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Clinical Trials/NCT06572774
NCT06572774
Active, not recruiting
Not Applicable

An Integrated Community Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya

Implenomics1 site in 1 country5,400 target enrollmentSeptember 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Implenomics
Enrollment
5400
Locations
1
Primary Endpoint
Breast and cervical cancer screening
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

Kenya has a high incidence of breast and cervical cancers, and most women are diagnosed with late-stage disease. The investigators will conduct a study to assess the effectiveness and cost-effectiveness of strategies to increase the uptake of cancer screening and completion of recommended diagnostic and treatment services. The findings can be used to design optimal approaches and plan investments in infrastructure to scale up implementation of breast and cervical cancer screening.

Detailed Description

Kenya has a high incidence of breast and cervical cancers, and most women are diagnosed with late-stage disease. Implementing effective programs to screen and detect these cancers at an early stage could substantially decrease the high mortality. Kenya has been increasing access to cancer screening, but less than one-sixth of eligible women have ever received breast and cervical cancer screening. The goal of the study is to assess the effectiveness and cost-effectiveness of multicomponent strategies to increase the uptake of breast and cervical cancer screening. A key gap that perpetuates the low screening rates in Kenya is the lack of community-clinic linkages. There is evidence that women are often unaware of the screening services offered in facilities, and, even among those who are aware, there is lack of motivation, anticipated or perceived stigma, and reduced self-efficacy to undergo screening. The investigators will conduct a pragmatic cluster randomized trial to evaluate the screening outcomes, including screening uptake, diagnostic test completion, and treatment initiation and implementation outcomes to support scale-up. The investigators will test two multicomponent packages of strategies: (1) Cancer Community-Clinic Linkage (C3Link) Core: Community health volunteer (CHV)-delivered group education for women and family members to increase screening uptake in the community setting and practice facilitation to improve the screening process and develop team-based care with CHV participation in the clinic setting; (2) C3Link Plus: C3Link Core strategies along with a sequential series of individual strategies that increase in intensity at 3-month intervals; women who remain unscreened will first receive one-on-one education; second, motivational interviewing; and, finally, navigation to address specific barriers. The investigators will implement the study across 27 communities in Kenya to address the following three specific aims: Aim 1: Conduct a cluster randomized trial to assess short-term (intervention implementation phase) and longer-term impacts (maintenance phase) of the two packages of multicomponent strategies on breast and cervical cancer screening outcomes along the continuum of care compared to enhanced standard of care (communities receiving a messaging campaign only); Aim 2: Use a mixed-methods approach to assess and compare multilevel implementation outcomes of the package of strategies focusing on acceptability, feasibility, appropriateness, fidelity, and sustainability; Aim 3: Perform cost-effectiveness and return-on-investment analysis to support scale-up of an effective package of implementation strategies across Kenya and other sub-Saharan African countries. The Kenyan Ministry of Health can use the findings from this study to design optimal approaches and plan investments in screening infrastructure to scale up implementation of guideline recommendations. The lessons learned can be applied to other sub-Saharan African settings.

Registry
clinicaltrials.gov
Start Date
September 3, 2024
End Date
January 31, 2028
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Implenomics
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women will be eligible to participate if they are 30 to 55 years old, due to receive both breast and cervical cancer screening during the study intervention implementation phase based on Kenyan guideline recommendations, not experiencing breast or cervical cancer symptoms (will be referred for diagnostic testing with facilitation support from the study team), not pregnant, fluent in a study language (English,Kiswahili, Kamba, Kalenjin, and Kikuyu) and plan to remain in the community for at least 2 years

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Breast and cervical cancer screening

Time Frame: 24 months

The primary endpoint is the proportion who complete both recommended breast and cervical cancer screenings at 24 months

Secondary Outcomes

  • Follow-up diagnostic procedure(24 months)
  • Initiation of cancer treatment(24 months)

Study Sites (1)

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