This webpage is intended to maintain communication among the CARES team about the progress of the trial. We hope that you will enjoy this way of keeping you informed of the trial progress. We encourage contributions from sites about pertinent issues as they arise.
Funded by Janssen, the CARES trial coordinated by the Joint Clinical Research Centre, has eight study sites, 3 in Uganda, 4 in Kenya and 2 in South Africa. The past year has seen us completing the contracting processes for all the sites, IQVIA CRO that is supporting data management and study monitoring and CSM for distribution of study drugs.
This has been on the backdrop of several milestones including creation and adoption of study documents, ethical and regulatory approvals, Site initiation visits, training and delivery of investigational product at the sites in Uganda, Kenya and South Africa with all the sites fully activated. We held the first Joint Trial Steering Committee (TSC) and Independent Data Monitoring Committee (IDMC) meeting on 11th March 2022.
Our Plan is complete screening and enrolment by mid-August 2022, and the focus is on the first IMDC meeting to be held on 25th August 2022, interim data analysis and organizing the first face to face Investigators Meeting and TSC meeting immediately after. There is also continued follow up on participants already recruited.
In this webpage, we focus on a brief background of the study, the sites and updates from the current activities.
It is my hope that these updates will be informative to you and that it will generate and maintain an interest in the study.
Dr. Cissy Mutuuluza Kityo
A target of 512 participants, will be enrolled in this study and randomized 1:1 to either continue on their ART or switch to the intervention for a treatment period of 24 months. Eligible participants must meet the following criteria: