Human Papillomavirus Self-sampling Research Articles

Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention.

BackgroundAsian American women face disproportionate burden of cervical cancer (CC) than non-Hispanic white women in the U.S. The goal of this study was to assess the feasibility and impact of a culturally tailored intervention to promote Human papillomavirus (HPV) self-sampling test among hard-to-reach Asian American women.MethodsWe adopted the community-based participatory research (CBPR) approach to conduct this efficacy study. A total of 156 female participants (56 Chinese, 50 Korean, and 50 Vietnamese) were recruited from community-based organizations (CBOs) in the greater Philadelphia metropolitan area. The intervention components included HPV-related education, HPV self-sampling test kit and instructions, group discussions, and patient navigations, all available in Asian languages. We examined several outcomes, including the completion of HPV self-sampling, HPV-related knowledge, perceived social support, self-efficacy, and comfort with the self-sampling test at post-intervention assessment.ResultsThe majority of Asian American women had low annual household income (62.3% earned less than $20,000) and low educational attainment (61.3% without a college degree). We found significant increase in participants’ knowledge on HPV (baseline: 2.83, post: 4.89, P <.001), social support (baseline: 3.91, post: 4.09, P < .001), self-efficacy (baseline: 3.05, post: 3.59, P < .001), and comfortable with HPV self-sample test (baseline: 3.62, post: 4.06, P < .001).ConclusionTo the best of our knowledge, this is the first intervention study that promoted HPV self-sampling test among Asian American women. Our findings showed that CBPR culturally tailored intervention of self-sampling was highly effective in empowering low-income Asian American women to conduct HPV self-sampling tests.

Cost of community-based human papillomavirus self-sampling in Peru: A micro-costing study

SummaryBackgroundCost data of human papillomavirus (HPV) self-sampling programs from low-and-middle-income countries is limited. We estimated the total and unit costs associated with the Hope Project, a community-based HPV self-sampling social entrepreneurship in Peru.MethodsWe conducted a micro-costing analysis from the program perspective to determine the unit costs of (1) recruitment/training of community women (Hope Ladies); (2) Hope Ladies distributing HPV self-sampling kits in their communities and the laboratory testing; and (3) Hope Ladies linking screened women with follow-up care. A procedural manual was used to identify the program’s activities. A structured questionnaire and in-depth interviews were conducted with administrators to estimate the resource/time associated with activities. We obtained unit costs for each input previously identified from budgets and expenditure reports.FindingsFrom November 2018 to March 2020, the program recruited and trained 62 Hope Ladies who distributed 4,882 HPV self-sampling kits in their communities. Of the screened women, 586 (12%) tested HPV positive. The annual cost per Hope Lady recruited/trained was $147·51 (2018 USD). The cost per HPV self-sampling kit distributed/tested was $45·39, the cost per woman followed up with results was $55·64, and the cost per HPV-positive woman identified was $378·14. Personnel and laboratory costs represented 56·1% and 24·7% of the total programmatic cost, respectively.InterpretationOur findings indicate that implementation of a community-based HPV self-sampling has competitive prices, which increases its likelihood to be feasible in Peru. Further economic evaluation is needed to quantify the incremental benefits of HPV self-sampling compared to more established options such as Pap tests.FundingThomas Francis Jr. Fellowship provided funding for data collection. The Hope Project was funded by grants from Grand Challenges Canada (TTS-1812-21131), Uniting for Health Innovation, Global Initiative Against HPV and Cervical Cancer, University of Manitoba, and the John E. Fogarty International Center (5D43TW009375-05).

Implementing community-based human papillomavirus self-sampling with SMS text follow-up for cervical cancer screening in rural, southwestern Uganda.

