Challenges and opportunities for patient recruitment
infection, HIV and contact tracing, predominantly gastrointestinal symptoms, fatigue
RECRUITMENT, RECRUITMENT, TUBERCULOSIS, COVID-19 INFECTION, INFECTION, MAY, HOLIDAY, INFLUENZA
Patient recruitment was initiated during a lull in COVID-19 infections and progressed very slowly at first (Fig. During the second wave (December 2020 to February 2021), new methods of working were implemented and the extreme pressure on the health service, including staff sickness absences, plus a break for the Christmas holiday, reduced the capacity to enrol patients. Notably, there was a shift in the presenting symptoms of COVID-19-infected patients, with more complaining of predominantly gastrointestinal symptoms as opposed to respiratory symptoms. This was likely due to the emergence and spread of the Beta variant (B.1.351; also called GH/501Y.V2), first detected in South Africa in December 2020 [Between January and April 2021 recruitment was mostly steady, despite a declining incidence of infection, as staff became accustomed to the new working methods, more staff were employed and trained, and staff sickness absences decreased (Fig. There was a high proportion of negative tests in the study, with a SARS-CoV-2 positivity rate of 2% in April 2021. This was slightly below the national average of approximately 4–5%, possibly because our screening population was more diverse, so less likely to have COVID-19, or it could indicate a higher than average false-negative rate, which could be due to inadequate specimen collection or sampling too early in the course of infection. There were ongoing efforts to optimise the number of procedures at screening, which improved screening capacity. For example, split screening was implemented to reduce time spent on the main study consenting procedures in participants who subsequently tested negative for SARS-CoV-2 on PCR. A protocol amendment to allow saliva specimens (November 2020) did not yield the expected increase in recruitment. Other than a negative COVID-19 test, common reasons for screen failure were lack of highly effective contraception for female patients, concomitant use of efavirenz-based antiretroviral therapy, and unwillingness to participate in the study.As pandemic fatigue set in, people became more complacent about regulations, and less likely to present to health facilities when developing mild symptoms, probably because of the negative economic consequences of self-isolation [South Africa has an established network of community health workers (CHWs) supporting people living with HIV and contact tracing for tuberculosis. Nationally, 28,000 CHWs were re-deployed to conduct COVID-19 screening and contact tracing [During the winter (May to August 2021), there was a double burden of COVID-19 and influenza, both presenting with similar symptoms. With the third wave worsening throughout June and July, recruitment was at its highest rate. However, widespread civil unrest (9–18 July) with violence and looting, closure of services and businesses, and disruption to transport, food, fuel, and medical supplies necessitated a pause in recruitment. Recruitment was concluded on 29 July 2021 at 192 patients because of the lower than anticipated drop-out rate (Fig. 