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Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya

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ClinicalTrials.gov Identifier: NCT03514459
Recruitment Status : Not yet recruiting
First Posted : May 2, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
McKenna Eastment, University of Washington

Brief Summary:
Cervical cancer is the most common cancer in women in sub-Saharan Africa, and the majority of cervical cancer mortality occur in low and middle income countries (LMICs). Many of the disparities between high and LMICs are attributed to differences in screening. Kenyan guidelines recommend screening with visual inspection methods followed by treatment of pre-cancerous lesions with cryotherapy and loop electrosurgical excision procedure (LEEP). Implementation of these are poor with only 14% of Kenyan women ever having been screened for cervical cancer as of 2014. To address this implementation gap, this application proposes three aims. In Aim 1, the investigators will describe the cervical cancer screening care cascade, from identification of female clients age 21-65 years old, through referral for follow-up of clients with positive or suspicious screens, in family planning (FP) clinics in Mombasa County. Following characterization of this cascade, an analysis will be conducted of correlates of failure to screen for cervical cancer in FP clients seen over a one-year period in Mombasa County. Aim 2 will test whether SAIA increases cervical cancer screening compared to usual procedures in a cluster randomized trial in 20 FP clinics in Mombasa County. Finally, in Aim 3, the investigators will determine the cost and budget impact of using SAIA to increase cervical cancer screening in FP clinics in Mombasa County. The results of this study have the potential to improve cervical cancer screening, and inform policy in the Mombasa DOH for a fiscally responsible evidenced-based approach for cervical cancer screening. The long-term goal is to decrease cervical cancer mortality and improve women's health.

Condition or disease Intervention/treatment Phase
Cervical Cancer Other: Systems Analysis and Improvement Approach Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized trial of family planning clinics
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial of an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
No Intervention: Control
Control clinics: Clinics randomized to the control arm will continue usual procedures. Periodic evaluation of cervical cancer screening rates will be examined every 3 months using FP register data.
Experimental: Intervention with SAIA
Clinics randomized to the intervention arm will be introduced to the five steps of SAIA by study staff. The cascade analysis will be performed within the FP clinic to identify drop-offs in cervical cancer screening and referrals, using an Excel-based tool adapted from previous SAIA trials. Flow mapping performed by clinic and study staff will describe the cervical cancer screening process including who the client interacts with, timing of these interactions, any cervical cancer screening performed, and any referrals made. Initial drafts will be reviewed together with clinic and study stuff to ensure adequate and complete representations of processes. Study staff will work with clinic staff to identify bottlenecks in the process and potential solutions to improve flow. Proposed solutions will be implemented, and the process will be examined again to determine the effect of the implemented changes. The cycle will be repeated approximately every 6-8 weeks during the RCT.
Other: Systems Analysis and Improvement Approach
SAIA has five steps. The first step uses an Excel-based tool to quantify drop- offs, or people who did not progress, in each step of a process (Figure 1). This tool also allows the user to see the downstream effect when improving one step in the cascade, and holding the other steps constant. Step 2 involves process flow mapping with clinic staff to identify modifiable bottlenecks in the process. Step 3 develops and implements a workflow modification to address a bottleneck identified in step 2 (continuous quality improvement [CQI] step). Step 4 assesses impact of the modification and recalculates the cascade analysis in step 1 (CQI step). Step 5 repeats the cycle for CQI. SAIA draws from systems engineering in the Toyota Production Systems and from research in LMICs. Studies in quality improvement in LMICs highlight that CQI processes led to more sustainable, effective, and appropriate interventions (42-44).
Other Name: (SAIA)




Primary Outcome Measures :
  1. Cervical cancer screening [ Time Frame: Following 1 year of cluster randomized trial ]
    Proportion of all FP clients aged 21-65 years who were screened for cervical cancer over the total number of eligible clients



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cervical cancer screening will only be performed in women. However, our unit of randomization and intervention are whole family planning clinics which have both men and women.
Accepts Healthy Volunteers:   Yes
Criteria

For FP Clinics:

Inclusion Criteria:

  • All FP clinics that receive County-supplied FP products will be eligible to participate.

Exclusion Criteria:

  • Any clinic that is expected to be closed during part or all of the SAIA intervention period will be excluded. Any FP clinic that was previously included in the FP HIV SAIA trial will be excluded.

FP clinic managers and staff:

Inclusion Criteria:

  • Any FP clinic manager that is 18 years and older is eligible to be interviewed.

Exclusion Criteria:

  • These clinic managers can be male or female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514459


Contacts
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Contact: McKenna C Eastment, MD 206-616-7217 mceast@uw.edu

Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: McKenna C Eastment, MD University of Washington

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Responsible Party: McKenna Eastment, Acting Instructor, School of Medicine: Department of Medicine: Allergy and Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT03514459     History of Changes
Other Study ID Numbers: STUDY00004431
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data from this study will be available upon request after publication of the main study manuscripts. A standard approach will be followed for data sharing. Researchers requesting access to data will need to first submit a request in writing describing their qualifications, local IRB approval for the planned analyses, statistical analysis plans, and plans to secure the confidentiality and safety of the data. They will be required to agree, in writing, that they will not share the data with others, will use it only for the research purpose(s) delineated, and will return or destroy the data upon completion. All data will be de-identified. Approval from the Kenyatta National Hospital-University of Nairobi Ethics and Research Committee (KNH-UON ERC) will also be required to have access to any data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female