Just when StatinTB was about to start recruiting patients, COVID-19 hit the world and the lockdown in South Africa forced the project to put the recruitment process on hold before it had even started. In the past months, Dr Sandra Mukasa, Local Principal Investigator, and her team have worked hard to adjust the recruitment plan to the current situation – and the effort is now paying off. Over the past two weeks, the first six patients were pre-screened for eligibility to participate in the trial.
StatinTB’s goal is to show that fewer patients will develop chronic lung disease after a TB episode by adding statins, widely used cholesterol-lowering drugs, at the end of standard TB therapy. The project, funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), is coordinated by Dr Reto Guler at the University of Cape Town.
The clinical trial includes two study arms (one where patients will receive atorvastatin and one where they will receive a placebo during 24 weeks after having completed standard treatment) and a control arm. Dr Sandra Mukasa and her team aim at pre-screening 260 patients over the next 18 months to be able to randomise 55 patients to each study arm by the end of 2021.
COVID-19 hit just as StatinTB was about to start recruiting patients
Just as the StatinTB team was about to start recruiting in March this year, all research at the UTC was put on hold due to the coronavirus outbreak, much to the worry of the study’s Chief Principal Investigator Dr Friedrich Thienemann. It took until early July before UCT’s Human Research Ethics Committee began reviewing research projects involving TB and HIV again to make case-by-case decisions on which could resume.
Once the StatinTB trial was given green light to start recruiting again, Dr Sandra Mukasa immediately re-connected with the trial’s two partner-clinics. Together, they quickly revised the initial patient recruitment process and calibrated it for the current pandemic to ensure the safety of both staff and patients. And they did so successfully – over the past two weeks, the first six patients have been pre-screened.
Patient recruitment process revised in the wake of COVID-19
StatinTB collaborates with two TB-clinics in Cape Town. The initial plan was for Dr Mukasa and her team to go to the clinics in the morning, when they used to be crowded with patients, to hand out flyers and present the study to patients in the waiting room. Breaking every social distancing rule there ever was, this method is no longer possible.
Instead, the StatinTB team has got access to the clinic’s patient registers, which they go through every week in search of patients that appear to meet the eligibility criteria to be enrolled in the study. After that, Ms Siphokazi Khonkwane, StatinTB Recrutier, calls each patient on the shortlist to invite them to a pre-screening. All meetings begin outside the clinics where patients are carefully screened for symptoms of being infected by the coronavirus before they are invited into the lab.
Tackling the extra challenges of recruiting by phone instead of in person
The current recruitment method has appeared to be more resource-demanding than the initially planned method, but all necessary measures have been taken to adapt to the current circumstances. Dr Mukasa explained that it is more challenging to win patient’s trust over the phone than when you meet them in person, which led her to re-work her initial speech. She now explains very clearly how StatinTB is related to the clinic where the patient receives treatment, and also invites the patient to reach out to his or her TB nurse to get the information verified.
Well-positioned to reach recruitment goals by the end of 2021
Recruitment is scheduled to go on until the end of 2021. Dr Mukasa says that she will take stock of the recruitment situation in December this year. If they are behind schedule then, she intends to look for additional clinics from which StatinTB can recruit next year.
Despite all the hoops the team has had to jump through in recent months, Dr Mukasa thinks that the StatinTB team is in a good position to wrap up the recruitment period on time successfully.
The photo shows the StatinTB recruitment team at the University of Cape Town. From the left: Ms Siphokazi Khonkwane, Ms Nosipho Mkuzangwe, Dr Mumin Ozturk, Dr Sandra Mukasa.