Trial Outcomes & Findings for Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya (NCT NCT03514459)
NCT ID: NCT03514459
Last Updated: 2024-05-22
Results Overview
Proportion of all FP clients aged 21-65 years who were screened for cervical cancer over the total number of eligible clients
COMPLETED
NA
20 participants
Aggregated data across 18 months, individual participants were not followed over time.
2024-05-22
Participant Flow
Family planning clinics were the unit of randomization and whole clinics were randomized to intervention arm or control arm. Individual participants were not enrolled. Outcomes about women were aggregated across each clinic and not all individual level data including age were collected as we were using paper registry records with identifiable information redacted.
Unit of analysis: Family planning clinics
Participant milestones
| Measure |
Intervention With SAIA
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).
|
Control Arm
Following usual procedures
|
|---|---|---|
|
Overall Study
STARTED
|
0 10
|
0 10
|
|
Overall Study
COMPLETED
|
0 10
|
0 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Aggregated data across 18 months, individual participants were not followed over time.Population: These are aggregated participants in intervention and control clinics. Individual participants were not enrolled in the trial as this was a cluster randomized trial. Results are aggregated across all clinics and presented here but these are not RCT participants as they were not enrolled.
Proportion of all FP clients aged 21-65 years who were screened for cervical cancer over the total number of eligible clients
Outcome measures
| Measure |
Control
n=10 Family planning clinics
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.
|
Intervention With SAIA
n=10 Family planning clinics
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).
|
|---|---|---|
|
Cervical Cancer Screening
|
198 individuals screened
|
289 individuals screened
|
Adverse Events
Control--no Individual Participants Enrolled
Intervention With SAIA--no Individual Participants Enrolled
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place