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

NCT03514459 | Completed Results

• 2 other identifiers: STUDY000044311K08CA228761
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Cervical Cancer Screening

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

  Aggregated data across 18 months, individual participants were not followed over time.

Study Arms (2)

Control

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Systems Analysis and Improvement Approach OTHER

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).

Also known as: (SAIA)

Intervention with SAIA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Any FP clinic manager that is 18 years and older is eligible to be interviewed.
• These clinic managers can be male or female.

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Family planning clinics

Mombasa, Kenya

Location

Related Publications (1)

• Eastment MC, Wanje G, Richardson BA, Mwaringa E, Patta S, Sherr K, Barnabas RV, Mandaliya K, Jaoko W, Mcclelland RS. 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. Implement Sci. 2023 Nov 27;18(1):66. doi: 10.1186/s13012-023-01322-y.

  PMID: 38012647 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. McKenna Eastment
• Organization: University of Washington

mceast@uw.edu

5742101120

Study Officials

• McKenna C Eastment, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Instructor, School of Medicine: Department of Medicine: Allergy and Infectious Diseases

Model Details: Cluster randomized trial of family planning clinics

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 2, 2018
• Study Start: January 29, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2023
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)