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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01764360
First received: January 7, 2013
Last updated: July 21, 2016
Last verified: July 2016
History of Changes
  Purpose
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.

Condition Intervention
Kaposi Sarcoma (KS)
HIV
 Other: KS structured clinical care training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.
Estimated Enrollment: 1024
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed 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.

  Eligibility
Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764360

Locations
Zimbabwe
University of Zimbabwe College of Health Sciences
Harare, Zimbabwe
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Thomas B. Campbell, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01764360     History of Changes
Other Study ID Numbers: 12-0816 
Study First Received: January 7, 2013
Last Updated: July 21, 2016
Health Authority: Zimbabwe: Medical Research Council

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on September 29, 2016