N/A
N=20
Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03514459 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Cervical Cancer Screening — 198; 289 individuals screened — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Systems Analysis and Improvement Approach (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cervical Cancer Screening |
198; 289 | <0.001 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03514459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.