Self-sampling Kits Research Articles

Human Papillomavirus Self-Sampling for Unscreened Women Aged 24 Years During the COVID-19 Pandemic.

The increasing trend of cervical cancer in women in their 20s in Japan is largely attributable to the low rate of cervical cancer screening. This study aimed to assess the usefulness of human papillomavirus (HPV) self-sampling among 24-year-old Japanese women who had never previously been screened for cervical cancer during the coronavirus disease (COVID-19) pandemic. In August 2021, consenting eligible women received HPV self-sampling kits. An Evalyn brush was used for self-sampling, and a Cobas 4800 PCR-based HPV DNA test was used to detect high-risk HPV genotypes. We analyzed the return rates of self-sampling kits and conducted a survey on the acceptability of the self-sampling method. Of the total 1997 eligible women, 13.4% (268/1997) agreed to participate. The return rate of the kits was 72.4% (194/268), corresponding to 9.7% of the eligible population. Among the participants who returned the kits, 14.9% (29/194) tested positive for HPV, and 41.4% (12/29) of these underwent subsequent cytological testing. The questionnaire results indicated that 57.8% of participants reported no pain during self-sampling, and 72.9% expressed a willingness to continue using the self-sampling method in the future. This study demonstrated that opt-in HPV self-sampling among 24-year-old women who had never been screened for cervical cancer had a favorable kit return rate and was well accepted by the participants, especially during the COVID-19 pandemic. However, the follow-up cytology test rates were low, highlighting the need for improved post-screening management.

Quality, acceptability and usability of self-sampling kits used by non-healthcare professionals for STI diagnosis in Spain: a single-blind study

ObjectivesSexually transmitted infections (STIs) have markedly increased over the last decade in Spain, calling for prevention and control innovative approaches. While there is evidence indicating the effectiveness of self-sampling for...

Assessment of the Effective Sensitivity of SARS-CoV-2 Sample Pooling Based on a Large-Scale Screening Experience: Retrospective Analysis.

The development of new large-scale saliva pooling detection strategies can significantly enhance testing capacity and frequency for asymptomatic individuals, which is crucial for containing SARS-CoV-2. This study aims to implement and scale-up a SARS-CoV-2 screening method using pooled saliva samples to control the virus in critical areas and assess its effectiveness in detecting asymptomatic infections. Between August 2020 and February 2022, our laboratory received a total of 928,357 samples. Participants collected at least 1 mL of saliva using a self-sampling kit and registered their samples via a smartphone app. All samples were directly processed using AutoMate 2550 for preanalytical steps and then transferred to Microlab STAR, managed with the HAMILTON Pooling software for pooling. The standard pool preset size was 20 samples but was adjusted to 5 when the prevalence exceeded 2% in any group. Real-time polymerase chain reaction (RT-PCR) was conducted using the Allplex SARS-CoV-2 Assay until July 2021, followed by the Allplex SARS-CoV-2 FluA/FluB/RSV assay for the remainder of the study period. Of the 928,357 samples received, 887,926 (95.64%) were fully processed into 56,126 pools. Of these pools, 4863 tested positive, detecting 5720 asymptomatic infections. This allowed for a comprehensive analysis of pooling's impact on RT-PCR sensitivity and false-negative rate (FNR), including data on positive samples per pool (PPP). We defined Ctref as the minimum cycle threshold (Ct) of each data set from a sample or pool and compared these Ctref results from pooled samples with those of the individual tests (ΔCtP). We then examined their deviation from the expected offset due to dilution [ΔΔCtP = ΔCtP - log2]. In this work, the ΔCtP and ΔΔCtP were 2.23 versus 3.33 and -0.89 versus 0.23, respectively, comparing global results with results for pools with 1 positive sample per pool. Therefore, depending on the number of genes used in the test and the size of the pool, we can evaluate the FNR and effective sensitivity (1 - FNR) of the test configuration. In our scenario, with a maximum of 20 samples per pool and 3 target genes, statistical observations indicated an effective sensitivity exceeding 99%. From an economic perspective, the focus is on pooling efficiency, measured by the effective number of persons that can be tested with 1 test, referred to as persons per test (PPT). In this study, the global PPT was 8.66, reflecting savings of over 20 million euros (US $22 million) based on our reagent prices. Our results demonstrate that, as expected, pooling reduces the sensitivity of RT-PCR. However, with the appropriate pool size and the use of multiple target genes, effective sensitivity can remain above 99%. Saliva pooling may be a valuable tool for screening and surveillance in asymptomatic individuals and can aid in controlling SARS-CoV-2 transmission. Further studies are needed to assess the effectiveness of these strategies for SARS-CoV-2 and their application to other microorganisms or biomarkers detected by PCR.

