Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya

August 10, 2026 updated by: Michael H Chung, Emory University

A Multi-Level Strategy for Integrating Information Technology and Mobile Health to Strengthen Linkages to Breast Cancer Screening and Early Detection Among Women Utilizing Primary Care in Kenya (MATITI YANGU)

This clinical trial develops and studies how well mobile health (m-Health) patient navigation (PN) strategies work to improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya. Although highly curable, breast cancer kills thousands of women in developing countries yearly. Mammography (MMG) is used for the early detection of breast cancer by creating a picture of the breast using film or a computer. Despite the availability of MMG in all 47 counties in Kenya, screening remains low in eligible women. Early detection of breast cancer may also be improved through access to high quality clinical breast exams (CBE). However, primary care providers in Kenya face barriers to incorporating CBE into practice, including limited patient awareness of breast cancer screening. m-Health uses applications on mobile phones to deliver PN directly to the patients. The PN strategies in this study include digital platforms and tools to help with education, reminders, navigation, and motivation around breast cancer screening. This may improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To design and evaluate a multi-component, multi-level, evidence-informed, m-Health-supported package of interventions and delivery strategies to promote uptake and access to resource stratified and guideline-informed breast cancer screening and early detection services in Kenya.

II. To identify and select candidate interventions that are effective in promoting uptake and access to breast cancer screening and early detection.

III. To implement a package and strategies of m-Health supported evidence-based interventions for screening and early detection of breast cancer.

IV. To evaluate feasibility (recruitment, retention, implementation) of each strategy, and identify the most effective strategy (or combination of strategies), for the lowest cost.

OUTLINE:

AIM 1: Participants complete a focus group over 60-90 minutes in support of the identification and selection of evidence-based interventions (EBIs) on study.

AIM 2: Participants are assigned to 1 of 2 groups.

GROUP I: Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.

GROUP II: Participants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study.

AIM 3: Patients are randomized to 1 of 8 arms.

ARM 1: Patients receive enhanced usual care (EUC) which may consist of viewing a motivational and educational peer testimonial video, motivational interviewing regarding breast health and cancer screening, and/or being offered clinical breast examination (CBE) access followed by standardized follow-up counseling about screening MMG or guideline-based recommendations on the need for further diagnostic testing on study.

ARM 2: Patients receive EUC as in arm I and adapted m-Health PN strategy C components on study.

ARM 3: Patients receive EUC as in arm I and adapted m-Health PN strategy B components on study.

ARM 4: Patients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study.

ARM 5: Patients receive EUC as in arm I and adapted m-Health PN strategy A components on study.

ARM 6: Patients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study.

ARM 7: Patients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study.

ARM 8: Patients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study.

After completion of study intervention, patients are followed up at 3 and 6 months and at study completion.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Principal Investigator:
          • Michael Chung
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • AIM 1: All members of BREAKTHROUGH's Stakeholder Advisory Board (SAB) breast cancer working group
  • AIM 1: Participants (patients and health providers) from primary health care clinics in Nairobi County
  • AIM 1: Will include women (patients) aged over 35 years and speak either Kiswahili or English

  • AIM 1: Include women who:

    • Have never undergone MMG screening
    • Previously undergone MMG screening
    • Experienced breast abnormalities and have been referred for or undergone diagnostic investigations
    • Are currently undergoing or have received breast cancer treatment
  • AIM 1: Health care providers and breast screening facility staff (i.e. primary care clinic nurses, MMG clinic staff and technicians) will also be recruited
  • AIM 2: Will engage with a diverse group of local and national interagency stakeholders, Nairobi County health leadership, and health providers across different levels of the health system
  • AIM 3: Women aged 35 years and older who are able to provide informed consent who are attending the outpatient clinics for primary health care
  • AIM 4: Members of SAB breast cancer group, health facilities leadership (all health facility levels)

Exclusion Criteria:

