Recruiting

Prostate Health Equity

Sponsor:

Mayo Clinic

Code:

NCT06541210

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Community Health Service

Questionnaire Administration

Study Details

Brief summary:

This clinical trial the possibility of establishing a Community Living Labs (CoLLab) Learning Health System to facilitate access to prostate health Risk, Education, and Assessment in the Community with Help (REACH) services in Black men and compares the impact to American Legion Posts with no CoLLab set up at the individual and community levels. Cancer is the second leading cause of death for Black men and Black men are less likely to receive prostate cancer screening. CoLLab Learning Health System utilizes community health workers (CHW) that are well-trained to form a bridge between communities and clinicians. In fact, Black men who work with CHW's typically have better access to health services, gain knowledge about cancer, cancer prevention, treatment and may have better overall health outcomes. Establishing a CoLLab Learning Health System at American Legion Posts may improve access to clinical trials and prostate cancer services in Black men.

Conditions

Prostate Carcinoma

Study ID

NCT06541210

Start date

May 4, 2024

Status verified date

Jan, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • AIMS 1 AND 3: Participants must be one of the following key personnel:

  • Community PI (n=1),
  • CoLLab Program Manager (n=1)
  • CoLLab Site Managers (n=3)
  • CoLLab CAB members (n=21)
  • 2 Community Health Workers (CHWs) per Post site (n=6)
  • AIMS 1 AND 3: Between the ages of 21 and 80.
  • AIMS 1 AND 3: Able to complete the survey in English.
  • AIMS 1 AND 3: Reside in the Jacksonville, FL and/or surrounding counties.
  • AIMS 1 AND 3: Willing and able to consent to the study.
  • AIM 2: Black adult of any gender.
  • AIM 2: Must be between the ages of 30 and 80.
  • AIM 2: Able to speak English.
  • AIM 2: Reside in the Jacksonville, FL and/or surrounding counties.
  • AIM 2: Willing and able to consent to the study.

Exclusion Criteria:

  • AIMS 1 AND 3: Younger than 21years or older than 80 years.
  • AIMS 1 AND 3: Not a resident of NE Florida. Unwilling or unable to consent to the study.
  • AIM 2: Younger than 30 years or older than 80 years.
  • AIM 2: Not a resident of NE Florida.
  • AIM 2: Unwilling or unable to consent to the study.

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Health services research (CoLLab Learning Health System)

Participants access CoLLab Learning Health System to use any of the services at least twice monthly for up to 1 year.

Interventions

Community Health Service

Access CoLLab Learning Health System to use any of the services

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Create real-life user centric CoLLab Learning Health System (program production) [ Time Frame: Up to 12 months ]
  • Impact of the CoLLab Learning Health Systems [ Time Frame: Baseline; up to 12 months ]
  • Feasibility of Replication - cost analysis [ Time Frame: Up to 24 months ]
  • Feasibility of Replication - qualitative [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Principal Investigator:

Folakemi T. Odedina, Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-20.