Kaposi Sarcoma (KS)SIKONCT01764360
Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe
A study testing KS structured clinical care training in people with Kaposi Sarcoma (KS) and HIV, run by University of Colorado, Denver at 1 site in Zimbabwe.
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. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Kaposi Sarcoma (KS), HIV
- What is being tested?
- KS structured clinical care training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 1 siteZimbabwe
- Study dates
- Feb 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None Noted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
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.
Read the 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.
- Conditions
- Kaposi Sarcoma (KS), HIV
- Being tested
- KS structured clinical care training
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KS structured clinical care trainingOther
Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
| Study group | Role | What they receive |
|---|---|---|
| KS structured clinical care training | Other | Eight primary care sites in Zimbabwe will be randomized at different timepoints to receive structured training for diagnosis and treatment of Kaposi sarcoma (KS) Receives: Other: KS structured clinical care training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kaposi Sarcoma (KS)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas B. Campbell, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764360
- Sponsor's protocol ID
- 12-0816
- Acronym
- SIKO
- Status last verified
- May 2022
- First submitted
- 7 Jan 2013
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36028920
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO)
- ClinicalTrials.gov ID
- NCT01764360
- Acronym / sponsor ID
- SIKO / 12-0816
- Conditions
- Kaposi Sarcoma (KS), HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KS structured clinical care training | Other | Other: KS structured clinical care trainingEight primary care sites in Zimbabwe will be randomized at different timepoints to receive structured training for diagnosis and treatment of Kaposi sarcoma (KS) |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None Noted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KS structured clinical care trainingEight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS) | Other | KS structured clinical care training |
Primary outcome
Change in identification of early stage diagnosis of Kaposi Sarcoma (KS)
Time frame: 2 years
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 36028920Sabourin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas B. Campbell, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KS structured clinical care training in people with Kaposi Sarcoma (KS) and HIV, run by University of Colorado, Denver at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in identification of early stage diagnosis of Kaposi Sarcoma (KS) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.