Community Clinic Model to Improve Early Detection of Breast and Cervical Cancers in Kenya

NCT06572774 | Active Not Recruiting DMC

• 1 other identifier: Imp002
• Study Type: interventional
• Target: 5,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Breast and cervical cancer screening

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

  24 months

Secondary Outcomes (2)

• Follow-up diagnostic procedure

  24 months

• Initiation of cancer treatment

  24 months

Study Arms (3)

C3Link strategies

EXPERIMENTAL

Community liaison will host group education sessions and facilitate cervical and breast cancer screening

Behavioral: C3Link Strategies

C3Link Plus Strategies

EXPERIMENTAL

In addition to group education sessions, the Community Liaison will offer women one-on-one education, counseling and navigation support to address barriers.

Behavioral: C3Link Strategies

One-time education

ACTIVE COMPARATOR

Participants will receive educational brochure on importance of breast and cervical cancer screening

Behavioral: C3Link Strategies

Interventions

C3Link Strategies BEHAVIORAL

Education sessions and community liaison support to link to services

C3Link Plus Strategies; C3Link strategies; One-time education

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Implenomics: lead
• Kenya Medical Research Institute: collaborator
• RTI International: collaborator

Study Sites (1)

Public Health Facilities in Machakos, Nyeri and Nakuru

Machakos, Kenya

Location

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

KE (1)