According to KAIS 2012, approximately 1.2 Million Kenyans are living with HIV and AIDs, HIV prevalence stands at 5.6 %. ART is a lifelong therapy for HIV infected individuals. The ARV medicines are associated with safety concerns ranging from minor to more serious Adverse Drug Reactions (ADRs). These ADRs can have both short and long-term effects for clients on ARVs.

There has been limited toxicity monitoring or systematic documentation and reporting of ADRs in the ART sites.  There is limited information on ADRs prevalence and risk factors associated with the use of ARVS amongst ART clients in Kenyans. It is therefore important to put in place a system to strengthen the identification, documentation, reporting and monitoring of ADRs amongst ART patients in Kenya. The overall goal of the study is to contribute towards drug safety for clients hence improve quality of care.  The main objective is to determine the safety of ARVs among cohorts of clients initiating ART in selected health facilities

This CEM will be a multicenter prospective observational study, free of selection bias, inceptional (each patient will be monitored from the beginning of treatment), dynamic (new patients will be added as the program proceeds), longitudinal (effects will be studied over a defined time period) and descriptive. The study population is adult and pediatric clients newly initiating on ART.  A sample size of 10,000 clients initiating clients in 8 sampled sites across the country shall be recruited and followed up for 24 months.  Ethical approval to implement the protocol shall be obtained from PPB.

The findings of CEM will help MOH/NASCOP as well as other stakeholders gain additional knowledge on adverse drug effects related to ARV regimens in Kenya. It will help in rolling out interventions that shall improve tolerability and effectiveness of ART, promoting the early recognition and reversal of potentially serious adverse effects and reducing the potential for adverse drug interactions. It will also improve adherence to ART.