NCT02076958

Brief Summary

The aim of the proposed project is to identify an optimal implementation strategy using a set of evidence-based interventions that aim to increase early detection of breast, prostate, and colorectal cancer among African Americans as a model. These three interventions will be packaged and interwoven into a single branded project, Project HEAL (Health through Early Awareness and Learning) which will be delivered through trained Community Health Advisors (CHA) in African-American church settings. The implementation and sustainability will be evaluated using the RE-AIM Framework. Fourteen African American churches in Prince George's County, MD will be randomized to a traditional classroom training approach or an online training approach, in which the CHA training approach and level of technical assistance is varied (in-person classroom training of CHAs + monitoring/evaluation + technical assistance and training vs. online training of CHAs + monitoring and evaluation only, respectively). By varying the training methodology and level of technical assistance, we will be able to determine what level of technical assistance leads to successful implementation and sustainability. We will also identify church organizational capacity characteristics that lead to successful implementation and sustainability. The specific aims of this research are to: (1) Package the three interventions into a single branded project (Project HEAL), develop a local cancer screening resource guide, and pilot test the materials and training. (2) Implement Project HEAL in 14 churches in Prince George's County, Maryland. We will evaluate the implementation outcomes involving treatment fidelity and identify church organizational capacity characteristics that led to successful implementation. We will compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance necessary for successful implementation. (3) Evaluate the sustainability of Project HEAL over a two-year period of time. We will identify church organizational capacity characteristics that led to sustainability, and compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance for successful sustainability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

7.6 years

First QC Date

February 27, 2014

Last Update Submit

May 16, 2022

Conditions

Keywords

ImplementationCancerEarly detectionFaith-basedCommunity health advisor

Outcome Measures

Primary Outcomes (1)

  • Adherence to program delivery protocol - Implementation of the 3-workshop series.

    Up to 10 months

Secondary Outcomes (19)

  • Number of training events (workshops)

    Up to 10 months

  • Number of CHA trainees

    Baseline

  • Completion of CHA training

    Baseline

  • Self-report of modifications or problems with program delivery

    Up to 12 months

  • Number of booster CHA training sessions over two-year period

    12-month; 24-month

  • +14 more secondary outcomes

Study Arms (2)

Traditional/classroom

ACTIVE COMPARATOR

Community health advisors trained using traditional/classroom methods and provided with technical assistance/support as needed

Behavioral: Community Health Advisor education

Technology

EXPERIMENTAL

Community health advisors trained using technology/online methods and provided minimal technical assistance/support

Behavioral: Community Health Advisor education

Interventions

TechnologyTraditional/classroom

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advisory Panel members: adults ages 21+
  • Pastors, representing each of the 14 churches enrolled in the project: active pastor of churches enrolled in the study.
  • Community Health Advisors:
  • self-identified African American
  • over 21 years of age
  • regularly attend church services
  • able to complete Project HEAL training
  • have regular access to the Internet and feel comfortable completing online training activities
  • able to recruit 30 participants for the 3-part workshop series
  • able to lead the 3-part workshop series
  • Workshop participants: Self-identified African American men and women ages 40-75 for women who are able to complete self-administered paper-and-pencil surveys.

You may not qualify if:

  • Workshop participants: Men and women who have had breast, prostate, or colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Public Health

College Park, Maryland, 20742, United States

Location

Related Publications (7)

  • Holt CL, Tagai EK, Scheirer MA, Santos SL, Bowie J, Haider M, Slade JL, Wang MQ, Whitehead T. Translating evidence-based interventions for implementation: Experiences from Project HEAL in African American churches. Implement Sci. 2014 May 31;9:66. doi: 10.1186/1748-5908-9-66.

    PMID: 24885069BACKGROUND
  • Santos SL, Tagai EK, Wang MQ, Scheirer MA, Slade JL, Holt CL. Feasibility of a web-based training system for peer community health advisors in cancer early detection among african americans. Am J Public Health. 2014 Dec;104(12):2282-9. doi: 10.2105/AJPH.2014.302237. Epub 2014 Oct 16.

    PMID: 25320894BACKGROUND
  • Huq MR, He X, Woodard N, Chen C, Knott CL. The role of community health advisors' cancer history in implementation and efficacy of a cancer control intervention. Health Educ Res. 2023 Jul 25;38(4):350-361. doi: 10.1093/her/cyad011.

  • Holt CL, Shelton RC, Allen JD, Bowie J, Jandorf L, Zara Santos SL, Slade J. Development of tailored feedback reports on organizational capacity for health promotion in African American churches. Eval Program Plann. 2018 Oct;70:99-106. doi: 10.1016/j.evalprogplan.2018.07.002. Epub 2018 Jul 21.

  • Holt CL, Tagai EK, Santos SLZ, Scheirer MA, Bowie J, Haider M, Slade J. Web-based versus in-person methods for training lay community health advisors to implement health promotion workshops: participant outcomes from a cluster-randomized trial. Transl Behav Med. 2019 Jul 16;9(4):573-582. doi: 10.1093/tbm/iby065.

  • Scheirer MA, Santos SL, Tagai EK, Bowie J, Slade J, Carter R, Holt CL. Dimensions of sustainability for a health communication intervention in African American churches: a multi-methods study. Implement Sci. 2017 Mar 28;12(1):43. doi: 10.1186/s13012-017-0576-x.

  • Santos SL, Tagai EK, Scheirer MA, Bowie J, Haider M, Slade J, Wang MQ, Holt CL. Adoption, reach, and implementation of a cancer education intervention in African American churches. Implement Sci. 2017 Mar 14;12(1):36. doi: 10.1186/s13012-017-0566-z.

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Cheryl L Holt, PhD

    University of Maryland School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 4, 2014

Study Start

March 1, 2011

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations