Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe
Condition: Kaposi Sarcoma (KS); HIV
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Interventional

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.
    

Intervention name(s): KS structured clinical care training
Intervention type(s): Other
Intervention description(s): Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment