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

Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)

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.

Health system resources, training, and requirements for EBI implementation (Aim 2)

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.

Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)

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).

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)

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).

Time to MMG screening (Aim 3)

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).

Time to diagnostic MMG (Aim 3)

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).

Time to breast ultrasound (Aim 3)

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).

Time to breast biopsy (if required) (Aim 3)

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).