Usability and acceptability of self-testing for hepatitis C virus exposure in a high-prevalence urban informal settlement in Karachi, Pakistan.

BACKGROUND: Hepatitis C virus (HCV) antibody self-testing (HCVST) may help expand screening access and support HCV elimination efforts. Despite potential benefits, HCVST is not currently implemented in Pakistan. This study aimed to assess the usability and acceptability of HCVST in a high HCV prevalence informal settlement in Karachi, Pakistan. METHODS: We performed a cross-sectional study in a hepatitis C clinic from April through June 2023. Participants were invited to perform a saliva-based HCVST (OraSure Technologies, USA) while following pictorial instructions. A study member evaluated test performance using a standardized checklist and provided verbal support if a step could not be completed. Perceived usability and acceptability were assessed using a semi-structured questionnaire. The HCVST was considered successful if the participant was able to complete all steps and correctly interpret test results. Overall concordance and positive and negative agreement were estimated in comparison with the HCVST result read by the study member (inter-reader concordance and agreement) and result of a second rapid HCV test (Abbott Diagnostics Korea Inc, South Korea) performed by a trained user (inter-operator concordance and agreement). RESULTS: The study included 295 participants of which 97 (32%) were illiterate. In total, 280 (95%, 95% CI 92-97%) HCVSTs were successful. Overall, 38 (13%) people performed the HCVST without verbal assistance, 67 (23%) needed verbal assistance in one step, 190 (64%) in two or more. Assistance was most often needed in managing the test buffer and test reading times. The inter-reader concordance was 96% and inter-operator concordance 93%. Inter-reader and inter-operator positive percent agreement were 84 and 70%, respectively. All participants reported they would use HCVST again and would recommend it to friends and family. CONCLUSION: Saliva-based HCVST was very well accepted in this clinic-based setting. However, many people requested verbal support in several steps, highlighting the need for clear instructions for use and test devices that are simple to use, particularly in low literacy settings. Moderately low positive percent agreement with the results of a rapid test performed by a trained user highlights potential uncertainty in the accuracy of HCVST in the hands of lay users.

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.

Decentralised same day test and treatment of hepatitis C levering existing peer support networks among men who inject drugs: feasibility and effectiveness.

BACKGROUND: Prevalence of hepatitis C virus (HCV) infection among people who inject drugs in the state of Manipur, India, is 43%; however, access to care is poor. We piloted a Community-led and comprehensive hepatitis care model that included same-day HCV treatment at drug treatment centres. METHODS: Screening was conducted through venipuncture samples collected by community peer PWID, using HCV antibody (HCV Ab) rapid screening and hepatitis B virus (HBV) surface antigen (HBsAg) rapid diagnostic tests. Reactive HCV Ab samples were tested for HCV RNA using near point-of-care Truenat® HCV on Truelab® Quattro. Eligible HCV RNA-positive participants were treated on the same day using direct-acting antivirals and followed for sustained virologic response (SVR). HBsAg-negative participants received rapid HBV vaccination regimen while those positive for HBsAg were tested for DNA and referred for treatment. RESULTS: Between November 2021 and August 2022, 643 individuals were approached and 503 consented and were screened. All screened were males with history of injection drug use, and a median age of 27 years (IQR 23-32). Of the 241 (47.9%) HCV Ab reactive all underwent RNA testing and 156 (64.7%) were RNA detectable. Of those with viraemia, 155 (99.4%) were initiated on treatment with 153 (98.1%) on same day, with 2 (1.2%) HBsAg positive and waiting for HBV DNA results. Among those 153, median time from HCV Ab screening to treatment was 6 h 38 min (IQR 5 h 42 min-8 h 23 min). In total 155 (100%) completed HCV treatment, of those 148 (95.5%) completed SVR testing and 130 (87.8%) achieved SVR12. 27 (5%) participants were HBsAg-positive, 3 (11.1%) were also living with HCV viraemia; 443 (97.6%) were eligible for vaccination and 436 (98.4%) received all 3 vaccine doses. CONCLUSION: Community-led hepatitis care incorporating same day "test and treat" for HCV was feasible and effective. HBV screening identified a large proportion who were unvaccinated. Peer support extended resulted in ensuring compliance to care and treatment cascade and completing all the three doses of HBV vaccination. As the screening, diagnostics infrastructure and vaccine are available in most countries with national viral hepatitis programs also in place, our model can be adapted or replicated to progress towards global elimination targets.