BackgroundSelf-collected HPV screening may improve cervical cancer screening coverage in low resource countries, yet data guiding implementation and follow-up of abnormal results are sparse.MethodsThis is a prospective cohort implementation study of HPV self-testing program in Mbarara, Uganda with mobile phones to facilitate result notification and referral for treatment at a regional hospital. The effectiveness of the interventions was analyzed using Proctor’s model of implementation. Women were interviewed following screening and at 6 months to assess acceptability and barriers to follow-up. Data were analyzed using descriptive statistics.Results159 of 194 (82%) of eligible women underwent HPV self-sampling; of these, 27 (17%) returned positive for high-risk HPV subtypes. We sent SMS messages providing test results and follow-up instructions to all participants. Seventeen (63%) hrHPV-positive participants reported receiving SMS text instructions for follow-up, of whom 6 (35%) presented for follow-up. The most common reasons for not returning were: lack of transportation (n = 11), disbelief of results (n = 5), lack of childcare (n = 4), and lack of symptoms (n = 3). Confidence in test results was higher for self-screening compared to VIA (Likert score 4.8 vs 4.4, P = 0.001).ConclusionsDespite the use of SMS text-based referrals, only one-third of women presented for clinical follow-up after abnormal HPV testing.

Exploring Factors Associated with Patients Who Prefer Clinician-Sampling to HPV Self-Sampling: A Study Conducted in a Low-Resource Setting.

Human papillomavirus (HPV) self-sampling (Self-HPV) is a promising strategy to improve cervical cancer screening coverage in low-income countries. However, issues associated with women who prefer conventional HPV clinical-sampling over HPV self-sampling may affect screening participation. To address this issue, our study assessed factors associated with women’s preferences related to Self-HPV. This study was embedded in a large clinical trial recruiting women aged 30–49 years in a primary HPV-based study termed “3T-Approach” (for Test-Triage-Treatment), launched in 2018 at Dschang District Hospital, West Cameroon. Participants were invited to perform a Self-HPV. After the sampling and before receiving the results, participants completed a questionnaire about cervical cancer screening and their preferences and perceptions around Self-HPV. The median age of the 2201 participants was 40.6 (IQR 35–45) years. Most (1693 (76.9%)) preferred HPV self-sampling or had no preference for either method, and 508 (23.1%) preferred clinician-sampling. Factors associated with an increased likelihood of reporting a clinician-sampling preference were tertiary educational level (29.4% CI: 25.6–33.6 vs. 14.4% CI: 12.8–16.1) and being an employee with higher grade professional or managerial occupations (5.5% CI: 3.8–7.9 vs. 2.7% CI: 2.0–3.5). The main reported reason for women preferring clinician-sampling was a lack of “self-expertise”. Most women (>99%) would agree to repeat HPV self-sampling and would recommend it to their relatives. HPV self-sampling in the cultural context of central Africa was well accepted by participants, but some participants would prefer to undergo clinician sampling. Health systems should support well-educated women to increase self-confidence in using HPV self-sampling.

Human papillomavirus self-sampling: A tool in cancer prevention and sexual health promotion.

This article examines human papillomavirus (HPV) self-sampling as an approach to cervical cancer prevention and the ways self-sampling kits are promoted directly to consumers in the United States. Public health, biomedicine and health tech have increasingly imagined self-sampling, which allows individuals to collect their own vaginal specimen, mail to a laboratory for testing and receive delivered results, as a component of cervical cancer prevention and sexual health promotion. This article examines the scientific and biomedical claims used to configure the problem in need of this solution and the ways persons, publics and markets are established. We analyse scientific literature, interviews with clinicians and other key actors, and websites of directly to consumers (DTC) companies. HPV self-sampling is constructed as both a solution to inequities and gaps in cervical cancer screening and a solution to the wants and needs of those already engaged in self-projects of body monitoring and risk reduction. These multidirectional biomedical tendencies also reveal how sexuality and sexual health and cervical cancer prevention and sexual health promotion are entangled objects. While we do not want to undermine the potential of HPV self-sampling, we encourage a focus on equity and care and not commodified markets that reinforce notions of 'good' patients monitoring their health.

A feasibility study on cervical screening in non-attenders invited to undergo HPV self-sampling with cytology triage versus repeat invitation for cytology screening in Hokkaido

Objectives We investigated the participation and detection rates of cervical lesions in cervical screening non-attenders offered HPV (human papillomavirus) self-sampling with cytology triage.Methods From 2016 to 2018, HPV self-sampling was routinely offered as an option, along with cytology, to all non-attenders in Ebetsu City, Japan. The primary endpoints were ≥CIN2 and ≥CIN3 detection rates, and secondary endpoints were abnormal cytology rates and follow-up compliance.Results Overall, recall invitations were mailed to 6,116 non-attenders, with a response rate of 15.9% (cytology: 6.5%, HPV testing: 9.4%). Of the responders to undergo HPV self-sampling, 11.7% had a positive result and were referred to cytology triage. Moreover, ≥CIN2 and ≥CIN3 detection rates were 1.7% and 0.9%, respectively, in the HPV self-sampling group, and 1.0% and 0.8%, respectively, in the cytology group, showing no statistically significant differences. In those who underwent cytology triage following an HPV positive test, ≥CIN2 and ≥CIN3 detection rates were 23.8% and 11.9%, respectively, which was significantly higher than those who only underwent cytology alone.Conclusion HPV self-sampling followed by cytology triage is highly effective at detecting high grade disease in non-attenders. Thus, multi-municipality-based studies to standardize processes involving this method are warranted. Furthermore, HPV self-sampling could be a promising method for inviting non-attenders who have difficulty undergoing cervical screening in the COVID-19 pandemic era.

Worldwide use of HPV self-sampling for cervical cancer screening

An increasing body of evidence supports the validity of self-sampling as an alternative to clinician collection for primary Human Papillomavirus (HPV) screening. Self-sampling effectively reaches underscreened women and can be a powerful strategy in low- and high-resource settings for all target ages. This work aims to summarize the current use of HPV self-sampling worldwide. It is part of a larger project that describes cervical cancer screening programmes and produces standardized coverage estimates worldwide. A systematic review of the literature and official documents supplemented with a formal World Health Organisation country consultation was conducted. Findings show that the global use of HPV self-sampling is still limited. Only 17 (12%) of countries with identified screening programs recommend its use, nine as the primary collection method, and eight to reach underscreened populations. We identified 10 pilots evaluating the switch to self-sampling in well-established screening programs. The global use of self-sampling is likely to increase in the coming years. COVID-19's pandemic has prompted efforts to accelerate HPV self-sampling introduction globally, and it is now considered a key element in scaling up screening coverage. The information generated by the early experiences can be beneficial for decision-making in both new and existing programs.

Feasibility of sending a direct send HPV self-sampling kit to long-term non-attenders in an organized cervical screening program

IntroductionNon-participation in screening is a main risk factor for cervical cancer. Human-papillomavirus (HPV) self-sampling may be an alternative to repeated invitations for non-attenders. Several studies have concluded that participation among non-attenders increases significantly when offering self-sampling kits for HPV. However, participation rates are highly variable between settings, and therefore pilots to determine optimal implementation strategy have been recommended before routine roll out. Materials and MethodsAll women who had not participated in the organized screening program for at least 10 years aged 33–62 in one Swedish county were identified through screening registers. HPV self-sampling kits were sent to all eligible women. Participation was defined as returning a self-sample kit or attending routine screening within 6 months. Women who did not submit the kit within 8 weeks were randomized to receive a written reminder. HPV-positive women were referred directly to colposcopy without prior triage. Biopsies for histopathologic confirmation were used as gold standard. ResultsAmong eligible women, 150/741 (20.2%) returned the self-sample kit or attended routine screening. A randomized written reminder was sent out to 319/591 non-responders and another 11 women returned the kit. In total, 23/147 (16.3%) of returned kits were HPV positive. Out of the 23 HPV-positive women, 17 (74%) attended colposcopy; 10/17 (59%) had a histopathological high-grade squamous intraepithelial lesions (HSIL) or cervical cancer. The most common HPV type was HPV 52, and 2 out of 3 women with HPV 16 had a histopathologically confirmed cancer. ConclusionThe direct send kit strategy and referral of all HPV-positive women to colposcopy without prior triage appears to be feasible if resources are available and should be prioritized given the high prevalence of HSIL lesions and cancer among non-attenders. A written reminder might further increase attendance.

