Back to resultsIncreasing PrEP Among African Americans in Louisville KY
Primary Purpose
HIV/AIDS PREVENTION
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Prevent
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS PREVENTION
Eligibility Criteria
Inclusion Criteria:
- Between ages 18-29 years old
- Self-identifies as African American or Black
- Resident of Louisville, KY
- Member of a priority group for PrEP HIV prevention (Men who have sex with men, people who inject drugs, trans women, high risk heterosexuals, people in serodiscordant relationships).
- Not diagnosed with HIV
Exclusion Criteria:
- Older than 29 and younger than 18 years old
- Does not identify as African American or Black
- Does not reside in Louisville, KY
- Not a member of a priority group
- Diagnosed with HIV
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
All study participants will be exposed to the intervention
Outcomes
Primary Outcome Measures
PrEP uptake
Reported use of PrEP
Secondary Outcome Measures
PrEP intentions
Intention to use PrEP
PrEP prescription
Prescription of PrEP to eligible individuals by medical personnel
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03559595
Brief Title
Increasing PrEP Among African Americans in Louisville KY
Official Title
Increasing Pre-exposure Prophylaxis Among High-Risk African Americans in Louisville KY
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the effectiveness of a multifaceted strategy to increase pre-exposure prophylaxis (PrEP; a medication regimen to reduce HIV risk) uptake among high risk African Americans in Louisville, KY. We will do this by 1) implementing a media campaign to raise awareness about PrEP, 2) providing PrEP education to medical personnel who can prescribe PrEP, and 3) partnering with AIDS service organizations to improve outreach and linkage to PrEP services.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS PREVENTION
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
All study participants will be exposed to the intervention
Intervention Type
Behavioral
Intervention Name(s)
Project Prevent
Intervention Description
The Project Prevent intervention entails 1) a media campaign to raise PrEP awareness, 2) geographically targeted education initiatives with medical personnel to increase access to consumers, and 3) programming with AIDS service organizations to improve service delivery around PrEP.
Primary Outcome Measure Information:
Title
PrEP uptake
Description
Reported use of PrEP
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PrEP intentions
Description
Intention to use PrEP
Time Frame
12 months
Title
PrEP prescription
Description
Prescription of PrEP to eligible individuals by medical personnel
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between ages 18-29 years old
Self-identifies as African American or Black
Resident of Louisville, KY
Member of a priority group for PrEP HIV prevention (Men who have sex with men, people who inject drugs, trans women, high risk heterosexuals, people in serodiscordant relationships).
Not diagnosed with HIV
Exclusion Criteria:
Older than 29 and younger than 18 years old
Does not identify as African American or Black
Does not reside in Louisville, KY
Not a member of a priority group
Diagnosed with HIV
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Increasing PrEP Among African Americans in Louisville KY
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