Are Kenyans Likely to Use COVID-19 Self-Testing Kits? Results From a Cross-Sectional Survey

Objectives: To understand the public’s perceptions around rapid SARS-CoV-2 antigen self-testing in Kenya, including the drivers of acceptability, willingness to pay, and adherence to hygiene and prevention recommendations following a positive self-test. Methods: A household-based, cross-sectional survey, using a 35-item questionnaire, was conducted in Mombasa and Taita–Taveta counties, Kenya, during August 2021. Individuals aged ≥18 years were enrolled using a stratified sampling approach. Results: There were 419 participants (mean age 35.7 years). A minority (10.5%) had ever tested for SARS-CoV-2. If SARS-CoV-2 self-testing were available, 39.9% and 41.5% would be likely and very likely, respectively, to use it. If unavailable free-of-charge, 63.01% would pay for it. Multivariate analyses suggested that people in rural areas (Coefficient 0.30, 95%CI: 0.11–0.48, p = 0.002), aged 36–55 (Coefficient 0.21, 95%CI: 0.03–0.40, p = 0.023), and employed full time (Coefficient 0.32, 95%CI: 0.06–0.58, p = 0.016) would have more odds to adhere to recommended hygiene and prevention actions. Conclusion: SARS-CoV-2 self-testing was considered acceptable. Availability of self-testing could expand access to COVID-19 testing in Kenya, particularly among rural communities who have limited access to testing, and among mildly symptomatic individuals

Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile Delta region of Egypt.

BACKGROUND: Self-testing for hepatitis C virus antibodies (HCVST) may be an additional strategy to expand access to hepatitis C virus (HCV) testing and support elimination efforts. We conducted a study to assess the usability and acceptability of HCVST among the general population in a semi-rural, high-HCV prevalence region in Egypt. METHODS: An observational study was conducted in two hospitals in the Nile Delta region. A trained provider gave an in-person demonstration on how to use the oral fluid HCVST followed by observation of the participant performing the test. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire. RESULTS: Of 116 participants enrolled, 17 (14.6%) had received no formal education. The majority (72%) of participants completed all testing steps without any assistance and interpreted the test results correctly. Agreement between participant-reported HCVST results and interpretation by a trained user was 86%, with a Cohen's kappa of 0.6. Agreement between participant-reported HCVST results and provider-administered oral fluid HCV rapid test results was 97.2%, with a Cohen's kappa of 0.75. The majority of participants rated the HCVST process as easy (53%) or very easy (44%), and 96% indicated they would be willing to use HCVST again and recommend it to their family and friends. CONCLUSION: Our study demonstrates the high usability and acceptability of oral fluid HCVST in a general population. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in both general and high-risk populations

Usability and acceptability of oral fluid hepatitis C self-testing among people who inject drugs in Coastal Kenya: a cross-sectional pilot study.

BACKGROUND: People who inject drugs (PWID) are disproportionally affected by hepatitis C virus (HCV) infection and many remain undiagnosed. HCV self-testing (HCVST) may be an effective approach to increase testing uptake, but has rarely been used among PWID. We assessed the usability and acceptability of HCVST among PWID in Kenya. METHODS: We conducted a cross-sectional study nested within a cohort study between August and December 2020 on Kenya's North Coast region. Participants were handed a prototype oral fluid HCVST kit and asked to conduct the test relying on the instructions for use. Usability was assessed by documenting errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. RESULTS: Among 150 participants, 19% were female and 65.3% had primary level education or lower. 71.3% made at least one error, 56.7% experienced some difficulty during at least one step, and the majority of participants (78%) required assistance during at least one step of the procedure. Most common errors occurred when placing the tube into the stand (18%), collecting the oral fluid sample (24%) and timing of reading results (53%). There was a strong association between presence of symptoms of opiate withdrawals and observed errors (94% vs 62%; p = 0.016) in a sub-group of 74 participants assessed. Inter-reader and inter-operator concordance were 97.7% (kappa: 0.92) and 99.2% (kappa: 0.95), respectively. Acceptability assessed by asking whether participants would choose to use HCVST prior to and after conducting HCVST was 98% and 95%, respectively. CONCLUSIONS: We found a high acceptability of oral fluid HCVST among PWID. User errors were common and were associated with the presence of withdrawal symptoms among users. Despite errors, most participants were able to obtain and interpret results correctly. These findings suggest that this group of users may benefit from greater messaging and education including options to receive direct assistance when self-testing for HCV

HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China

Background Hepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China. Methods An observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. Results Among 100 participants with median age 27 (interquartile range 23–30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7–64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5–99.4%) and 98% (95%CI: 93.0–99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8–62.1%) or easy (41%, 95%CI: 31.3–51.3%), 76% (95%CI: 66.4–84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3–83.1%) would recommend it to their family and friends. Conclusions Our findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems

HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China.

