Improving cervical cancer screening participation by introducing HPV vaginal self-sampling to women living with HIV in Denmark – a cross-sectional study

doi:10.21203/rs.3.rs-4977958/v1

Background:
Cervical cancer, despite being largely preventable through vaccination and screening, continues to pose a significant global health challenge. Women living with HIV (WLWH) are at a six-fold higher risk of developing cervical cancer, primarily due to persistent infection with high risk HPV (hrHPV). While effective screening methods have the potential to reduce this risk, WLWH remain inadequately screened.
The aims of this study were fourfold: To estimate the proportion of WLWH who are not screened according to WHO guidelines; to establish the proportion of WLWH who accepted the self-sampling offer; to estimate the hrHPV DNA prevalence; and to estimate the compliance to follow-up among women with a hrHPV-positive vaginal self-sample.

Methods:
This single-centre, cross-sectional study was conducted from February to May 2022 at the Department of Infectious Diseases, Aarhus University Hospital, Central Denmark Region. Eligible women were contacted by phone and invited to participate. Participants were provided with a self-sampling kit and detailed instructions. The collected samples were analysed for hrHPV DNA. Demographic, clinical, and screening history data were obtained from medical records and the Danish Pathology Databank.

Results:
Of the 100 eligible participants, 50 (50%) accepted the offer of self-sampling, and 40 (80%) returned their samples for analysis. The prevalence of hrHPV among these women was 25%. Follow-up compliance among hrHPV-positive women was 40%. The analysis revealed that 42% of WLWH had not been screened in accordance with WHO guidelines, and 18% had never undergone screening. No significant differences were observed in demographic or clinical characteristics between participants and non-participants.

Conclusions:
Our study highlights a substantial gap in cervical cancer screening among WLWH. Although home-based hrHPV self-sampling was well-received, overall participation and compliance to follow-up HPV-screen positive were insufficient. To improve cervical cancer prevention, more personalized and clinic-based screening strategies, combined with enhanced follow-up procedures, are essential. Addressing these barriers is critical to improving health outcomes and reducing the incidence and mortality of cervical cancer among WLWH.

Trial registration:
The Central Denmark Region Committee on Health Research Ethics deemed this study as a quality improvement study on the 9^th of November 2021 (request approval j.no: 204/1-10-72-274-21). Clinical trial number: Not applicable.

Cervical cancer screening

women living with HIV

high risk human papillomavirus

HPV self-sampling

Despite cervical cancer (CC) is preventable through vaccination and screening and preventive treatment of precursor lesions, it remains the fourth most common cancer in women worldwide with 604,000 diagnoses and more than 342,000 deaths in 2020 (1). Almost all CC cases and its pre-cancerous lesions are attributed to persistent infection with high risk human papilloma virus (hrHPV) (2). Screening programs allow pre-cancerous lesions to be detected and treated and have resulted in reduced incidence and mortality of the disease (2).

Women living with HIV (WLWH) are at greater risk of having persistent hrHPV infection and have a six-fold higher risk of developing CC compared to the background population (2, 3). The Danish Shade cohort study, found a hrHPV prevalence of 28% among WLWH in Denmark (4) while reports on the hrHPV prevalence in third-world countries showed an even higher prevalence (range: 40.6–53.6%) among WLWH (5, 6). Thus, screening for CC is of particular importance among WLWH. Nevertheless, a large proportion of WLWH are either immigrants or belong to lower socio-economic groups, both of which are acknowledged risk factors linked to being non-screened or under screened compared to the background population (7, 8). Interventions aimed at increasing participation in CC screening among WLWH are therefore urgently needed.

Since 2021, WHO has recommended CC screening among WLWH every third to fifth year when using HPV DNA detection as primary screening test and every third year when using visual inspection with acetic acid (VIA) or cytology-based screening (2). This recommendation relies on evidence that attest the superior sensitivity of HPV-based screening to detect high-grade cervical intraepithelial neoplasia (CIN grade 2 or worse, CIN2+) and cancer as compared to VIA and cytology-based screening (2). Several countries are currently transitioning from cytology-based to HPV-based screening, which allows women to collect cervico-vaginal material themselves in their own home or at a clinic using a device and return it for hrHPV testing at the laboratory (HPV self-sampling). HPV self-sampling have proven accurate (9, 10), highly acceptable (11, 12, 13), and has improved cervical cancer screening participation in both low-income and high-income countries including Denmark, especially among under-screened women (8, 14, 15).

