Clinical trial NCT06233383: Developing Screening Clinical Breast Examination Implementation Strategies in South Africa
Official title: Developing an Approach to Implementing Breast Cancer Screening Using Clinical Breast Exam in the Primary Health Centers of Soweto, South Africa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
First posted: 2024-01-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Implementation Strategies Suite
timeFrame: 2 years
Secondary outcomes:
measure: Intervention Domain Characteristics
timeFrame: 2 years
measure: Inner Setting Domain Characteristics
timeFrame: 2 years
measure: Outer Setting Domain Characteristics
timeFrame: 2 years
measure: Individuals Domain Characteristics
timeFrame: 2 years
measure: Implementation Domain Characteristics
timeFrame: 2 years
measure: Change Matrices
timeFrame: 2 years
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: University of Witwatersrand, Faculty of Health Sciences
Study officials:
affiliation: Yale University
name: Daniel O'Neil, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: