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

Not Applicable

Active, not recruiting

• Conditions: Preexposure Prophylaxis; HIV Infections
• Interventions: Behavioral: GYN Residency Training; Behavioral: Social Media Campaign

• 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
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• 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

Arm && Interventions

Group	Intervention	Description
Start the Conversation Package	GYN Residency Training	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.
Start the Conversation Package	Social Media Campaign	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.

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