Research ParticipationCONFIRMNCT07489144
CO-creating Novel, Feasible, and Inclusive Research Methods
A study testing Participant co-design in people with Research Participation, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Research Participation
- What is being tested?
- Participant co-design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- identify as Black or African American
- English speaking
- Must weigh at least 110 pounds
Who cannot join
- hearing impaired (requires use of American Sign Language interpreter)
- employed in medical research discipline
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Participant co-design
- Keywords
- research participation, co-researcher, co-design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant co-designOther
Participants will meet with researchers to co-design study procedures
| Study group | Role | What they receive |
|---|---|---|
| Participant co-designed procedures | Active comparator | Not described Receives: Other: Participant co-design |
| Pre-designed procedures | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention
Percent of participants who complete study across two data collection cycles
Measured: 2 years
Data completeness
Percent of items and tasks that participants complete across the study
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 posted23 Mar 2026
- Study start21 Jun 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Research ParticipationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489144
- Sponsor's protocol ID
- 2291664
- Other IDs
- SOE-2024C1-36758
- Acronym
- CONFIRM
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40982136Ledford 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.
PubMed 41121290Ledford 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.
PubMed 41768473
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO-creating Novel, Feasible, and Inclusive Research Methods
- ClinicalTrials.gov ID
- NCT07489144
- Acronym / sponsor ID
- CONFIRM / 2291664
- Conditions
- Research Participation
- Keywords
- research participation, co-researcher, co-design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 21 Jun 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 23 Mar 2026 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant co-designed procedures | Active comparator | Other: Participant co-design |
| Pre-designed procedures | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female
- identify as Black or African American
- English speaking
- Must weigh at least 110 pounds
Key exclusion criteria (2 listed)
- hearing impaired (requires use of American Sign Language interpreter)
- employed in medical research discipline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant co-designParticipants will meet with researchers to co-design study procedures | Other | Participant co-designed procedures |
Primary outcome
retention
Time frame: 2 years
Percent of participants who complete study across two data collection cycles
Data completeness
Time frame: 2 years
Percent of items and tasks that participants complete across the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 40982136Jones 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.
- Background: PubMed 41121290Ledford 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.
- Background: PubMed 41768473Ledford 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant co-design in people with Research Participation, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
retention (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07489144, which also lists 3 linked publications.
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 8 Apr 2026.