Developing Screening Clinical Breast Examination Implementation Strategies in South Africa

NCT06233383 | Completed

• 1 other identifier: 2000036834
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Implementation Strategies Suite

  A collection of strategies for implementing routine screening clinical breast examination in Soweto's primary care clinics.

  2 years

Secondary Outcomes (6)

• Intervention Domain Characteristics

  2 years

• Inner Setting Domain Characteristics

  2 years

• Outer Setting Domain Characteristics

  2 years

• Individuals Domain Characteristics

  2 years

• Implementation Domain Characteristics

  2 years

Study Arms (3)

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

University of Witwatersrand, Faculty of Health Sciences

Johannesburg, South Africa

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel O'Neil, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)