CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Systems Analysis and Improvement Approachother
Likely dose
Not stated in record
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Search/NCT03514459
NCT03514459N/ACompleted

Randomized Controlled Trial of an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya

University of Washington·interventional·Posted May 2, 2018·Updated May 22, 2024

In Brief

A clinical study evaluating Systems Analysis and Improvement Approach for Cervical Cancer. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesKenya

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 2, 2018
Enrollment StartJan 29, 2020
Primary CompletionJul 31, 2021
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.2 years ago

Interventions

Systems Analysis and Improvement Approachother

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).