thanks to all the people who contributed to the crowdfunding campaign, whose generosity made this study possible.

ORCID iD

Amy MacDonald Shearer

Statements and Declarations

Author Contributions

NT, IF, and MG conceived the initial study concept. All other authors contributed equally to the development of the study protocol. NT drafted the initial version of the protocol, which was subsequently revised and methodology refined by NT, MG, SB, LBE, AS, and MK. All authors participated in the review and editing process, providing equal contributions. All authors approved the final version for publication.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: To fund the initial needed PCR machine and HPV self-sampling kits, a crowdfunding campaign was initiated to raise the calculated amount of 15 000 EUR. The amount has been successfully reached. The campaign is available at: . The authors received no other specific funding for this work.

Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Supplemental Material

Supplemental material for this article is available online.

Appendix

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