Primary role

The Clinical Trials Department (CTD) is primarily responsible for the conduct of clinical trials on behalf of the Program. This includes registration of the trial protocols with local and international regulatory bodies and ensuring that the Good Clinical Practices according to the International Conference on Harmonization are followed. The department has a fully equipped pharmacy where investigational and other medicinal products are stored and dispensed.

It is the primary contact of the program with the clinical trial participants. Here, the participants are recruited ensuring that they meet the protocol requirements, give their consent to participate and ensure their safety throughout their participation in the clinical trials.

The primary research population are the fishing communities around Lake Victoria, Uganda in the districts of Wakiso, Mukono and Kalangala. Studies have demonstrated that fishing communities have an HIV prevalence  five times more than the national average  making them a  most-at-risk population. This is partly because of their life styles, being under served by the general healthcare service programs and that the communities themselves are largely mobile.

The CTD has worked with unique populations within the general fishing communities. These have included the healthy populations, special cohorts to characterize the general fishing communities, women-alone populations, and emancipated minors among others.

Over the years, the department has conducted and garnered experience and expertise in phase I and II HIV vaccine clinical trials and other epidemiological studies. Most recently, the CTD is participating in a DAIDS sponsored phase III PrEP trial.