Clinical trial · Interventional
Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
Randomized Controlled Trial of an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Systems Analysis and Improvement Approach | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
- type
- EXPERIMENTAL
- label
- Intervention with SAIA
- description
- 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.
- interventionNames
- Other: Systems Analysis and Improvement Approach
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For FP Clinics: Inclusion Criteria: * All FP clinics that receive County-supplied FP products will be eligible to participate. Exclusion Criteria: * 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: Inclusion Criteria: * Any FP clinic manager that is 18 years and older is eligible to be interviewed. Exclusion Criteria: * These clinic managers can be male or female.
References
Publications (1)
- DERIVEDEastment 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