Church-based HIV Screening: Taking It to the Pews

Not Applicable

• Conditions: HIV

• Registration Number: NCT02529644
• Lead Sponsor: University of Missouri, Kansas City

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1540

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported Receipt of HIV screening	12 months	This measure is self-reported receipt of HIV screening received in last 12 months
Self-reported Receipt of HIV Screening	6 months	This measure is self-reported receipt of HIV screening recieved in last 12 months

Secondary Outcome Measures

Name	Time	Method
HIV Sexual Risk Behavior Score	12 months	HIV sexual risk behavior will be assessed as a composite measure: a) if participant had vaginal, oral, or anal sex with (No=0, Yes=1); b) the number of men and the number of women they had sex with, recoded as 1 to 5 sex partners=1 and 6 or more sex partners=2; and c) how often they or partner(s)/spouse used condoms or barriers (Always=0, Usually=1, Sometimes=2, or Never=3) within last 12 months. Higher scores indicate more sexual risk (range 0-8).

Trial Locations

Locations (1)

University of Missouri-Kansas City; 🇺🇸 Kansas City, Missouri, United States