Role of human papillomavirus self-sampling in cervical cancer screening

Cervical cancer screening has successfully reduced the incidence and mortality of cervical cancer in many countries. In Slovenia, the incidence of cervical cancer decreased in 2003–2015 by almost 50%. Participation in screening has reached about 72% over the last 3 years. The main cause of cervical cancer is infection with human papillomaviruses (HPVs). For this reason, in 2010, HPV testing was included in the national screening programme ZORA for triage of low-grade lesions and as a test of cure in 2010. Even though screening is free ofcharge and accessible in Slovenia, about 30% of women still do not respond to invitations and are not screened regularly, especially women aged 50–64 years. HPV self-sampling could improve the detection of precancerous changes among non-attenders of the cervical cancer screening program. By using a validated PCR HPV DNA test, cervical and vaginal HPV sampling have similar accuracy for the detection of CIN 2+, resulting in the same or higher accuracy than the Pap test. Women describe HPV self-sampling as user-friendly, intimate, less embarrassing, and less painful than the Pap smear. About one-quarter to one-third of non-attenders of regular screening responded to the invitation to perform self-sampling. In a Slovenian randomised trial, the overall response rate was more than one-third and was not much higher in an opt-outcompared to opt-in approach. HPV self-sampling could lead to an improvement in the detection of precancerous cervical lesions. European guidelines for quality assurance on cervical cancer screening recommend HPV self-sampling in women who do not attend regular cervical screening programmes.

Switching clinic-based cervical cancer screening programs to human papillomavirus self-sampling: A cost-effectiveness analysis of vaccinated and unvaccinated Norwegian women.

Several countries have implemented primary human papillomavirus (HPV) testing for cervical cancer screening. HPV testing enables home-based, self-collected sampling (self-sampling), which provides similar diagnostic accuracy as clinician-collected samples. We evaluated the impact and cost-effectiveness of switching an entire organized screening program to primary HPV self-sampling among cohorts of HPV vaccinated and unvaccinated Norwegian women. We conducted a model-based analysis to project long-term health and economic outcomes for birth cohorts with different HPV vaccine exposure, that is, preadolescent vaccination (2000- and 2008-cohorts), multiage cohort vaccination (1991-cohort) or no vaccination (1985-cohort). We compared the cost-effectiveness of switching current guidelines with clinician-collected HPV testing to HPV self-sampling for these cohorts and considered an additional 44 strategies involving either HPV self-sampling or clinician-collected HPV testing at different screening frequencies for the 2000- and 2008-cohorts. Given Norwegian benchmarks for cost-effectiveness, we considered a strategy with an additional cost per quality-adjusted life-year below $55 000 as cost-effective. HPV self-sampling strategies considerably reduced screening costs (ie, by 24%-40% across cohorts and alternative strategies) and were more cost-effective than clinician-collected HPV testing. For cohorts offered preadolescent vaccination, cost-effective strategies involved HPV self-sampling three times (2000-cohort) and twice (2008-cohort) per lifetime. In conclusion, we found that switching from clinician-collected to self-collected HPV testing in cervical screening may be cost-effective among both highly vaccinated and unvaccinated cohorts of Norwegian women.

