Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01764360
First received: January 7, 2013
Last updated: February 4, 2014
Last verified: February 2014

January 7, 2013
February 4, 2014
February 2013
June 2015   (final data collection date for primary outcome measure)
  • Change in identification of early stage diagnosis of Kaposi Sarcoma (KS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Earlier diagnosis of Kaposi Sarcoma (KS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01764360 on ClinicalTrials.gov Archive Site
Not Provided
  • Improved quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Increased survival/retention in care [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe
Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kaposi Sarcoma (KS)
  • HIV
Other: KS structured clinical care training
Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
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)
Intervention: Other: KS structured clinical care training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1024
June 2016
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria: Subjects, between the ages of 1 and 80, will be recruited from the eight (8) participating primary care sites. All persons will be newly identified with Kaposi sarcoma (KS) and HIV-1 infection.

Exclusion Criteria: None

Both
1 Year to 80 Years
No
Contact: Margaret Z. Borok, MBChB, FRCP +263-4-791631 mborok@mweb.co.zw
Zimbabwe
 
NCT01764360
12-0816
Yes
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Thomas B. Campbell, MD University of Colorado, Denver
University of Colorado, Denver
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP