Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
Primary Purpose
Kaposi Sarcoma (KS), HIV
Status
Completed
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
KS structured clinical care training
Sponsored by
About this trial
This is an interventional treatment trial for Kaposi Sarcoma (KS)
Eligibility 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
Sites / Locations
- University of Zimbabwe College of Health Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
KS structured clinical care training
Arm Description
Eight primary care sites in Zimbabwe will be randomized at different timepoints to receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
Outcomes
Primary Outcome Measures
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.
Change in access to palliative care
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01764360
First Posted
January 7, 2013
Last Updated
May 19, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01764360
Brief Title
Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe
Acronym
SIKO
Official Title
Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
For power estimations we assumed each site would enroll between 0·5 to 0·7 subjects per week, resulting in final sample sizes of 158 to 221 in the Pre-Intervention Period and 318 to 445 in the Intervention Period. To evaluate the effect of the Intervention Package on T0 (T0/(T0 + T1)) we assumed T0 proportions of 0·12 to 0·15 during the Pre-Intervention Period, within site correlations of 0·10, 0·15 and 0·20, and a maximum enrollment of 100 per site. We estimated 80% power to detect a minimum increase of the T0 proportion from 0·12 to 0·37 or from 0·15 to 0·40. Power estimation for evaluation of time to loss-to-care assumed a Kaplan-Meier approach and provided 80% power to detect a hazard ratio (HR) ≥ 1·89 with a total sample of up to 512 KS cases. Sample sizes were calculated using PASS, (NCSS software, Kayesville UT), assuming a 0·05 two-sided significance level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kaposi Sarcoma (KS), HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1024 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KS structured clinical care training
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
KS structured clinical care training
Intervention Description
Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
Primary Outcome Measure Information:
Title
Change in identification of early stage diagnosis of Kaposi Sarcoma (KS)
Description
Compare the proportions of new KS diagnoses identified as Stage T0 (early stage) during the standard-of-care and the SIKO intervention periods.
Time Frame
2 years
Title
Change in access to palliative care
Description
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.
Time Frame
2 years
Title
Change in survival and retention in care
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas B. Campbell, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zimbabwe College of Health Sciences
City
Harare
Country
Zimbabwe
12. IPD Sharing Statement
Citations:
PubMed Identifier
36028920
Citation
Sabourin KR, Borok M, Mawhinney S, Matimba M, Jaji F, Fiorillo S, Chifamba DD, Muserere C, Mashiri B, Bhodheni C, Gambiza P, Mandidewa R, Mutimuri M, Gudza I, Mulvahill M, Moore CM, Kutner JS, Simoes EAF, Campbell TB. Evaluation of a training intervention to improve cancer care in Zimbabwe: Strategies to Improve Kaposi Sarcoma Outcomes (SIKO), a prospective community-based stepped-wedge cluster randomized trial. J Int AIDS Soc. 2022 Aug;25(8):e25998. doi: 10.1002/jia2.25998.
Results Reference
derived
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Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe
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