Church-based HIV Screening: Taking It to the Pews (TIPS)

August 19, 2019 updated by: Jannette Berkley-Patton, University of Missouri, Kansas City

Assessing HIV Screening in African American Churches

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64110
        • University of Missouri-Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Comparison (Standard Information Arm)
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)
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.
Other Names:
  • TIPS
Experimental: Intervention
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)
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.
Other Names:
  • TIPS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported Receipt of HIV Screening
Time Frame: Baseline
This measure is self-reported receipt of HIV screening received in last 12 months
Baseline
Self-reported Receipt of HIV Screening
Time Frame: 6 months
This measure is self-reported receipt of HIV screening recieved in last 12 months
6 months
Self-reported Receipt of HIV screening
Time Frame: 12 months
This measure is self-reported receipt of HIV screening received in last 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV Sexual Risk Behavior Score
Time Frame: Baseline
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).
Baseline
HIV Sexual Risk Behavior Score
Time Frame: 6 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).
6 months
HIV Sexual Risk Behavior Score
Time Frame: 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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri, Kansas City

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Mercy Hospital Kansas City
RAND
City of Kansas City Missouri Health Department
Kansas City CARE Clinic
Caanon Worship Center
Christian Fellowship Baptist Church
Friendship Baptist Church
JayDoc Free Clinic
Metropolitan Spiritual Church of Christ
NBC Community Development Corporation
Concord Fortress of Hope Church
Victorious Life Church
Calvary Community Outreach Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jannette Y. Berkley-Patton, PhD, University of Missouri, Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV

Clinical Trials on Taking It to the Pews (Comparison)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings