Clinical trial NCT01764360: Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe
Official title: Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kaposi Sarcoma (KS)
HIV
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 1024
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in identification of early stage diagnosis of Kaposi Sarcoma (KS)
timeFrame: 2 years
measure: Change in access to palliative care
timeFrame: 2 years
measure: Change in survival and retention in care
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: University of Zimbabwe College of Health Sciences
Study officials:
affiliation: University of Colorado, Denver
name: Thomas B. Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.