Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01764360 |
| Other study ID # |
12-0816 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2013 |
| Est. completion date |
June 2017 |
Study information
| Verified date |
May 2022 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
