Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03514459|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : May 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Other: Systems Analysis and Improvement Approach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster randomized trial of family planning clinics|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya|
|Actual Study Start Date :||January 29, 2020|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
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)
- 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
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
|Family planning clinics|
|Principal Investigator:||McKenna C Eastment, MD||University of Washington|