NCT02529644

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,540

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

August 6, 2015

Last Update Submit

August 19, 2019

Conditions

HIV

Keywords

HIV ScreeningAfrican AmericanChurch

Outcome Measures

Primary Outcomes (3)

  • Self-reported Receipt of HIV Screening

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

    Baseline

  • Self-reported Receipt of HIV Screening

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

    6 months

  • Self-reported Receipt of HIV screening

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

    12 months

Secondary Outcomes (3)

  • HIV Sexual Risk Behavior Score

    Baseline

  • HIV Sexual Risk Behavior Score

    6 months

  • HIV Sexual Risk Behavior Score

    12 months

Study Arms (2)

Comparison (Standard Information Arm)

ACTIVE COMPARATOR

The comparison/standard information churches will receive standard multilevel HIV education information that is similar in type to those provided to the intervention churches. These churches will receive: a) non-tailored project materials (videos, brochures) collected from health organizations and b) standard, non-tailored activities (e.g., community-based HIV testing events) coordinated by their church liaisons. These churches will receive all Taking It to the Pews HIV Tool Kit materials after the completion of 12-month assessments.

Behavioral: Taking It to the Pews (Comparison)

Intervention

EXPERIMENTAL

Taking It to the Pews (TIPS) will be delivered through church-based multilevel (community, church-wide, ministry group, interpersonal/individual) activities by trained church leaders using religiously/ culturally-tailored study materials packaged in a TIPS HIV Tool Kit and following a scripted, study implementation manual.

Behavioral: Taking It to the Pews (Experimental)

Interventions

Taking It to the Pews (Comparison)BEHAVIORAL

Pastors and Health Action Team members will be trained and receive manualized pastor/church liaison trainings on study procedures, HIV basics and local resources and coordination of HIV screening events. Comparison churches will receive: a) non-tailored project materials (videos, brochures) collected from health organizations and b) standard, non-tailored activities (e.g., community-based HIV testing events) coordinated by their church liaisons. The comparison churches will offer 3 HIV screening events and deliver 1-2 standard materials per month for the 12 month study period. All comparison churches will receive all Taking It to the Pews HIV Tool Kit materials after the completion of 12-month assessments.

Also known as: TIPS
Comparison (Standard Information Arm)
Taking It to the Pews (Experimental)BEHAVIORAL

Pastors and Health Action Team members will be trained in treatment implementation procedures using the scripted, study implementation manual. Intervention churches will receive the TIPS HIV Tool Kit, including a study manual. These churches will hold a Kick-off event, where tools will be distributed, and motivational strategies implemented. After the Kick-off, liaisons will deliver 1-2 Tool Kit materials/activities per month through targeted multilevel church activities minimum of 24 tools over the 12 month study period. Two additional HIV screening events will be planned (one for community members) and will be open to all persons seeking screening, including study nonparticipants. Both groups will receive manualized pastor/church liaison trainings on study procedures, HIV basics and local resources and coordination of HIV screening events.

Also known as: TIPS
Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Kansas City

Kansas City, Missouri, 64110, United States

Location

Related Publications (1)

  • Berkley-Patton J, Thompson CB, Bauer AG, Berman M, Christensen K, Bradley-Ewing A, Goggin K, Catley D, Williams E, Wainright C, Derose KP, Geyer A, Thompson F, Dennis L, Smith S, Allsworth JE. HIV Testing in African American Churches: Results from the Taking It to the Pews Cluster-Randomized Trial. AIDS Behav. 2026 Jan;30(1):118-129. doi: 10.1007/s10461-025-04852-2. Epub 2025 Aug 29.

    PMID: 40880008DERIVED

MeSH Terms

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Jannette Y. Berkley-Patton, PhD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Biomedical and Health Informatics

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 20, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Locations

US(1)