Self-sampling Kits Research Articles

Anal and oropharyngeal HPV distribution in HIV-negative multipartner MSM using self-sampling kits for HIV and sexually transmitted infection screening.

Men who have sex with men (MSM) are at high risk of sexually transmitted infections, among which HPV infections are particularly prominent. We took advantage of the MémoDépistages study to evaluate HPV distribution at anal and oropharyngeal sites in HIV-negative multipartner MSM. HPV DNA was detected in 82% (n = 344) of anal and 11% (n = 45) of oropharyngeal self-collected samples taken from 421 participants. Multiple HPV types were detected in 70% of anal samples, and single HPV types in 91% of oropharyngeal samples. HPV16 was the most frequent type detected in the anus, followed by HPV6, HPV51, and HPV52. HPV6, HPV16, and HPV11 were the most prevalent types in the oropharynx. HPV targeted by the nonavalent vaccine was detected in 71% and 50% of HPV-positive anal and oropharyngeal samples, respectively. The main risk factor associated with HPV detection was frequenting gay meeting places, living in large cities, and having an anal Chlamydia trachomatis/Neisseria gonorrhoeae infection. In this cohort of highly sexually active MSM, HPV detection was highly frequent and rendered them at high risk of precancerous and cancerous lesions. Universal vaccination against HPV before sexual debut is an important public health strategy to prevent HPV-associated cancers in this highly vulnerable population of HIV-negative MSM.

HPV self-sampling among women in the United States: preferences for implementation.

With the inclusion of primary HPV testing in 2018 U.S. Preventive Services Taskforce guidelines, at-home HPV self-sampling may provide a future option for cervical cancer screening, especially among hard-to-reach populations in the U.S. This study evaluated the association of implementation preferences with the willingness of at-home HPV self-sampling. We conducted a cross-sectional study in 2018 among U.S. women ages 30-65years, without a hysterectomy (n = 812). The outcome was willingness to have at-home HPV self-sampling (yes/no). Primary predictor variables (i.e., information source, methods of payment, methods of sending or receiving self-sampling kits) measured self-sampling implementation preferences. Adjusted logistic regression identified associations with willingness to have at-home HPV self-sampling. Participants who preferred receiving information from healthcare providers (OR = 2.64; 95% CI 1.54,4.52) or from media or other sources (OR = 2.30; 95% CI 1.51,3.48) had higher HPV self-sampling willingness than participants who did not prefer those sources. Participants who did not want to pay for self-sampling (OR = 0.21; 95% CI 0.14,0.32) or did not know if they would pay for self-sampling (OR = 0.35; 95% CI 0.22,0.54) had lower odds of HPV self-sampling willingness compared to participants willing to pay. Participants who did not know which method they preferred for receiving a self-sampling kit (OR = 0.15, 95% CI 0.07,0.31) or preferred delivering the sample to the lab themselves (OR = 0.59; 95% CI 0.36,0.96) had lower odds for self-sampling willingness compared to participants who preferred the mail. Understanding the preferences of women regarding the implementation of HPV self-sampling can improve uptake in cervical cancer screening, especially among hard-to-reach populations.

Self- and physician-collected high-risk human papillomavirus (HPV) testing to detect high-grade cervical lesions among Thai women

ObjectiveWe compared the performance of high-risk human papillomavirus (HPV) messenger RNA testing of physician- and self-collected specimens for detecting histological grade 2 or higher cervical intraepithelial neoplasia (CIN) among women...

