Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
The "Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe" (SIKO Study) will
consist of both an interventional and an observational component. Eight (8) primary care
sites in Zimbabwe will be randomized to receive structured training on Kaposi sarcoma (KS)
diagnosis and treatment. This intervention will be evaluated through the utilization of
three components; the KS Standardized Evaluation (KS-SE), integration of palliative care and
an algorithm-based KS management strategy at the sites. The impact of the overall
intervention will be evaluated using a step-wedge randomized cluster trial design in which
the 8 primary care sites will be randomized to receive the intervention at different time
points such that the intervention will be eventually be implemented at all sites during the
2 year (102 weeks) course of the study. The 2 year evaluation period will consist of a
monitoring period, followed by an intervention period.
The observational component of the SIKO study will be the enrollment of all patients who are
found to have Kaposi sarcoma (KS) during either the monitoring or intervention periods at
any of eight study sites. After informed consent is obtained, information of HIV status, KS
diagnosis and staging, demographic data and a quality of life questionnaire will be
collected, along with A glycoprotein predominantly found on the surface of helper T cells.
(CD4+) counts (if available), antiretroviral (ARV) medication and tuberculosis and KS
treatment history. Patients will continue to be followed over the course of the study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in identification of early stage diagnosis of Kaposi Sarcoma (KS)
Compare the proportions of new KS diagnoses identified as Stage T0 (early stage) during the standard-of-care and the SIKO intervention periods.
Thomas B. Campbell, MD
University of Colorado, Denver
Zimbabwe: Medical Research Council