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319 result(s) for "At-home testing"
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An implementation study of text invitation, mailed at-home human papillomavirus (HPV) self-testing and telehealth management in Aotearoa New Zealand, with a nested randomised controlled trial that compared offering an incentive vs. no offer with a repeat test kit
Introduction In Aotearoa New Zealand, human papillomavirus (HPV) self-testing was introduced simultaneously with HPV primary screening in September 2023 to improve access and reduce inequities for priority populations, including Indigenous Māori, Pacific and under-screened people. To contribute policy-relevant information, we implemented non-standard engagement and screening strategies, including text message invitation, mailed test kits, at-home self-testing, telehealth support and follow-up by a central nurse-led co-ordination team. Methods We partnered with an Auckland primary health organisation (PHO) with high enrolment of priority populations. We invited people eligible for cervical screening aged 30—69 years by text message to receive mailed test kits (April–October 2023); people who did not respond were re-invited (October–November 2023). Offering a financial incentive to return a sample (intervention group) was compared with no offer (control group) in a sub-group of eligible Māori and Pacific who received a repeat mailed test kit in a nested randomised controlled trial (April–May 2024). Self-tested participants were invited by text message to an online survey. Results We invited 25,315 people and 24.0% opted in. Lower initial consent rates were increased after additional re-invitation reminders for Māori (20.0% to 30.4%) and Pacific (13.7% to 24.9%), with the final consent rate in Māori equal to European/Other (29.2%; p  = 0.284). Almost half (48.2%) of consenting participants returned a sample, giving a self-test uptake of 11.6% ( n  = 2,925). Uptake was significantly lower (all p  < 0.001) for Māori (12.7%) and Pacific (8.4%) vs. European/Other (19.0%), and for those under-screened (10.5%) vs. those overdue by < 6 months (19.4%). In the RCT, sample return rate did not differ significantly ( p  = 0.704) between the intervention (7.9%) and control (8.5%) groups. HPV was detected in 7.7% of 3,018 valid results. Follow-up test rates were high (96.8% for cytology, 90.5% for colposcopy). Almost all survey respondents preferred a mailed at-home self-test for their next screen (91.9%; n  = 193 of 210). Discussion Invitation by text message to mailed at-home HPV self-testing engaged priority populations in cervical screening. Central co-ordination support achieved high rates of sample return and follow-up testing where required. A mailed at-home testing option, strongly preferred by survey respondents, warrants consideration in a broader programme to improve access to cervical screening, with additional targeted strategies to improve sample return rates for priority populations. Clinical trial registration While the overall study did not reach the ICJME or WHO criteria for clinical trial registration, the nested RCT was retrospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12625000798460) and World Health Organization (WHO UTN U1111—1324—8454).
Population-Based Digital Health Interventions to Deliver at-Home COVID-19 Testing: SCALE-UP II Randomized Clinical Trial
Digital health interventions could be a scalable approach to delivering at-home COVID-19 testing. SCALE-UP II aimed to investigate the effectiveness of three digital health interventions on the delivery of mailed at-home COVID-19 testing: text messaging (TM), automated chatbot (CA), and patient navigation upon request (PN). Pragmatic randomized controlled trial. Participants who self-reported that they had a smartphone were randomized in a 2x2x2 factorial design (Smartphone study) to receive (i) chatbot or TM; (ii) option to request PN; and (iii) intervention frequency every 10 or 30 days. All other participants were randomized in a 2x2 factorial design (Non-Smartphone study) to receive (i) option to request PN; and (ii) intervention frequency every 10 or 30 days. Study settings were safety net community health centers (CHCs) located across the state of Utah, USA. Eligible patients were >18 years old, with a primary care visit in the last three years, and a valid cellphone in the CHC electronic health record. The primary outcome was proportion of participants requesting at-home COVID-19 tests. The trial enrolled 2,117 in the Smartphone study and 31,439 in the Non-Smartphone study. In the Smartphone study, the proportion of participants who requested test kits in the Chatbot arm was lower than in TM (16.6% vs. 52.1%, aRR=0.317 [98.33% CI 0.27-0.38], P<.0001). In the Non-Smartphone study, the proportion of participants who requested test kits was higher if they were messaged every 10 days rather than every 30 days (5.5% vs 4.8%, aRR=1.144 [97.5% CI 1.03-1.28], P=.005). Yet, participants in the 10-day vs. 30-day condition were more likely to opt out of receiving study interventions (12.6% vs 7.3%, aRR=1.72 [97.5% CI 1.59-1.86], P<.0001). In the Non-Smartphone study, the proportion of participants who requested test kits was lower for those in the PN condition compared to No PN (4.3% vs 5.9%, aRR=0.729 [97.5% CI 0.65-0.81], P<.0001). Simple bidirectional TM was more effective than an interactive Web-based chatbot on the delivery of COVID-19 testing. Although messaging every 10 days was more effective than every 30 days, it also led to a larger opt-out rate. Digital health interventions based on automated bidirectional text messaging is a simple, scalable, and low-cost strategy to offer access to at-home COVID-19 testing. Similar approaches may be used to support public health response and other forms of at-home testing. Clinicaltrials.gov (NCT05533918 and NCT05533359). RR2-doi: 10.1136/bmjopen-2023-081455.
