NCT01764360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,024

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

4.3 years

First QC Date

January 7, 2013

Last Update Submit

May 19, 2022

Conditions

Kaposi Sarcoma (KS)HIV

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    2 years

Study Arms (1)

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)

Other: KS structured clinical care training

Interventions

KS structured clinical care trainingOTHER

Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)

KS structured clinical care training

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None Noted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zimbabwe College of Health Sciences

Harare, Zimbabwe

Location

Related Publications (1)

  • 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.

    PMID: 36028920DERIVED

MeSH Terms

Conditions

Sarcoma, Kaposi

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Study Officials

  • Thomas B. Campbell, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 9, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

ZI(1)