Human papillomavirus self-sampling for long-term non-attenders in cervical cancer screening: A randomised feasibility study in Estonia

Organised cervical cancer screening was started in Estonia in 2006, but participation is still low. Human papillomavirus (HPV) self-sampling has proved to increase screening uptake. This study addressed the feasibility of HPV self-sampling and the acceptance of this method among long-term screening non-attenders. A randomised intervention study was conducted in Estonia in 2020. Women born in 1958-1983 without a Pap smear in 2013-2019 were identified in the Estonian Health Insurance Fund database. From them, 12,000 women were randomly allocated to three equal-sized study groups. The opt-out group received a questionnaire and a Qvintip® sampling device by regular mail. Two opt-in groups received a questionnaire and an e-mail invitation to order a self-sampler online; one received Qvintip and the other Evalyn® Brush. Participantś background characteristics were obtained from the Population Register. The effect of covariates on participation rate was estimated with multivariate Poisson regression. Acceptance of self-sampling was analysed according to agreement with statements in the questionnaire. The overall participation rate was 16% with significant differences between opt-out (26%) and opt-in (11%) groups. Compared to the opt-out Qvintip group, adjusted relative risks for the Qvintip and Evalyn Brush opt-in groups were 0.41 (95% confidence interval (CI) 0.37-0.45) and 0.44 (95% CI 0.40-0.49), respectively. Participation was associated with living place, citizenship, and education. Self-sampling was well accepted: 98% agreed that it was easy to use, 88% preferred it as a screening method in future. The results show the feasibility and good acceptance of HPV self-sampling among long-term screening non-attenders in Estonia.

Human Papillomavirus (HPV) Self-Sampling among Never-and Under-Screened Indigenous Māori, Pacific and Asian Women in Aotearoa New Zealand: A Feasibility Study.

In Aotearoa, New Zealand, the majority of cervical cancer cases occur in women who have never been screened or are under-screened. Wāhine Māori, Pacific and Asian women have the lowest rate of cervical screening. Self-sampling for human papillomavirus (HPV-SS) has been shown to increase participation in cervical cancer screening. A whole-of-system approach, driven by evidence in the most effective delivery of HPV-SS, is required to mitigate further widening of the avoidable gap in cervical screening access and outcomes between groups of women in Aotearoa. This single-arm feasibility and acceptability study of HPV self-sampling invited never- and under-screened (≥5 years overdue) 30–69-year-old women from general practices in Auckland, Aotearoa. Eligible women were identified by data matching between the National Cervical Programme (NCSP) Register and practice data. Focus groups were additionally held with eligible wāhine Māori, Asian and Pacific women to co-design new patient information materials. Questionnaires on HPV knowledge and post-test experience were offered to women. Our follow-up protocols included shared decision-making principles, and we committed to follow-up ≥90% of women who tested positive for HPV. Data matching identified 366 eligible never- and under-screened wāhine Māori, Pacific and Asian women in participating practices. We were only able to contact 114 women, and 17, during the discussion, were found to be ineligible. Identifying and contacting women overdue for a cervical screen was resource-intensive, with a high rate of un-contactability despite multiple attempts. We found the best uptake of self-sampling was at focus groups. Of the total 84 HPV-SS tests, there were five positive results (6%), including one participant with HPV18 who was found to have a cervical Adenocarcinoma at colposcopy. In our feasibility study, self-sampling was acceptable and effective at detecting HPV and preventing cervical cancer in under-screened urban wāhine Māori, Pacific and Asian women in Aotearoa. This is the first report of cervical Adenocarcinoma (Grade 1B) as a result of an HPV-18 positive self-sample in Aotearoa. We co-designed new patient information materials taking a health literacy and ethnicity-specific approach. This work provides policy-relevant information to the NCSP on the resources required to implement an effective HPV self-sampling programme to improve equity in national cervical cancer screening.

Acceptability of human papillomavirus (HPV) self-sampling among never- and under-screened Indigenous and other minority women: a randomised three-arm community trial in Aotearoa New Zealand.

