Clinical trial NCT02529644: Church-based HIV Screening: Taking It to the Pews
Official title: Assessing HIV Screening in African American Churches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV Screening
African American
Church
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: City of Kansas City Missouri Health Department
name: Kansas City CARE Clinic
name: RAND
name: Children's Mercy Hospital Kansas City
name: Caanon Worship Center
name: Christian Fellowship Baptist Church
name: Friendship Baptist Church
name: JayDoc Free Clinic
name: Metropolitan Spiritual Church of Christ
name: NBC Community Development Corporation
name: Concord Fortress of Hope Church
name: Victorious Life Church
name: Calvary Community Outreach Network
First posted: 2015-08-20
Enrollment: 1540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported Receipt of HIV Screening
timeFrame: Baseline
measure: Self-reported Receipt of HIV Screening
timeFrame: 6 months
measure: Self-reported Receipt of HIV screening
timeFrame: 12 months
Secondary outcomes:
measure: HIV Sexual Risk Behavior Score
timeFrame: Baseline
measure: HIV Sexual Risk Behavior Score
timeFrame: 6 months
measure: HIV Sexual Risk Behavior Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Missouri-Kansas City
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Jannette Y. Berkley-Patton, PhD
role: PRINCIPAL_INVESTIGATOR
References: