Developing Screening Clinical Breast Examination Implementation Strategies in South Africa

Developing an Approach to Implementing Breast Cancer Screening Using Clinical Breast Exam in the Primary Health Centers of Soweto, South Africa

The goal of this observational study is to engage with multilevel stakeholders to collaboratively and to systematically develop a suite of strategies for implementing breast cancer screening using clinical breast examination (CBE) in the primary health centers within the catchment area of Chris Hani Baragwanath Academic Hospital (Bara Hospital), Johannesburg, South Africa.

The main questions it aims to answer are: What barriers and facilitators exist to conducting screening CBE in Soweto's primary care setting and what implementation strategies would support CBE in primary care clinics?

Participants will:

• Allow observation of study clinic workflows
• Participate in focus group discussions regarding screening CBE implementation

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• South Africa
  • Johannesburg, South Africa
    • University of Witwatersrand, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Focus group participants will consist of three categories: screening CBE "adopter" (e.g., clinic administrators/managers, department of health officials, etc), "implementers" (e.g., nurses, physicians, community health workers), and "recipients" (e.g., women from the community eligible for CBE screening and community breast cancer survivors).

All participants will be drawn from the four study clinics in Soweto, South Africa.

Description

In order to be eligible for inclusion in the focus group discussions held with screening CBE "adopters" and "implementers," an individual must meet all of the following criteria:

1. Be an employee or volunteer working at a participating PHC OR Be an employee or volunteer working at South Africa's National Department of Health OR Be an employee or volunteer working with a non-governmental organization that performs breast cancer related activities within the catchment area of a participating PHC
2. Be willing to commit to keeping the content of focus group discussions confidential

In order to be eligible for inclusion in the focus group discussions held with screening CBE "recipients," an individual must meet all of the following criteria:

1. Be female
2. Be between the ages of 40 and 65 years
3. Be living within the catchment area of a participating PHC
4. Be willing to commit to keeping the content of focus group discussions confidential

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Adopters; Individuals responsible for deciding to institute screening CBE in Soweto's primary care clinics (e.g., policymakers, clinic administrators, nurse managers)
Implementers; Individuals responsible for actually performing the screening CBE in Soweto's primary care clinics (e.g., nurses, doctors, fieldworkers, clerical workers)
Recipients; Individuals eligible for a screening CBE (e.g., women over the age of 40 years from the community surrounding study clinics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Strategies Suite	A collection of strategies for implementing routine screening clinical breast examination in Soweto's primary care clinics.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Domain Characteristics	Characteristics of routine clinical breast examination itself that are potential barriers and facilitators to screening implementation	2 years
Inner Setting Domain Characteristics	Characteristics of the primary care clinics that are potential barriers and facilitators to screening implementation	2 years
Outer Setting Domain Characteristics	Characteristics of both the community surrounding the clinics and the district-wide health system that are potential barriers and facilitators to screening implementation	2 years
Individuals Domain Characteristics	Characteristics of individuals involved in screening that are potential barriers and facilitators to screening implementation	2 years
Implementation Domain Characteristics	Characteristics of activities and strategies used to implement screening that are potential barriers and facilitators to screening implementation	2 years
Change Matrices	Matrices for all individuals relevant to implementation that define performance objectives and corresponding performance determinants	2 years

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: University of Witwatersrand, South Africa
• Investigators: Principal Investigator: Daniel O'Neil, MD, MPH, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2000036834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to comply with local legal requirements, individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No