CalScope: methodology and lessons learned for conducting a remote statewide SARS-CoV-2 seroprevalence study in California using an at-home dried blood spot collection kit and online survey
Background To describe the methodology for conducting the CalScope study, a remote, population-based survey launched by the California Department of Public Health (CDPH) to estimate SARS-CoV-2 seroprevalence and understand COVID-19 disease burden in California. Methods Between April 2021 and August 2022, 666,857 randomly selected households were invited by mail to complete an online survey and at-home test kit for up to one adult and one child. A gift card was given for each completed survey and test kit. Multiple customized REDCap databases were used to create a data system which provided task automation and scalable data management through API integrations. Support infrastructure was developed to manage follow-up for participant questions and a communications plan was used for outreach through local partners. Results Across 3 waves, 32,671 out of 666,857 (4.9%) households registered, 6.3% by phone using an interactive voice response (IVR) system and 95.7% in English. Overall, 25,488 (78.0%) households completed surveys, while 23,396 (71.6%) households returned blood samples for testing. Support requests ( n  = 5,807) received through the web-based form (36.3%), by email (34.1%), and voicemail (29.7%) were mostly concerned with the test kit (31.6%), test result (26.8%), and gift card (21.3%). Conclusions Ensuring a well-integrated and scalable data system, responsive support infrastructure for participant follow-up, and appropriate academic and local health department partnerships for study management and communication allowed for successful rollout of a large population-based survey. Remote data collection utilizing online surveys and at-home test kits can complement routine surveillance data for a state health department.
Potential of Point-of-Care and At-Home Assessment of Immune Status via Rapid Cytokine Detection and Questionnaire-Based Anamnesis
Monitoring the immune system’s status has emerged as an urgent demand in critical health conditions. The circulating cytokine levels in the blood reflect a thorough insight into the immune system status. Indeed, measuring one cytokine may deliver more information equivalent to detecting multiple diseases at a time. However, if the reported cytokine levels are interpreted with considering lifestyle and any comorbid health conditions for the individual, this will promote a more precise assessment of the immune status. Therefore, this study addresses the most recent advanced assays that deliver rapid, accurate measuring of the cytokine levels in human blood, focusing on add-on potentials for point-of-care (PoC) or personal at-home usage, and investigates existing health questionnaires as supportive assessment tools that collect all necessary information for the concrete analysis of the measured cytokine levels. We introduced a ten-dimensional featuring of cytokine measurement assays. We found 15 rapid cytokine assays with assay time less than 1 h; some could operate on unprocessed blood samples, while others are mature commercial products available in the market. In addition, we retrieved several health questionnaires that addressed various health conditions such as chronic diseases and psychological issues. Then, we present a machine learning-based solution to determine what makes the immune system fit. To this end, we discuss how to employ topic modeling for deriving the definition of immune fitness automatically from literature. Finally, we propose a prototype model to assess the fitness of the immune system through leveraging the derived definition of the immune fitness, the cytokine measurements delivered by a rapid PoC immunoassay, and the complementary information collected by the health questionnaire about other health factors. In conclusion, we discovered various advanced rapid cytokine detection technologies that are promising candidates for point-of-care or at-home usage; if paired with a health status questionnaire, the assessment of the immune system status becomes solid and we demonstrated potentials for promoting the assessment tool with data mining techniques.
O22.5 Providing Discrete and Reliable STD Testing in Alaska Via a Web-Based At-Home Service
Background Alaska has one of the highest rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in the United States. Alaska Native people, women and youth (ages 15–29) are disproportionately affected. Alaska Native health organisations have jurisdictions over large geographic areas, containing small isolated communities where a perceived lack of confidentiality and privacy is an identified barrier to accessing Sexually Transmitted Disease (STD) testing. The Alaska Native Tribal Health Consortium (ANTHC) has partnered with the “ I Want the Kit” programme (IWTK) at Johns Hopkins University (JHU) to provide a discrete and reliable STD testing alternative. Methods Alaska residents 14 years of age and older can request a no-cost STD testing kit online or by phone, which is mailed via U.S. Postal Service. After collection, the kit is returned in a prepaid envelope to JHU where it is tested for Chlamydia, gonorrhoea and Trichomonas . JHU reports all testing results to ANTHC, where a nurse notifies all participants of their results and refers positive cases for treatment. IWTK Alaska focuses its advertising efforts in rural Alaskan areas where the disease burden can be high and the barriers to accessing confidential healthcare are greatest. Results In 2012, JHU received a total of 439 home testing kit requests from Alaska of which 161 (37%) were returned. Alaska Native and/or American Indian participants comprised 30% and Whites 53% of kits tested; other minority groups made up the remaining 17% of kits tested. The ages of individuals who returned kits ranged from 16 to 63 years, with a median age of 28 years. Among the 161 kits tested, 14 (8.6%) tested positive for Chlamydia, two of these also tested positive for gonorrhoea, and four kits were positive for Trichomonas. Conclusion This web-based STD testing option increases access to STD testing by alleviating privacy and confidentiality concerns.
Opportunistic offer of human papillomavirus (HPV) self-testing in ethnically diverse primary care clinics in Aotearoa New Zealand: an implementation study
Background Human papillomavirus (HPV) self-testing was introduced in Aotearoa New Zealand in September 2023, with the potential to improve screening access and reduce inequities for priority populations: Māori, Pacific, and those overdue for screening by ≥ 2 years (underscreened). To contribute towards informing this change, we tested the implementation of offering the self-test opportunistically in primary care (with a take-home option) with follow-up by a central nursing team. Methods Trained general practice clinicians offered HPV self-tests to eligible people aged 30–69 years who attended for any reason between November 2021 and September 2023. Six clinics were selected for high proportions of priority populations. The central team reminded participants to return samples (if tested at home), and notified and managed HPV results via telehealth. Results Of 9,292 potentially eligible people, 37.9% ( n  = 3,524) were self-tested. A lower rate of self-testing was seen in all priority populations: 34.7% in Māori and 36.3% in Pacific vs. 40.4% in European/Other ( p  < 0.01, p  < 0.05, respectively), and 32.2% in underscreened vs. 52.3% in those < 6 months overdue (due) ( p  < 0.001). In the 16.8% of participants who took self-test kits home ( n  = 635), 61.1% ( n  = 388) returned a sample. Priority populations were more likely to take a test kit home: 22.2% of Māori and 20.0% of Pacific vs. 12.1% of European/Other, and 21.5% of underscreened vs. 11.7% of due (all p  < 0.001). Although a similar return rate was seen in Māori (64.3%) vs. European/Other (70.3%), fewer Pacific (51.1% vs. 70.3% in European/Other; p  < 0.05) and underscreened (48.7% vs. 89.4% in due; p  < 0.001) returned their sample. HPV was detected in 9.5% of 3,524 returned results. Follow-up testing rates were high (96.4% for cytology; 92.8% for colposcopy). Conclusions Opportunistically offering HPV self-tests in primary care engaged priority populations in cervical screening. Intensive support is required to achieve high rates of sample return (if tested at home) and follow-up where HPV was detected. Opportunistic offer of HPV self-testing in primary care should be considered as an important component of a broader strategy to increase equitable participation in cervical screening, with more focus needed for Māori, Pacific and those who are underscreened. Trial registration This study did not reach the ICJME or WHO criteria for clinical trial registration.