Availability and accessibility of HIV self-tests and self-sample kits at community pharmacies in the Netherlands

BackgroundIn 2016 the WHO declared HIV self-testing and self-sampling an effective and safe test option that can reduce testing barriers. HIV self-tests and self-sampling kits (HIVST/HIVSS) are available for purchase at Dutch community pharmacies since 2019. We investigated the availability and accessibility of HIVST/HIVSS in community pharmacies, and factors associated with test availability.MethodsAn online survey among all Dutch community pharmacies (n = 1,987) was conducted between April and June 2021. Availability of HIVST/HIVSS and experiences of pharmacists with the test offer were analyzed with descriptive statistics. The association of pharmacy and pharmacists’ characteristics with HIVST/HIVSS availability was explored by logistic regression analysis.ResultsIn total, 465 pharmacists completed the questionnaire. Of the responding pharmacists, 6.2% (n = 29) offered HIVST/HIVSS. The majority (82.8%) sold between 0 and 20 tests per year. In total, pharmacies sold an estimated 370 HIVST/HIVSS per year. Pharmacies having HIVST/HIVSS available were less often located in moderately-urbanized to rural neighborhoods (OR 0.35, 95%CI 0.16–0.77 versus highly-urbanized), and were less often located in moderate-to-low SES neighborhoods (OR 0.40, 95%CI 0.18–0.88 versus high-SES). Reasons for not offering HIVST/HIVSS by pharmacists were no or little demand (69.3%), and not being familiar with these tests (17.4%). 52% of the pharmacists provided information about testing to test buyers. Reported options to improve the test offer were giving advice about (performing) the test to test buyers (72.4%), placing tests visible on the counter (51.7%), and advertisement (37.9%).ConclusionHIVST/HIVSS have a limited practical availability in Dutch community pharmacies since their introduction in 2019, especially in lower-urbanized and lower-SES areas. Further research is needed to explore how to expand access to HIVST/HIVSS through community pharmacies in the Netherlands, and how to tailor it to the needs of pharmacy clients.

STI testing, diagnoses and online chlamydia self-sampling among young people during the first year of the COVID-19 pandemic in England.

COVID-19 control measures reduced face-to-face appointments at sexual health services (SHSs). Remote access to SHSs through online self-sampling was increased. This analysis assesses how these changes affected service use and STI testing among 15-24year olds ('young people') in England. Data on all chlamydia, gonorrhoea and syphilis tests from 2019-2020, among English-resident young people were obtained from national STI surveillance datasets. We calculated proportional differences in tests and diagnoses for each STI, by demographic characteristics, including socioeconomic deprivation, between 2019-2020. Binary logistic regression was used to determine crude and adjusted odds ratios (OR) between demographic characteristics and being tested for chlamydia by an online service. Compared to 2019, there were declines in testing (chlamydia-30%; gonorrhoea-26%; syphilis-36%) and diagnoses (chlamydia-31%; gonorrhoea-25%; syphilis-23%) among young people in 2020. Reductions were greater amongst 15-19year-olds vs. 20-24 year-olds. Amongst people tested for chlamydia, those living in the least deprived areas were more likely to be tested using an online self-sampling kit (males; OR = 1.24 [1.22-1.26], females; OR = 1.28 [1.27-1.30]). The first year of the COVID-19 pandemic in England saw declines in STI testing and diagnoses in young people and disparities in the use of online chlamydia self-sampling which risk widening existing health inequalities.

An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial.

Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed--a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654. DERR1-10.2196/43645.

Experience and acceptability for HPV self-sampling among women in Jiangsu province, China: a cross-sectional survey

This aim of this study was to investigate women’s knowledge about HPV along with their experience and acceptability of self-sampling in Jiangsu province, China. A total of 862 women aged 25–63 years old from Jiangsu province who purchased an HPV self-sampling test kit were invited to complete a questionnaire designed by the authors. Participants had high acceptability for HPV self-sampling with a mean score of 4.2 (95% [CI], 4.1–4.22) out of 5 points. 27% of participants preferred clinician-sampling, 33% preferred self-sampling, other 40% expressed no preference. Women with good knowledge about HPV and with a good experience with HPV self-sampling were more acceptable for self-sampling (P < 0.05). The biggest concern about HPV self-sampling of the participants includes ‘specimens’ spoilage’, ‘incorrect sampling’, ‘can’t get results in time’, and so on. HPV self-sampling can be used to improve cervical cancer screening coverage and participation rates in China.