BackgroundInternationally, self-sampling for human papillomavirus (HPV) has been shown to increase participation in cervical-cancer screening. In Aotearoa New Zealand, there are long-standing ethnic inequalities in cervical-cancer screening, incidence, and mortality, particularly for indigenous Māori women, as well as Pacific and Asian women.MethodsWe invited never- and markedly under-screened (≥5 years overdue) 30-69-year-old Māori, Pacific, and Asian women to participate in an open-label, three-arm, community-based, randomised controlled trial, with a nested sub-study. We aimed to assess whether two specific invitation methods for self-sampling improved screening participation over usual care among the least medically served populations. Women were individually randomised 3:3:1 to: clinic-based self-sampling (CLINIC – invited to take a self-sample at their usual general practice); home-based self-sampling (HOME – mailed a kit and invited to take a self-sample at home); and usual care (USUAL – invited to attend a clinic for collection of a standard cytology sample). Neither participants nor research staff could be blinded to the intervention. In a subset of general practices, women who did not participate within three months of invitation were opportunistically invited to take a self-sample, either next time they attended a clinic or by mail.FindingsWe randomised 3,553 women: 1,574 to CLINIC, 1,467 to HOME, and 512 to USUAL. Participation was highest in HOME (14.6% among Māori, 8.8% among Pacific, and 18.5% among Asian) with CLINIC (7.0%, 5.3% and 6.9%, respectively) and USUAL (2.0%, 1.7% and 4.5%, respectively) being lower. In fully adjusted models, participation was statistically significantly more likely in HOME than USUAL: Māori OR=9.7, (95%CI 3.0-31.5); Pacific OR=6.0 (1.8-19.5); and Asian OR=5.1 (2.4-10.9). There were no adverse outcomes reported. After three months, 2,780 non-responding women were invited to participate in a non-randomised, opportunistic, follow-on substudy. After 6 months,192 (6.9%) additional women had taken a self-sample.InterpretationUsing recruitment methods that mimic usual practice, we provide critical evidence that self-sampling increases screening among the groups of women (never and under-screened) who experience the most barriers in Aotearoa New Zealand, although the absolute level of participation through this population approach was modest. Follow-up for most women was routine but a small proportion required intensive support.Trial registrationANZCTR Identifier: ACTRN12618000367246 (date registered 12/3/2018) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371741&isReview=true; UTN: U1111-1189-0531FundingHealth Research Council of New Zealand (HRC 16/405)Protocolhttp://publichealth.massey.ac.nz/assets/Uploads/Study-protocol-V2.1Self-sampling-for-HPV-screening-a-community-trial.pdf

Performance of a six-methylation-marker assay on self-collected cervical samples – A feasibility study

ObjectivesIn high-income countries, a high proportion of cervical cancers is diagnosed in screening non-attendees. One approach to improve screening coverage is to offer self-sampling for human papillomavirus (HPV) testing. However, especially young women are often HPV positive without having a precancerous lesion in need of treatment. To improve the rather low specificity of HPV testing additional markers such as DNA-methylation can be used. The aim of this feasibility study was to examine the performance of the methylation marker assay GynTect®, comprising six methylation markers, on dry self-collected cervico-vaginal samples compared to physician-taken samples. MethodsWe recruited 89 patients from our colposcopy clinic of whom 87 qualified for the study. The women took a self-sample with the Evalyn-Brush. Afterwards the planned colposcopy was performed and smears for cytology and reference HPV testing were taken as well as a biopsy in cases of abnormalities. Physician-taken and self-collected samples were tested for HPV DNA and were analyzed with GynTect®. ResultsWe obtained 95.5 % valid results for the self-collected samples which was very close to the physician-taken samples. Only about half of the self-collected samples were GynTect® positive in comparison to the physician-taken samples. GynTect® scores were significantly lower for self-collected than for physician-taken samples (p = 0.001, paired t-test). The overall concordance for GynTect® results was moderate (kappa 0.394; p < 0.001). For HPV testing we obtained a good concordance (kappa 0.586; p < 0.001). The GynTect® results for the self-collected samples showed a sensitivity for the detection of cervical intraepithelial neoplasia 2 or worse (CIN2+) of 26.1 % (95 %-CI: 0.13−0.46) and a specificity of 95.6 % (95 %-CI: 0.85−0.99), in comparison to a sensitivity of 45.5 % (95 %-CI: 0.27−0.65) and a specificity of 78.3 % (95 %-CI: 0.64−0.88) for the physician-taken samples. ConclusionsGynTect® methylation marker testing has a satisfactory amount of valid results on self-collected samples. However, the results of the self-collected samples differed clearly in comparison to the reference samples. To justify an application in screening, a larger study with more cases of high-grade cervical dysplasia and HPV positive patients will be needed.