Background: Hepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China. Methods: An observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. Results: Among 100 participants with median age 27 (interquartile range 23-30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7-64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5-99.4%) and 98% (95%CI: 93.0-99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8-62.1%) or easy (41%, 95%CI: 31.3-51.3%), 76% (95%CI: 66.4-84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3-83.1%) would recommend it to their family and friends. Conclusions: Our findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems

Usability and acceptability of oral-based HCV self-testing among key populations: a mixed-methods evaluation in Tbilisi, Georgia

Background: Hepatitis C virus self-testing (HCVST) is an additional approach that may expand access to HCV testing. We conducted a mixed-methods cross-sectional observational study to assess the usability and acceptability of HCVST among people who inject drugs (PWID), men who have sex with men (MSM) and transgender (TG) people in Tbilisi, Georgia. Methods: The study was conducted from December 2019 to June 2020 among PWID at one harm reduction site and among MSM/TG at one community-based organization. We used a convergent parallel mixed-methods design. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. A subset of participants participated in cognitive and in-depth interviews. Results: A total of 90 PWID, 84 MSM and 6 TG were observed performing HCVST. PWID were older (median age 35 vs 24) and had a lower level of education compared to MSM/TG (27% vs 59%). The proportion of participants who completed all steps successfully without assistance was 60% among PWID and 80% among MSM/TG. The most common error was in sample collection and this was observed more often among PWID than MSM/TG (21% vs 6%; p = 0.002). More PWID requested assistance during HCVST compared to MSM/TG (22% vs 8%; p = 0.011). Acceptability was high in both groups (98% vs 96%; p = 0.407). Inter-reader agreement was 97% among PWID and 99% among MSM/TG. Qualitative data from cognitive (n = 20) and in-depth interviews (n = 20) was consistent with the quantitative data confirming a high usability and acceptability. Conclusions: HCVST was highly acceptable among key populations in Georgia of relatively high educational level, and most participants performed HCVST correctly. A significant difference in usability was observed among PWID compared to MSM/TG, indicating that PWID may benefit from improved messaging and education as well as options to receive direct assistance when self-testing for HCV

Acceptability and Usability of HCV Self-Testing in High Risk Populations in Vietnam.

HIV self-testing has emerged as a safe and effective approach to increase the access to and uptake of HIV testing and treatment, especially for key populations. Applying self-testing to hepatitis C virus (HCV) may also offer an additional way to address low coverage of HCV testing and to accelerate elimination efforts. To understand the potential for HCV self-testing (HCVST), an observational study was conducted to assess the acceptability and usability of the OraQuick® HCV Self-Test (prototype) among people who inject drugs (PWID) and men who have sex with men (MSM) in Thai Nguyen, a province in northern Vietnam. A total of 105 PWID and 104 MSM were eligible and agreed to participate in the study. Acceptability, defined as the proportion of participants among eligible subjects who agreed to participate in the study, was 92.9% in PWID and 98.6% in MSM. Compared to MSM, PWID were older (median age: 45 vs. 22 years; p < 0.0001) and had a lower education level (high school and college: 38.1% vs. 100%; p < 0.0001). HCVST usability was high among MSM with fewer observed mistakes, difficulties, or participants requiring assistance (33.7%, 28.8%, and 17.3%, respectively) compared to PWID (62.9%, 53.3%, and 66.7%, respectively; all p < 0.0001)). Inter-reader and inter-operator agreement were good in both groups (Kappa coefficient range: 0.61-0.99). However, the concordance between HCVST and study staff -read or performed HCV testing was lower among PWID than MSM (inter-reader concordance 88.6% vs. 99.0% and inter-operator concordance 81.9% vs. 99%). Overall, HCVST was highly acceptable with moderate to high usability among PWID and MSM in Thai Nguyen. Efforts to provide support and assistance may be needed to optimize performance, particularly for PWID populations and for those who are older and with lower literacy or education levels

Home-based hepatitis C self-testing in people who inject drugs and men who have sex with men in Georgia: a protocol for a randomised controlled trial

