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

Conditions

• Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Best Practice — OTHER
  Receive EUC
• Discussion — OTHER
  Complete a focus group
• Interview - Stakeholder — OTHER
  Complete stakeholder interview
• Interview - Key Informant — OTHER
  Complete key informant interview
• Interview - Ancillary studies — OTHER
  Ancillary studies
• Patient Navigation - C Components — BEHAVIORAL
  Receive adapted m-Health PN strategy C components
• Patient Navigation - B components — BEHAVIORAL
  Receive adapted m-Health PN strategy B components
• Patient Navigation - A components — BEHAVIORAL
  Receive adapted m-Health PN strategy A components
• Survey Administration — OTHER
  Complete EBI adaptation and implementation surveys
• Survey Administration - Ancillary studies — OTHER
  Ancillary studies

Study Details

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.

Key Dates

First listed

Aug 14, 2026

Start date

Jul 22, 2025

Status verified

Aug 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SCREENING

Arms

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Primary Outcome Measure

Adapted evidence-based intervention (EBI) delivery strategies (Aim 1) [ Time Frame: Up to 2 years ]

Locations (1)

Find similar trials in Atlanta, GA

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