Clinician and patient experiences with opportunistic offer of HPV self-testing in Aotearoa New Zealand primary care clinics: interview and survey findings
Background To support the introduction of human papillomavirus (HPV) self-testing in the New Zealand National Cervical Screening Programme, we conducted an implementation study aimed to explore the acceptability and feasibility of opportunistically offering HPV self-testing in general practice from both clinician and participant perspectives with a home testing option and centralised follow-up. Methods Primary care clinicians trained to offer the HPV self-test were invited to semi-structured interviews exploring their perception of receptivity to the opportunistic offer and challenges and enablers to implementation. Reflexive thematic analysis was undertaken on transcripts. Participants (aged 30–69 years) were sent a link to an online survey after HPV result notification. Survey results were analysed using descriptive statistics with an inductive approach to analysis of free text responses. Participant recruitment and data collection occurred between November 2021 and January 2024. Results Of the 40 clinicians trained to offer HPV self-testing, 12 primary care clinicians from six ethnically diverse primary care sites in Auckland completed an interview. ‘Positive reception’ was the strongest theme with clinicians reporting that overwhelmingly, participants were receptive to the HPV self-test offer. The four enabler themes were: ‘supportive practice systems’, ‘importance of the discussion’, ‘options for testing' and ‘specialised support and consistency’. Key challenge themes in implementing opportunistic self-testing were ‘competing demands’ and ‘communicating what it’s all about’. Of the 3,524 self-tested participants, 394 responded to the survey. Most (93%) found the amount of information they received about HPV self-testing ‘about right’ and 86% were comfortable in their decision to self-test. Considering their next cervical screening, more respondents preferred home-based self-testing options than self-testing at a clinic (46% versus 37%). Conclusion Offering the HPV self-test opportunistically to people due for screening when they visited their primary care provider for any reason was generally well received and feasible for clinic staff. The option to take kits home for sampling was an enabler of participation. Supportive systems and resources for clinicians will be important if opportunistic HPV self-testing is offered more widely in primary care, including further consideration of a central specialist team to follow-up and support home testing and participants with HPV detected results. Trial registration This study did not reach the ICJME or WHO criteria for clinical trial registration.
Acceptability of self-sampling and self-testing for infections: a rapid systematic review on public users’ views
Background Self-sampling and self-testing have been increasingly used for sexually transmitted infections (STIs) and quickly became widespread during the COVID-19 pandemic. User acceptability, preferences, and experiences are important factors affecting self-sampling/self-testing uptake. Understanding these factors is key to managing infections and planning responses to health emergencies. This review aimed to identify user views and experiences related to the acceptability, usability, motivations and preferences for self-sampling/self-testing for infections. Methods We conducted a rapid systematic review. We searched Medline, EMBASE, PsycINFO, CINAHL, and Web of Science, limiting records to those published in English between 2014 and 2023. We also searched manually for additional peer-reviewed and grey literature. We included reports of public users’ views on self-sampling/self-testing for any symptomatic and asymptomatic infections (except human papillomavirus) with qualitative, mixed-methods or survey data relevant to the review aim. Data were extracted into tables and qualitative findings were coded in NVivo. We synthesised data narratively. Results We identified 194 eligible reports, including 64 from Europe (which we prioritised for detailed synthesis) and 130 from outside of Europe. In Europe, the studied infections were respiratory ( n  = 42, including 37 for COVID-19), STIs/HIV/genital infections ( n  = 20), and hepatitis C ( n  = 2). Findings indicate that users found self-sampling/self-testing acceptable across infection/sampling types, populations, settings, and countries. Users wanted self-sampling/self-testing to help determine infection status and protect others. The main benefits were privacy and convenience, helping reduce the potential stigma of STIs/HIV/genital infections, and (for COVID-19) informing behaviour (e.g., socialising, self-isolating) and contributing to research. Easier to perform and less invasive sampling approaches were more acceptable. However, some participants reported challenges to self-sampling/self-testing, such as not understanding instructions, pain/discomfort in collecting samples, and lack of confidence in interpreting results. Conclusions This review synthesised evidence on the acceptability of SS/ST and factors affecting it across different infections, sampling approaches, settings, and populations. Evidence shows that most people with experience of self-sampling/self-testing found it acceptable and were willing to accept some discomfort in favour of several perceived benefits. This amenability to self-sampling/self-testing could be leveraged for diagnosing infections and preventing transmission. It can be used to support the viability of new models of clinical care and pandemic preparedness. Trial registration The review was pre-registered on PROSPERO (ref. CRD42024507656 ).
