Developing Screening Clinical Breast Examination Implementation Strategies in South Africa

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233383
• Other study ID #: 2000036834
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Daniel O'Neil, MD, MPH
• Phone: 347-414-0560
• Email: daniel.oneil[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	University of Witwatersrand, South Africa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation Strategies Suite	A collection of strategies for implementing routine screening clinical breast examination in Soweto's primary care clinics.	2 years
Secondary	Intervention Domain Characteristics	Characteristics of routine clinical breast examination itself that are potential barriers and facilitators to screening implementation	2 years
Secondary	Inner Setting Domain Characteristics	Characteristics of the primary care clinics that are potential barriers and facilitators to screening implementation	2 years
Secondary	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
Secondary	Individuals Domain Characteristics	Characteristics of individuals involved in screening that are potential barriers and facilitators to screening implementation	2 years
Secondary	Implementation Domain Characteristics	Characteristics of activities and strategies used to implement screening that are potential barriers and facilitators to screening implementation	2 years
Secondary	Change Matrices	Matrices for all individuals relevant to implementation that define performance objectives and corresponding performance determinants	2 years