Engagement and factors associated with annual anal human papillomavirus screening among sexual and gender minority individuals.

While self-sampling could help address anal cancer screening barriers, no studies have investigated annual engagement with this method or compared it to annual screening with a provider. Building on our baseline paper,(7) we compared annual anal screening engagement between home-based self-sampling and clinic-based clinician sampling. The Prevent Anal Cancer Self-Swab Study recruited and randomized sexual and gender minority individuals 25 years and over who have sex with men to a home or clinic arm. Home-based participants were mailed an anal human papillomavirus self-sampling kit at baseline and 12 months, while clinic-based participants were asked to schedule and attend one of five participating clinics at baseline and 12 months. Using Poisson regression, we conducted an intention-to-treat analysis of 240 randomized participants who were invited to screen at both timepoints. 58.8% of participants completed annual (median = 370 days) anal screening. In the home arm, 65.0% of participants engaged in annual screening compared to 52.5% of clinic-based participants (p = 0.049). When stratified by HIV status, persons living with HIV had a higher proportion of home (71.1%) versus clinic (22.2%) annual screening (p < 0.001). Non-Hispanic Black participants participated more in home-based annual anal screening(73.1%) than annual clinic screening(31.6%) (p = 0.01). Overall, annual screening engagement was significantly higher among participants who had heard of anal cancer from an LGBTQ organization, reported "some" prior anal cancer knowledge, preferred an insertive anal sex position, and reported any prior cancer diagnosis. Annual screening engagement among those at disproportionate anal cancer risk was higher in the home arm.

Identifying optimum implementation for human papillomavirus self-sampling in underserved communities: A systematic review.

To review the existing evidence to identify the optimum methods for implementing human papillomavirus self-sampling to increase screening uptake for underserved groups. Specific groups are less likely to participate in cervical screening. These include individuals from low socioeconomic status groups, ethnic minority groups, younger age groups (25-29), older age groups (≥50), with a physical disability, with a learning disability and with an LGBTQ+ identity. The advent of human papillomavirus self-sampling for cervical screening presents an opportunity to promote equitable access to screening. Implementation for human papillomavirus self-sampling can vary, for example, opt-out or opt-in approaches. However, it is unclear which of these is the best method of offering human papillomavirus self-sampling to underserved groups. Six databases were searched through May 2023. Studies comparing cervico-vaginal human papillomavirus self-sampling provision using different implementation strategies with the standard screening pathway in underserved groups were identified. A narrative synthesis was conducted. In total, 4574 studies were identified; 25 studies were included, of which 22 were from high-income countries. Greater uptake was found for offering human papillomavirus self-sampling compared to standard clinician-based sampling. Directly mailing human papillomavirus self-sampling kits to participants resulted in higher uptake of screening than using an 'opt-in' approach or standard recall in low socioeconomic status and ethnic minority groups, and older women. Strategies that used community health workers or educational materials increased uptake in ethnic minority and low socioeconomic status groups. Directly mailing human papillomavirus self-sampling kits to low socioeconomic status groups, ethnic minority groups and older women has the potential to increase uptake of human papillomavirus self-sampling. Using community health workers to offer human papillomavirus self-sampling should be considered for ethnic minority and low socioeconomic status groups. Further research exploring the preferences of younger women is needed.

