Comparable performance of antigen-detecting rapid test by healthcare worker-collected and self-collected swabs for SARS-CoV-2 diagnostic: A systematic review and meta-analysis.

Usage of self-screening tests has become increasingly relevant in public health perspective for early detection of SARS-CoV-2 infection in the transitioning era of the COVID-19 pandemic into an endemic. This study was designed to compare the diagnostic accuracy of self-conducted and health professional-conducted SARS-CoV-2 rapid antigen tests (Ag-RDTs) and whether the sample was taken from anterior nasal or nasal mid-turbinate. Eligible comparative Ag-RDTs accuracy studies were retrieved from electronic databases systematically, in accordance with PRISMA. Selected studies were assessed for risk of bias using QUADAS-2 and QUADAS-C. In total, we selected five out of 1952 studies retrieved using the keywords. The overall sensitivity for the self-collected nasal swab method and healthcare worker-collected nasopharyngeal swab method was 79% (95% CI 68-87; I2  = 62%) and 83% (95% CI 75-89; I2  = 32%), respectively, which was not statistically different (p = 0.499). Nasal mid-turbinate swabs have a significantly higher sensitivity compared to anterior nasal swabs (p < 0.01). Both sampling methods represent high and comparable specificity values of 98% (95% CI 97-99; I2  = 0%) and 99% (95% CI 98-99; I2  = 0%). Positive predictive value (range 90%-99%) and negative predictive value (range 87%-98%) were equivalent for both methods. Our findings indicated the accuracy of self-collected Ag-RDT on nasal swabs was comparable to those performed by healthcare worker-collected on nasopharyngeal swabs. Self-collected Ag-RDT could be considered as a transmission prevention method in the transition of COVID-19 pandemic.

Distribution of rapid HCV antibody self-test kits via needle/syringe dispensing machines: Implementation and evaluation of the Vend-C pilot study in Melbourne, Australia.

Recent guidance from the World Health Organization strongly recommended hepatitis C virus (HCV) self-testing. We implemented the Vend-C pilot study to explore the effectiveness and feasibility of distributing rapid HCV antibody self-test kits to people who inject drugs via needle/syringe dispensing machines (SDMs). Over a 51-day study period between August and September 2022, we distributed HCV antibody self-test kits via two SDMs. During the study period, 63 self-test kits were dispensed, averaging 1.2 self-test kits per day. Our access methods for evaluation questionnaires failed to attract participants (n = 4). We implemented the Vend-C pilot study in direct response to recent WHO recommendations. While self-test kits were effectively distributed from the two SDMs, our evaluation methodology failed. Consequently, we cannot determine the success of linkage to care. Even so, with HCV treatment numbers dropping in Australia, innovative engagement solutions are needed, and considering the number of self-test kits provided in our pilot, the model could have an important future place in HCV elimination efforts.

Outcomes of Warfarin Home INR Monitoring vs Office-Based Monitoring: a Retrospective Claims-Based Analysis.

BACKGROUND: Home INR testing (patient self-testing) is feasible and effective for warfarin patients but little is known about real-world differences in outcomes for patients using PST versus laboratory-based INR monitoring. OBJECTIVE: To compare the safety/efficacy of patient self-testing of real-world warfarin therapy versus office/lab-based monitoring of therapy. DESIGN/SETTING/PARTICIPANTS/EXPOSURE: A retrospective claims-based analysis of warfarin patients enrolled in the MarketScan® Commercial Claims and Encounters and Medicare databases between January 1, 2013, and March 30, 2020. Stratification was based on INR testing method: patient self-testing versus testing at physicians' offices/local laboratory. The probability of adverse events in each cohort was determined after adjusting for demographic and baseline clinical characteristics using a repeated measures analysis. MAIN MEASURES: Rates of all adverse events: deep venous thrombosis, pulmonary embolism, bleeding, and stroke. A secondary outcome of interest was emergency department visits. KEY RESULTS: A total of 37,837 patients were included in the analysis: 1592 patients in the patient self-testing group and 36,245 in the office-based therapy group. After adjusting for demographic and baseline clinical characteristics, patients in the office-based group had statistically significantly higher rates of all adverse events (incidence rate ratio [IRR]=2.07, 95% CI [1.82, 2.36]), and specific adverse events including thromboembolism (IRR=4.38, 95% CI [3.29, 5.84]), major bleed (IRR=1.45, 95% CI [1.28, 1.64]), and stroke (IRR=1.30, 95% CI [1.05, 1.61]) than patients in the patient self-testing group. Office-based patients also had a statistically significant higher rate of emergency department visits than patient self-testing patients (IRR = 1.65, 95% CI [1.47, 1.84]). CONCLUSIONS/RELEVANCE: This analysis of real-world claims data shows lower rates of stroke, thromboembolism, and major bleeding, as well as fewer emergency department visits, with patient self-testing compared to office-based/lab INR monitoring. Our finding that PST is safe and effective among current users suggests that more patients may benefit from its use.