Molecular point of care testing for hepatitis C: available technologies, pipeline and promising future directions.

Hepatitis C (HCV) remains a major public health problem, despite the availability of effective treatments. In many areas, the ability to diagnose HCV infection at the point of care is key to scaling up access to care and treatment. To achieve this, an accurate, easy-to-use and affordable diagnostic tool is required - this would enable decentralized testing and the creation of one-stop centers to eliminate gaps in the care cascade, which would help reach the millions of people with undiagnosed HCV in low- and middle-income countries and high-risk populations in high income countries. In this review, we examine the current state of point-of-care molecular technologies, the advantages and limitations of currently available devices (both near- and true-point-of-care), the potential of molecular testing to transform diagnostic medicine in the future, and the challenges that need to be addressed for broader adoption of this technology in routine clinical practice.

Assessing feasibility of a modified same-day test-and-treat model for hepatitis C among rural people who inject drugs.

BACKGROUND: Despite advancements in hepatitis C virus (HCV) treatment, low uptake among hard-to-reach populations remains a global issue. The current study aimed to assess the feasibility of a modified same-day test-and-treat model in improving HCV care for people who inject drugs (PWID) living in resource-constrained rural areas. METHODS: A pilot study was conducted in four primary healthcare (PHC) centers in Malaysia. The model's key features included on-site HCV ribonucleic acid (RNA) testing using a shared GeneXpert® system; noninvasive biomarkers for cirrhosis diagnosis; and extended care to PWID referred from nearby PHC centers and outreach programs. The feasibility assessment focused on three aspects of the model: demand (i.e., uptake of HCV RNA testing and treatment), implementation (i.e., achievement of each step in the HCV care cascade), and practicality (i.e., ability to identify PWID with HCV and expedite treatment initiation despite resource constraints). RESULTS: A total of 199 anti-HCV-positive PWID were recruited. They demonstrated high demand for HCV care, with a 100% uptake of HCV RNA testing and 97.4% uptake of direct-acting antiviral treatment. The rates of HCV RNA positivity (78.4%) and sustained virologic response (92.2%) were comparable to standard practice, indicating the successful implementation of the model. The model was also practical, as it covered non-opioid-substitution-therapy-receiving individuals and enabled same-day treatment in 71.1% of the participants. CONCLUSIONS: The modified same-day test-and-treat model is feasible in improving HCV care for rural PWID. The study finding suggests its potential for wider adoption in HCV care for hard-to-reach populations.

Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral-based treatment regimens: Evidence from a global data set.

Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12 weeks post-treatment (SVR12). We assembled a global data set of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique) and two pharmaceutical-sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90th, 95th, 97th and 99th percentiles. We used logistic regression to assess characteristics associated with low-level virological treatment failure (defined as <1000 IU/mL). There were 5973 cases of detectable viraemia at SVR12 from the combined data set. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95th percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viraemia at SVR12 compared to men (adjusted odds ratio AOR = 1.60 95% confidence interval [CI] 1.30-1.97 and those with cirrhosis (AOR = 1.49 95% CI 1.15-1.93). In conclusion, an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure.

Values and preferences of the general population in Indonesia in relation to rapid COVID-19 antigen self-tests: A cross-sectional survey.

OBJECTIVES: Home diagnostics are essential to assist members of the general population become active agents of case detection. In Indonesia, a country with an over-burdened healthcare system, individuals could use rapid SARS-CoV-2 antigen tests to self-detect COVID-19. To assess the general population's values and attitudes towards SARS-CoV-2 self-testing, a survey was conducted in mid-2021 in Jakarta and the provinces of Banten and North Sulawesi. METHODS: This was a quantitative survey that approached respondents in >600 randomly selected street-points in the three study geographies in July-August 2021. A 35-item questionnaire was used to collect data on key variables, such as likelihood to use a SARS-CoV-2 self-test, willingness to pay for a self-test device, and likely actions following a positive self-test result. Bivariate and multivariate regression analyses were performed. RESULTS: Of 630 respondents (318 were female), 15.53% knew about COVID-19 self-testing, while 62.70% agreed with the idea of people being able to self-test at home, unassisted, for COVID-19. If self-tests were available in Indonesia, >60% of respondents would use them if they felt it necessary and would undertake regular self-testing for example weekly if recommended. Upon receiving a positive self-test result, most respondents would communicate it (86.03%), request post-test counselling (80.79%), self-isolate (97.46%), and/or warn their close contacts (90.48%). CONCLUSIONS: The use of rapid SARS-CoV-2 antigen detection tests for self-testing appears acceptable to a majority of the Indonesian public, to learn whether they have COVID-19. Self-testing should be prioritised to complement to an over-burdened healthcare system by helping the public, asymptomatic individuals included, become agents of change in epidemiological surveillance of SARS-CoV-2 in their communities.