Introduction Globally, it is estimated that more than three-quarters of people with chronic hepatitis C virus (HCV) are unaware of their HCV status. HCV self-testing (HCVST) may improve access and uptake of HCV testing particularly among key populations such as people who inject drugs (PWID) and men who have sex with men (MSM) where HCV prevalence and incidence are high and barriers to accessing health services due to stigma and discrimination are common. Methods and analysis This randomised controlled trial compares an online programme offering oral fluid-based HCVST delivered to the home with referral to standard-of-care HCV testing at HCV testing sites. Eligible participants are adults self-identifying as either MSM or PWID who live in Tbilisi or Batumi, Georgia, and whose current HCV status is unknown. Participants will be recruited through an online platform and randomised to one of three arms for MSM (courier delivery, peer delivery and standard-of-care HCV testing (control)) and two for PWID (peer delivery and standard-of-care HCV testing (control)). Participants in the postal delivery group will receive an HCVST kit delivered by an anonymised courier. Participants in the peer delivery groups will schedule delivery of the HCVST by a peer. Control groups will receive information on how to access standard-of-care testing at a testing site. 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, and attitudes around HCV testing and cost will also be evaluated. The target sample size is 1250 participants (250 per arm)

A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol.

BACKGROUND: Malaysia has an estimated hepatitis C virus (HCV) prevalence of 1.9% among its adult population and a history of providing HCV treatment in the public sector. In 2019, Malaysia launched a 5-year national strategic plan for viral hepatitis control and has been expanding HCV testing and treatment to the primary care and community levels, while actively engaging key populations in services for hepatitis care. The Ministry of Health (MoH) is seeking to specifically understand how to better target HCV services at men who have sex with men (MSM); HCV self-testing could increase the uptake of HCV testing among this group. METHODS: We aim to integrate HCV antibody self-testing into an existing online platform used for HIV self-testing, to evaluate the acceptability and impact of an online HCV self-testing programme in Malaysia. This is a non-blinded parallel group quasi-randomised superiority study comparing HCV self-testing via an online distribution model with the standard care, which involves attending a clinic for facility-based HCV antibody testing (control, 2:1). Participants will be randomised to either the HCV self-testing via online distribution arm, in which either an oral fluid- or blood-based HCV self-test kit will be mailed to them, or the control arm, where they will be provided with information about the nearest centre with HCV testing. 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 around HCV testing, and cost will also be evaluated. The target sample size is 750 participants. DISCUSSION: This study is one of the first in the world to explore the real-world impact of HCV self-testing on key populations using online platforms and compare this with standard HCV testing services. The outcomes of this study will provide critical evidence about testing uptake, linkage to care, acceptability, and any social harms that may emerge due to HCV self-testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT04982718

Assessing Values and Preferences Toward SARS-CoV-2 Self-testing Among the General Population and Their Representatives, Health Care Personnel, and Decision-Makers: Protocol for a Multicountry Mixed Methods Study

BackgroundAccessible, safe, and client-centered SARS-CoV-2 testing services are an effective way to halt its transmission. Testing enables infected individuals to isolate or quarantine to prevent further transmission. In countries with limited health systems and laboratory capacity, it can be challenging to provide accessible and safe screening for COVID-19. Self-testing provides a convenient, private, and safe testing option; however, it also raises important concerns about lack of counseling and ensuring timely reporting of self-test results to national surveillance systems. Investigating community members’ views and perceptions regarding SARS-CoV-2 self-testing is crucial to inform the most effective and safe strategies for implementing said testing. ObjectiveWe aimed to determine whether SARS-CoV-2 self-testing was useful to diagnose and prevent the spread of SARS-CoV-2 for populations in low-resource settings and under which circumstances it would be acceptable. MethodsThis multisite, mixed methods, observational study will be conducted in 9 countries—Brazil, India, Indonesia, Kenya, Malawi, Nigeria, Peru, the Philippines, and South Africa—and will consists of 2 components: cross-sectional surveys and interviews (semistructured and group) among 4 respondent groupings: the general population, general population representatives, health care workers, and decision-makers. General population and health care worker survey responses will be analyzed separately from each other, using bivariate and multivariate inferential analysis and descriptive statistics. Semistructured interviews and group interviews will be audiorecorded, transcribed, and coded for thematic comparative analysis. ResultsAs of November 19, 2021, participant enrollment is ongoing; 4364 participants have been enrolled in the general population survey, and 2233 participants have been enrolled in the health care workers survey. In the qualitative inquiry, 298 participants have been enrolled. We plan to complete data collection by December 31, 2021 and publish results in 2022 via publications, presentations at conferences, and dissemination events specifically targeted at local decision-makers, civil society, and patient groups. ConclusionsThe views and perceptions of local populations are crucial in the discussion of the safest strategies for implementing SARS-CoV-2 self-testing. We intend to identify sociocultural specificities that may hinder or accelerate the widespread utilization of SARS-CoV-2 self-testing. International Registered Report Identifier (IRRID)DERR1-10.2196/3308