HPV self-sampling participation rates found in previous studies conducted in high-income countries vary and depend on the invitation strategy and accessibility of self-sampling kits. A recent study from UK, assessing the feasibility and acceptability of offering HPV self-sampling to WLWH, found a participation rate of 88% (16).

Our study evaluated for the first time the feasibility of offering home-based hrHPV self-sampling as a novel, non-invasive screening method for CC among under-screened WLWH in a Scandinavian country. The aims of this study were fourfold: To estimate the proportion of WLWH who are not screened according to WHO guidelines; to establish the proportion of WLWH who accepted the self-sampling offer; to estimate the hrHPV DNA prevalence; and to estimate the compliance to follow-up among women with a hrHPV positive vaginal self-sample.

Setting

The organized Danish CC screening program targets women aged 23–64 years. The women receive an invitation to attend screening at their general practitioner (GP) every third or fifth year depending on age. Participation and eventual diagnostic follow-up and treatment are free of charge. During this study period, women aged 23–29 were screened with cytology, whereas women aged 30–59 years underwent HPV-based screening if born on uneven dates and cytology-based screening if born on even dates. Women aged 60–64 have an HPV-DNA exit test. Non-participants receive two screening reminders. In the Central Denmark Region and three additional regions, women are in the second reminder also offered to opt-in for vaginal self-sampling (Evalyn brush device). This current study took place in the Central Denmark Region, where all cervical cytology samples are routinely handled and analysed by the Department of Pathology, Randers Regional hospital.

Design and study population

This single centre cross-sectional study was conducted between February and May 2022 at the Department of Infectious Diseases at Aarhus University Hospital, Central Denmark Region, where HIV treatment and care is provided for individuals living with HIV at an outpatient clinic. Women between age 23–64 years were eligible for study inclusion. Exclusion criteria were pregnancy, hysterectomy, screening for CC within the last 12 months prior to February 1st, 2022, non-Danish-speaking women (because user instructions were in Danish), and inability to follow the instructions.

Study intervention

Eligible women were contacted by phone by an HIV counsellor from the department. Women who did not respond to multiple phone calls (at least three), received a text message with information about the study and were offered to participate. Information, either verbal (phone call) or text (text message), consisted of brief background information on hrHPV, CC and CC screening recommendations, followed by an introduction to this study. Women who agreed to participate received a package by mail including a vaginal self-sampling kit including the dry Evalyn® Brush (Rovers Medical Devices, B.V, Oss, Netherlands), written and picture-based user instructions, and a pre-paid return envelope addressed to Randers Pathology Department. Women who did not return their self-sample within one month received one reminder on text message.

Samples were analysed for hrHPV DNA using the COBAS® 4800 assay (Roche Diagnostics, Switzerland), which provides results for HPV16, HPV18 and pooled detection of 12 other HPV types (HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) (17). Women with a hrHPV positive self-sample (regardless of genotype) were phoned by a doctor from The Infectious Disease clinic and recommended to contact their GP for a cervical cytology sample to evaluate the need for the referral for colposcopy. Thereafter, the women were followed-up according to national guidelines (18). A copy of the test result was sent to the GP of each participant.

Data sources

Information about age, ethnicity, time since HIV diagnosis, quantitative HIV RNA levels, and current pregnancy were collected from the women’s medical journals. Data on CC screening history, hysterectomy, hrHPV results of the vaginal self-collected samples as well as results of any triage and/or histological follow-up was retrieved from the nationwide Danish Pathology Databank (19). The number of women who participated (performed a vaginal self-collected sample and send it for successful analysis) were evaluated six months after the study started. Compliance to follow-up at the GP was evaluated after one year. The collection of data and subsequent follow up was possible due to a unique Civil Personal Registration (CPR) number which is assigned to each Danish citizen upon birth or to residents upon immigration. This number is linked to the individual's medical journal and the pathology bank, enabling continuous data management.