Feasibility and effectiveness of HCV viraemia testing at harm reduction sites in Georgia: A prospective three-arm study.

BACKGROUND AND AIMS: In 2015, Georgia began a hepatitis C virus (HCV) elimination programme. Although screening programmes have been decentralized for high-risk groups, viraemic testing remains a bottleneck for people who inject drugs. Here, we describe two models of viraemic testing that aimed to address this gap. METHODS: We assigned eight harm reduction sites (HRS) to one of three arms (2,1:1): Xpert HCV viral load testing on-site, blood draw on-site with centralized HCV core antigen testing (HCVcAg), or standard-of-care (SOC) referral with viremia testing performed at treatment centres. RESULTS: 1671 HCV-seropositive participants were enrolled (Xpert, 37.1%; HCVcAg, 29.1%; referral, 33.8%). Participants were predominantly male (95.4%), mean age (IQR) 43 (37, 50) years and 1290 (77.2%) were currently injecting drugs. Significantly higher proportions of participants in the Xpert (100%) and HCVcAg (99.8%) arms received viraemia testing compared with the referral arm (91.3%) (Xpert vs referral, p < 0.0001; HCVcAg vs referral, p < 0.0001). Among viraemic participants, treatment uptake was similar (Xpert, 84.0%; HCVcAg, 79.5%; referral, 88.4%). The time between screening and sample collection for viraemia testing was significantly longer in the referral arm compared with both Xpert and HCVcAg arms (median 1 day compared with 0 days respectively), and the overall time between screening to treatment initiation was longer for the referral arm (median 67 days) compared with both Xpert and HCVcAg arms (median 57 and 50 days respectively). CONCLUSIONS: Point-of-care viraemia testing and blood drawn on-site for HCVcAg testing yielded more HCV-seropositive patients receiving viraemic testing within a shorter timeframe compared with referrals.

Feasibility, effectiveness and cost of a decentralized HCV care model among the general population in Delhi, India.

BACKGROUND AND AIMS: India has a significant burden of hepatitis C virus (HCV) infection and has committed to achieving national elimination by 2030. This will require a substantial scale-up in testing and treatment. The "HEAD-Start Project Delhi" aimed to enhance HCV diagnosis and treatment pathways among the general population. METHODS: A prospective study was conducted at 5 district hospitals (Arm 1: one-stop shop), 15 polyclinics (Arm 2: referral for viral load (VL) testing and treatment) and 62 screening camps (Arm 3: referral for treatment). HCV prevalence, retention in the HCV care cascade, and turn-around time were measured. RESULTS: Between January and September 2019, 37 425 participants were screened for HCV. The median (IQR) age of participants was 35 (26-48) years, with 50.4% male and 49.6% female. A significantly higher proportion of participants in Arm 1 (93.7%) and Arm 3 (90.3%) received a VL test compared with Arm 2 (52.5%, P < .001). Of those confirmed positive, treatment was initiated at significantly higher rates for participants in both Arms 1 (85.6%) and 2 (73.7%) compared to Arm 3 (41.8%, P < .001). Arm 1 was found to be a cost-saving strategy compared to Arm 2, Arm 3, and no action. CONCLUSIONS: Delivery of all services at a single site (district hospitals) resulted in a higher yield of HCV seropositive cases and retention compared with sites where participants were referred elsewhere for VL testing and/or treatment. The highest level of retention in the care cascade was also associated with the shortest turn-around times.

Cost-Effectiveness of a Core Antigen-Based Rapid Diagnostic Test for Hepatitis C.

OBJECTIVES: Hepatitis C virus (HCV) affects 58 million worldwide and > 79% of people remain undiagnosed. Rapid diagnostic tests (RDTs) for HCV can help improve diagnosis and treatment rates. Nevertheless, the high price and infrastructure needed to use current molecular HCV RDT options present a barrier to widespread use-particularly in low- and middle-income countries. We evaluated the performance and cost-effectiveness of a theoretical core antigen (cAg) RDT for HCV viremia confirmation, which requires fewer resources. METHODS: We adapted a previously validated microsimulation model to simulate HCV disease progression and outcomes under different HCV testing algorithms in Georgia and Malaysia. We compared standard of care testing with laboratory-based ribonucleic acid HCV to a cAg-based RDT for HCV confirmation. We simulated a cohort of 10 000 adults in each country, with an HCV-ribonucleic acid prevalence of 5.40% in Georgia and 1.54% in Malaysia. We projected the cumulative healthcare costs, quality-adjusted life-years, and diagnosis coverage rates over a lifetime horizon. RESULTS: Compared with the standard of care testing, the cAg-based RDT would increase quality-adjusted life-years by 270 in Georgia and 259 in Malaysia per 10 000 people. The high diagnosis rate and treatment rate of the cAg-based RDT result in substantial cost savings because of averted HCV sequelae management costs. Cost savings are $281 000 for Georgia and $781 000 for Malaysia. CONCLUSIONS: We found that a cAg-based RDT for HCV could improve the diagnosis rate and result in cost savings. Such a test could have a substantial impact on the feasibility and cost of HCV elimination.

Self-testing for SARS-CoV-2 in São Paulo, Brazil: results of a population-based values and attitudes survey.

BACKGROUND: Brazil is among the countries in South America where the COVID-19 pandemic has hit the general population hardest. Self-testing for SARS-CoV-2 infection is one of the community-based strategies that could help asymptomatic individuals at-risk of COVID-19, as well as those living in areas that are difficult for health personnel to reach, to know their infectious status and contribute to impeding further transmission of the virus. METHODS: A population-based survey was conducted in November 2021, to assess the acceptability of rapid SARS-CoV-2 antigen self-testing among the population of São Paulo. Survey respondents were approached at more than 400 different street-points that were randomly selected using a five-stage randomization process. A 35-item structured questionnaire was used. Dependent variables for our analyses were the likelihood to use and willingness to pay for self-testing, and the likelihood of taking preventive measures to prevent onward transmission of SARS-CoV-2 following a reactive self-test result. Bivariate and multivariate regression analyses were performed. RESULTS: Overall, 417 respondents (44.12% female) participated; 19.66% had previously had COVID-19 disease. A minority (9.59%) felt at high-risk of COVID-19. The majority of both females and males (73.91% and 60.09%, respectively) were in favor of the idea of SARS-CoV-2 self-testing. Overall, if self-tests were available, almost half of the sample would be very likely (n = 54, 12.95%) or likely (n = 151, 36.21%) to use one if they felt they needed to. Upon receiving a positive self-test result, the majority of respondents would communicate it (88.49%), request facility-based post-test counseling (98.32%), self-isolate (97.60%), and warn their close contacts (96.64%). CONCLUSION: Rapid SARS-CoV-2 antigen self-testing could be an acceptable screening tool in São Paulo. The population would be empowered by having access to a technology that would allow them to test, even if asymptomatic, when traveling, or going to work or school. If there is a surge in the incidence of cases, self-testing could be a good approach for mass case detection by Brazil's already overstretched Unified Health System.

Protocol for a cluster randomised controlled trial of secondary distribution of hepatitis C self-testing within the context of a house-to-house hepatitis C micro-elimination programme in Karachi, Pakistan.

