Overview

This trial is active, not recruiting.

Conditions kaposi sarcoma (ks), hiv
Treatment ks structured clinical care training
Sponsor University of Colorado, Denver
Start date February 2013
End date June 2017
Trial size 1024 participants
Trial identifier NCT01764360, 12-0816

Summary

Kaposi sarcoma (KS) is an AIDS-related cancer and is the most commonly reported cancer in Zimbabwe. If it is found early on, it may be treatable with antiretroviral therapy (ARVs) alone and this will improve general well-being and ease of care. It may also be possible to avoid use of expensive chemotherapy if the KS is picked up early on in the course of the disease. Early KS is often overlooked or not recognized by health professionals. The purpose of the study is to learn more about if the level of medical care and treatment provided at primary care clinics in Zimbabwe will help people with AIDS-KS do better and maintain their health longer. This will be done by monitoring how KS is diagnosed and treated at the primary care clinics. Clinics will then have training in how to recognize and treat KS so that they can better identify and care for patients with the disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Eight primary care sites in Zimbabwe will be randomized at different timepoints to receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
ks structured clinical care training
Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)

Primary Outcomes

Measure
Change in identification of early stage diagnosis of Kaposi Sarcoma (KS)
time frame: 2 years
Change in access to palliative care
time frame: 2 years
Change in survival and retention in care
time frame: 2 years

Eligibility Criteria

Male or female participants from 1 year up to 80 years old.

Inclusion Criteria: - Subjects between the ages of 1 and 80, - Recruited from the eight (8) participating primary care sites, - Subjects newly identified with Kaposi sarcoma (KS) and HIV-1 infection. Exclusion Criteria: - None Noted

Additional Information

Official title Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
Principal investigator Thomas B. Campbell, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.