Economic Evaluation of Mailed Home-Based Human Papillomavirus Self-sampling Kits for Cervical Cancer Screening

Human papillomavirus (HPV) self-sampling addresses barriers to cervical cancer screening, and mailed self-sampling kits have been reported to increase screening uptake. International research suggests mailed kits are cost-effective in certain settings. However, the cost-effectiveness of mailing HPV self-sampling kits for increasing screening uptake has not been evaluated in the US. To conduct an economic evaluation of a mailed HPV self-sampling intervention among underscreened women enrolled in an integrated US health care system. This economic evaluation involved a cost-effectiveness analysis of results from a randomized clinical trial of 19 851 women aged 30 to 64 years enrolled in a health plan from Kaiser Permanente Washington (KPWA), a US-based integrated health care system. Women were identified through electronic medical records, and eligible participants were enrolled in a health plan for at least 3 years and 5 months, had a primary care clinician, had not received a Papanicolaou test for at least 3 years and 5 months, and had not received a hysterectomy. Enrollment occurred from February 25, 2014, to August 29, 2016, with follow-up through February 25, 2018. The current economic evaluation was conducted between August 2, 2021, and July 30, 2022. Intervention delivery costs were calculated from both the KPWA and Medicare perspectives and were based on either wellness visit or Papanicolaou test-only visit costs. Participants in the control group received usual care, which comprised patient reminders and ad hoc outreach for screening. Participants in the intervention group received usual care plus a mailed HPV self-sampling kit. The primary economic outcome was the incremental cost-effectiveness ratio (ICER) for increased screening uptake, defined as the incremental difference in cost (intervention group minus control group) divided by the difference in the number of participants completing screening (intervention group minus control group) within 6 months of randomization. Among 19 851 women (mean [SD] age, 50.1 [9.5] years; 76.7% White), 9960 were randomized to the intervention group, and 9891 were randomized to the control group. Baseline ICERs ranged from $85.84 (95% CI, $85.68-$85.99) using KPWA wellness visits as the cost basis to $146.29 (95% CI, $146.20-$146.38) using Medicare Papanicolaou test-only visits as the cost source. Subgroups of participants aged 50 to 64 years and participants most recently overdue for screening achieved cost-effectiveness at lower levels of willingness to pay for an additional completed screening than other subgroups. In this economic evaluation, mailing HPV self-sampling kits to women overdue for cervical cancer screening was cost-effective for increased screening uptake relative to usual care. These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates among eligible women in US health care systems.

Mailing human papillomavirus self-sampling kits to women under-screened for cervical cancer improved detection in cervical cancer screening in a general population study in Japan

BackgroundOne cause of the increase in cervical cancer rates in Japan is the long-term stagnation in the cervical cancer screening consultation rate. Therefore, improving the screening consultation rate is of urgent concern to reduce cervical cancer incidence. Self-collected human papilloma virus (HPV) tests have been successfully adopted in several countries, such as the Netherlands and Australia, as a measure of individuals who have not undergone cervical cancer screening in national programs. This study aimed to verify whether self-collected HPV tests presented an effective countermeasure for individuals who had not undergone the recommended cervical cancer screenings.MethodsThis study was conducted from December 2020 to September 2022 in Muroran City, Japan. The primary evaluated endpoint was the percentage of citizens who underwent cervical cancer screening at a hospital with positive self-collected HPV test results. The secondary endpoint was the percentage of included participants who were diagnosed with cervical intraepithelial neoplasia (CIN) or higher among those who visited a hospital and underwent cervical cancer screening.ResultsThe included study participants were 7,653 individuals aged 20–50 years with no record of previous cervical cancer examination in the past 5 years. We mailed these participants information on self-administered HPV tests as an alternative screening procedure and sent the kit to 1,674 women who requested the test. Among them, 953 returned the kit. Among the 89 HPV-positive individuals (positive rate, 9.3%), 71 (79.8%) visited the designated hospital for an examination. A closer examination revealed that 13 women (18.3% of hospital visits) had a CIN finding of CIN2 or higher, among whom one each had cervical cancer and vulvar cancer, eight presented with CIN3, and three presented with CIN2; two cases of invasive gynecologic cancer were also identified.ConclusionsWe conclude that the self-collected HPV tests showed a certain efficacy as a measure of individuals who had not undergone the recommended cervical cancer screening. We devised ways to have the unexamined patients undergo HPV testing and ensure that HPV-positive individuals visited the hospital. Despite a few limitations, our findings suggest the effectiveness of this public health intervention.