BACKGROUND: Globally, just 21% of the estimated 58 million people living with hepatitis C virus (HCV) know their status. Thus, there is considerable need to scale-up HCV testing if the World Health Organization (WHO) 2030 hepatitis elimination goals are to be achieved. HCV self-testing may assist with this; however, there are currently no data on the real-world impact of HCV self-testing. With an estimated 5% of the general population living with HCV, Pakistan has the second highest HCV burden in the world. This study aims to evaluate the acceptability and impact of home delivery of HCV self-testing for secondary distribution in the context of a house-to-house HCV micro-elimination programme in Pakistan. METHODS: This is a parallel group, non-blinded, cluster randomised trial comparing secondary distribution of HCV self-testing with secondary distribution of information pamphlets encouraging individuals to visit a testing facility for HCV screening. The cluster allocation ratio is 1:1. Clusters will be randomised either to HCV self-testing distributed via study staff or control clusters where information on HCV will be given and the participant will be requested to attend their local hospital for HCV screening. In both clusters, only households with a member who has not yet been screened as part of the larger micro-elimination project will be included. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who a) receive a positive result and are made aware of their status, b) are referred to and complete HCV RNA confirmatory testing, and c) start treatment. Acceptability, feasibility, attitudes towards HCV testing, and cost will also be evaluated. The target sample size is 2,000 participants. DISCUSSION: This study will provide the first ever evidence regarding secondary distribution of HCV self-testing. By comparing HCV self-testing with facility-based testing, we will assess whether HCV self-testing increases the uptake of HCV testing. The findings will inform micro-elimination programmes and determine whether HCV self-testing can enable individuals to be reached who may otherwise be missed. TRIAL REGISTRATION: This study and was registered on clinicaltrials.gov ( NCT04971538 ) 21 July 2021.

Outcomes of the CT2 study: A 'one-stop-shop' for community-based hepatitis C testing and treatment in Yangon, Myanmar.

BACKGROUND: With the advent of low-cost generic direct-acting antivirals (DAA), hepatitis C (HCV) elimination is now achievable even in low-/middle-income settings. We assessed the feasibility and effectiveness of a simplified clinical pathway using point-of-care diagnostic testing and non-specialist-led care in a decentralized, community-based setting. METHODS: This feasibility study was conducted at two sites in Yangon, Myanmar: one for people who inject drugs (PWID), and the other for people with liver disease. Participants underwent on-site rapid anti-HCV testing and HCV RNA testing using GeneXpert(R) . General practitioners determined whether participants started DAA therapy immediately or required specialist evaluation. Primary outcome measures were progression through the HCV care cascade, including uptake of RNA testing and treatment, and treatment outcomes. FINDINGS: All 633 participants underwent anti-HCV testing; 606 (96%) were anti-HCV positive and had HCV RNA testing. Of 606 tested, 535 (88%) were RNA positive and had pre-treatment assessments; 30 (6%) completed specialist evaluation. Of 535 RNA positive participants, 489 (91%) were eligible to initiate DAAs, 477 (98%) completed DAA therapy and 421 achieved SVR12 (92%; 421/456). Outcomes were similar by site: PWID site: 91% [146/161], and liver disease site: 93% [275/295]). Compensated cirrhotic patients were treated in the community; they achieved an SVR12 of 83% (19/23). Median time from RNA test to DAA initiation was 3 days (IQR 2-5). CONCLUSIONS: Delivering a simplified, non-specialist-led HCV treatment pathway in a decentralized community setting was feasible in Yangon, Myanmar; retention in care and treatment success rates were very high. This care model could be integral in scaling up HCV services in Myanmar and other low- and middle-income settings.

Values and preferences for hepatitis C self-testing among people who inject drugs in Kyrgyzstan.

BACKGROUND: The prevalence of hepatitis C virus (HCV) among people who inject drugs (PWID) continues to be a major public-health burden in this highly stigmatised population. To halt transmission of HCV, rapid HCV self-testing kits represent an innovative approach that could enable PWID to know their HCV status and seek treatment. As no HCV test has yet been licenced for self-administration, it is crucial to obtain knowledge around the factors that may deter or foster delivery of HCV self-testing among PWID in resource-constrained countries. METHODS: A qualitative study to assess values and preferences relating to HCV self-testing was conducted in mid-2020 among PWID in the Bishkek and Chui regions of Kyrgyzstan. Forty-seven PWID participated in 15 individual interviews, two group interviews (n = 12) and one participatory action-research session (n = 20). Responses were analysed using a thematic analysis approach with 4 predefined themes: awareness of HCV and current HCV testing experiences, and acceptability and service delivery preferences for HCV self-testing. Informants' insights were analysed using a thematic analysis approach. This research received local ethics approval. RESULTS: Awareness of HCV is low and currently PWID prefer community-based HCV testing due to stigma encountered in other healthcare settings. HCV self-testing would be accepted and appreciated by PWID. Acceptability may increase if HCV self-testing: was delivered in pharmacies or by harm reduction associations; was free of charge; was oral rather than blood-based; included instructions with images and clear information on the test's accuracy; and was distributed alongside pre- and post-testing counselling with linkage to confirmatory testing support. CONCLUSIONS: HCV self-testing could increase awareness of and more frequent testing for HCV infection among PWID in Kyrgyzstan. It is recommended that peer-driven associations are involved in the delivery of any HCV self-testing. Furthermore, efforts should be maximised to end discrimination against PWID at the healthcare institutions responsible for confirmatory HCV testing and treatment provision.

