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OpenTrials
Completed

NCT Number: NCT06233383

Developing Screening Clinical Breast Examination Implementation Strategies in 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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Witwatersrand, Faculty of Health Sciences

Johannesburg, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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
  • 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:

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

Treatment and study plan

Primary outcomes

  1. Implementation Strategies Suite

    Time frame: 2 years

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

Secondary outcomes

  1. Intervention Domain Characteristics

    Time frame: 2 years

    Characteristics of routine clinical breast examination itself that are potential barriers and facilitators to screening implementation

  2. Inner Setting Domain Characteristics

    Time frame: 2 years

    Characteristics of the primary care clinics that are potential barriers and facilitators to screening implementation

  3. Outer Setting Domain Characteristics

    Time frame: 2 years

    Characteristics of both the community surrounding the clinics and the district-wide health system that are potential barriers and facilitators to screening implementation

  4. Individuals Domain Characteristics

    Time frame: 2 years

    Characteristics of individuals involved in screening that are potential barriers and facilitators to screening implementation

  5. Implementation Domain Characteristics

    Time frame: 2 years

    Characteristics of activities and strategies used to implement screening that are potential barriers and facilitators to screening implementation

  6. Change Matrices

    Time frame: 2 years

    Matrices for all individuals relevant to implementation that define performance objectives and corresponding performance determinants

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • University of Witwatersrand, South Africa

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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