Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
Testing an Implementation Science Tool to Increase Cervical Cancer Screening in Mombasa, Kenya
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.
Specific Aims Eighty-seven percent of cervical cancer deaths worldwide occur in low and
 middle income countries (LMICs) and cervical cancer is the most common cancer in sub-Saharan
 Africa (SSA) (1-4). The significant disparity between cervical cancer outcomes in the United
 States and LMICs is largely attributed to differences in screening (5). While approximately
 89% of US women receive cervical cancer screening (7), less than 5% of women in LMICs have
 been screened (4). Barriers to screening in LMICs include challenges with infrastructure to
 support screening, competing health interests, lack of education, low health literacy, and
 poverty (2, 8-12).

 In addition to the general lack of cervical cancer screening, SSA carries the highest global
 burden of human immunodeficiency virus (HIV) infection. Women account for 59% of all people
 living with HIV (13) and cervical cancer incidence is higher in women with HIV (14). With the
 advent of antiretroviral therapy (ART), women receiving HIV treatment have increased life
 expectancy approaching that of HIV-negative women (15). However, cervical cancer rates do not
 significantly decline despite ART and immune reconstitution (16), and invasive cervical
 cancer incidence remains high even with ART (17). The aging population of HIV-positive women
 will continue to face a large lifetime risk of cervical cancer (18).

 Because of the burden of both cervical cancer and HIV infection in SSA, improving
 implementation of cervical cancer screening and treatment of pre-cancerous lesions in this
 region is critical. Existing methods for cervical cancer screening include cytology, human
 papillomavirus testing (14), and visual inspection methods (19). Pairing screening with
 treatment of positive screens using cryotherapy or loop electrosurgical excision procedures
 (LEEP) could prevent progression to cervical cancer (20), and greatly reduce morbidity and
 mortality in women. To address this implementation gap, simple, scalable, and sustainable
 interventions are imperative to improve screening and treatment of pre-cancers. The Kenyan
 Ministry of Health (MOH) guidelines stress the need to strengthen capacity, streamline, and
 standardize screening, diagnosis, and treatment of cancer (21). To achieve this, our
 long-term partners in the Mombasa County Department of Health (DOH) are eager to increase
 rates of cervical cancer screening. The investigators aim to test an implementation science
 methodology, Systems Analysis and Improvement Approach (SAIA), to address systems barriers to
 screening and provide quality improvement while relying on existing infrastructure to conduct
 screening. Rather than directly offering screening, this intervention aims to support
 systematic improvements in screening processes in facilities throughout the county. The
 investigators propose a collaborative research project with Mombasa County to achieve the
 following specific aims:

 ￼AIM 1:To 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, we will conduct an analysis of correlates of failure to
 screen for cervical cancer in FP clients seen over a one-year period.

 HYP 1: While many FP clinics are capable of providing cervical cancer screening, the majority
 of clients are not screened appropriately. Failure to screen for cervical cancer will be
 associated with both patient-level (e.g. age) and clinic-level (e.g. resources available)
 factors.

 AIM 2: To test whether SAIA increases cervical cancer screening compared to usual procedures
 in a cluster randomized trial in 20 FP clinics in Mombasa County.

 HYP 2: Family planning clinics randomized to SAIA will have increased rates of cervical
 cancer screening by modifying bottlenecks in screening processes compared to clinics
 randomized to usual procedures.

 AIM 3: To determine the cost and budget impact of using SAIA to increase cervical cancer
 screening in FP clinics in Mombasa County.

 Expected Outcomes and Public Health Impact As one of the leading causes of cancer mortality
 in African women, immediate attention to increase rates of cervical cancer screening and
 treatment of pre-cancers is crucial. This implementation tool holds potential for addressing
 gaps in cervical cancer prevention and lowering cancer morbidity and mortality. Use of the
 reproducible SAIA methodology could provide a template for broader rollout of cervical cancer
 screening throughout the country and region. Using the Consolidated Framework for
 Implementation Research (CFIR) to guide the evaluation of this intervention will provide
 insight about the potential generalizability of the intervention, and improve the likelihood
 of its successful implementation in diverse settings (22).

 The proposed aims will provide valuable training in key competencies in implementation
 research, with measurable and objective indicators of success in skills building and career
 development. The proposal leverages exceptional resources at the University of Washington
 (UW) and our longstanding and productive partnership with multiple institutions in Kenya (see
 letters from Mombasa County DOH, University of Nairobi, Kenyatta National Hospital) to
 facilitate Dr. Eastment's career advancement.
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.