Self-swabbing versus assisted swabbing for viral detection by qRT-PCR: the experience from SARS-CoV-2 based on a meta-analysis of six prospectively designed evaluations conducted in a UK setting.

PURPOSE: In April 2020, the UK Government implemented NHS Test and Trace to provide SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (qRT-PCR) testing for the public, with nose-and-throat swabbing for samples performed by trained staff. Self-swabbing (SS) would allow rapid scale-up of testing capacity and access. Six studies were undertaken to determine whether SS was as effective for detecting SARS-CoV-2 as swabbing performed by trained staff. METHODS: Six prospective studies were conducted between April-October 2020, using six swab/media combinations. Differences between assisted swabbing (AS) and SS were evaluated for concordance, positivity, sensitivity, cycle threshold (Ct) values and void rates. Statistical analysis was performed using 95% confidence intervals (CIs), paired t-tests and model-based methods. RESULTS: Overall, 3,253 individuals were recruited (median age 37 years, 49% female), with 2,933 having valid paired qRT-PCR results. Pooled concordance rate was 98% (95% CI: 96%, 99%). Positivity rate differences for SS (8.1%) and AS (8.4%) and differences in pooled sensitivities between SS (86%; 95% CI: 78%, 92%) and AS (91%; 95% CI: 78%, 96%) were nonsignificant. Both types of swabbing led to pooled void rates below 2% and strongly correlated Ct values. Age, sex and previous swabbing experience did not have a significant impact on concordance or sensitivity. CONCLUSION: The UK adopted a policy to promote self-testing for SARS-CoV-2 based on data demonstrating equivalence of SS versus AS. Positive outcomes with SS are likely generalisable to testing for other respiratory pathogens, and we consider self-sampling and self-testing essential for future pandemic preparedness.

Willingness to Receive HIV Self-Testing Kits from Recent Sexual Partners Among Men in Dar Es Salam, Tanzania: Findings from the STEP Project Baseline Survey.

Globally, men are less likely to access HIV services, and addressing HIV service challenges among men is crucial to the global HIV/AIDS response. HIV self-testing (HIVST) has been shown to be a potentially effective strategy in improving HIV testing coverage among men. This study assessed and identified factors influencing willingness to receive HIVST kits from sexual partners among men in Tanzania. Data are from the baseline survey of the Self-Testing Education and Promotion (STEP) project, a five-year study comprising male participants aged 18 or older who self-reported as HIV-negative. Logistic regression models were used to assess factors associated with men's willingness to receive HIVST kits from their sexual partners. There were 505 heterosexual male participants enrolled in the study with an average age of 29 years, of whom 69% reported being willing to receive HIVST kits from their sexual partner. Logistic regression models demonstrated that willingness to receive HIVST kits from sexual partners was significantly associated with number of sexual partners within 12 months (aOR = 1.2, 95% CI [1.1-1.3]), awareness of HIVST (aOR = 5.6, 95% CI [3.2-9.5]), previous discussion of HIVST with sexual partners aOR = 14.0, 95% CI [8.0-24.6]), and previous testing for HIV with sexual partners not (aOR = 2.5, 95% CI [1.3-4.7]). These findings suggest additional promotional strategies to improve men's awareness of HIVST and support open conversations about HIVST and HIV testing with sexual partners could improve men's willingness to receive HIVST kits when distributed through their sexual partners.

Targeted HIV Self-Testing Identifies Persons with Undiagnosed HIV and Active Engagement Links them to Care: The GetaKit Study.

Current international HIV testing guidelines recommend that HIV negative persons from HIV priority groups complete repeat screening every 3-6 months; local guidelines in our jurisdiction recommend that such retesting should occur every 3 months. Such an approach allows for timely HIV diagnosis and linkage to care - and aligns with the UNAIDS 95-95-95 targets to have 95% of undiagnosed persons be aware of their HIV status. To meet these aims, new approaches to HIV testing have been developed, including our HIV self-testing initiative, GetaKit.ca, which uses an online screening algorithm to determine eligibility and has built in pathways for re-test reminders, linkage HIV prevention care, and rapid follow-up for positive test results. To understand self-testing frequency in relation to our local recommendations for resting every 3 months, we evaluated data from participants who ordered repeat HIV self-tests through GetaKit.ca. Descriptive analyses were performed on participant characteristics and chi-square tests were performed on aggregated participant risk data. During the study period, 5235 HIV self-tests were distributed to 3627 participants, of whom, 26% ordered more than once and 27% belonged to an HIV priority population. Participants who retested were more likely to have been white, male, and part of an HIV priority population; they were also more likely to have completed prior STI or HIV testing or had a prior STI diagnosis, compared to those who did not. We identified 16 new HIV diagnoses, 2 of which were among repeat testers. Our results suggest that HIV self-testing can be useful to help meet UNAIDS targets to identify undiagnosed infections; however, such efforts are less likely to be successful without adequate linkage to follow-up services, including HIV treatment and prevention care.