Impact of different financial incentive structures on a web-based health survey: do timing and amount matter?

Financial incentives improve response to electronic health surveys, yet little is known about how unconditional incentives (guaranteed regardless of survey completion), conditional incentives, and various combinations of incentives influence response rates. We compared electronic health survey completion with two different financial incentive structures. We invited women aged 30-64 years enrolled in a U.S. healthcare system and overdue for Pap screening to complete a web-based survey after receiving a mailed human papillomavirus (HPV) self-sampling kit in a pragmatic trial. HPV kit returners (n = 272) and non-returners (n = 1,083) were allocated to one of two different incentive structures: (1) Unconditional: $5 pre-incentive only (n = 653); (2) Combined: $2 pre-incentive plus $10 post-incentive conditional on completion (n = 702). Chi-square tests evaluated whether survey completion differed by incentive structure within kit return groups or was modified by kit return status. For each incentive-by-kit status group, the cost-per-survey response was calculated as: ([number invited*pre-incentive amount] + [number responses*post-incentive amount]) / number responses. Overall, survey response was higher in kit returners vs. kit non-returners (42.6% vs. 11.0%, P < 0.01), and survey response was higher in the combined (20.1%) vs. unconditional (14.4%) incentive group (P = 0.01). Kit return status did not modify the association between incentive type and survey response (P = 0.52). Among respondents, time to survey completion did not differ by incentive type among either kit returners or non-returners. Among returners, the cost-per-survey response was similar between groups ($13.57 unconditional; $14.15 combined); among non-returners, the cost was greater in the unconditional ($57.78) versus the combined ($25.22) group. A combined incentive can be cost-effective for increasing survey response in health services research, particularly in hard-to-reach populations.

Abstract A108: Improving communication and management following a positive home HPV self-sampling kit result

Abstract Background: Over 14,000 cervical cancers are diagnosed annually in the U.S. In 2019, ~30% of individuals with a cervix were under-screened based on current guidelines. Previous studies established feasibility of mailed self-sampling high-risk HPV test kits to improve screening adherence. Qualitative findings from our HOME trial found unmet information needs and anxiety among patients with a positive kit result. We designed the STEP trial to test optimized implementation strategies for educating patients about screening when offering the kit to patients due/overdue for screening, and when reporting results. Purpose: To evaluate acceptability of the implementation strategies, we interviewed individuals after receiving a positive kit result about the result communication processes and their information needs. Methods: The STEP trial added a centralized licensed practical nurse to communicate about and arrange scheduling for all patients with positive kit results, and provided an educational pamphlet to explain the purpose of HPV testing (especially difference to Pap testing) and how latent infections can reactivate. Telephone interviews were conducted from December 2021 to March 2022 with 29 patients (56% of invited) who had a positive kit result. Interview guide asked about reaction to the kit, results communication, patient-provider interactions, and follow-up visit experiences; and included a survey regarding attitudes toward the kit. Five coders analyzed interview transcripts using iterative content analysis; 12 transcripts were double-coded. Codes were organized into node reports to identify overarching themes. Results: Of 29 participants, most (65.5%) were non-Hispanic White and the average age was 47.5 years (SD=11.2). Participants appreciated the convenience of the kit, though a few worried about the accuracy of self-sampling test results, especially compared to screening performed by a provider. While surprised by the positive kit result, all reported feeling reassured after talking with the nurse and understood next steps in the diagnosis and management process, although some reported still wanting to check with their primary care provider about the test findings. Though an educational pamphlet was provided with the home HPV kit, most participants did not recall receiving it or using it to understand their kit results. After reflecting on home kit versus in-clinic screening, most (69%) preferred using the kit on their own to provider-collected screening. All (100%) agreed that the kit instructions were easy to understand, however 90% were sure that they had sampled the right place, and 86% believed that the home test results were correct. Discussion: Unlike the prior HOME trial, there was less negative affect expressed by patients after receiving results. This suggests patients received the information needed to continue with the screening process and supports the value of a centralized nurse. Providing educational materials at multiple timepoints may further improve results communication in the future. Citation Format: Meera Muthukrishnan, Jasmin A. Tiro, Kris Hansen, John Lin, Caitlin Dorsey, Hongyuan Gao, Catherine Troja, Melissa Anderson, Richard Meenan, Beverly B. Green, Diana S.M. Buist, Rachel Winer. Improving communication and management following a positive home HPV self-sampling kit result [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A108.

