Project description:BackgroundCervical cancer is the fourth most common cancer affecting women worldwide, with 85% of the burden estimated to occur among women in low and middle-income countries (LMICs). Recent developments in cervical cancer screening include a novel self-collection method for the detection of oncogenic HPV strains in the collected samples. The purpose of this review is to synthesise qualitative research on self-collection for HPV-based testing for cervical screening and identify strategies to increase acceptability and feasibility in different settings, to alleviate the burden of disease.MethodsThis review includes qualitative studies published between 1986 and 2020. A total of 10 databases were searched between August 2018 and May 2020 to identify qualitative studies focusing on the perspectives and experiences of self-collection for HPV-based cervical screening from the point of view of women, health care workers and other key stakeholders (i.e., policymakers). Two authors independently assessed studies for inclusion, quality, and framework thematic synthesis findings. The Socio-Ecological Model (SEM) was used to synthesize the primary studies.ResultsA total of 1889 publications were identified, of which 31 qualitative studies were included. Using an adapted version of SEM, 10 sub-themes were identified and classified under each of the adapted model's constructs: (a) intrapersonal, (b) interpersonal, and (c) health systems/public policy. Some of the themes included under the intrapersonal (or individual) construct include the importance of self-efficacy, and values attributed to self-collection. Under the intrapersonal construct, the findings centre around the use of self-collection and its impact on social relationships. The last construct of health systems focuses on needs to ensure access to self-collection, the need for culturally sensitive programs to improve health literacy, and continuum of care.ConclusionThis review presents the global qualitative evidence on self-collection for HPV-based testing and details potential strategies to address socio-cultural and structural barriers and facilitators to the use of self-collection. If addressed during the design of an HPV-based cervical cancer screening testing intervention program, these strategies could significantly increase the acceptability and feasibility of the intervention and lead to more effective and sustainable access to cervical screening services for women worldwide.
Project description:BackgroundCervical cancer is a leading cause of death in low- and middle-income countries. Self-collection testing for human papillomavirus (HPV) is an alternative form of cervical cancer screening that can be completed privately and at home. Understanding how the use of HPV testing influences follow-up care in low-resourced settings is crucial before broad implementation. This study aimed to identify if access to self-collection HPV testing impacts participation in established cervical cancer screening programs among women in two rural communities in Guatemala.MethodsA cohort of 956 women was recruited in 2016 and followed for 2 years for the HPV Multiethnic Study (HPV MES). At baseline, women answered a questionnaire assessing cervical cancer screening history and were offered self-collection HPV testing. Women were re-contacted yearly to determine receipt of additional screening. Statistical changes in screening behavior before and throughout study participation, stratified by self-collection status, were assessed using McNemar pair tests for proportions. Alluvial plots were constructed to depict changes in individual screening behavior. The odds of changes in Pap-compliance (screened in past 3 years), given collection status, were assessed using multivariate logistic regressions.ResultsReported screening rates increased 2 years after enrollment compared to rates reported for the 3 years before study entry among women who collected a sample (19.1% increase, p < 0.05), received results of their test (22.1% increase, p < 0.05), and received positive (24.2% increase, p < 0.1) or negative results (21.7% increase, p < 0.05). However, most increases came from one community, with minimal changes in the other. The adjusted odds of becoming Pap compliant were higher for women who collected a sample vs. did not (OR: 1.48, 95% CI: 0.64, 3.40), received their result vs. did not (OR: 1.29, 95% CI: 0.52, 3.02), and received a positive result vs. negative (OR: 2.43, 95% CI: 0.63, 16.10).ConclusionsParticipation in self-collection HPV testing campaigns may increase likelihood of involvement in screening programs. However, results varied between communities, and reporting of screening histories was inconsistent. Future work should identify what community-specific factors promote success in HPV testing programs and focus on improving education on existing cervical cancer interventions.
