Randomized clinical trials (RCT) aiming to rapidly identify effective and safe therapeutics played a key role in the fight against the COVID-19 pandemic. The success of RCT highly depends on adequate patient enrolment and retention. The urgency and uncertainty surrounding the management of emerging infectious diseases may influence patients’ willingness to participate. We aimed to explore the motivations, facilitators and challenges of enrolling patients with mild/moderate COVID-19 in a therapeutic RCT in Guinea (G) and Burkina Faso (BF) from the perspectives of trial patients and healthcare providers.

he ANTICOV ANRS COV33 Coverage Africa trial (2021-2022) evaluated the efficacy and safety of repurposed drugs to prevent clinical worsening among COVID-19 patients with mild to moderate symptoms. Trial recruitment was done both at clinic and patients’ home level. A total of 482 patients (BF: N=427; G: N=55) were enrolled for a 28-day follow-up (55% female; 23% being >60 years old; 50% with a university diploma). This qualitative sub-study included 24 trial patients (BF: n=16; G: n=8), purposively selected. Individual interviews, conducted 4 days after enrolment, explored their decision-making process and reasons for agreeing to participate. Eighteen healthcare providers in charge of recruitment (BF: n=10, G: n=8) were also individually interviewed about their experiences, including facilitators, challenges, and patient refusal for participation. Data were analysed using a deductive thematic analysis approach, adapting the Houghton conceptual framework on the determinants of clinical trial enrolment.

Trial patients mostly explained that their participation was motivated by the opportunity to access free care, with medical check-up and medication. They also mentioned altruism, i.e., being able to contribute to scientific progress and help fighting COVID-19. Some patients reported a sense of responsibility to participate, that they associated with their high education level. Others appreciated the support of their family in deciding to enrol. Competency, professionalism and warmth of the research team was also cited as essential in motivating patients. Yet, some patients, perceiving healthcare providers workload, reported lacking time to read the consent form in full or to consult their family before enrolling. Healthcare providers mentioned that lack of financial or non-financial incentives discouraged some patients from participating in the trial. They also reported that the trial duration could have deterred some patients to enroll, especially those with travel or work commitments. Healthcare providers additionally indicated that concerns about the outcome of the randomization process, i.e., not knowing in advance which medication will be received and their potential side effects, led some patients to decline participation. Fear of stigmatization was another barrier, as some people were afraid that taking part in the trial could disclose their COVID-19 status.

Interviewees reported both individual and collective interests as motivators for enrolling in this COVID-19 RCT. Challenges were mainly related to the trial design and implementation conditions with non-optimal conditions for seeking informed consent for trial recruitment. Study findings overall highlighted the complexity of patient enrolment that should be considered in future RCT in the context of health crises and infectious emerging diseases.