"It's cancer screening after all". Barriers to cervical and colorectal cancer screening and attitudes to promotion of self-sampling kits upon attendance for breast cancer screening.

To explore barriers to cervical and colorectal cancer screening and attitudes to promotion of self-sampling kits upon attendance for breast cancer screening. Interview study with women who had not responded to one or more invitations to cervical or colorectal cancer screening. A semi-structured interview guide was used and interviews were audio recorded and transcribed verbatim. Concepts from Temporal Motivation Theory were used to structure and analyse the data. Twenty-two women were interviewed. Screening was highly valued but the women perceived screening for cervical cancer and colorectal cancer as more troublesome to participate in, compared with participation in breast cancer screening. The lack of a pre-booked appointment or a suggested deadline attenuated the perceived value of cervical and colorectal cancer screening and this further increased procrastination. Promotion of self-sampling kits for cervical and colorectal cancer screening upon attendance for breast cancer screening was considered a feasible way to increase salience of both types of screening. A high number of micro steps and absence of a deadline in cervical and colorectal cancer screening diverted attention away from screening participation in cervical and colorectal cancer screening. The main facilitator could be reduction of micro actions, proposing a suggested deadline, and promotion of self-sampling kits when attending breast cancer screening to increase salience and a renewed attention to all three screening programmes.

Results of Self-Sampling Methodology Impression for Cervical Cancer Screening in Mongolia.

Mongolia is a sparsely populated country; however, almost fifty percent of the population lives in the capital city. Medical care services and exceptionally well-organized cervical cancer screening tests are limited in remote areas. To improve cervical cancer screening test coverage, we compared the interest between physicians taking samples and self-sampling among the attendees in this study. A total of 175 women participated in this study. The hundred twelve women visited the Gynecology ward, and the sixty-three women were provided with the cervical self-sampling test kit and filled out a questionnaire. Subsequently, the acceptability of physician taking and self-sampling were evaluated using a questionnaire. All specimens were processed using the TACAS LBC system, and the quality of samples was tested by cytology. Regarding the acceptability of self-sampling, the selections for subsequent screening were 36% self-sampling and 64% gynecologist-sampling methods. The acceptability rates were higher in the remote areas than the urban areas. However, 64% of the participants lacked knowledge that the causative agent of cervical cancer is the human papillomavirus, and 66.9% mainly were sexually transmitted. In addition, 82.3% of the women surveyed were unaware that there was a vaccine to prevent cervical cancer, but 88.6% wanted to be vaccinated. Of most women, 44.4% chose self-sampling due to no embarrassment in the gynecological examination. The self-sampling preferences were dominant in the old age group (61.6%). The cytology satisfaction rate in physician-sampling (99.1%) was higher than in the self-sampling group (69.8%). The Implementation of the self-sampling tool may be considered a primary screening. The self-sampling test can adopt into the early screening program and may increase the coverage of the screening program and improve the quality.

