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Completed

NCT Number: NCT05909176

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not meeting above criteria

Treatment and study plan

GYN Residency Training

Behavioral

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

Social Media Campaign

Behavioral

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

Primary outcomes

  1. Number of Women Engaged in Conversation

    Time frame: Up to 18 months (from month 5 to month 22)

    Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP (pre-exposure prophylaxis)

  2. Total Number of Women Initiating PrEP

    Time frame: Up to 18 months (from month 5 to month 22)

    Total number of women initiating PrEP (Pre-exposure Prophylaxis) at the LSU (Louisiana State University) GYN clinic (or after referral to a PrEP clinic).

Secondary outcomes

  1. 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

    Time frame: Up to 18 months (from month 5 to month 22)

  2. Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment

    Time frame: Up to 18 months (from month 5 to month 22)

  3. Total Number of Contacts With the LaHub Website

    Time frame: Up to 8 months (from month 15 to month 22)

    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.

Other outcomes

  1. Proportion of PrEP-eligible Participants Initiating PrEP at the LSU GYN Clinic Across the Two Implementation Time Periods

    Time frame: Up to 18 months (from month 5 to month 22)

  2. 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

    Time frame: Up to 18 months (from month 5 to month 22)

  3. 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.

    Time frame: Up to 18 months (from month 5 to month 22)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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