Patient recruitment has now begun across all TriageTB’s three recruitment sites, South Africa, the Gambia, and Uganda. The first recruitment phase is scheduled to run until the end of April this year. By then, the goal is to have enrolled approximately 50 participants per site, amounting to 150 participants in total.
TriageTB was initially planning to begin recruiting patients in the second quarter of 2020, but the COVID-19 pandemic forced the consortium to push back the recruitment start.
In late November 2020, Stellenbosch University in Cape Town, South Africa, was able to enroll TriageTB’s first participants. A few weeks later, recruitment also kicked off at the Medical Research Council Unit the Gambia at LSHTM in Fajara, the Gambia, and at Makerere University in Kampala, Uganda.
TriageTB's team is constantly monitoring the COVID-19 infection rates in the areas where the study is recruiting participants. All necessary measures have been taken to ensure the safety of both patients and staff.
The Medical Research Council in the Gambia is recruiting through the Outpatients Department, which sees around 150 participants per day. Here, everyone who comes into the clinic is initially funneled through a COVID-19 triage system. The people who show symptoms such as coughing or shortness of breath are moved to a 'hot zone' where they are being tested for both COVID-19 and TB. The TriageTB clinic team works to identify potential study participants both in and out of the hot zone. Similar safety precautions have been taken at the clinics where TriageTB recruits patients in South Africa and Uganda.
Makerere University employs a full-time nurse who works with the university’s extensive referral network to get in touch with potential study participants. The network consists of government hospitals, outpatient departments, health care centers, and non-governmental organization health providers in Kampala.
Stellenbosch University is currently recruiting at six sites in Cape Town. Each site has a clinical research worker who works full-time in the TB clinic and assists the staff while identifying eligible participants for the TriageTB study.
Everyone who is suspected of having TB is eligible to enroll in TriageTB's study. The project's recruitment staff provide those who are eligible to enroll with information about TriageTB before they offer them the chance to partake in the study.
The TriageTB team is currently recruiting for phase one of the study. The goal is to wrap up the first recruitment round in April this year. By then, the consortium aims to have enrolled around 50 patients per site. Over 80 participants have already been recruited across all three sites (as of March 12, 2021).
The findings from recruitment phase one should form the basis for developing the signature that will be used in the Point-of-Care test that the TriageTB consortium aims to validate in the second recruitment phase. The signature will be developed by scientists at Leiden University Medical Center (LUMC) in the Netherlands.
The initial project plan included a six-month recruitment pause between the end of the first recruitment phase and the beginning of the second. This half-year-long recruitment pause was built in to ensure that the scientists at LUMC would have sufficient time to develop the signature. However, the team is now preparing to begin its work in parallel to the ongoing recruitment. This should help the TriageTB team to kick off the second recruitment phase earlier and make up for some of the time that was lost during the initial COVID-19-related recruitment delay.
The goal is to enroll approximately 250 patients per site in the second recruitment phase, which is scheduled to end mid-next year. The second recruitment phase will be followed by comprehensive data analyses and a thorough evaluation of the Point-of-Care triage test used in the second round.