  • AIM 1: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study
  • AIM 2: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study
  • AIM 3: Women undergoing breast cancer treatment and women aged 70 years and above will be excluded
  • AIM 4: Members of SAB breast cancer group, and health facilities leadership who will be unwilling and unable to consent will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
Other: Discussion
Complete a focus group
Other Names:
  • Discuss
Experimental: Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
Other: Interview - Stakeholder
Complete stakeholder interview
Other: Survey Administration
Complete EBI adaptation and implementation surveys
Experimental: Aim 2 group II (key informant interview, surveys)
Participants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study.
Other: Survey Administration
Complete EBI adaptation and implementation surveys
Other: Interview - Key Informant
Complete key informant interview
Active Comparator: Aim 3 arm 1 (EUC)
Patients receive EUC which may consist of viewing a motivational and educational peer testimonial video, motivational interviewing regarding breast health and cancer screening, and/or being offered CBE access followed by standardized follow-up counseling about screening MMG or guideline-based recommendations on the need for further diagnostic testing on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Experimental: Aim 3 arm 2 (EUC, PN strategy C)
Patients receive EUC as in arm I and adapted m-Health PN strategy C components on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Behavioral: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Other Names:
  • Patient Navigator Program
Experimental: Aim 3 arm 3 (EUC, PN strategy B)
Patients receive EUC as in arm I and adapted m-Health PN strategy B components on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Behavioral: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Other Names:
  • Patient Navigator Program
Experimental: Aim 3 arm 4 (EUC, PN strategy B and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Behavioral: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Other Names:
  • Patient Navigator Program
Behavioral: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Other Names:
  • Patient Navigator Program
Experimental: Aim 3 arm 5 (EUC, PN strategy A)
Patients receive EUC as in arm I and adapted m-Health PN strategy A components on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Behavioral: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Other Names:
  • Patient Navigator Program
Experimental: Aim 3 arm 6 (EUC, PN strategy A and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Behavioral: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Other Names:
  • Patient Navigator Program
Behavioral: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Other Names:
  • Patient Navigator Program
Experimental: Aim 3 arm 7 (EUC, PN strategy A and B)
Patients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Behavioral: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Other Names:
  • Patient Navigator Program
Behavioral: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Other Names:
  • Patient Navigator Program
Experimental: Aim 3 arm 8 (EUC, PN strategy A, B, and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study.
Other: Best Practice
Receive EUC
Other Names:
  • standard of care
  • standard therapy
Other: Interview - Ancillary studies
Ancillary studies
Other: Survey Administration - Ancillary studies
Ancillary studies
Behavioral: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Other Names:
  • Patient Navigator Program
Behavioral: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Other Names:
  • Patient Navigator Program
Behavioral: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Other Names:
  • Patient Navigator Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Time Frame: Up to 2 years
The research team will have two independent members who will translate and code the transcripts of the focus group discussions (FGDs). They will be using the Capability, Opportunity, and Motivation-based Behavior model to categorize and code the barriers and opportunities associated with the implementation of candidate evidence-based intervention. Topic prompts related to factors that facilitate EBI implementation will be thematically coded to inform selection and adaptation of EBI delivery (implementation) strategies.
Up to 2 years
Health system resources, training, and requirements for EBI implementation (Aim 2)
Time Frame: Up to 4 years
Will use descriptive statistics to analyze quantitative data from the Service Availability and Readiness Assessment survey, service mapping, Technology Acceptance Model, and Organizational Readiness for Implementing Change. FGDs and key informant interviews will be digitally recorded, transcribed, then translated into English by an experienced study translator. Experienced study team members, supported by trainees, will develop codebooks using an iterative, abductive technique, which allows coders to reference the Consolidated Framework for Implementation Research (CFIR), the process will involve remaining receptive to informative deviations. The coding process will start with reading the transcripts individually to detect initial themes, patterns, and questions that can generate ideas. Then, focused coding will be conducted to identify concepts that cluster together, organize thoughts, identify major themes that emerge, and connect them to relevant CFIR constructs.
Up to 4 years
Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)
Time Frame: Up to 6 months
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 6 months
Access to diagnostic MMG or breast ultrasound for women who have a breast abnormality identified on clinical breast examination offered at the clinic (Aim 3)
Time Frame: Up to 6 months
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to MMG screening (Aim 3)
Time Frame: Up to 2 years
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 2 years
Time to diagnostic MMG (Aim 3)
Time Frame: Up to 2 years
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 2 years
Time to breast ultrasound (Aim 3)
Time Frame: Up to 2 years
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 2 years
Time to breast biopsy (if required) (Aim 3)
Time Frame: Up to 2 years
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 2 years
Time to participant receipt of screening MMG result (Aim 3)
Time Frame: Up to 2 years
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 2 years
Time to receipt of ultrasound and/or biopsy result (Aim 3)
Time Frame: Up to 2 years
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 2 years
Proportion of participants who receive access to the entire (or partial) screening and diagnosis care pathway (Aim 3)
Time Frame: Up to 2 years
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant. The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants. Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michael Chung, Emory University Hospital/Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008713 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (U.S. NIH Grant/Contract)
  • U54CA284036 (U.S. NIH Grant/Contract)
  • NCI-2025-05473 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • EU6635-25 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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