Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in Nola

Not Applicable

Completed

• Conditions: Preexposure Prophylaxis; HIV Infections

• Registration Number: NCT05909176
• Lead Sponsor: Duke University

Brief Summary

The study objectives are to:

* Evaluate implementation outcomes from piloting the Start the Conversation Initiative

* Assess initial indicators of clinical effectiveness among patients engaged in the Start the Conversation Initiative

These outcomes will be assessed qualitatively through in-depth interviews (IDIs), debriefing sessions with GYN residents and leadership, medical chart reviews and/or de-identified Epic queries, training records, discussions with the Black Women and PrEP (BWAP) Task Force, and social media metrics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study Start: 2023-05-30
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Primary Completion: 2024-10-31
• Status Verified: 2024-12
• Study Completion: 2025-06-30
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• LSU GYN residents
• Black cisgender women eligible for PrEP per CDC guidelines

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP.	Up to 12 months
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.	Up to 12 months
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.	Up to 12 months
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	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
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 campaign.	Up to 12 months
Proportion of women initiating PrEP at the LSU resident GYN clinic who complete their first follow-up PrEP care visit (can only assess at the LSU GYN resident clinic or UMC PrEP clinic).	Up to 12 months
Proportion of women choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider.	Up to 12 months
Number of contacts with the LDH navigator	Up to 12 months
Number of appointments made through the LDH navigator	Up to 12 months

Trial Locations

Locations (1)

Louisiana State University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States