Effect of Patient Characteristics on Uptake of Screening Using a Mailed Human Papillomavirus Self-sampling Kit

Mailing human papillomavirus (HPV) self-sampling kits increases cervical cancer screening participation, but effects may differ across subpopulations. Subpopulation data can inform US health care system implementation. To identify patient characteristics that modify effectiveness of a mailed kit intervention at increasing screening. This was a secondary analysis of data from the Home-Based Options to Make Cervical Cancer Screening Easy (HOME) randomized clinical trial conducted from 2014 to 2018 at Kaiser Permanente Washington. Data analysis was performed from March 2018 to May 2022. Individuals aged 30 to 64 years with female sex, health plan enrollment longer than 3 years and 5 months, a current primary care clinician, and no Papanicolaou test within the prior 3 years and 5 months were identified through electronic medical records and randomized (1:1) to the control or intervention group. The control group received usual care Papanicolaou screening reminders and outreach. The intervention group received usual care plus an unsolicited mailed HPV self-sampling kit. Screening uptake was captured within 6 months after randomization. Baseline patient characteristics (age, race, ethnicity, travel time to clinic, income, body mass index, tobacco use, health plan enrollment duration, time since last Papanicolaou test, mammography, comorbidities, and colorectal cancer screening adherence) were extracted from the electronic medical record. Of 19 734 individuals (mean [SD] age, 50.1 [9.5] years; 14 129 [71.6%] White), 9843 were randomized to the intervention group, and 9891 were randomized to the control group. Screening uptake was 26.3% (2592 of 9843 individuals) in the intervention group vs 17.4% (1719 of 9891 individuals) in the control group (relative risk [RR], 1.51; 95% CI, 1.43-1.60). Although absolute differences in uptake by group varied little by screening history, relative effects were greater with longer vs shorter time since last Papanicolaou test (no prior Papanicolaou test: RRs, 1.85-3.25; ≥10 years: RR, 2.78; 5-10 years: RRs, 1.69-1.86; <5 years: RRs 1.29-1.37). Relative effects were greater in participants overdue (RR, 2.03; 95% CI, 1.73-2.38) vs up-to-date with mammography (RR, 1.53; 95% CI, 1.41-1.67), although absolute difference was greater in the up-to-date group. Differences by age were not significant, with RRs of 1.33 to 1.48 across 5-year age groups in participants 30 to 54, vs 1.60 (95% CI, 1.40-1.82) in participants 55 to 59 and 1.77 (95% CI, 1.56-2.01) in participants 60 to 64 years. Among those mailed kits, there were differences in kit use vs in-clinic screening by age, race, plan enrollment duration, underscreening duration, and colorectal cancer screening adherence. In this secondary analysis of a randomized clinical trial, clinically important improvements in screening uptake were observed for all subgroups. Differences in magnitude of intervention effect and kit use highlighted opportunities to optimize HPV self-sampling for priority groups. ClinicalTrials.gov Identifier: NCT02005510.

The Influence of Vaginal HPV Self-Sampling on the Efficacy of Populational Screening for Cervical Cancer-An Umbrella Review.

Early detection of cervical cancer is a matter of great importance as the prognosis depends on the stage of the disease. The objective of the study consisted in the assessment of the impact of HPV self-sampling on the efficacy of populational screening programs aimed at early CC detection. The analysis was performed taking into account the Cochrane Collaboration guidelines for systematic reviews. The analyzed articles were searched for in the following databases: Medline (PubMed), Embase (Ovid), and Cochrane Library. From a total of 60 citations, 16 studies were included in this review. The HPV test is highly sensitive and specific although the diagnostic accuracy of tests carried out in self-collected samples is slightly lower than that of tests carried out in samples collected by clinicians. The results of meta-analyses for HPV tests performed on self-collected samples indicate that the sensitivity for detecting CIN2+ ranges from 74% to 86% (depending on the publication and the analyzed population), and for CIN3+ from 75% to 86%. One publication showed a clearly lower sensitivity of 42% in detecting CIN3+, but the result is for a high-risk population and comes from only 1 RCT. The specificity of the assay exceeds 80% and 79.5% with regard to the detection of CIN2+ and CIN3+, respectively. As shown by the studies included in the review, both the offering of HPV self-sampling kits to patients and the mailing of such kits significantly increase the uptake of and participation in cervical cancer screening programs. In addition, self-sampling was found to be acceptable by the female subjects. HPV self-sampling is an innovative and cost-effective way to perform screening tests. In addition, self-sampling significantly increases the willingness to participate in screening programs among female subjects.

The cost-effectiveness of opt-in and send-to-all HPV self-sampling among long-term non-attenders to cervical cancer screening in Norway: The Equalscreen randomized controlled trial

ObjectiveWe assessed the cost-effectiveness of mailing a human papillomavirus self-sampling (HPV-ss) kit, directly or via invitation to order, compared with mailing reminder letters among long-term non-attenders in Norway. MethodsWe conducted a secondary analysis using the Equalscreen study data with 6000 women aged 35–69 years who had not screened in 10+ years. Participants were equally randomized into three arms: reminder letter (control); invitation to order HPV-ss kit (opt-in); directly mailed HPV-ss kit (send-to-all). Cost-effectiveness (2020 Great British Pounds (GBP)) was estimated using incremental cost-effectiveness ratios (ICERs) per additional screened woman, and per additional cervical intraepithelial neoplasia grade 2 or worse (CIN2+) from extended and direct healthcare perspectives. ResultsParticipation, CIN2+ detection, and total screening costs were highest in the send-to-all arm, followed by the opt-in and control arms. Non-histological physician appointments contributed to 67% of the total costs in the control arm and ≤ 31% in the self-sampling arms. From an expanded healthcare perspective, the ICERs were 135 GBP and 169 GBP per additional screened woman, and 2864 GBP and 4165 GBP per additional CIN2+ detected for the opt-in and send-to-all, respectively. ConclusionsOpt-in and send-to-all self-sampling were more effective and, depending on willingness-to-pay, may be considered cost-effective alternatives to improve screening attendance in Norway.

Combined incentive actions, focusing on primary care professionals, to improve cervical cancer screening in women living in socioeconomically disadvantaged geographical areas: a study protocol of a hybrid cluster randomised effectiveness and implementation trial- RESISTE

IntroductionCervical cancer (CC) causes thousands of deaths each year. Nearly 100% of cases are caused by oncogenic strains of human papillomavirus (HPV). In most industrialised countries, CC screening (CCS) is...

HPV self-sampling as an additional option in cervical cancer screening: a pilot study in Estonia

Abstract Background Cervical cancer incidence and mortality rates remain high in Estonia and participation in organized cervical cancer screening program is low. The aim of this pilot study was to estimate the impact of offering an HPV self-sampling option on screening uptake. Methods A randomized intervention study was conducted within Estonian organized cervical cancer screening program in 2021. Among target group women who had not participated in screening by August 2021, 26,000 women were randomly selected and allocated to two equally sized intervention arms offering a choice between attending a clinic or taking a self-sample. The opt-out group received a Qvintip sampler by regular mail to home address, the opt-in group received by e-mail a link to order the sampler from a web-site. A control group of 32,000 women received the usual reminder to attend screening at a clinic. Participation rates were calculated and data on user experience were collected with a questionnaire. Results Significant difference in participation rates was observed between opt-out (41%) (among them 20% chose self-sampling, 21% chose clinic attendance), opt-in (34%) (8% self-sampling, 26% clinic) and control group (28%). Intervention arms showed higher screening uptake in all age-groups and regions, but the largest effect was seen at ages 60 and 65 years and in regions showing the lowest screening participation rates. Among self-sampling users, 99% agreed that self-sampling was easy and only 3% prefer testing at a clinic. Conclusions Offering women a choice between HPV self-sampling or attending a clinic significantly increased cervical cancer screening uptake. Sending an HPV self-sampling kit to home address was the most effective approach. Majority of women who chose HPV self-sampling want to use this option in the future. HPV self-sampling should be integrated in the cervical cancer screening program in Estonia. Key messages

Design of a pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake in a U.S. healthcare system: The STEP trial