HPV self-sampling implementation strategies to engage under screened communities in cervical cancer screening: a scoping review to inform screening programs.

Human papillomavirus (HPV) testing as a method of cervical cancer screening can be performed by healthcare providers or by patients through self-sampling directly in the community, removing several barriers experienced by under screened populations. The objective of this scoping review was to determine which HPV self-sampling implementation and engagement strategies have been used to engage under screened populations (i.e., Indigenous, newcomer, and rural and remote communities) in cervical cancer screening. A scoping review was conducted searching MEDLINE, CINAHL, EMBASE, Cochrane Library, and SocINDEX from inception to August 2023. The inclusion criteria were: (1) Indigenous, newcomer, and rural and remote communities; (2) countries identified as members of the Organization for Economic Co-operation and Development; and (3) intervention included HPV self-sampling. The review was registered prior to conducting the search (https://osf.io/zfvp9). A total of 26 studies out of 2,741 studies met the inclusion criteria. In-person engagement with trusted community leaders was the most widely used and accepted recruitment and engagement strategy across all three populations. Six out of seven studies with Indigenous communities distributed HPV self-sampling kits to eligible participants in person in a clinical setting for collection on site or at home. Similarly, nine of the identified studies that engaged newcomers recruited participants in person through the community, where eligible participants were either given a kit (n = 7) or received one in the mail (n = 2). Lastly, of the 10 identified studies engaging rural and remote participants in HPV self-sampling, six recruited eligible participants in person at various community locations and four used electronic medical records or registries to identify and mail kits to participants. HPV self-sampling through in person kit distribution and mail out of HPV self-sampling kits is an effective way to increase participation rates amongst under screened populations.

Experiences and Perceptions of Cervical Cancer Screening Using Self-Sampling among Under-Screened Women in Flanders.

Primary Human Papillomavirus (HPV) screening on samples collected by women themselves has proven to be an effective strategy for cervical cancer screening (CCS) and may increase participation rates in women who do not partake (regularly) in screening. The aim of this study is to investigate reasons for non-participation and perceptions of CCS using self-sampling methods among under-screened women in Flanders. Individual interviews with 15 underscreened women aged 30-64 years were conducted. During the interviews, participants were given the opportunity to try out a urine and vaginal self-sampling kit. Thematic analysis was based on Ajzen's model of the Theory of Planned Behavior. The results showed that 14 out of 15 participants were more likely to participate in CCS if they had the option to self-sample. One of the main findings was a lack of knowledge on different aspects of cervical cancer. Most women had a positive attitude toward cancer screening and primary prevention such as HPV vaccination. Subjective norms were influenced by healthcare professionals, peers, and organized government initiatives. Informational, organizational, contextual, and emotional factors were mentioned as barriers as well as facilitators for participation. Additionally, high self-efficacy was considered to make self-sampling more convenient. All women showed the intention to use at least one method of self-sampling. We can conclude that women who do not participate in CCS would be more motivated to participate using self-sampling methods. Adequate education and guidance should be provided.

Nationwide registry-based trial of risk-stratified cervical screening.

In well-screened populations, most cervical cancers arise from small groups of women with inadequate screening. The present study aims to assess whether registry-based cancer risk assessment could be used to increase screening intensity among high-risk women. The National Cervical Screening Registry identified the 28,689 women residents in Sweden who had either no previous cervical screening or a screening history indicating high risk. We invited these women by SMS and/or physical letter to order a free human papillomavirus (HPV) self-sampling kit. The Swedish national HPV reference laboratory performed extended HPV genotyping and referred high-risk HPV-positive women to their regional gynecologist. A total of 3691/28,689 (12.9%) women ordered a self-sampling kit and 10.0% (2853/28,689) returned a sample for testing. Participation among women who had never attended screening was low, albeit improved. Up to 22.5% of women in other high-risk groups attended. High-risk HPV types were detected in 8.3% of samples. High-risk HPV-positive women (238/2853) were referred without further triaging and severe cervical precancer or cancer (HSIL+) in histopathology were detected in 36/158 (23%) of biopsied women. Repeat invitations gave modest additional participation. Nationwide contacting of women with high risk for cervical cancer with personal invitations to order HPV self-sampling kits resulted in high yield of detected CIN2+. Further efforts to improve risk-stratified screening strategies should be directed to improving (i) the precision of the risk-stratification algorithm, (ii) the convenience for the women to participate and, (iii) ensuring that screen-positive women are followed-up.

