CO-creating Novel, Feasible, and Inclusive Research Methods

NCT07489144 | Active Not Recruiting

• 2 other identifiers: 2291664SOE-2024C1-36758
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The lessons researchers learn and evidence researchers discover from research studies are limited by who volunteered as participants in each research study. Currently, research studies do not represent the full diversity of the American people. Community engagement is one method to increase research participation. But, there is a lack of evidence for recommending a particular level of community engagement over others. This team of scientists, physicians, and community members developed an innovative approach to increase full participation of participants in research studies. The proposed project, Co-creating Novel, Feasible, and Inclusive Research Methods (CONFIRM), is designed to test if researchers can increase research participation by creating methods in partnership with the research participants themselves. As the team has conducted research around breast cancer, these researchers have repeatedly encountered Black women who see the importance of the overall topic and want to help people like them. But when they hear about what exactly they have to do as part of the study, they do not volunteer. This team wants to change that. Researchers plan to recruit participants to answer research questions, and then with those volunteers, researchers will decide together on the tasks and activities volunteers will complete in the study. In contrast to how researchers usually do science, this innovative approach switches the order of design and participant recruitment. Researchers enroll and engage volunteers before methods are selected. This team engages research participants as "co-researchers." This word emphasizes the act of carrying out research with/by participants who are not professional researchers, instead of to/about/for them. The team proposes that participants will design a method that is acceptable, feasible, and relevant to themselves and their community. Researchers will recruit 240 participants from community sites, such as health fairs, retail stores, churches, and schools, who will be divided into two groups based on where they signed up for the study. Half of the participants will complete research procedures (survey, health measurements, blood draw) as the research team designed them before the study started. The other half of participants will work with the research team to adjust the procedures to be acceptable and relevant to the participants before completing the revised procedures. Researchers predict that the group of participants who co-design procedures will have a higher completion rate of inidividual items and stay in the study for longer than the group of participants who complete the pre-designed procedures. By demonstrating the effectiveness of this innovative approach, researchers aim to empower people to become more involved in research.

Conditions

Research Participation

Keywords

research participation; co-researcher; co-design

Outcome Measures

Primary Outcomes (2)

• retention

  Percent of participants who complete study across two data collection cycles

  2 years

• Data completeness

  Percent of items and tasks that participants complete across the study

  2 years

Study Arms (2)

Participant co-designed procedures

ACTIVE COMPARATOR

Other: Participant co-design

Pre-designed procedures

NO INTERVENTION

Interventions

Participant co-design OTHER

Participants will meet with researchers to co-design study procedures

Participant co-designed procedures

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• identify as Black or African American
• English speaking
• Must weigh at least 110 pounds

You may not qualify if:

• hearing impaired (requires use of American Sign Language interpreter)
• employed in medical research discipline

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Publications (3)

• Jones SR, Barsh D, Williamson LD, McIntyre K, Ledford CJW. The Consequence of the Cape: A Mixed-Methods Inquiry into the Sociocultural Stressors Impacting Black Women's Health. J Racial Ethn Health Disparities. 2025 Sep 22. doi: 10.1007/s40615-025-02636-x. Online ahead of print.

  PMID: 40982136 BACKGROUND

• Ledford CJW, Williamson LD, Whisenant EB, Greene TT, Jones SR, Waller JL, Sidibe TS, Jackson FD Jr, Lawson NL, Moore JX, Wolf LE. Building and sustaining restorative community trust and engagement: the Co-Researcher Activation Network. Res Involv Engagem. 2025 Oct 21;11(1):123. doi: 10.1186/s40900-025-00792-2.

  PMID: 41121290 BACKGROUND

• Ledford CJW, Williamson LD, Waller JL, Wolf LE, Chase A, Desrochers E, Kye B, Gunthert Z, Hayes HC, Morgan JC, Hess DC. Researcher photographs in recruitment materials to increase willingness to participate in brain health research. Alzheimers Dement (N Y). 2026 Feb 26;12(1):e70215. doi: 10.1002/trc2.70215. eCollection 2026 Jan-Mar.

  PMID: 41768473 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 23, 2026
• Study Start: June 21, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)