Factors Associated with the First-time HIV Testing Among Chinese men who have sex with men Who Received HIV Self-tests from Partners or Friends.

Secondary distribution of HIV self-testing (HIVST) among individual social networks was an effective approach to expanding HIV testing among men who have sex with men (MSM). However, understanding the factors associated with first-time HIV testing behaviors in the secondary distribution of HIVST programs is limited. Hence, this study aims to identify factors related to first-time testers in the secondary distribution of HIVST. Participants were recruited from five provinces in southern China through Blued, a geo-social gay networking app in China from January 2021 to December 2021. Eligible consented participants (referred to as "seeds") finished a baseline survey and then applied for up to five HIVST kits. They were encouraged to distribute HIVST kits to other MSM (referred to as "alters") and alters were encouraged to scan a QR code to return their photographed testing results. All alters were invited to finish an online survey. In total, 229 seeds reached 292 alters, among whom 126 (43.2%) were first-time testers whereas 166 (56.8%) were non-first-time testers. Importantly, our results demonstrated that the first-time HIV testers were more likely to self-report as heterosexual (aOR = 4.88, 95% CI 1.01-23.61), disclose sexual orientation and/or SSB (aOR = 1.73, 95% CI 1.01-2.96), and receive HIVST knowledge from the seeds (aOR = 3.25, 95% CI 1.02-10.34). However, those who had sex with male partners in the last three months were less likely to be first-time testers (aOR = 0.43, 95% CI 0.23-0.82). Practical implications and limitations were also discussed to improve future HIV prevention programs.

Village health team-delivered oral HIV self-testing increases linkage-to-care and antiretroviral-therapy initiation among men in Uganda.

Targeted strategies are central to increasing HIV-status awareness and progress on the care cascade among men. We implemented Village-Health-Team (VHT)-delivered HIV self-testing (HIVST) among men in a peri-urban Ugandan district and assessed linkage to confirmatory-testing, antiretroviral-therapy (ART) initiation and HIV-status disclosure following HIVST. We conducted a prospective cohort study from November 2018 to June 2019 and enrolled 1628 men from 30-villages of Mpigi district. VHTs offered each participant one HIVST-kit and a linkage-to-care information leaflet. At baseline, we collected data on demographics, testing history and risk behavior. At one-month, we measured linkage to confirmatory-testing and HIV-status disclosure, and at three months ART-initiation if tested HIV-positive. We used Poisson regression generalized estimating equations to evaluate predictors of confirmatory-testing. We found that 19.8% had never tested for HIV and 43% had not tested in the last 12-months. After receiving HIVST-kits, 98.5% self-reported HIVST-uptake in 10-days, 78.8% obtained facility-based confirmation in 30-days of HIVST with 3.9% tested HIV-positive. Of the positives, 78.8% were newly diagnosed, 88% initiated ART and 57% disclosed their HIV-status to significant others. Confirmatory testing was associated with having a higher level of education and knowing a partner's HIV-status. VHT-delivered HIVST may be effective for boosting testing, ART-initiation and HIV-status disclosure among men.

Organisation of testing services, structural barriers and facilitators of routine HIV self-testing during sexually transmitted infection consultations: a qualitative study of patients and providers in Abidjan, Côte d'Ivoire.

BACKGROUND: Consultations for sexually transmitted infection (STI) provide an opportunity to offer HIV testing to both patients and their partners. This study describes the organisation of HIV self-testing (HIVST) distribution during STI consultations in Abidjan (Côte d'Ivoire) and analyse the perceived barriers and facilitators associated with the use and redistribution of HIVST kits by STI patients. MATERIALS AND METHODS: A qualitative study was conducted between March and August 2021 to investigate three services providing HIVST: an antenatal care clinic (ANC), a general health centre that also provided STI consultations, and a dedicated STI clinic. Data were collected through observations of medical consultations with STI patients (N = 98) and interviews with both health professionals involved in HIVST distribution (N = 18) and STI patients who received HIVST kits for their partners (N = 20). RESULTS: In the ANC clinic, HIV testing was routinely offered during the first prenatal visit. HIVST was commonly offered to women who had been diagnosed with an STI for their partner's use (27/29 observations). In the general health centre, two parallel pathways coexisted: before the consultation, a risk assessment tool was used to offer HIV testing to eligible patients and, after the consultation, patients who had been diagnosed with an STI were referred to a care assistant for HIVST. Due to this HIV testing patient flow, few offers of HIV testing and HIVST were made in this setting (3/16). At the dedicated STI clinic, an HIVST video was played in the waiting room. According to the health professionals interviewed, this video helped reduce the time required to offer HIVST after the consultation. Task-shifting was implemented there: patients were referred to a nurse for HIV testing, and HIVST was commonly offered to STI patients for their partners' use (28/53). When an HIVST was offered, it was generally accepted (54/58). Both health professionals and patients perceived HIVST positively despite experiencing a few difficulties with respect to offering HIVST to partners and structural barriers associated with the organisation of services. CONCLUSION: The organisation of patient flow and task-shifting influenced HIV testing and offers of HIVST kits. Proposing HIVST is more systematic when HIV testing is routinely offered to all patients. Successful integration requires improving the organisation of services, including task-shifting.

Costs of distributing HIV self-testing kits in Eswatini through community and workplace models.

BACKGROUND: This study evaluates the implementation and running costs of an HIV self-testing (HIVST) distribution program in Eswatini. HIVST kits were delivered through community-based and workplace models using primary and secondary distribution. Primary clients could self-test onsite or offsite. This study presents total running economic costs of kit distribution per model between April 2019 and March 2020, and estimates average cost per HIVST kit distributed, per client self-tested, per client self-tested reactive, per client confirmed positive, and per client initiating antiretroviral therapy (ART). METHODS: Distribution data and follow-up phone interviews were analysed to estimate implementation outcomes. Results were presented for each step of the care cascade using best-case and worst-case scenarios. A top-down incremental cost-analysis was conducted from the provider perspective using project expenditures. Sensitivity and scenario analyses explored effects of economic and epidemiological parameters on average costs. RESULTS: Nineteen thousand one hundred fifty-five HIVST kits were distributed to 13,031 individuals over a 12-month period, averaging 1.5 kits per recipient. 83% and 17% of kits were distributed via the community and workplace models, respectively. Clients reached via the workplace model were less likely to opt for onsite testing than clients in the community model (8% vs 29%). 6% of onsite workplace testers tested reactive compared to 2% of onsite community testers. Best-case scenario estimated 17,458 (91%) clients self-tested, 633 (4%) received reactive-test results, 606 (96%) linked to confirmatory testing, and 505 (83%) initiated ART. Personnel and HIVST kits represented 60% and 32% of total costs, respectively. Average costs were: per kit distributed US$17.23, per client tested US$18.91, per client with a reactive test US$521.54, per client confirmed positive US$550.83, and per client initiating ART US$708.60. Lower rates for testing, reactivity, and linkage to care in the worst-case scenario resulted in higher average costs along the treatment cascade. CONCLUSION: This study fills a significant evidence gap regarding costs of HIVST provision along the client care cascade in Eswatini. Workplace and community-based distribution of HIVST accompanied with effective linkage to care strategies can support countries to reach cascade objectives.

Lessons learned from implementation of four HIV self-testing (HIVST) distribution models in Zambia: applying the Consolidated Framework for Implementation Research to understand impact of contextual factors on implementation.

BACKGROUND: Although Zambia has integrated HIV-self-testing (HIVST) into its Human Immunodeficiency Virus (HIV) regulatory frameworks, few best practices to optimize the use of HIV self-testing to increase testing coverage have been documented. We conducted a prospective case study to understand contextual factors guiding implementation of four HIVST distribution models to inform scale-up in Zambia. METHODS: We used the qualitative case study method to explore user and provider experiences with four HIVST distribution models (two secondary distribution models in Antenatal Care (ANC) and Antiretroviral Therapy (ART) clinics, community-led, and workplace) to understand factors influencing HIVST distribution. Participants were purposefully selected based on their participation in HIVST and on their ability to provide rich contextual experience of the distribution models. Data were collected using observations (n = 31), group discussions (n = 10), and in-depth interviews (n = 77). Data were analyzed using the thematic approach and aligned to the four Consolidated Framework for Implementation Research (CFIR) domains. RESULTS: Implementation of the four distribution models was influenced by an interplay of outer and inner setting factors. Inadequate compensation and incentives for distributors may have contributed to distributor attrition in the community-led and workplace HIVST models. Stockouts, experienced at the start of implementation in the secondary-distribution and community-led distribution models often disrupted distribution. The existence of policy and practices aided integration of HIVST in the workplace. External factors complimented internal factors for successful implementation. For instance, despite distributor attrition leading to excessive workload, distributors often multi-tasked to keep up with demand for kits, even though distribution points were geographically widespread in the workplace, and to a less extent in the community-led models. Use of existing communication platforms such as lunchtime and safety meetings to promote and distribute kits, peers to support distributors, reduction in trips by distributors to replenish stocks, increase in monetary incentives and reorganisation of stakeholder roles proved to be good adaptations. CONCLUSION: HIVST distribution was influenced by a combination of contextual factors in variable ways. Understanding how the factors interacted in real world settings informed adaptations to implementation devised to minimize disruptions to distribution.

Accuracy of and preferences for blood-based versus oral-fluid-based HIV self-testing in Malawi: a cross-sectional study.

BACKGROUND: HIV self-testing (HIVST) can use either oral-fluid or blood-based tests. Studies have shown strong preferences for self-testing compared to facility-based services. Despite availability of low-cost blood-based HIVST options, to date, HIVST implementation in sub-Saharan Africa has largely been oral-fluid-based. We investigated whether users preferred blood-based (i.e. using blood sample derived from a finger prick) or oral fluid-based HIVST in rural and urban Malawi. METHODS: At clinics providing HIV testing services (n = 2 urban; n = 2 rural), participants completed a semi-structured questionnaire capturing sociodemographic data before choosing to test using oral-fluid-based HVST, blood-based HIVST or provider-delivered testing. They also completed a self-administered questionnaire afterwards, followed by a confirmatory test using the national algorithm then appropriate referral. We used simple and multivariable logistic regression to identify factors associated with preference for oral-fluid or blood-based HIVST. RESULTS: July to October 2018, N = 691 participants enrolled in this study. Given the choice, 98.4% (680/691) selected HIVST over provider-delivered testing. Of 680 opting for HIVST, 416 (61.2%) chose oral-fluid-based HIVST, 264 (38.8%) chose blood-based HIVST and 99.1% (674/680) reported their results appropriately. Self-testers who opted for blood-based HIVST were more likely to be male (50.3% men vs. 29.6% women, p < 0.001), attending an urban facility (43% urban vs. 34.6% rural, p = 0.025) and regular salary-earners (49.5% regular vs. 36.8% non-regular, p = 0.012). After adjustment, only sex was found to be associated with choice of self-test (adjusted OR 0.43 (95%CI: 0.3-0.61); p-value < 0.001). Among 264 reporting blood-based HIVST results, 11 (4.2%) were HIV-positive. Blood-based HIVST had sensitivity of 100% (95% CI: 71.5-100%) and specificity of 99.6% (95% CI: 97.6-100%), with 20 (7.6%) invalid results. Among 416 reporting oral-fluid-based HIVST results 18 (4.3%) were HIV-positive. Oral-fluid-based HIVST had sensitivity of 88.9% (95% CI: 65.3-98.6%) and specificity of 98.7% (95% CI: 97.1-99.6%), with no invalid results. CONCLUSIONS: Offering both blood-based and oral-fluid-based HIVST resulted in high uptake when compared directly with provider-delivered testing. Both types of self-testing achieved high accuracy among users provided with a pre-test demonstration beforehand. Policymakers and donors need to adequately plan and budget for the sensitisation and support needed to optimise the introduction of new quality-assured blood-based HIVST products.

HIV self-testing adoption and post-test linkage to care among men who have sex with men in China: a nationwide cross-sectional survey.

BACKGROUND: HIV self-testing (HIVST) was recommended to improve HIV testing services. China initiated some of the first HIVST pilots in the world, providing a unique opportunity for implementation research. We aim to investigate HIVST adoption and its following linkage to care among Chinese men who have sex with men (MSM). METHODS: Data were collected using an online questionnaire distributed on major social media platforms in 2018, one year after HIVST was officially endorsed and allowed for sale. MSM who were at least 16 years old, assigned as male at birth, and ever tested for HIV were eligible. Primary outcome, adoption was defined as ever use of HIVST. Bivariate and multivariable logistic regressions were performed to explore the association between HIVST adoption and sociodemographic and behavioral factors. Linkage to care was also described via the following sequential events as indicators: (1) receiving result after recent test (2), seeking care from healthcare facility if test result was positive or indeterminate, and (3) delayed time before seeking care. RESULTS: A total of 540 participants were included with an average age of 27.4 ± 6.6. Most were never married (87.4%) and half completed college (52.2%). Overall, 75.2% had adopted HIVST. Self-test kits were commonly obtained from community-based organizations (54.4%) and from online (46.6%). HIVST adoption was positively associated with having college or higher education (OR = 1.66, 95%CI: 1.07-2.57), and negatively associated with age older than 30 (AOR = 0.52, 95%CI: 0.32-0.84). Adoption was not associated with other socio-demographic or behavioral factors. After receiving HIV-positive or indeterminate results, 25/25 of HIVST adopters sought care while 3 out of 7 (42.9%) non-adopters sought care (p < 0.001). Delays before seeking care were not significantly different between HIVST adopters compared to non-adopters (P = 0.366). CONCLUSION: Many MSM adopted HIVST shortly after its launch. Our findings suggested that HIVST linkage to care is promising among MSM in China. Integration of HIVST with other essential sexual health services is needed.

