Developing Screening Clinical Breast Examination Implementation Strategies in South Africa

NCT ID: NCT06233383

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

Brief Summary

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adopters

Individuals responsible for deciding to institute screening CBE in Soweto's primary care clinics (e.g., policymakers, clinic administrators, nurse managers)

No interventions assigned to this group

Implementers

Individuals responsible for actually performing the screening CBE in Soweto's primary care clinics (e.g., nurses, doctors, fieldworkers, clerical workers)

No interventions assigned to this group

Recipients

Individuals eligible for a screening CBE (e.g., women over the age of 40 years from the community surrounding study clinics)

No interventions assigned to this group

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel O'Neil, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

University of Witwatersrand, Faculty of Health Sciences

Johannesburg, , South Africa

Countries

South Africa

Other Identifiers

2000036834

Identifier Type: -

Identifier Source: org_study_id