Project description:BackgroundTo reach non-participants, reluctant to undergo clinician-based cervical cancer screening and vaginal self-sampling, urine collection for high-risk human papillomavirus detection (hrHPV) may be valuable. Using two hrHPV DNA assays, we evaluated the concordance of hrHPV positivity in urine samples in comparison with vaginal self-samples and cervical cytology samples taken by the general practitioner (GP). We also studied women's acceptance of urine collection and preferences towards the different sampling procedures.MethodsOne hundred fifty paired self-collected urine and vaginal samples and GP-collected cervical cytology samples were obtained from 30 to 59-year-old women diagnosed with ASC-US within the Danish cervical cancer screening program. After undergoing cervical cytology at the GP, the women collected first-void urine and vaginal samples at home and completed a questionnaire. Each sample was hrHPV DNA tested by the GENOMICA CLART® and COBAS® 4800 assays. Concordance in hrHPV detection between sample types was determined using Kappa (k) statistics. Sensitivity and specificity of hrHPV detection in urine was calculated using cervical sampling as reference.ResultsWith the COBAS assay, urine showed good concordance to the vaginal (k = 0.66) self-samples and cervical samples (k = 0.66) for hrHPV detection. The corresponding concordance was moderate (k = 0.59 and k = 0.47) using CLART. Compared to cervical sampling, urinary hrHPV detection had a sensitivity of 63.9% and a specificity of 96.5% using COBAS; compared with 51.6 and 92.4% for CLART. Invalid hrHPV test rates were 1.8% for COBAS and 26.9% for CLART. Urine collection was well-accepted and 42.3% of the women ranked it as the most preferred future screening procedure.ConclusionsUrine collection provides a well-accepted screening option. With COBAS, higher concordance between urine and vaginal self-sampling and cervical sampling for hrHPV detection was found compared to CLART. Urinary hrHPV detection with COBAS is feasible, but its accuracy may need to be improved before urine collection at home can be offered to non-participants reluctant to both cervical sampling and vaginal self-sampling.
Project description:In order to achieve the global elimination of cervical cancer as a public health problem, close surveillance of progress in public health and clinical activities and outcomes across the three pillars of vaccination, screening and treatment will be required. Surveillance should ideally occur within an integrated system that is planned, funded, and regularly evaluated to ensure it is providing timely, accurate and relevant feedback for action. In this paper, we conceptualise the main public health surveillance objectives as process and outcome measures in each of the three pillars. Process measures include coverage/participation measures for vaccination, screening and treatment alongside the ongoing assessment of the quality and reach of these programs and activities. Outcome measures related to the natural history of human papillomavirus (HPV) infection include HPV infection prevalence, precursor cervical lesions and cervical cancers (including stage at diagnosis, cancer incidence and mortality). These outcome measures can be used for monitoring the effectiveness of the three core activities in the short, medium and long term to assess whether these interventions are effectively reducing their occurrence. We discuss possible methods for the surveillance of these measures in the context of country capacity, drawing from examples in Australia, the USA and in low and middle income countries.
Project description:About 95% of cervical cancers worldwide are caused by human papillomavirus (HPV). Cervical cancer is preventable and curable if it is detected and treated early. We reviewed the latest national cervical cancer indicators, and barriers to HPV vaccination and cervical cancer screening in 21 Asian National Cancer Centers Alliance (ANCCA) member countries. Half (n = 11, 52%) of the countries have introduced HPV vaccination for girls as part of their national vaccination programme, three countries reported coverage of over 90%. Most ANCCA member countries have cervical cancer screening programmes, only five countries reported screening uptake of over 50%. The barriers to HPV vaccination coverage and cervical cancer screening participation have been identified. Ensuring health service accessibility and affordability for women, addressing sociocultural barriers, and strengthening the healthcare system and continuum of care are essential to increase HPV vaccination and cervical cancer screening coverage.