Point-of-care testing, near-patient testing and patient self-testing: warning points.

Point-of-care testing (POCT), near-patient testing (NPT) and patient self-tests (PST) are diagnostic examinations performed at the time and place of patient care. While POCT and NPT are performed and analyzed by medical professionals, PST are based on samples and parameters directly collected and analyzed by lay users. These tests are spreading both in high income countries and in low to middle income countries as they are expected to improve healthcare efficiency and equity, by saving resources, releasing pressure from hospitals and reducing logistical barriers. However, accurate multidisciplinary assessment is mandatory to ensure that what they promise is real. We reviewed some important ethical aspects, international standards and regulations. The current risks associated with alternative ways of testing are explained by the principles of respect for patient autonomy and non-maleficence. Further evidence from multidisciplinary assessment is needed to evaluate pros and cons in light of the principles of beneficence and justice. Although POCT or NPT need common regulation and accurate provider training to ensure safe and appropriate interpretation of results, PST needs even more attention as they are subject to direct patient use. Randomized controlled trails including patient education should be conducted in order to provide reliable evidence on clinical outcomes, patient acceptance and cost-effectiveness. Mandatory regulation is needed to avoid harm and EU regulation should help different countries maintain a safe use of devices in a global population of producers and users.

Knowledge, and utilization of HIV self-testing, and its associated factors among women in sub-Saharan Africa: evidence from 21 countries demographic and health survey.

BACKGROUND: HIV Self-Testing (HIVST) holds great significance in the fight against the HIV epidemic in Sub-Saharan Africa (SSA). It offers a convenient and confidential option for individuals to know their HIV status and seek appropriate care and support. For women in this region, where stigma, discrimination, and lack of access to healthcare services are prevalent, HIVST can empower them to take control of their health and make informed decisions. However, no study in the region has been conducted on this topic. Hence, this study aimed to fill the evidence, and population gaps by identifying women's HIVST knowledge, and utilization, and its associated factors in SSA. METHODS: The data used were gathered from the most recent demographic and health surveys conducted in SSA nations between 2015 and 2022. We incorporated DHS data from 21 countries into our investigation. For our analysis, we used a weighted sample of 270,241 women overall was utilized. To handle both individual and community level factors, a multilevel logistic regression was used for the analysis. The adjusted odds ratio and its 95% confidence interval were then presented, and variables with univariate multilevel regression p-values of ≤ 0.25 and in multivariable multilevel logistic regression < 0.05 p value were considered significant factors of HIVST. RESULTS: The overall prevalence of knowledge, and utilization of HIVST among women was about 2.17 (95% CI: 2.12, 2.23) only. Women aged 25-34 years old (AOR = 1.78, 95% CI: 1.65,1.92), and 35-49 years old (AOR = 1.33, 95% CI: 1.22,1.46), primary education(AOR = 1.25, 95%CI: 1.12, 1.38), and secondary/higher education (AOR = 3.08, 95% CI: 2.79, 3.41), poorer (AOR = 1.22, 95% CI: 1.08, 1.38), middle (AOR = 1.19, 95% CI: 1.06, 1.37), richer (AOR = 1.45, 95% CI 1.45, 1.64), and richest (AOR = 1.81, 95% CI: 1.59, 2.05), employed (AOR = 1.73 05% CI: 1.62, 1.85), mass media exposure (AOR = 1.39, 95% CI: 1.31, 1.49), knew modern contraception (AOR = 2.75, 95% CI: 1.84, 4.13), health facility delivery (AOR = 1.17, 95% CI: 1.02, 1.37), being from urban (AOR = 1.53, 95% CI: 1.63, 1.73), divorced or widowed (AOR = 77, 95% CI:1.13, 1.34), have more than one sexual partners (AOR =, 95% CI: 1.24, 1.41), heard about STIs (AOR 7.47 =, 95% CI: 5.16, 10.81), high community ANC coverage (AOR = 1.46, 95% CI: 1.31, 1.63), high community mass media (AOR = 1.37 95% CI: 1.21, 1.56), Central/Southern Africa (AOR = 0.66 95% CI: 0.59,0.74), and East Africa regions (AOR = 0.87 95% CI: 0.81,0.94) were associated with the knowledge and utilization of HIVST. CONCLUSIONS: The level of knowledge and utilization of HIVST among women in SSA was very low. To improve this situation, maternal health services can be enhanced. This can be achieved by facilitating institutional delivery, promoting access to modern contraception, increasing ANC coverage, empowering women's associations, creating culturally respectful mass media content, and involving rural and economically disadvantaged women. By implementing these measures, we can enhance women's knowledge and improve their use of HIVST.

Implementing a pilot study of COVID-19 self-testing in high-risk populations and remote locations: results and lessons learnt.

BACKGROUND: Rapid antigen-detection tests for SARS-CoV-2 self-testing represent a useful tool for pandemic control and expanding access to community-level case screening. COVID-19 self-tests have been extensively used in high-income countries since 2021; however, their introduction and programmatic implementation in low- and middle-income countries was delayed. We aimed to identify and continuously improve a weekly COVID-19 self-testing model among staff at healthcare facilities and schools. METHODS: This mixed-methods, observational prospective study was conducted in 5 healthcare centres and 24 schools in Georgia, between June and December 2022. The study comprised the integration of COVID-19 self-testing into the national mandatory testing programme for high-risk groups, with primary distribution of self-tests among staff performed weekly, plus secondary distribution to their household members. These use cases were selected because NCDC was seeking to strengthen their already strong weekly testing programme, by investigating self-testing to ease the burden of testing in the healthcare system. Online surveys and semi-structured interviews were used for data collection. RESULTS: In total, 2156 participants were enrolled (1963 female, 72%). At baseline and mid- and end-points, 88%, 97% and 99%, respectively, of participants agreed/strongly agreed they would self-test. Similarly, the majority were willing to report their self-testing results (88%, 98% and 96% at baseline and mid- and end-points, respectively). Weekly reporting of test results to the national COVID-19 database was high during all the implementation. There were 622 COVID-19 positive results reported, and linked to care, from 601 individuals (282 participants and 319 household members). Findings from qualitative interviews showed great satisfaction with self-testing for its convenience, ease of use, trust in the results, no need to travel for diagnostics, and increased perception of safety. CONCLUSIONS: Our findings contribute to the evidence-base regarding self-testing strategies conducted via workplaces and secondary distribution to households. Willingness to perform a COVID-19 self-test increased after implementation. This pilot enhanced pandemic preparedness through expansion of the national self-testing reporting system, development of communications materials, changes in the national legal framework and coordination mechanisms, and improved perceptions around self-care in the community. The lessons learnt can inform operational aspects of the introduction and scale-up of self-care strategies.

Real world outcomes of distributing Lucira Check-It® COVID self-tests in Ontario, Canada: the GetaKit COVID study.

BACKGROUND: In Ontario, Canada we developed and implemented an online screening algorithm for the distribution of HIV self-tests, known as GetaKit. During the COVID pandemic, we adapted the GetaKit algorithm to screen for COVID based on population and infection data and distributed COVID rt-LAMP self-tests (using the Lucira Check-It®) to eligible participants. METHODS: GetaKit/COVID was a prospective observational study that occurred over a 7-month period from September 2021 to April 2022. All potential participants completed an online registration and risk assessment, including demographic information, COVID symptoms and risk factors, and vaccination status. Bivariate comparisons were performed for three outcomes: results reporting status, vaccination status, and COVID diagnosis status. Data were analysed using Chi-Square for categorial covariates and Independent Samples T-Test and Mann-Whitney U test for continuous covariates. Bivariate logistic regression models were applied to examine associations between the covariates and outcomes. RESULTS: During the study period, we distributed 6469 COVID self-tests to 4160 eligible participants; 46% identified as Black, Indigenous or a Person of Colour (BIPOC). Nearly 70% of participants reported their COVID self-test results; 304 of which were positive. Overall, 91% also reported being vaccinated against COVID. Statistical analysis found living with five or fewer people, having tested for COVID previously, and being fully vaccinated were positive factors in results reporting. For COVID vaccination, people from large urban centers, who identified their ethnicity as white, and who reported previous COVID testing were more likely to be fully vaccinated. Finally, being identified as a contact of someone who had tested positive for COVID and the presence of COVID-related symptoms were found to be positive factors in diagnosis. CONCLUSIONS: While most participants who accessed this service were vaccinated against COVID and the majority of diagnoses were identified in participants who had symptoms of, or an exposure to, COVID, our program was able to appropriately link participants to recommended follow-up based on reported risks and results. These findings highlight the utility of online screening algorithms to provide health services, particularly for persons with historical barriers to healthcare access, such as BIPOC or lower-income groups.

Exploring acceptability, opportunities, and challenges of community-based home pregnancy testing for early antenatal care initiation in rural Kenya.

