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

Primary Purpose

Preexposure Prophylaxis, HIV Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GYN Residency Training
Social Media Campaign
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preexposure Prophylaxis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: LSU GYN residents Black cisgender women eligible for PrEP per CDC guidelines

Sites / Locations

  • Louisiana State University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Start the Conversation Package

Arm Description

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 will take place at UMCNO for 4 months (months 5-8). Then we will add implementation of the social media campaign in the NOLA area for 4 months (months 9-12); 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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

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 company.
Proportion of women choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider.
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).
Number of contacts with the LDH navigator
Number of appointments made through the LDH navigator

Full Information

First Posted
May 23, 2023
Last Updated
August 14, 2023
Sponsor
Duke University
Collaborators
Louisiana State University Health Sciences Center in New Orleans, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05909176
Brief Title
Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in Nola
Official Title
Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in New Orleans, Louisiana
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Louisiana State University Health Sciences Center in New Orleans, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preexposure Prophylaxis, HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Start the Conversation Package
Arm Type
Experimental
Arm Description
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 will take place at UMCNO for 4 months (months 5-8). Then we will add implementation of the social media campaign in the NOLA area for 4 months (months 9-12); 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.
Intervention Type
Behavioral
Intervention Name(s)
GYN Residency Training
Intervention Description
The combined care model will be implemented and during months 5-8.
Intervention Type
Behavioral
Intervention Name(s)
Social Media Campaign
Intervention Description
The social media campaign will be implemented along with the combined care model in months 9-12.
Primary Outcome Measure Information:
Title
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.
Time Frame
Up to 12 months
Title
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.
Time Frame
Up to 12 months
Title
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
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
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 company.
Time Frame
Up to 12 months
Title
Proportion of women choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider.
Time Frame
Up to 12 months
Title
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).
Time Frame
Up to 12 months
Title
Number of contacts with the LDH navigator
Time Frame
Up to 12 months
Title
Number of appointments made through the LDH navigator
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: LSU GYN residents Black cisgender women eligible for PrEP per CDC guidelines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Conelli, MPH, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meredith Clement, MD
Organizational Affiliation
Louisiana State University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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