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

Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in New Orleans, Louisiana

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Preexposure Prophylaxis
• Intervention / Treatment: Behavioral: GYN Residency Training; Behavioral: Social Media Campaign

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not meeting above criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Care Model Only; 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 8 months (months 15-22); 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.	Behavioral: GYN Residency Training; The combined care model will be implemented and during months 5-14.
Experimental: Combined Care Model + Social Media; 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 8 months (months 15-22); 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.	Behavioral: GYN Residency Training; The combined care model will be implemented and during months 5-14.; Behavioral: Social Media Campaign; The social media campaign will be implemented along with the combined care model in months 15-18.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women Engaged in Conversation	Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP (pre-exposure prophylaxis)	Up to 18 months (from month 5 to month 22)
Total Number of Women Initiating PrEP	Total number of women initiating PrEP (Pre-exposure Prophylaxis) at the LSU (Louisiana State University) GYN clinic (or after referral to a PrEP clinic).	Up to 18 months (from month 5 to month 22)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women Choosing Follow-up Care at the LSU (Louisiana State University) GYN Resident Clinic Versus Transition to a Local PrEP (Pre-exposure Prophylaxis) Provider		Up to 18 months (from month 5 to month 22)
Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment		Up to 18 months (from month 5 to month 22)
Total Number of Contacts With the LaHub Website	Measured by verifiable clicks to the LaHub Website from social media campaign pages. Data reflects the total number of "clicks" across all social media campaign pages.	Up to 8 months (from month 15 to month 22)

Other Outcome Measures

Outcome Measure	Time Frame
Proportion of PrEP-eligible Participants Initiating PrEP at the LSU GYN Clinic Across the Two Implementation Time Periods	Up to 18 months (from month 5 to month 22)
Difference in Number of Women Seen at LSU (Louisiana State University) GYN Clinic and UMC PrEP (Pre-exposure Prophylaxis) Clinic Combined Compared to the Number of Patients Seen at Tulane GYN & PrEP Clinics Combined	Up to 18 months (from month 5 to month 22)
Difference in Number of Women Initiating PrEP at the LSU GYN Clinic During the Pre-implementation Period (Phase 1: Months 1-4) Compared to the Same Time Frame at the Tulane GYN Clinic.	Up to 18 months (from month 5 to month 22)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH); Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Meredith Clement, MD, Louisiana State University Health Sciences Center; Principal Investigator: Amy Corneli, MPH, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: PRO00113159; R34MH129211 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data sharing during study implementation: Implementation outcomes will be fed back in real-time to the gynecology residents and the Training Director to inform the residents of implementation fidelity and gain feedback into strategy adaptation. Data sharing will thus be part of the quality improvement process for providers.

Data sharing after study implementation: Within two months of publication of any manuscript presenting major study findings, study investigators will make the study data available upon request. For the qualitative data, given its descriptive nature, sharing individual transcripts could potentially identify a participant. We will therefore provide de-identified, aggregated data summaries. De-identified implementation outcome data will be made available upon request following publication; we will ensure that data cannot be used to determine resident provider identities or patients.

Our research will not produce patentable products or involve model organisms.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No