Increasing coverage in cervical and colorectal cancer screening by leveraging attendance at breast cancer screening: A cluster-randomised, crossover trial.

Screening participation remains suboptimal in cervical cancer (CC) and colorectal cancer (CRC) screening despite their effectiveness in reducing cancer-related morbidity and mortality. We investigated the effectiveness of an intervention by leveraging the high participation rate in breast cancer (BC) screening as an opportunity to offer self-sampling kits to nonparticipants in CC and CRC screening. A pragmatic, unblinded, cluster-randomised, multiple period, crossover trial was conducted in 5 BC screening units in the Central Denmark Region (CDR) between September 1, 2021 and May 25, 2022. On each of 100 selected weekdays, 1 BC screening unit was randomly allocated as the intervention unit while the remaining units served as controls. Women aged 50 to 69 years attending BC screening at the intervention unit were offered administrative check-up on their CC screening status (ages 50 to 64 years) and CRC screening status (aged 50 to 69), and women with overdue screening were offered self-sampling. Women in the control group received only standard screening offers according to the organised programmes. The primary outcomes were differences between the intervention group and the control group in the total screening coverage for the 2 programmes and in screening participation among women with overdue screening, measured 6 months after the intervention. These were assessed using intention-to-treat analysis, reporting risk differences with 95% confidence intervals (CIs). A total of 27,116 women were included in the trial, with 5,618 (20.7%) in the intervention group and 21,498 (79.3%) in the control group. Six months after the intervention, total coverage was higher in the intervention group as compared with the control group in CC screening (88.3 versus 83.5, difference 4.8 percentage points, 95% CI [3.6, 6.0]; p < 0.001) and in CRC screening (79.8 versus 76.0, difference 3.8 percentage points, 95% CI [2.6, 5.1]; p < 0.001). Among women overdue with CC screening, participation in the intervention group was 32.0% compared with 6.1% in the control group (difference 25.8 percentage points, 95% CI [22.0, 29.6]; p < 0.001). In CRC screening, participation among women overdue with screening in the intervention group was 23.8% compared with 8.9% in the control group (difference 14.9 percentage points, 95% CI [12.3, 17.5]; p < 0.001). Women who did not participate in BC screening were not included in this study. Offering self-sampling to women overdue with CC and CRC screening when they attend BC screening was a feasible intervention, resulting in an increase in participation and total coverage. Other interventions are required to reach women who are not participating in BC screening. ClinicalTrials.gov NCT05022511. The record of processing activities for research projects in the Central Denmark Region (R. No.: 1-16-02-217-21).

HPV Self-Sampling for Cervical Cancer Screening in Under-Screened Saskatchewan Populations: A Pilot Study.

Of all cancers in female Canadians, the most rapidly increasing incidence is that of cervical cancer. The objective of this pilot study was to assess how HPV self-sampling might improve cervical cancer screening participation in both urban and rural settings in Saskatchewan, one of the most sparsely populated provinces in Canada. Study groups consisted of n = 250 participants to whom self-swabbing kits were mailed with instructions and n = 250 participants to whom kits were handed out in 6 urban and rural clinics. The inclusion criteria selected subjects aged 30-69 years who were Saskatchewan residents for at least 5 years with valid health coverage, had a cervix, and had no record of cervical cancer screening in 4 years. The returned samples were analyzed for specific HPV strains using the Roche Molecular Diagnostics Cobas 4800® System. The overall response rate was ~16%, with the response to the handout distribution being roughly double that of the mailout. While HPV positivity did not differ across the distribution groups, participants at a specific inner-city clinic reported significantly higher positivity to at least one HPV strain as compared to any other clinic and all mailouts combined. For this high-risk population, in-person handout of self-sampling kits may be the most effective means of improving screening.

