Evaluation of COVID-19 antigen rapid diagnostic tests for self-testing in Lesotho and Zambia.

INTRODUCTION: The use of antigen rapid tests (Ag-RDTs) for self-testing is an important element of the COVID-19 control strategy and has been widely supported. However, scale-up of self-testing for COVID-19 in sub-Saharan Africa is still insufficient and there is limited evidence on the acceptability of self-testing and agreement between Ag-RDT self-testing and Ag-RDT testing by professional users. A joint collaboration (Botnar Research Centre for Child Health-European & Developing countries Clinical Trials Partnership)was established between Lesotho and Zambia to address these gaps in relation to Ag-RDT self-testing and contribute to increasing its use in the region. METHODS: A cross-sectional study was conducted with qualitative and quantitative data analysis. Firstly, 14 in-depth cognitive interviews (5 in Zambia and 9 in Lesotho) were performed to assess the participants' understanding of the instructions for use (IFU) for self-testing. In a second step, evaluation of test agreement between Ag-RDT self-testing and Ag-RDT testing by professional user using SD Biosensor STANDARD Q COVID-19 Ag-RDT was performed. In Zambia, usability and acceptability of self-testing were also assessed. RESULTS: Cognitive interviews in Lesotho and Zambia showed overall good understanding of IFU. In Zambia, acceptability of self-testing was high, though some participants had difficulties in conducting certain steps in the IFU correctly. Agreement between Ag-RDT self-test and Ag-RDT by professional users in Lesotho (428 participants) and Zambia (1136 participants) was high, 97.3% (403/414, 95% CI: 95.3-98.7) and 99.8% (1116/1118, 95% CI: 99.4-100) respectively. CONCLUSION: Findings from this study support the use of Ag-RDT self-testing within COVID-19 control strategies in sub-Saharan Africa, contributing to increase the testing capacity and access in hard-to reach settings.

Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: Protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi.

BACKGROUND: In absence of contraindications, same-day initiation (SDI) of antiretroviral therapy (ART) is recommended for people testing HIV-positive who are ready to start treatment. Until 2021, World Health Organization (WHO) guidelines considered the presence of TB symptoms (presumptive TB) a contraindication to SDI due to the risk of TB-immune reconstitution inflammatory syndrome (TB-IRIS). To reduce TB-IRIS risk, ART initiation was recommended to be postponed until results of TB investigations were available, and TB treatment initiated if active TB was confirmed. In 2021, the WHO guidelines changed to recommending SDI even in the presence of TB symptoms without awaiting results of TB investigations based on the assumption that TB investigations often unnecessarily delay ART initiation, increasing the risk for pre-ART attrition from care, and noting that the clinical relevance of TB-IRIS outside the central nervous system remains unclear. However, this guideline change was not based on conclusive evidence, and it remains unclear whether SDI of ART or TB test results should be prioritized in people with HIV (PWH) and presumptive TB. DESIGN AND METHODS: SaDAPT is an open-label, pragmatic, parallel, 1:1 individually randomized, non-inferiority trial comparing two strategies for the timing of ART initiation in PWH with presumptive TB ("ART first" versus "TB results first"). PWH in Lesotho and Malawi, aged 12 years and older (re)initiating ART who have at least one TB symptom (cough, fever, night sweats or weight loss) and no signs of intracranial infection are eligible. After a baseline assessment, participants in the "ART first" arm will be offered SDI of ART, while those in the "TB results first" arm will be offered ART only after active TB has been confirmed or refuted. We hypothesize that the "ART first" approach is safe and non-inferior to the "TB results first" approach with regard to HIV viral suppression (<400 copies/ml) six months after enrolment. Secondary outcomes include retention in care and adverse events consistent with TB-IRIS. EXPECTED OUTCOMES: SaDAPT will provide evidence on the safety and effects of SDI of ART in PWH with presumptive TB in a pragmatic clinical trial setting. TRIAL REGISTRATION: The trial has been registered on clinicaltrials.gov (NCT05452616; July 11 2022).

Facilitators and barriers to COVID-19 testing in community and clinical settings: Lessons learned from Lesotho and Zambia.

The sudden emergence of the coronavirus disease 2019 (COVID-19) had a devastating impact on health systems and population health globally. To combat the spread of COVID-19, countries enacted guidelines and safety measures, including testing, contact tracing, and quarantine. It was unclear the extent to which uptake of COVID-19 testing and other health initiatives would be accepted in countries with a history of dealing with widespread communicable disease transmission such as HIV or Tuberculosis. The objective of this study was to understand and compare the facilitators and barriers to COVID-19 testing at hospital sites in two rural communities in Lesotho and community spaces (referred to as hubs) in one urban community in Zambia during active phases of COVID-19 pandemic. Individual interviews and focus group discussions (FGDs) were held during March-October 2021 to explore facilitators and barriers to COVID-19 testing. FGDs with 105 community members and health care workers, and 16 individual interviews with key informants and four mystery shoppers were conducted across the two countries. In Zambia, four mystery shopper observations, and eight hub observations were also conducted. Individual country codebooks were developed and combined; thematic analyses were then conducted using the combined codebook. Findings were compared across the two countries, and most were consistent across the two countries. Two primary themes emerged that related to both barriers and facilitators: (1) structural conditions; (2) social implications and attitudes. The structural conditions that operated as barriers in both countries included public health isolation measures and misinformation. In Lesotho, the cost of tests was an additional barrier. The only structural facilitators were in Zambia where the community hubs were found to be accessible and convenient. The social implication barriers related to fear of isolation, stigma, and mental health implications because of quarantine, perceived pain of the test, and compromised privacy. Social facilitators that led to people testing included experiencing COVID-19 firsthand and knowing people who had died because of COVID-19. Across both countries, primary barriers and facilitators to COVID-19 related to structural conditions and social implications and attitudes. Public health measures can be at odds with social and economic realities; pandemic response should balance public health control and the socio-economic needs. Data from Zambia revealed that community-based settings have the potential to increase uptake of testing services. Community-based campaigns to normalize and reduce stigma for COVID-19 testing services are needed.