At-home Testing and Risk Factors for Acquisition of SARS-CoV-2 Infection in a Major US Metropolitan Area
Abstract Background Unbiased assessment of the risks associated with acquisition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical to informing mitigation efforts during pandemics. The objective of our study was to understand the risk factors for acquiring coronavirus disease 2019 (COVID-19) in a large prospective cohort of adult residents in a large US metropolitan area. Methods We designed a fully remote longitudinal cohort study involving monthly at-home SARS-CoV-2 polymerase chain reaction (PCR) and serology self-testing and monthly surveys. Results Between October 2020 and January 2021, we enrolled 10 289 adults reflective of the Boston metropolitan area census data. At study entry, 567 (5.5%) participants had evidence of current or prior SARS-CoV-2 infection. This increased to 13.4% by June 15, 2021. Compared with Whites, Black non-Hispanic participants had a 2.2-fold greater risk of acquiring COVID-19 (hazard ratio [HR], 2.19; 95% CI, 1.91–2.50; P < .001), and Hispanics had a 1.5-fold greater risk (HR, 1.52; 95% CI, 1.32–1.71; P < .016). Individuals aged 18–29, those who worked outside the home, and those living with other adults and children were at an increased risk. Individuals in the second and third lowest disadvantaged neighborhood communities were associated with an increased risk of acquiring COVID-19. Individuals with medical risk factors for severe disease were at a decreased risk of SARS-CoV-2 acquisition. Conclusions These results demonstrate that race/ethnicity and socioeconomic status are the biggest determinants of acquisition of infection. This disparity is significantly underestimated if based on PCR data alone, as noted by the discrepancy in serology vs PCR detection for non-White participants, and points to persistent disparity in access to testing. Medical conditions and advanced age, which increase the risk for severity of SARS-CoV-2 disease, were associated with a lower risk of COVID-19 acquisition, suggesting the importance of behavior modifications. These findings highlight the need for mitigation programs that overcome challenges of structural racism in current and future pandemics.
“You know, it feels like you can trust them”: mixed methods implementation research to inform the scale up of a health disparities-responsive COVID-19 school testing program
Background Health disparities lead to negative COVID-19 outcomes for Hispanic/Latino communities. Rapid antigen testing was an important mitigation tool for protecting schools and their communities as in-person learning resumed. Within the context of a 3-middle-school non-inferiority trial we assessed acceptability and appropriateness of at-home and school-based COVID-19 antigen testing and implementation barriers and facilitators to facilitate district-wide scale up. Methods Guided by the Consolidated Framework for Implementation Research (CFIR) and acceptability and appropriateness implementation outcomes, we collected post-implementation qualitative (n = 30) and quantitative ( n  = 454) data in English and Spanish from trial participants, in-depth feedback sessions among program implementers ( n  = 19) and coded 137 project meeting minutes. Verbatim transcripts were thematically analyzed. We used multivariate linear models to evaluate program acceptability and appropriateness by COVID-19 testing modality and mixed qualitative and quantitative findings for interpretation. Results Questionnaire respondents closely matched school demographics (> 80% Hispanic/Latino and 8% Filipino/Asian Pacific Islander). While both testing modalities were rated as highly acceptable and appropriate, at-home testing was consistently favorable. Qualitative findings provided actionable areas for at-home testing program refinement, guiding district-wide scale up including: maintaining a learning climate to accommodate modifications as guidelines changed, needs of the school community, and implementation challenges; ensuring an engaged school leadership and sufficient human resources; improving educational communication about COVID-19 and technology ease of use; and increased time for pre-implementation planning and engagement. Conclusions Results underscore the value of the CFIR to inform program implementation, particularly programs to reduce disparities during a public health emergency. Results support optimal testing implementation strategies centering the needs and perspectives of Hispanic/Latinos.