Statistics

Baseline characteristics of study participants and non-participants were reported using descriptive statistics (n and proportions) and for continuous data, medians, and interquartile ranges (IQR) were calculated.

The chi-2 test was used to test for differences in categorical variables between participants and non-participants, differences in proportions were tested with two-sample test, and the Mann-Whitney U-test was used as a test of population medians. The association between CC screening history and the hrHPV test result was graphed as a boxplot.

P-values < 0.05 were considered statistically significant. Data was entered and stored in RedCap (20, 21). Statistical analyses were performed using STATA version 17 and GraphPad version 10.

Ethical approval

The Central Denmark Region Committee on Health Research Ethics deemed this study as a quality improvement study (request approval j.no: 204/1-10-72-274-21). Thus, written informed consent was therefore not required. However, participating women gave verbal informed consent when they were contacted by phone.

Inclusion of patients
From a total of 199 WLWH followed in the outpatient clinic, 100 women (50.3%) were eligible for inclusion (Figure 1). Eleven (11%) women did not wish to participate, while 39 (39%) women were unreached by phone and text message. The remaining 50 women (50.0%) accepted to receive the hrHPV self-sampling kit of whom 40 (80%) returned the self-sample for HPV testing.

Demographics, clinical characteristics, and screening history

Baseline demographics and clinical characteristics of the study cohort are shown in Table 1.

Table 1. Demographics and clinical characteristics

Variables	hrHPV self-test (participants)	No hrHPV self-test (non-participants)	p-value
	n = 40	n = 60
Age (years) at inclusion (median) (IQR)	51.5 (42.3-56.0)	49.0 (44.3-55.0)	0.5
Age range at inclusion, n (%)			0.4
23-40 years	7 (17.5)	7 (11.7)
41-64 years	33 (82.5)	53 (88.3)

Time (years) since HIV diagnosis, (median) (IQR)	15 (12.0-24.0)	16 (11.0-21.0)	0.8
Time range since HIV diagnosis, n (%)			0.6
0-10 years	7 (17.5)	14 (23.3)
11-20 years	20 (50.0)	31 (51.7)
> 20 years	13 (32.5)	15 (25.0)

Danish ethnicity, n (%)	15 (37.5)	18 (30.0)	0.8

Time (years) since last CC screening, (median) (IQR)	3 (2.0-6.0)	4 (2.0-8.0)	0.4
Time range since last CC screening, n (%)			0.9
3-5 years	24 (60.0)	35 (58.3)
> 5 years	9 (22.5)	16 (26.7)
Never screened	7 (17.5)	9 (15.0)

Quantitative HIV RNA range, n (%)			0.6
Undetectable	35 (87.5)	54 (90)
< 50 copies/ml	3 (7.5)	5 (8.3)
> 50 copies/ml	2 (5.0)	1 (2.7)

The women who received the hrHPV self-sampling kit but did not return it for analysis (n=10) was pooled together with women who did not wish to participate or did not respond to the invitation as these groups did not differ in terms of age distribution, time since HIV diagnosis, ethnicity, CC screening history, and quantitative HIV RNA levels (data not tabulated).

We found no difference between women screened by hrHPV self-sampling (participants) and non-participants with regards to age (51.5 vs 49.0, respectively, p_mwhit=0.5), time since HIV diagnosis (15.0 vs 16.0 years, respectively, p_mwhit=0.8), ethnicity (n=15.0 vs. n=18.0, respectively, p_chi=0.8), and quantitative HIV RNA levels (p_chi =0.6) (Table 1).
Prior to the study, 59 (59%, n=59/100) of all eligible women (both participants and non-participants) had been CC screened according to WHO recommendations (within 3-5 years). Altogether, 42 (42%, n=42/100) women had not previously been screened according to WHO recommendations of whom (25%, n=25/100) had not been screened within the last five years and 18 (18%, n=18/100) were unscreened. There was no difference between women screened by hrHPV self-sampling (participants) and non-participating women (p_chi=0.3) with regards to prior screening participation.

hrHPV DNA prevalence among WLWH

The hrHPV prevalence was 25%, (95% CI: 12.7-41.2%, n=10/40). Of the 10 hrHPV-positive samples, HPV16/18 was found in 30% (95% CI: 6.7-65.2%, n=3/10) and HPV other types in 70.0% (95% CI: 34.8-93.3%, n=7/10). The compliance to follow-up at the GP was 40%, 95% CI: 12.2-73.7%, n= 4/10). Two of these women were diagnosed with CIN2 and the remaining two women had normal cytology and ended follow-up.

