Clinical trial NCT06572774: Community Clinic Model to Improve Early Detection of Breast and Cervical Cancers in Kenya
Official title: An Integrated Community Clinic Model of Optimized Implementation Strategies to Increase Early Detection of Breast and Cervical Cancers in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Lead sponsor: Implenomics
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: RTI International
First posted: 2024-08-27
Enrollment: 5400
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We are randomly assigning women to the three study arms. We are also requesting that the women select one caregiver for inclusion in the caregiver education sessions
Primary purpose: SCREENING

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.

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:

-

Primary outcomes:
measure: Breast and cervical cancer screening
timeFrame: 24 months
Secondary outcomes:
measure: Follow-up diagnostic procedure
timeFrame: 24 months
measure: Initiation of cancer treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Machakos
country: Kenya
facility: Public Health Facilities in Machakos, Nyeri and Nakuru
Study officials:
References: