Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
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|ClinicalTrials.gov Identifier: NCT01764360|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Kaposi Sarcoma (KS) HIV||Other: KS structured clinical care training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1024 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
KS structured clinical care training
Eight primary care sites in Zimbabwe will be randomized at different timepoints to receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
Other: KS structured clinical care training
Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
- Change in identification of early stage diagnosis of Kaposi Sarcoma (KS) [ Time Frame: 2 years ]Compare the proportions of new KS diagnoses identified as Stage T0 (early stage) during the standard-of-care and the SIKO intervention periods.
- Change in access to palliative care [ Time Frame: 2 years ]Compare the Functional Living Index-Cancer (FLI-C) quality-of-life score in evaluating physical and emotional symptom distress during the standard-of-care and the SIKO intervention periods.
- Change in survival and retention in care [ Time Frame: 2 years ]Evaluate the events (failure to attend clinic, refill prescriptions; to include both death and non-death causes of loss of care) leading to non-retention in care. Compare time to loss of care for all new AIDS-KS patients diagnosed during the standard-of-care and the SIKO intervention periods.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764360
|University of Zimbabwe College of Health Sciences|
|Principal Investigator:||Thomas B. Campbell, MD||University of Colorado, Denver|