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Clinical Trials/NCT02529644
NCT02529644UnknownNot Applicable

Assessing HIV Screening in African American Churches

University of Missouri, Kansas City2 sites in 1 country1,540 target enrollmentStarted: July 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
1,540
Locations
2
Primary Endpoint
Self-reported Receipt of HIV screening

Study Overview

Brief Summary

The primary aim of this study is to fully test a culturally/religiously-tailored, church-based HIV screening intervention (TIPS) against a standard HIV information intervention on HIV screening rates at 6 and 12 months with adult African American church members and community members who use church outreach services. Our secondary outcome is to reduce sexual risk behaviors with this same population.

Detailed Description

The primary aim of this study is to fully test a culturally/religiously-tailored, church-based HIV screening intervention against a standard HIV information intervention on HIV screening rates at 6 and 12 months with adult AA church members and community members who use church outreach services. In this two-arm clustered, randomized community trial, churches will be matched on SES, membership size, and denomination, then randomized to treatment condition. It is projected that 14 churches (7 churches per arm; 110 church and community members per church; 1,540 participants total) will be required to detect significant increases in HIV screening in the intervention arm. Intervention content is guided by the Theory of Planned Behavior (TPB). Intervention delivery will be guided by a Community Engagement and Social-Ecological approach. This approach includes church leaders delivering culturally/religiously-appropriate HIV education and screening materials (e.g., sermon guides, HIV screening testimonials, church bulletins) and activities (e.g., pastors modeling receipt of HIV screening, HIV screening events) from a church-based HIV Tool Kit through multilevel church outlets (community-wide, church-wide services, ministry and outreach groups, individual) to increase intervention reach and dosage. It was hypothesized that this church-based HIV screening intervention will significantly increase HIV screening rates vs a standard HIV information intervention in AA church-populations at 6 and 12 months. The role of potential mediators and moderators related to receipt of HIV screening will be evaluated and a process evaluation to determine modifiable implementation fidelity, facilitators, barriers, and costs related to increasing church-based HIV testing rates will be conducted. This intervention study could provide an effective, scalable model for HIV screening interventions in AA churches.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • All participants must be: aged 18 to 64; willing to participate in 3 surveys after church services or church outreach activities
  • Willing to provide contact information (two phone numbers, mailing and email address, phone numbers for two persons with whom they have ongoing contact)
  • Attend church at least once a month or use church outreach services, such as food and clothing programs, at least 4 times per year.

Exclusion Criteria

  • Minors 18 and under are intentionally excluded since the intervention study has been designed specifically for adults with information of how HIV affects the African American adult population.

Outcomes

Primary Outcomes

Self-reported Receipt of HIV screening

Time Frame: 12 months

This measure is self-reported receipt of HIV screening received in last 12 months

Self-reported Receipt of HIV Screening

Time Frame: 6 months

This measure is self-reported receipt of HIV screening recieved in last 12 months

Secondary Outcomes

  • HIV Sexual Risk Behavior Score(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jannette Berkley-Patton

Associate Professor of Biomedical and Health Informatics

University of Missouri, Kansas City

Study Sites (2)

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