BACKGROUND: Many women in low- and middle-income countries, including Kenya, access antenatal care (ANC) late in pregnancy. Home pregnancy testing can enable women to detect pregnancy early, but it is not widely available. Our study explored the acceptability and potential of home pregnancy testing delivered by community health volunteers (CHV) on antenatal care initiation in rural Kenya. METHODS: This study was part of a public health intervention to improve uptake and quality of ANC. Between November and December 2020, we conducted 37 in-depth interviews involving women who tested positive or negative for a urine pregnancy test provided by CHVs; CHVs and their supervisors involved in the delivery of the pregnancy tests; facility healthcare workers; and key informants. Using Sekhon et al.'s framework of acceptability, the interviews explored participants' perceptions and experiences of home pregnancy testing, including acceptability, challenges, and perceived effects on early ANC uptake. Data were analysed thematically in NVivo12 software. RESULTS: Home pregnancy testing was well-received by women who trusted test results and appreciated the convenience and autonomy it offered. Adolescents cherished the privacy, preferring home testing to facility testing which could be a stigmatising experience. Testing enabled earlier pregnancy recognition and linkage to ANC as well as reproductive decision-making for those with undesired pregnancies. Community delivery of the test enhanced the reputation and visibility of the CHVs as credible primary care providers. CHVs in turn were motivated and confident to deliver home pregnancy testing and did not find it as an unnecessary burden; instead, they perceived it as a complement to their work in providing ANC in the community. Challenges identified included test shortages, confidentiality and safeguarding risks, and difficulties accessing facility-based care post-referral. Newly identified pregnant adolescents hesitated to seek ANC due to stigma, fear of reprimand, unwanted parental notification, and perceived pressure from healthcare workers to keep the pregnancy. CONCLUSION: Home pregnancy testing by CHVs can improve early ANC initiation in resource-poor settings. Mitigating privacy, confidentiality, and safeguarding concerns is imperative. Additional support for women transitioning from pregnancy identification to ANC is essential to ensure appropriate care. Future research should focus on integrating home pregnancy testing into routine community health services.

Improving linkage to HIV care following a reactive HIV self-testing result among men in KwaZulu-Natal, South Africa.

BACKGROUND: Despite the many interventions that have been implemented in sub-Saharan Africa to improve the uptake of HIV testing and antiretroviral (ART) initiation services, the rates at which men are tested for HIV and initiated on ART have remained consistently lower compared to those for women. We aim to investigate barriers and facilitators for linkage to care following HIVST positive results among men aged between 18 and 49 years, and use these findings to design an intervention to improve linkage to care among men in a high-HIV prevalent district in KwaZulu-Natal province, South Africa. METHODS: This multi-method study will be conducted over 24 months in eight purposively selected HIV testing and treatment facilities from December 2023 to November 2025. For the quantitative component, a sample of 197 HIV positive men aged 18-49 years old who link to care after HIV self-test (HIVST) will be recruited into the study. HIVST kits will be distributed to a minimum of 3000 men attending community services through mobile clinics that are supported by the Health Systems Trust, at different service delivery points, including schools, taxi ranks and other hotspots. The qualitative component will consist of in-depth interviews (IDIs) with 15 HIVST users and IDIs with 15 key informants. To design and develop acceptable, feasible, effective, and sustainable models for improving linkage to care, three groups of HIVST users (2*positive (N = 12) and 1*negative (N = 12)) will be purposively select to participate in a design workshop. Chi square tests will be used to identify social and demographic factors associated with linkage, while logistic regression will be used to identify independent factors. Kaplan Meier curves and cox proportional hazard models will be used to identify factors associated with time to event. Content and thematic approaches will be used to analyze the qualitative data. DISCUSSION: There remains an urgent need for designing and implementing innovative intervention strategies that are convenient and tailored for addressing the needs of men for improving HIV testing and linkage to care at early stages in resource-limited settings, to improve individual health outcomes, reduce transmission from HIV and minimize HIV-related mortality rates. Our proposed study offers several important innovations aimed at improving linkage to care among men. Our study targets men, as they lag the HIV continuum but are also under-researched in public health studies.

Phenomenology and empowerment in self-testing apps.

Although self-testing apps, a form of mobile health (mHealth) apps, are often marketed as empowering, it is not obvious how exactly they can empower their users-and in which sense of the word. In this article, I discuss two conceptualisations of empowerment as polar opposites-one in health promotion/mHealth and one in feminist theory-and demonstrate how both their applications to individually used self-testing apps run into problems. The first, prevalent in health promotion and mHealth, focuses on internal states and understands empowerment as an individual process. However, this version of empowerment has been accused of paternalism and responsibilisation. The second, feminist version considers structural conditions and foregrounds collective, political change, whose realisation is not obviously attainable for an individually used app. By pointing out the flaws of the positions that focus on either internal states or external conditions, and by engaging with theory from critical phenomenology, I argue that the interplay between them is where empowerment can take place. I propose to formulate empowerment in phenomenological terms as a shift in being-in-the-world and discuss how this conceptualisation of empowerment would avoid the criticism of previous empowerment narratives while being realisable by self-testing apps.