Attitudes Toward Human Papillomavirus Self-Sampling in Regularly Screened Women in Edmonton, Canada: A Cross-Sectional Study

The aim of the study was to determine the level of interest in human papillomavirus (HPV) self-sampling as a method of cervical cancer screening in a population of women affiliated with a primary care clinic. A survey was given to women (N = 182) between the ages of 25 and 69 years attending a family medicine clinic in Edmonton, Canada. Primary outcome measures include (1) the percentage of women who feel that HPV self-sampling should be available and (2) the percentage of women who would prefer HPV self-sampling to the Pap test. Secondary outcomes include the percentage of women aware of HPV self-sampling and factors associated with a preference for HPV self-sampling using logistic regression. Most women (84%) were up-to-date on Pap testing, and most (85%) had had postsecondary education (either completed or in progress). The percentage of the women who moderately or strongly felt that HPV self-sampling should be available was 60%; the percentage of the women who would prefer HPV self-sampling was 24%. Only 7% of the women reported being previously aware of HPV self-sampling. The factor associated with a preference for HPV self-sampling was the Pap comfort score, with an odds ratio of 1.51 (95% CI = 1.05-2.16, p = .026). In this population of well-educated women who were mostly up-to-date on cervical screening, there was a clear interest to have the option of HPV self-sampling. It is important for cancer screening programs to take this into account, given that women are the ultimate beneficiaries of these programs.

Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening

IntroductionSquamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of...

Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: protocol for a cluster randomized feasibility trial

BackgroundCervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.MethodsWe designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.DiscussionOur trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.Trial registrationClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.

Promotion of Cervical Screening among Long-term Non-attendees by Human Papillomavirus Self-sampling.

Cervical cancer is preventable through gynecological screening. To promote participation among non-attending women, self-collected vaginal samples for detection of high-risk human papillomavirus (hr-HPV) is an option. The aims of this study were to investigate the response of self-collected vaginal samples for hr-HPV testing among long-term non-attendees, to explore the attendance at follow-up among HPV-positive women, and to analyze the prevalence of hr-HPV and severe cervical dysplasia or cancer among the responders. A vaginal self-sampling kit was sent to 19,766 women aged 30-70 years who had not provided a cervical screening sample for ≥ 7 years in Skåne, Sweden. The self-sample was analyzed by the Aptima HPV mRNA assay (Hologic). Women testing positive for HPV were invited for follow-up. The response was 18.5% (3,646/19,757). The prevalence of HPV mRNA was 11.3% (412/3,636). Among HPV-positive women, 85.7% (353/412) attended follow-up, and of these, 44.8% (158/353) had HPV in the cervical sample. The HPV mRNA test of self-samples showed a positive predictive value of 9.3% ([33/353], 95% CI = 6.5-12.9) for detection of cytologically severe dysplasia. Histologically severe dysplasia or cancer was detected in 0.88% ([32/3,636], 95% CI = 0.6-1.2) among responders, including two cervical- and one vaginal cancer. In conclusion, almost one fifth of the long-term non-attendees participated in self-collected vaginal hr-HPV sampling. The prevalence of histologically confirmed high grade squamous intraepithelial lesion or cervical cancer was not increased significantly compared to regularly screened women in Sweden. The relatively high HPV prevalence among the self-samples indicates the importance of diagnostic follow-up with cervical HPV testing and reflex-cytology of HPV-positive cases.