BackgroundMailing HPV self-sampling kits to overdue individuals increases cervical cancer screening adherence; offering self-sampling to previously adherent individuals has not been evaluated in the U.S. Given heterogeneity of the U.S. health system and population, data are needed to optimize how HPV self-sampling is offered to individuals who are overdue, due after successful past screening, or have an unknown screening history. MethodsSTEP is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system, designed to compare different outreach approaches for offering HPV self-sampling in populations defined by prior screening behavior (previously-adherent, overdue, or unknown screening history). Over 14 months, eligible individuals were identified through electronic medical record (EMR) data and randomized to Usual Care (UC), Education (UC + educational materials about cervical cancer screening), Direct-Mail (UC + Education + a mailed self-sampling kit) or Opt-In (UC + Education + option to request a kit), depending on screening history. The primary objective is to compare screening completion by outreach approach and screening history. Secondary objectives include evaluating incremental cost-effectiveness of outreach approaches, and identifying patient preference for, and satisfaction with, HPV self-screening, and barriers to abnormal results follow-up (measured through interviews and focus groups). ConclusionsThe trial was designed to generate data that U.S. health systems can use to inform primary HPV screening implementation strategies that incorporate HPV self-sampling options to improve screening access, adherence, and patient satisfaction. The objective of this report is to describe the rationale and design of this pragmatic trial.

Accelerated partner therapy contact tracing for people with chlamydia (LUSTRUM): a crossover cluster-randomised controlled trial

Accelerated partner therapy has shown promise in improving contact tracing. We aimed to evaluate the effectiveness of accelerated partner therapy in addition to usual contact tracing compared with usual practice alone in heterosexual people with chlamydia, using a biological primary outcome measure. We did a crossover cluster-randomised controlled trial in 17 sexual health clinics (clusters) across England and Scotland. Participants were heterosexual people aged 16 years or older with a positive Chlamydia trachomatis test result, or a clinical diagnosis of conditions for which presumptive chlamydia treatment and contact tracing are initially provided, and their sexual partners. We allocated phase order for clinics through random permutation within strata. In the control phase, participants received usual care (health-care professional advised the index patient to tell their sexual partner[s] to attend clinic for sexually transmitted infection screening and treatment). In the intervention phase, participants received usual care plus an offer of accelerated partner therapy (health-care professional assessed sexual partner[s] by telephone, then sent or gave the index patient antibiotics and sexually transmitted infection self-sampling kits for their sexual partner[s]). Each phase lasted 6 months, with a 2-week washout at crossover. The primary outcome was the proportion of index patients with a positive C trachomatis test result at 12-24 weeks after contact tracing consultation. Secondary outcomes included proportions and types of sexual partners treated. Analysis was done by intention-to-treat, fitting random effects logistic regression models. This trial is registered with the ISRCTN registry, 15996256. Between Oct 24, 2018, and Nov 17, 2019, 1536 patients were enrolled in the intervention phase and 1724 were enrolled in the control phase. All clinics completed both phases. In total, 4807 sexual partners were reported, of whom 1636 (34%) were steady established partners. Overall, 293 (19%) of 1536 index patients chose accelerated partner therapy for a total of 305 partners, of whom 248 (81%) accepted. 666 (43%) of 1536 index patients in the intervention phase and 800 (46%) of 1724 in the control phase were tested for C trachomatis at 12-24 weeks after contact tracing consultation; 31 (4·7%) in the intervention phase and 53 (6·6%) in the control phase had a positive C trachomatis test result (adjusted odds ratio [OR] 0·66 [95% CI 0·41 to 1·04]; p=0·071; marginal absolute difference -2·2% [95% CI -4·7 to 0·3]). Among index patients with treatment status recorded, 775 (88·0%) of 881 patients in the intervention phase and 760 (84·6%) of 898 in the control phase had at least one treated sexual partner at 2-4 weeks after contact tracing consultation (adjusted OR 1·27 [95% CI 0·96 to 1·68]; p=0·10; marginal absolute difference 2·7% [95% CI -0·5 to 6·0]). No clinically significant harms were reported. Although the evidence that the intervention reduces repeat infection was not conclusive, the trial results suggest that accelerated partner therapy can be safely offered as a contact tracing option and is also likely to be cost saving. Future research should find ways to increase uptake of accelerated partner therapy and develop alternative interventions for one-off sexual partners. National Institute for Health Research.