NCT03514459

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

Completed NA Results posted Last updated 22 May 2024

What this trial tests

NA trial testing Systems Analysis and Improvement Approach in Cervical Cancer in 20 participants. Completed in 31 December 2023.

Timeline

29 January 2020

Primary endpoint
31 July 2021

31 December 2023

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	20
Start date	29 January 2020
Primary completion	31 July 2021
Estimated completion	31 December 2023
Sites	1 location across Kenya

Drugs / interventions tested

• Systems Analysis and Improvement Approach

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cervical Cancer Screening Primary · Aggregated data across 18 months, individual participants were not followed over time.

Proportion of all FP clients aged 21-65 years who were screened for cervical cancer over the total number of eligible clients

Group	Value	95% CI
Control	198
Intervention With SAIA	289

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Results of a cluster randomized trial testing the Systems Analysis and Improvement Approach to increase cervical cancer screening in family planning clinics in Mombasa County, Kenya.
   Eastment MC, Wanje G, Richardson BA, Mwaringa E, et al · · 2023 · cited 2× · PMID 38012647 · DOI 10.1186/s13012-023-01322-y