Cost of community-based human papillomavirus self-sampling in Peru: a micro-costing study

BackgroundCost is an essential component of economic evaluations and a determinant of implementation feasibility of human papillomavirus (HPV) self-sampling programmes. Yet, reliable evidence that can be used in low-income and middle-income countries, where cervical cancer burden is highest, remains scarce. Here, we estimate the total and unit costs associated with the Hope Project, a community-based HPV self-sampling social entrepreneurship programme in the peri-urban area of Lima, Peru. MethodsWe conducted a micro-costing analysis from the programme perspective to determine the unit costs of: (1) recruitment and training of community leaders (known as Hope Ladies); and (2) Hope Ladies distributing HPV self-sampling kits (named careHPV) in their communities. A procedural manual was used to identify the programme's activities. A structured questionnaire was administered, and in-depth interviews were conducted with three programme administrators to estimate the resource use for each activity and time associated with intervention delivery. Laboratory materials (disposable and durable) and equipment were also costed. We obtained unit costs for each input previously identified from programme budgets and expenditure reports from Nov 1, 2018, to Dec 30, 2019. FindingsThe annual cost per community leader recruited and trained was US$86·21 (2019 USD); cost per HPV self-sampling kit distributed was $39·44. The cost per HPV-positive woman identified was $328·54; and the cost per woman who received the intervention was $49·38. Personnel and laboratory costs represented 47% and 28% of programmatic costs, respectively. During the study period (Nov 1, 2018, to Dec 30, 2019), the programme recruited and trained 62 Hope Ladies, who distributed 4882 HPV self-sampling kits to women in their communities. Of the screened women, 586 (12%) tested positive for HPV. InterpretationCommunity-based HPV self-sampling appears to be a feasible way to improve cervical cancer screening coverage. These findings can be used as the basis for economic evaluations, such as a cost-effectiveness analysis, or to model the scaling of the intervention. FundingThomas Francis Jr Fellowship.

Self-sampling for high-risk human papillomavirus as a follow-up alternative after treatment of high-grade cervical intraepithelial neoplasia.

Women treated for high-grade cervical-intraepithelial-neoplasia (CIN) require long-term follow-up with high-risk human-papillomavirus (HPV) testing. Self-sampling for HPV is well-accepted among these patients, but its role in follow-up for this group requires investigation. The present study examined how well HPV findings from self-sampled vaginal (VSS) and urine specimens correctly identified women from this cohort with recurrent CIN2+ compared with samples collected by clinicians. At 1st post-conization follow-up, 531 patients (99.8% participation) gave urine samples, performed VSS, underwent colposcopy with punch biopsy of visible lesions and clinician-collected cervical sampling for HPV analysis and liquid-based cytology. A total of 113 patients with positive HPV and/or abnormal cytology at 1st follow-up underwent 2nd follow-up. At 1st follow-up, all patients with recurrent CIN3 had positive HPV results by all methods. Clinician sampling and VSS revealed HPV16 positivity in 50% of recurrent cases and urine sampling revealed HPV16 positivity in 25% of recurrent cases. At 2nd follow-up, all 7 newly-detected CIN2/3 recurrences were associated with HPV positivity on VSS and clinician-samples. Only clinician-collected samples detected HPV positivity for two adenocarcinoma-in-situ recurrences, and both were HPV18 positive. A total of 77 patients had abnormal cytology at 1st follow-up, for which HPV positivity via VSS yielded highest sensitivity. The HPV findings were positive from VSS in 12 patients with high-grade squamous-intraepithelial-lesions (HSIL), and 11 patients with HSIL had positive HPV findings in clinician-collected and urine samples. All methods for assessing HPV presence yielded significant age-adjusted odds ratios for predicting abnormal lesions at 1st follow-up. For overall HPV results, Cohen's kappa revealed substantial agreement between VSS and clinician sampling, and moderate agreement between urine and clinician sampling. Clinician sampling and VSS were highly concordant for HPV16. Insofar as the pathology was squamous (not glandular), VSS appeared as sensitive as clinician sampling for HPV in predicting outcome among the present cohort. Since VSS can be performed at home, this option can maximize participation in the required long-term follow-up for these women at high-risk.