Values and preferences for hepatitis C self-testing among the general population and healthcare workers in Rwanda.

BACKGROUND: In 2018, Rwanda launched a 5-year hepatitis C virus (HCV) elimination plan as per the World Health Organization global targets to eliminate HCV by 2030. To improve awareness of HCV status, strategies are needed to ensure easy access to HCV testing by as-yet unreached populations. HCV-self-testing, an innovative strategy, could further increase HCV testing uptake. This assessment explores perceptions around HCV self-testing among members of the public and healthcare workers in Rwanda. METHODS: A qualitative study was undertaken in Masaka District Hospital, comprising individual interviews, group interviews and participatory action research (PAR) activities. Purposive and snowball sampling methods guided the selection of informants. Informed consent was obtained from all participants. A thematic analysis approach was used to analyse the findings. RESULTS: The participants comprised 36 members of the public and 36 healthcare workers. Informants appreciated HCV self-testing as an innovative means of increasing access to HCV testing, as well as an opportunity to test privately and subsequently autonomously decide whether to seek further HCV care. Informants further highlighted the need to make HCV self-testing services free of charge at the nearest health facility. Disadvantages identified included the lack of pre/post-test counselling, as well as the potential psychosocial harm which may result from the use of HCV self-testing. CONCLUSION: HCV self-testing is perceived to be an acceptable method to increase HCV testing in Rwanda. Further research is needed to assess the impact of HCV self-testing on HCV cascade of care outcomes.

Usability and acceptability of oral fluid- and blood-based hepatitis C virus self-testing among the general population and men who have sex with men in Malaysia.

Hepatitis C self-testing (HCVST) is emerging as an additional strategy that could help to expand access to HCV testing. We conducted a study to assess the usability and acceptability of two types of HCVST, oral fluid- and blood-based, among the general population and men who have sex with men (MSM) in Malaysia. An observational study was conducted in three primary care centres in Malaysia. Participants who were layman users performed the oral fluid- and blood-based HCVST sequentially. Usability was assessed by calculating the rate of errors observed, the rate of difficulties faced by participants as well as inter-reader (self-test interpreted by self-tester vs interpreted by trained user) and inter-operator concordances (self-test vs test performed by trained user). The acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire. Participants were also required to read contrived test results which included "positive", "negative", and "invalid". There was a total of 200 participants (100 general population, 100 MSM; mean age 33.6 ± 14.0 years). We found a high acceptability of oral fluid- and blood-based HCVST across both general population and MSM. User errors, related to timekeeping and reading within stipulated time, were common. However, the majority of the participants were still able to obtain and interpret results correctly, including that of contrived results, although there was substantial difficulty interpreting weak positive results. The high acceptability of HCVST among the participants did not appreciably change after they had experienced both tests, with 97.0% of all participants indicating they would be willing to use HCVST again and 98.5% of them indicating they would recommend it to people they knew. There was no significant difference between the general population and MSM in these aspects. Our study demonstrates that both oral fluid- and blood-based HCVST are highly acceptable among both the general population and MSM. Both populations also showed comparable ability to conduct the tests and interpret the results. Overall, this study suggests that HCVST could be introduced as an addition to existing HCV testing services in Malaysia. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in the country.

Implementation pilot study of community self-testing for COVID-19 among employees of manufacturing industries and their household members in 2022 to 2023.

COVID-19 self-testing is essential for enabling individuals to self-care, screen themselves and, if positive, isolate themselves. Since 2021, COVID-19 self-tests have been extensively used in high-income countries, however, their programmatic implementation in low- and middle-income countries has been delayed. An implementation pilot, mixed-methods study, was conducted in four industrial manufacturing companies, in Kedah State between November 2022 and May 2023. Participants were asked to take COVID-19 self-tests home for themselves and their household members and to use the tests according to national guidelines. At enrolment and at the end of the study, participants completed an online sociodemographic, knowledge and satisfaction survey. Data were cleaned and analysed using SPSS Statistics V28.0. Qualitative data were collected through semi-structured interviews and focus group discussions. Thematic analysis was conducted. A total of 1768 employees from four manufacturing industries enrolled in the pilot, representing 60% of the total employees and more than 50% of employees at each site. There were 40 COVID-19-positive cases detected in participants from the manufacturing industries, and 100 positive household members. Participants reported 27 invalid test results. Individuals aged 30 or less [adjusted odds ratio (AOR): 2.65; 95% CI: 1.63 to 4.31; p<0.001] and males (AOR: 1.54; 95% CI: 1.09 to 2.17; p = 0.014) showed a significant higher likelihood of self-testing compared to older and female participants. Additionally, individuals who received three or more doses of a COVID-19 vaccine had higher odds of using self-tests (OR 1.56 (95% CI: 1.03 to 2.36, p = 0.037)). There was a significant increase in participants' knowledge on how to correctly collect a self-sample using a nasal swab from 36,9% at baseline to 43,6% post-implementation (p = 0.004) and correct interpretation of a positive result from 80,5% at baseline to 87,6% post-implementation (p<0.001). Furthermore, there was a notable increase in the correct understanding of actions following a positive result, especially regarding self-isolation, which rose from 59.1% to 71.9% (p<0.001). A total of 44 SSIs, and 4 FGDs with a total of 14 participants, were performed. The five main themes explored were: 1) previous experiences with COVID-19, 2) COVID-19 ST experiences during the pilot study, 3) advantages of COVID-19 ST, 4) feelings related to COVID-19 ST, 5) willingness to use COVID-19 ST again, and 6) ST for other diseases. This research shows the feasibility of a self-testing model in the community through workplaces due to participants' high acceptability to enrol and high self-tests' uptake. Lessons learnt can inform operational aspects of the introduction and scale-up of self-care strategies in low- and middle-income countries, in particular the South-East Asia region.

Point-of-care biochemistry for primary healthcare in low-middle income countries: a qualitative inquiry.

BACKGROUND: Access to essential diagnostics is crucial for primary healthcare (PHC) in low-and-middle income countries (LMICs). Many LMICs have invested in equipping PHC with point-of-care (PoC) diagnostics for infectious diseases, however there has been no similar investment to improve PHC capacities for clinical chemistry. The biochemistry gap is among the deterrents to universal health coverage. METHODS: A social sciences project was conducted with the aim to understand the key PHC stakeholders' insights on the pertinence of PoC biochemistry for PHC in LMICs. Data generation was conducted between July-November 2023 in Mongolia, Nigeria and Peru. Decision-makers in healthcare delivery, healthcare professionals, and patient and community advocates were engaged using a combination of sampling techniques. Unstructured individual and group conversations, and non-participant observation were conducted. Analysis involved an inductive line-by-line coding on printed transcripts, followed by a deductive coding and theme-by-theme analysis on digitized transcripts. RESULTS: Fifteen, 51 and 20 informants from Mongolia, Nigeria and Peru, respectively, participated. Fifty-five of the 94 informants were female. Most informants considered that PoC biochemistry in PHC would be pertinent, from a clinical and a resources-saving perspective. Those households that currently bear the burden of referrals (i.e., the poor, the bedridden, the older adults) would benefit the most from the deployment of PoC biochemistry for essential biochemistry parameters. Improved access to PoC glycated hemoglobin (HbA1c), lipid, liver and kidney profile was perceived as helpful to inform clinicians' decision-taking. The value of PoC biochemistry for the management of noncommunicable diseases (diabetes, hypertension) and infectious conditions (dengue, malaria, tuberculosis), to improve child health outcomes (severe dehydration in children with diarrhea and/or malnutrition) and to reduce preventable causes of death (dengue-related renal failure) was highlighted. CONCLUSIONS: PoC biochemistry holds potential to revert the impact that the biochemistry gap has for patient care in some LMICs' PHC settings. PoC equipment for parameters such as HbA1c, urea, creatinine or electrolytes could enhance community-level management of preventable causes of mortality, improve service delivery for patients affected by locally-prevalent infectious conditions, and improve the psychosocial and economic wellbeing of patients facing the burden of referrals to remote biochemistry-equipped centers. TRIAL REGISTRATION: Not applicable.

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya.

BACKGROUND: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. METHODS: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.