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PrEP Awareness Program for HIV Prevention in Black Women

N/A
Waitlist Available
Led By Amy Corneli, MPH, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial aims to measure the effectiveness of a program that encourages conversations about PrEP for Black women. It will use interviews, reviews, records and social media metrics.

Who is the study for?
This trial is for LSU GYN residents and Black cisgender women who meet the CDC guidelines for PrEP, a medication that helps prevent HIV. It's designed to evaluate an initiative aimed at increasing PrEP use among these women in New Orleans.Check my eligibility
What is being tested?
The 'Start the Conversation' Initiative includes training for GYN residents and a social media campaign, both aiming to boost awareness and uptake of PrEP among eligible Black cisgender women to prevent HIV infection.See study design
What are the potential side effects?
Since this study focuses on implementation rather than drug effects, it doesn't directly involve side effects from interventions. However, general side effects of PrEP can include nausea, headaches, stomach pain, and weight loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of the difference in patient numbers at the LSU GYN clinic during pre-implementation and the two implementation period phases with the difference in patient numbers during the same time frame at the Tulane GYN clinic.
Number of patients seen at LSU GYN clinic & UMC PrEP clinic combined compared to the number of patients seen at Tulane GYN & PrEP clinics combined
Total number of women overall and number of Black cisgender women initiating PrEP at the LSU GYN clinic during the pre-implementation period compared to during the two implementation period phases.
+1 more
Secondary outcome measures
Number of appointments made through the LDH navigator
Number of contacts with the LDH navigator
Proportion of PrEP-eligible women overall and Black cisgender women initiating PrEP at the LSU GYN clinic across the two implementation time periods. care model plus social media company.
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Start the Conversation PackageExperimental Treatment2 Interventions
The pre-intervention phase will last for 4 months (months 1-4). The only study activity during the pre-intervention phase is the collection of routine PrEP uptake data to establish a baseline for PrEP prescribing at the GYN residency clinics and local PrEP clinics. The implementation of the combined-care model at the LSU GYN residency clinic at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 4 months (months 5-18); implementation of the combined-care model at LSU GYN residency clinic at UMCNO will continue. The layered approach allows for an opportunity to assess the effect of the combined-care model, and subsequently, to what extent the social media campaign additionally engages Black women and builds demand for PrEP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Social Media Campaign
2022
N/A
~57910

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,655 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansOTHER
114 Previous Clinical Trials
43,787 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,693 Total Patients Enrolled

Media Library

Start the Conversation Package Clinical Trial Eligibility Overview. Trial Name: NCT05909176 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: Start the Conversation Package
Human Immunodeficiency Virus Infection Clinical Trial 2023: Start the Conversation Package Highlights & Side Effects. Trial Name: NCT05909176 — N/A
Start the Conversation Package 2023 Treatment Timeline for Medical Study. Trial Name: NCT05909176 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment of participants still open for this research project?

"As per the clinicaltrials.gov information, this medical trial is not enrolling at present. The study was first listed on May 5th 2023 and revised on June 8th of the same year; however, there are presently 475 other studies actively searching for patients to participate in their trials."

Answered by AI
~0 spots leftby May 2024