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NCT Number: NCT06541210

Building Community Living Labs in Black Communities to Advance Prostate Health Equity and Reduce Prostate Cancer Disparities in Black Men

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.

Recruiting

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

PRIMARY OBJECTIVES:

I. Co-create real-life user centric CoLLab Learning Health System at three American Legion Posts, compared to an American Legion Post with no CoLLab set-up. American Legion Post 197 will serve as the hub and Post 244 and Post 194 as the spokes.

II. Assess and evaluate the impact of the CoLLab Learning Health Systems compared to the comparison Post at the individual and community levels.

III. Explore the feasibility of replicating the CoLLab Learning Health System in Black communities nationally.

OUTLINE:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community Health Service

Other

Access CoLLab Learning Health System to use any of the services

Other names: non-interventional study

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Create real-life user centric CoLLab Learning Health System (program production)

    Time frame: Up to 12 months

    Qualitative data collection will be employed during a town hall meeting with the CoLLab Community Advisory Board (CAB) to ensure that we get unbiased and objective feedback from participants.

  2. Impact of the CoLLab Learning Health Systems

    Time frame: Baseline; up to 12 months

    Will be assessed using pre-test and post-test survey scores from a Prostate Health Resources Questionnaire, which consists of 6 multiple choice questions, 8 true/false/don't know questions, 13 questions answered on a 5-point scale (e.g., very favorable to unfavorable or strongly agree to strongly disagree), and 20 yes/no questions.

  3. Feasibility of Replication - cost analysis

    Time frame: Up to 24 months

    Will be assessed using cost analysis of direct and indirect costs.

  4. Feasibility of Replication - qualitative

    Time frame: Up to 24 months

    Will be assessed qualitatively based on interviews of key personnel and users

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Quincy Wimberly

CONTACT

[email protected]

904-953-0974

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

Building Community Living Labs (CoLLab) in Black Communities With the Goal of Advancing Prostate Health Equity and Reducing Prostate Cancer Disparities in Black Men

Acronym: CoLLab

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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