HIV/AIDS PREVENTIONNCT03559595
Increasing PrEP Among African Americans in Louisville KY
A study testing Project Prevent in people with HIV/AIDS PREVENTION, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS PREVENTION
- What is being tested?
- Project Prevent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Increasing Pre-exposure Prophylaxis Among High-Risk African Americans in Louisville KY
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.
- Conditions
- HIV/AIDS PREVENTION
- Being tested
- Project Prevent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project PreventBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | All study participants will be exposed to the intervention Receives: Behavioral: Project Prevent |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
Reported use of PrEP
Measured: 12 months
Secondary outcomes (2)
PrEP intentions
Intention to use PrEP
Measured: 12 months
PrEP prescription
Prescription of PrEP to eligible individuals by medical personnel
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start4 Jun 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDS PREVENTIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jelani Kerr, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559595
- Sponsor's protocol ID
- 18.0020
- Status last verified
- Mar 2021
- First submitted
- 5 Jun 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Pre-exposure Prophylaxis Among High-Risk African Americans in Louisville KY
- ClinicalTrials.gov ID
- NCT03559595
- Acronym / sponsor ID
- 18.0020
- Conditions
- HIV/AIDS PREVENTION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Project PreventAll study participants will be exposed to the intervention |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project PreventThe 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. | Behavioural | Intervention group |
Primary outcome
PrEP uptake
Time frame: 12 months
Reported use of PrEP
2 secondary outcomes
PrEP intentions
Time frame: 12 months
PrEP prescription
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Prevent in people with HIV/AIDS PREVENTION, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.