NCT03559595

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 4, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

2.6 years

First QC Date

June 5, 2018

Last Update Submit

March 25, 2021

Conditions

HIV/AIDS PREVENTION

Outcome Measures

Primary Outcomes (1)

  • PrEP uptake

    Reported use of PrEP

    12 months

Secondary Outcomes (2)

  • PrEP intentions

    12 months

  • PrEP prescription

    12 months

Study Arms (1)

Intervention group

EXPERIMENTAL

All study participants will be exposed to the intervention

Behavioral: Project Prevent

Interventions

Project PreventBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 18, 2018

Study Start

June 4, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations

US(1)