The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program

BackgroundIn Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening. MethodsThe ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31–64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories. ConclusionThe ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region. Trial registrationClinicalTrials.gov: NCT05656976

Opportunistic offering of self-sampling to non-attenders within the English cervical screening programme: a pragmatic, multicentre, implementation feasibility trial with randomly allocated cluster intervention start dates (YouScreen)

Self-sampling has game-changing potential to tackle the declining participation and inequities seen in many organised cervical screening programmes. Wide variation in uptake between settings and mode of kit offer highlight the importance of local piloting. Furthermore, harnessing the benefits of self-sampling in real-world settings has been surprisingly challenging. The YouScreen study estimated the impact of offering self-sampling to non-attenders within the English Programme and evaluated large-scale opportunistic offering of self-sampling in primary care. A pragmatic modified stepped-wedge implementation feasibility trial with randomly-allocated cluster intervention start dates at primary care practices in England (133 participating, 62 non-participating). Eligible women were aged 25-64 years and ≥6 months overdue for screening ("non-attenders"). Between January 13, 2021 and 30 November, 2021 self-sampling kits were distributed to non-attenders via an opportunistic offer in primary care when they consulted for any reason and direct mailout to those unscreened 15-months after routine invitation. Primary outcomes were the proportion of non-attenders screened each month; change in coverage; and uptake (90 days). YouScreen is registered with ISRCTN:12759467. 8338 women provided self-samples following recruitment between January 13, 2021 and 30 November, 2021. Self-samples were returned from 65.5% (6061/9248) who accepted an opportunistically offered kit and 12.9% (2777/17,604) directly-mailed kits. Responders were representative of the ethnically diverse and deprived underlying non-attendee population (64% ethnic minority groups, 60% from the two most deprived national quintiles). The self-sampling intervention resulted in a 22% (95% CI 18-26) increase in non-attenders screened per month (per-protocol analysis) and 12% (95% CI 9-15) (intention-to-treat analysis). Change in coverage at participating (mean intervention duration 7.5 months) vs non-participating practices was 1.6% (95% CI 0.4-2.8). Adverse effects were not formally collected. Opportunistically offering self-sampling to under-screened women in primary care could increase coverage in England and potentially reach underserved populations. North Central London and North East London Cancer Alliance.

Knowledge, Attitude toward Screening and Prevention or Cervical Cancer among Women at HCT in UAE

Purpose: Cervical cancer is one of the leading causes of death in the United Arab Emirates (UAE) among females. Knowledge and awareness toward cervical cancer has been proven to be essential toward decreasing the number of cervical cancer cases. In fact, adequate knowledge towards cervical cancer screening will help in early diagnosis and good prognosis outcome towards cervical cancer. The aim of this capstone project was to address the knowledge, attitude toward screening and prevention of cervical cancer among women at HCT in the UAE. Methodology: A quantitative cross-sectional study was conducted using an online survey that contained 22 multiple choice questions and was distributed via email. The sample size of this study is to target approximately 250-300 respondents and random sampling is used to select the participants. The data downloaded from Microsoft Forms into a Microsoft Excel sheet (version 16.36). To analyze the data, SPSS version 25.0 was used and the frequency, percentage tables were constructed for each section of the survey. Results: Responses of 196 participants were used in the data analysis. The vast majority of the participants (55.1%) were aged between 21- 25 years old and were mainly from Abu Dhabi campus (91.8%). A significant association was observed between the field of education and the knowledge of cervical cancer (p=0.002, p˂0.05). Additionally, screening knowledge and attitude toward cervical cancer were also noted to have an association between age (p=0.022, p˂0.05) and field of education (p=0.002, p˂0.05). Cervical cancer prevention had a strong association between age (p=0.007, p˂0.05), nationality (p=0.004, p˂0.05), and field of education (p=0.000, p˂0.05). Furthermore, 54.08% of participants had average knowledge and attitude toward screening and prevention of cervical cancer. Unique Contribution to Theory, Practice and Policy: Despite the strong association between field of education and the overall knowledge toward cervical cancer. Awareness sessions conducted by wide sponsors such as students’ life, campus operation, and department of health, will help in increasing cervical cancer knowledge and attitude. Based on the findings, it is recommending exploring female’s perspective in the UAE towards receiving HPV self-sampling kit at home, which helps to identify HPV positive females, therefore estimating the chances of developing cervical cancer.

Qualitative evaluation of digital vending machines to improve access to STI and HIV testing in South West England: using a Person-Based Approach

ObjectivesTo report the development, implementation, acceptability and feasibility of vending machines offering HIV and sexually transmitted infection (STI) testing kits.DesignA qualitative study using the Person-Based Approach with patient and public...

Service user experiences of using internet-based testing for sexually transmitted infections (STIs): a qualitative study

ObjectivesInternet-based testing for sexually transmitted infections allows individuals to order a self-sampling kit online, send samples to a central laboratory and receive their results electronically, reducing the need to attend...

Sociodemographic characteristics associated with cervical cancer screening participation by send-to-all and opt-in HPV self-sampling: Who benefits? Results from a randomized controlled trial among long-term non-attending women in Norway.

With the objective to investigate associations between sociodemographic characteristics and participation in interventions designed to increase participation in cervical cancer screening among under-screened women, we randomized a random sample of 6000 women in Norway aged 35-69 years who had not attended cervical screening for ≥10 years to receive either (i) a reminder to attend regular screening (control), (ii) an offer to order a self-sampling kit (opt-in), or (iii) a self-sampling kit unsolicited (send-to-all). We analyzed how sociodemographic characteristics were associated with screening participation within and between screening arms. In the send-to-all arm, increased screening participation ranged from 17.1% (95% confidence interval [95% CI] = 10.3% to 23.8%) to 30.0% (95% CI = 21.5% to 38.6%) between sociodemographic groups. In the opt-in arm, we observed smaller, and at times, non-significant increases within the range 0.7% (95% CI = -5.8% to 7.3%) to 19.1% (95% CI = 11.6% to 26.7%). In send-to-all versus control comparisons, there was greater increase in participation for women in the workforce versus not (6.1%, 95% CI = 1.6% to 10.6%), with higher versus lower income (7.6%, 95% CI = 2.2% to 13.1%), and with university versus primary education (8.5%, 95% CI = 2.4% to 14.6%). In opt-in versus control comparisons, there was greater increase in participation for women in the workforce versus not (4.6%, 95% CI = 0.7% to 8.5%), with higher versus lower income (6.3%, 95% CI = 1.5% to 11.1%), but lower increase for Eastern European versus Norwegian background (-12.7%, 95% CI = -19.7% to -5.7%). Self-sampling increased cervical screening participation across all sociodemographic levels, but inequalities in participation should be considered when introducing self-sampling, especially with the goal to reach long-term non-attending women.

Culturally Competent Education and Human Papillomavirus Self-Sampling Achieves Healthy People 2030 Cervical Screening Target Among Low-Income Non-Hispanic Black and Hispanic Women.

Disparities in cervical cancer screening, incidence, and mortality exist in the United States. Cervical cancer incidence and mortality rates in Texas are 20% and 32% higher, respectively, than national averages. Within Texas, these rates are significantly higher among non-Hispanic (NH) Black and Hispanic women. Cervical cancer screening uptake is lower among NH Black and Hispanic women (72.9% and 75.9%, respectively) compared with White women (85.5%) in Texas. During March-August 2023, we conducted a pilot study that offered culturally competent education and human papillomavirus (HPV) self-sampling kits to women in two public housing projects in Houston, TX, that have predominantly NH Black or Hispanic residents. Among those eligible for cervical cancer screening, 35% (n = 24) of the NH Black and 34% (n = 16) of the Hispanic women were found to be underscreened per the US Preventive Services Task Force Guideline. We recruited 40 (24 NH Black and 16 Hispanic) eligible women for our study. The study was approved by the MD Anderson institutional review board and registered with ClinicalTrials.gov (NCT04614155-March 11, 2020). Seventy-five percent of the NH Black and 87% of the Hispanic participants completed the HPV self-sampling procedures per protocol. Samples of 17% NH Black and 12% Hispanic participants showed a performance error. Overall, cervical cancer screening uptake improved from 65% to 91% among NH Black and from 66% to 96% among Hispanic participants. Culturally competent education and HPV self-sampling resulted in remarkable improvement in cervical cancer screening uptake among underscreened NH Black and Hispanic women residents of Houston public housing projects. Implementing this strategy could significantly reduce cervical cancer incidence and mortality among similar populations in the United States and globally.

Effectiveness of self-sampling human papillomavirus test on precancer detection and screening uptake in Japan: The ACCESS randomized controlled trial.

Japan is lagging in cervical cancer prevention. The effectiveness of a self-sampling human papillomavirus (HPV) test, a possible measure to overcome this situation, has not yet been evaluated. A randomized controlled trial was performed to evaluate the effectiveness of a self-sampling HPV test on detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and screening uptake. Women between 30 and 58 years old who did not participate in the cervical cancer screening program for ≥3 years were eligible and assigned to the intervention group (cytology or self-sampling HPV test) or control group (cytology). Participants assigned to the intervention group were sent a self-sampling kit according to their ordering (opt-in strategy). A total of 7337 and 7772 women were assigned to the intervention and control groups, respectively. Screening uptake in the intervention group was significantly higher than that in the control group (20.0% vs. 6.4%; risk ratio: 3.10; 95% confidence interval [CI]: 2.82, 3.42). The compliance rate with cytology triage for HPV-positive women was 46.8% (95% CI: 35.5%, 58.4%). CIN2+ was detected in five and four participants in the intervention and control groups, respectively; there was no difference for intention-to-screen analysis (risk ratio: 1.32; 95% CI: 0.36, 4.93). Self-sampling of HPV test increased screening uptake; however, no difference was observed in the detection of CIN2+, probably due to the low compliance rate for cytology triage in HPV-positive women. Efforts to increase cytology triage are essential to maximize precancer detections.

Acceptability of self-collected vaginal samples for human papillomavirus testing for primary cervical cancer screening: comparison of face-to-face and online recruitment modes

BackgroundThis study aimed to assess the acceptability and attitudes of women towards human papillomavirus (HPV) self-sampling and compare the effectiveness of two delivery modes utilising face-to-face and online website for cervical cancer screening in Hong Kong.MethodsWomen aged 30–65 years were invited to participate by distributing the study information pamphlets at the specialist clinics of a regional acute hospital. Those who were interested in participating were given the option to join directly face-to-face or through an online website. All participants provided informed consent and received self-sampling kits and acceptability questionnaires either immediately (face-to-face) or through the post after registering at the website (online). All participants were requested to collect their own vaginal samples using a swab which was then brushed on a DNA sample storage card and returned to the hospital either in person or by post. The self-collected samples were tested for high-risk HPV using the Sentis™ HPV assay, a validated isothermal nucleic acid amplification real-time fluorescent detection assay. The primary outcome was the uptake rate of HPV self-sampling.ResultsOf the 1998 women recruited (1200 face-to-face, 798 online), 1377 returned their samples, giving an overall uptake rate of 68.9%. The uptake rate was significantly greater in the face-to-face mode than in the online mode (74.6% vs. 60.4%, p < 0.001). The median age of the participants was 49 years, 43.7% were never or under-screened, and 7.1% had high-risk HPV detected. Overall, 82.1% of the participants reported self-sampling convenient, and 79.3% were not embarrassed when collecting self-samples. However, only 49.8% were confident that they had collected the self-samples correctly. Most (91.1%) of the participants expressed willingness to perform self-sampling again, mostly because it was simple (79.2%) and quick (56.3%).ConclusionsHPV self-sampling can serve as an alternative primary screening method for cervical cancer in Hong Kong, especially for individuals who have not been adequately screened in the past. Both face-to-face and online website recruitment were associated with high acceptability, emphasising the potential benefits of utilising different platforms and strategies for reaching diverse populations.

Abstract 3942: Mailed at-home self-sampling for HPV testing increases screening participation among under-screened patients in a U.S. safety net health system: Results of the PRESTIS trial

Abstract Background: In global settings, self-sampling for human papillomavirus (HPV) testing is associated with a pooled 2-fold increase in cervical cancer screening participation over usual care among underscreened persons. The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Trial is the first pragmatic randomized controlled trial (RCT) in the U.S. to evaluate the effectiveness of mailed at-home self-sampling for HPV testing in a safety net health system setting. Safety net systems provide care to medically underserved individuals at elevated cervical cancer risk. We hypothesized that patients who were mailed a self-sampling kit would have greater screening participation compared with those receiving usual care; and that patient navigation, a patient-centered intervention to address barriers to care, would further increase participation. Methods: PRESTIS is a three-arm pragmatic RCT of n=2,270 patients in a U.S. safety net health system who are under-screened for cervical cancer (i.e., no Pap in 3.5 years or Pap/HPV co-test in 5.5 years). Eligible participants were identified through the electronic health record (EHR) and randomized to arms: 1) telephone recall to provider-performed screening (usual care); 2) telephone recall + mailed self-sampling kit for HPV testing; or 3) telephone recall + mailed self-sampling kit + telephone-based patient navigation. Self-sampled swabs were tested for high-risk (HR)-HPV. HR-HPV+ patients were navigated to clinical follow-up. The primary outcome, incidence of screening participation, was ascertained by EHR review at 6 months post-randomization and defined as return of a completed kit or attendance for provider-performed screening. Results: Participants were enrolled 02/2020-08/2023. Primary outcomes have been ascertained for n=2,115 participants. Participants were predominantly Hispanic/Latina (68.6%); 53.4% indicated Spanish as primary language; and 60.3% were uninsured. Mean age was 47.9 years (SD: 10.4 years); median time since last screening test was 9.5 years (range: 1.6-21.7 years). In intent-to-treat analyses, screening participation was 15.3% (95% CI 13.0% - 17.9%) in Arm 1; 44.0% (40.4% - 47.6%) in Arm 2; and 51.4% (47.7% - 55.0%) in Arm 3. Relative incidence of screening in Arms 2 and 3 versus Arm 1 was 2.90 (2.42 - 3.47) and 3.36 (2.82 - 4.01), respectively. Relative incidence of screening in Arm 3 versus Arm 2 was 1.16 (1.04 - 1.29). Conclusion: Compared with usual care, mailed at-home self-sampling increased screening participation among an under-screened population by almost three-fold when used alone and over 3.3-fold when combined with telephone-based patient navigation. After FDA approval, self-sampling for HR-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations. Citation Format: Jane R. Montealegre, Elizabeth Y. Chiao, Matthew L. Anderson, Susan G. Hilsenbeck, Shaun Bulsara, Susan L. Parker, Maria Daheri, Trisha L. Amboree, Kathleen M. Schmeler, Maria L. Jibaja-Weiss, Mohammad Zare, Ashish A. Deshmukh, Michael E. Scheurer. Mailed at-home self-sampling for HPV testing increases screening participation among under-screened patients in a U.S. safety net health system: Results of the PRESTIS trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3942.