Developing Screening Clinical Breast Examination Implementation Strategies in Nigeria

NCT07080515 | Recruiting

• 2 other identifiers: 2000040678K08CA279913
• Study Type: observational
• Target: 50
• 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 of Abuja, Nigeria. The main questions it aims to answer are: What barriers and facilitators exist to conducting screening CBE in Abuja'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 interviews and focus group discussions regarding screening CBE implementation

Conditions

Breast Cancer Detection

Outcome Measures

Primary Outcomes (5)

• Intervention Domain Characteristics

  Characteristics of routine clinical breast examination itself that are potential barriers and facilitators to screening implementation, emerging from thematic analysis of qualitative data organized according to the Consolidated Framework for Implementation Research.

  1 year

• Inner Setting Domain Characteristics

  Characteristics of the primary care clinics that are potential barriers and facilitators to screening implementation, emerging from thematic analysis of qualitative data organized according to the Consolidated Framework for Implementation Research.

  1 year

• 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, , emerging from thematic analysis of qualitative data organized according to the Consolidated Framework for Implementation Research.

  1 year

• Individuals Domain Characteristics

  Characteristics of individuals involved in screening that are potential barriers and facilitators to screening implementation, emerging from thematic analysis of qualitative data organized according to the Consolidated Framework for Implementation Research.

  1 year

• Implementation Domain Characteristics

  Characteristics of activities and strategies used to implement screening that are potential barriers and facilitators to screening implementation, emerging from thematic analysis of qualitative data organized according to the Consolidated Framework for Implementation Research.

  1 year

Study Arms (3)

Adopters

Individuals responsible for deciding to institute screening CBE in Abuja's primary care clinics (e.g., policymakers, clinic administrators, nurse managers)

Implementers

Individuals responsible for actually performing the screening CBE in Abuja'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 two study clinics in Abuja, Nigeria.

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 Nigeria's Ministry 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
• National Cancer Institute (NCI): collaborator
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

Institute of Human Virology, Nigeria

Abuja, Nigeria

RECRUITING

Study Officials

• Daniel O'Neil, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel O'Neil, MD, MPH

CONTACT

347-414-0560; daniel.oneil@yale.edu

Study Design

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

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 23, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)