Project description:Human papillomavirus (HPV) self-collect shows promise to increase cervical cancer screening rates in underscreened populations, such as Somali patients, but little is known about how to integrate such an approach in primary care. In this study, primary care providers and staff who provide primary care services to Somali women were asked for their views on integrating HPV self-collect into routine care to address cervical cancer screening disparities. Thirty primary care providers and staff participated in semi-structured interviews exploring their views on HPV self-collect and their anticipated needs or barriers to implementing this approach into the clinic generally and with specific patient populations, such as Somali women. A thematic analysis using the constructivist version of grounded theory was undertaken. Providers and staff anticipate positive patient reaction to the option of HPV self-collect, and were interested in using this approach both for Somali patients and for all patients in general. HPV self-collect was viewed as straightforward to integrate into existing clinic workflows. Providers largely lacked awareness of the evidence supporting primary HPV testing and HPV self-collect specifically, sharing concerns about effectiveness of self-collect and the lack of a physical exam. Providers felt clinic-wide staff education and patient education, along with strategies to address disparities, such as cultural and linguistic tailoring would be needed for successful implementation. Integrating HPV self-collect as an option in the cervical cancer screening process in a primary care clinical encounter offers considerable opportunity to address health disparities and may benefit all patients.
Project description:With the availability of a low-cost HPV DNA test that can be administered by either a healthcare provider or a woman herself, programme planners require information on the costs and cost-effectiveness of implementing cervical cancer screening programmes in low-resource settings under different models of healthcare delivery. Using data from the START-UP demonstration project and a micro-costing approach, we estimated the health and economic impact of once-in-a-lifetime HPV self-collection campaign relative to clinic-based provider-collection of HPV specimens in Uganda. We used an individual-based Monte Carlo simulation model of the natural history of HPV and cervical cancer to estimate lifetime health and economic outcomes associated with screening with HPV DNA testing once in a lifetime (clinic-based provider-collection vs a self-collection campaign). Test performance and cost data were obtained from the START-UP demonstration project using a micro-costing approach. Model outcomes included lifetime risk of cervical cancer, total lifetime costs (in 2011 international dollars [I$]), and life expectancy. Cost-effectiveness ratios were expressed using incremental cost-effectiveness ratios (ICERs). When both strategies achieved 75% population coverage, ICERs were below Uganda's per capita GDP (self-collection: I$80 per year of life saved [YLS]; provider-collection: I$120 per YLS). When the self-collection campaign achieved coverage gains of 15-20%, it was more effective than provider-collection, and had a lower ICER unless coverage with both strategies was 50% or less. Findings were sensitive to cryotherapy compliance among screen-positive women and relative HPV test performance. The primary limitation of this analysis is that self-collection costs are based on a hypothetical campaign but are based on unit costs from Uganda. Once-in-a-lifetime screening with HPV self-collection may be very cost-effective and reduce cervical cancer risk by > 20% if coverage is high. Demonstration projects will be needed to confirm the validity of our logistical, costing and compliance assumptions.
Project description:BackgroundPrimary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening.MethodsWe recruited women ages 25-65 years at two colposcopy clinics in North Carolina between November 2016 and January 2019, and obtained self-collected cervico-vaginal samples, provider-collected cervical samples, and cervical biopsies from all enrolled women. Self- and provider-collected samples were tested for 14 hr-HPV genotypes using the Onclarity Assay (Becton Dickinson). We calculated hr-HPV genotype-specific prevalence and assessed agreement between results in self- and provider-collected samples. We ranked the hr-HPV genotypes according to their positive predictive value (PPV) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+).ResultsA total of 314 women participated (median age, 36 years); 85 women (27%) had CIN2+. More women tested positive for any hr-HPV on self-collected (76%) than on provider-collected samples (70%; P = 0.009) with type-specific agreement ranging from substantial to almost perfect. HPV-16 was the most common genotype in self-collected (27%) and provider-collected samples (20%), and HPV-16 prevalence was higher in self- than provider-collected samples (P < 0.001). In self- and provider-collected samples, HPV-16 had the highest PPV for CIN2+ detection.ConclusionsOverall sensitivity for CIN2+ detection was similar for both sample types, but the higher HPV-16 prevalence in self-collected samples could result in increased colposcopy referral rates.ImpactAdditional molecular markers might be helpful to improve the triage of women who are hr-HPV positive on self-collected samples.
Project description:ObjectiveTo assess triage compliance and the effect of the time from screening to triage on follow-up among HPV-positive women.MethodsWe recruited 1232 women in a screening campaign in Madagascar from February to October 2015. In the first period (February-May), HPV tests were performed remotely using the cobas test. In the second period (May-October), testing was performed on-site using the Xpert HPV assay. HPV-positive women were invited for triage with visual inspection with acetic acid (VIA) and Lugol's iodine (VILI). Systematic biopsy and endocervical brushing were performed on all HPV-positive women for quality control. Three groups were defined according to time from HPV testing to triage invitation for HPV-positive women-Group I: delayed (> 3 months), Group II: prompt (24-48 hours), and Group III: immediate (< 24 hours).ResultsA total 1232 self-sampled HPV tests were performed in the study period (496 in Group I, 512 in Group II, and 224 in Group III). Participants' mean age was 43.2 ± 9.3 years. Mean time from screening to VIA/VILI testing was 103.5 ± 43.6 days. Overall HPV prevalence was 28.0%. HPV prevalence was 27.2% in Group I (cobas test), 29.2% in Group 2 (Xpert test), and 26,7% in Group III (Xpert test). The VIA/VILI compliance rate was 77.8% for Group I, 82.7% for Group II, and 95.0% for Group III. Of women undergoing VIA/VILI, 56.3% in Group I and 43.5% in Groups II/III had positive results. Prevalence of cervical intraepithelial neoplasia grade 2 or worse among HPV-positive women was 9.8% for Group I and 6.8% for Groups II/III. Non-adherence was higher among rural women, uneducated women, and women in Group I.ConclusionHPV-positive women with immediate VIA/VILI triage invitation had the best triage compliance. A single-day test and triage strategy is preferred for low-resource settings.
Project description:BackgroundPrimary human papillomaviruses (HPV) cervical cancer screening can be strengthened by offering home-collection of biological specimen as a valuable option to increase screening coverage. As recommended by World Health Organization (WHO), screening programs should consider whether the inclusion of HPV self-sampling as a complementary option within their existing screening algorithms could address the gaps in current coverage. However, few HPV screening tests are validated for self-sampling according to international guidelines. This study aimed to test a self-sampling-based screening strategy, complementary to the main screening program based on clinician-collected cervical samples. The study took place in Trieste, Italy, and it aimed to evaluate the feasibility of self-testing at home under an opt-in system during COVID-19 pandemic in order to exploit self-sampling to reduce the screening delay generated by the lockdown.Methods500 women, who should have received the screening call in 2020, were asked, via phone call, to participate in the study. To whom agreed, a home-collection kit, including a vaginal dry swab for specimen collection, was sent. The recipients performed the sample self-collection and sent back the swab through traditional mail using a prepaid envelope. Once received by the hospital, the samples were analyzed with HPV Selfy (Ulisse BioMed, Italy), a CE-IVD HPV screening test specifically validated for self-collection. Results were further compared using cobas® 4800 HPV (Roche, Switzerland).Results80% women sent back their swab, showing one of the highest return rate obtained in comparable studies. 34 HPV-positive women were followed up and underwent the Pap test, that revealed 8 low squamous intraepithelial lesions (LSIL) cases, later triaged to colposcopy. HPV Selfy was confirmed to be an adequate test for self-sampling-based screening.ConclusionsThis study further confirmed the feasibility of self-test at home screening strategy based on self-sampling with an opt-in system as a support method to enhance cervical cancer screening coverage in Italy. Enrolled women showed a high appreciation for this approach. HPV Selfy test demonstrated to be a valuable assay for cervical cancer screening based on home self-collection.Trial registrationASUGI Trieste n. 16008/2018 and amendment 02-11/09/2020.