Breast CancerNCT06233383
Developing Screening Clinical Breast Examination Implementation Strategies in South Africa
An observational study of Breast Cancer, run by Yale University at 1 site in South Africa.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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:
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Witwatersrand, Faculty of Health Sciences
Johannesburg
About this study
Official title: Developing an Approach to Implementing Breast Cancer Screening Using Clinical Breast Exam in the Primary Health Centers of Soweto, 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?
Read more
Participants will:
- Allow observation of study clinic workflows
- Participate in focus group discussions regarding screening CBE implementation
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Strategies Suite
A collection of strategies for implementing routine screening clinical breast examination in Soweto's primary care clinics.
Measured: 2 years
Secondary outcomes (6)
Intervention Domain Characteristics
Characteristics of routine clinical breast examination itself that are potential barriers and facilitators to screening implementation
Measured: 2 years
Inner Setting Domain Characteristics
Characteristics of the primary care clinics that are potential barriers and facilitators to screening implementation
Measured: 2 years
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
Measured: 2 years
Individuals Domain Characteristics
Characteristics of individuals involved in screening that are potential barriers and facilitators to screening implementation
Measured: 2 years
Implementation Domain Characteristics
Characteristics of activities and strategies used to implement screening that are potential barriers and facilitators to screening implementation
Measured: 2 years
Change Matrices
Matrices for all individuals relevant to implementation that define performance objectives and corresponding performance determinants
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jun 2024
- Primary completion1 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Daniel O'Neil, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233383
- Sponsor's protocol ID
- 2000036834
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to comply with local legal requirements, individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Approach to Implementing Breast Cancer Screening Using Clinical Breast Exam in the Primary Health Centers of Soweto, South Africa
- ClinicalTrials.gov ID
- NCT06233383
- Acronym / sponsor ID
- 2000036834
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implementation Strategies Suite
Time frame: 2 years
A collection of strategies for implementing routine screening clinical breast examination in Soweto's primary care clinics.
6 secondary outcomes
Intervention Domain Characteristics
Time frame: 2 years
Inner Setting Domain Characteristics
Time frame: 2 years
Outer Setting Domain Characteristics
Time frame: 2 years
Individuals Domain Characteristics
Time frame: 2 years
Implementation Domain Characteristics
Time frame: 2 years
Change Matrices
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No. In order to comply with local legal requirements, individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel O'Neil, MD, MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Yale University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Strategies Suite (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.