Association between CC screening history and hrHPV test result

Figure 2 shows the association between the time since last CC screening and having a positive or negative hrHPV vaginal self-collected sample. Women who had never been screened are not shown in the figure. The median time since last CC screening test was significantly higher among women having a hrHPV-positive vaginal sample (median: 7 years, IQR: 2.0-13 years) than among women with a hrHPV-negative vaginal sample (median: 3 years, IQR:2.0-5.3 years, p_mwhit= 0.02.)

Main findings

In this study, we found that 42% of 23-64-year-old WLWH followed at a single Infectious Disease Clinic in Denmark had not been CC screened according to WHO recommendations (no screening test within the last 5 years). Of these women, 18% had no record of previous screening in the Danish Pathology Databank. The opportunity of home-based hrHPV self-sampling was accepted by 50% of the eligible WLWH and of those 80% returned it for hrHPV testing with an hrHPV prevalence of 25%. Close to every fifth (17.5%) WLWH who returned the vaginal self-collected sample had no previous record of screening. Compliance to follow-up at the GP among those with an HPV positive self-collected vaginal sample was low (40%).

Strengths and limitations
This study holds several noteworthy strengths. First, we employed a thoroughly validated vaginal self-sampling device for the detection of hrHPV. The device has previously been evaluated to have a high acceptability among women who feel safe using it (8). Secondly, the risks of loss to follow-up and misclassification of the outcomes are minimized, as data concerning hrHPV test results and the following cytology analyses performed at the GP are systematically gathered via the Danish Pathology Bank.

Nevertheless, this study has potential limitations. First, the sample size was small, which may weaken the external validity or generalizability of our findings. Secondly, the absence of a control group in our study makes it challenging to establish causation and differentiate between the impact of the intervention and other potential influencing factors.

Interpretation and comparison with previous research
Our findings highlight the need for interventions aiming at increasing the CC screening among WLWH, since almost half of these women are not screened according to WHO recommendations and have a high prevalence of hrHPV. Our findings support that hrHPV self-sampling offers a promising way of improving the screening participation among WLWH, and most importantly this screening modality reached women who have the highest risk of CC.
The participation rate of HPV self-sampling in our study was 80%, while a similar study from UK where WLWH were offered HPV self-sampling face-to-face, found a participation rate of 88% (16).
Only 11% of invited women in our study declined to participate, while 39% did not respond to the invitation (phone call or text message). Given a large proportion of the WLWH are immigrants and/or belong to a lower stratum of society, one could argue that an invitation strategy where the women were offered to participate in person might increase the participation rate. One way to do this, could be to offer the women to participate and perform the hrHPV self-sampling when they are scheduled for their annual HIV control in the outpatient clinic. Through this approach, women that need more information and help with instructions can be better guided, and the risk of the woman forgetting to return the sample for analysis is diminished. Furthermore, this approach would allow non-Danish speaking women to be included, as the health professional could explain the information in English or use an interpreter. Results from a previous Danish study on HPV self-sampling in CC screening show that the invitation strategy is highly important and especially western immigrants and lower socioeconomic groups seem to benefit from a more direct invitation approach (8).

Another approach to increase CC screening among WLWH could be to offer urine sampling for hrHPV detection. This method represents a promising non-invasive approach in the field of CC screening (22). Several studies have explored the feasibility and accuracy of urine-based HPV testing, demonstrating its potential as a reliable screening method (22, 23, 24, 25, 26, 27). This approach offers advantages such as increased acceptability among individuals, especially those averse to invasive procedures, and the potential for self-sampling, empowering individuals to participate in their own health monitoring (24, 25, 28).

WLWH have a higher risk of acquiring persistent hrHPV and developing CC. Herein, we found the prevalence of hrHPV among WLWH to be 25%, which was consistent with the HPV prevalence of 28% detected in a previous Danish study using clinician-collected cervical samples (4). The effectiveness of hrHPV self-sampling relies on a strong adherence to subsequent follow-up procedures among those testing positive for hrHPV. In this context, the follow-up compliance at the GP in our study was only 40%, contrasting with another Danish study on hrHPV self-sampling that reported a significantly higher follow-up compliance of 90.7% among non-participants (8). One possible explanation for the low follow-up rate among women living with WLWH could be attributed to the fact that these individuals attend annual check-ups at the HIV clinic. During these check-ups, comprehensive care is provided, addressing not only their HIV status but also other health concerns such as lifestyle diseases and symptoms of malignant diseases. As a result, these women may have infrequent visits to their GP, contributing to a distanced relationship to the GP. Enhancing compliance to follow-up among WLWH could involve strategies such as direct communication from the GP to the woman upon a positive hrHPV test, inviting her for a follow-up. Alternatively, offering the option for the woman to undergo a clinician-collected cervical sample at the HIV clinic could also contribute to improved compliance.

Our study revealed that a significant proportion of WLWH remain under-screened, with 42% not adhering to WHO screening guidelines and 18% having never been screened. While the vaginal hrHPV self-sampling approach demonstrated promising acceptability, with an 80% return rate among participants, the overall participation rate (50%) and subsequent follow-up compliance at 40% were suboptimal. These results suggest that more personalized and accessible screening strategies, such as in-clinic hrHPV vaginal self-sampling or urine-based HPV testing but also improved follow-up strategies could be solutions to bridge the gap in screening coverage and ensure timely and effective CC prevention for WLWH.

CC

Cervical Cancer

CIN

Cervical Intraepithelial Neoplasia

CPR

Civil Personal Registration Number

GP

General Practitioner

hrHPV

High Risk Human Papillomavirus

IQR

Interquartile range

VIA

Visual Inspection with Acetic Acid

WLWH

Women Living With HIV

WHO

World Health Organization

Ethics approval and consent to participate

This study was conducted in accordance with ethical guidelines and principles for research involving human subjects. On November 9th, 2021, the Central Denmark Region Committee on Health Research Ethics reviewed and deemed this study as a quality improvement study (request approval j.no: 204/1-10-72-274-21). As such, the study was determined to be exempt from formal ethical approval under Danish regulations, as it falls within the scope of quality improvement rather than research requiring full ethical oversight. Clinical trial number: Not applicable.

All participants were fully informed about the nature, purpose, and scope of the study. Verbal consent was obtained from all participants prior to their inclusion in the study. This approach was deemed appropriate given the minimal risk nature of the study and was conducted in accordance with the guidelines set forth by the Central Denmark Region Committee on Health Research Ethics.

The confidentiality and privacy of participants were maintained throughout the study. All data collected were anonymized to prevent the identification of individual participants, and measures were taken to ensure that any information disclosed during the study was protected against unauthorized access.

The findings from this study are intended to contribute to the continuous improvement of healthcare practices and patient outcomes within the Central Denmark Region.

Consent for publication

Not Applicable.

Availability of data and materials

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests. MT has participated in other studies with HPV test kits sponsored by Roche. MT has received honoraria fee from Roche Diagnostics and AstraZeneca for lectures on HPV self-sampling and HPV triage-methods, respectively.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Authors contribution

All authors contributed significantly to the conception and design of the study. Data acquisition was done by SNHS, while analysis and interpretation of the data was carried out by SNHS, MT, MS and SJ. SNHS was responsible for drafting the manuscript, MT, BA, LKP, MS and SJ revised it critically for important intellectual content and all authors provided final approval for the version to be published and accept responsibility for all aspects of the work.

Acknowledgements
The authors would like to take this opportunity to extend our gratitude to the laboratory staff at the Department of Pathology, Randers Regional Hospital, for their great work in the laboratory and collaboration during this study.

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No competing interests reported.

Improving cervical cancer screening participation by introducing HPV vaginal self-sampling to women living with HIV in Denmark – a cross-sectional study

Status:

Version 1

Abstract

Figures

Background

Methods

Setting

Design and study population

Study intervention

Data sources

Statistics

Ethical approval

Results

Discussion

Main findings

Conclusions

Abbreviations

Declarations