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

NCT05909176 | Completed

• 2 other identifiers: PRO00113159R34MH129211
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Preexposure Prophylaxis; HIV Infections

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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 choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider.

  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

• Number of contacts with the LDH navigator

  Up to 12 months

• Number of appointments made through the LDH navigator

  Up to 12 months

Study Arms (1)

Start the Conversation Package

EXPERIMENTAL

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.

Behavioral: GYN Residency Training; Behavioral: Social Media Campaign

Interventions

GYN Residency Training BEHAVIORAL

The combined care model will be implemented and during months 5-14.

Start the Conversation Package

Social Media Campaign BEHAVIORAL

The social media campaign will be implemented along with the combined care model in months 15-18.

Start the Conversation Package

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Amy Corneli, MPH, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Meredith Clement, MD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 18, 2023
• Study Start: May 30, 2023
• Primary Completion: October 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)