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

Sponsor
Duke University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05909176
Collaborator
Louisiana State University Health Sciences Center in New Orleans (Other), National Institute of Mental Health (NIMH) (NIH)
414
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1
10.3
40.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: GYN Residency Training
  • Behavioral: Social Media Campaign
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
414 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in New Orleans, Louisiana
Actual Study Start Date :
Jun 23, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Start the Conversation Package

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.

Behavioral: GYN Residency Training
The combined care model will be implemented and during months 5-8.

Behavioral: Social Media Campaign
The social media campaign will be implemented along with the combined care model in months 9-12.

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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

  1. 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. [Up to 12 months]

  2. Proportion of women choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider. [Up to 12 months]

  3. 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]

  4. Number of contacts with the LDH navigator [Up to 12 months]

  5. Number of appointments made through the LDH navigator [Up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • LSU GYN residents

  • Black cisgender women eligible for PrEP per CDC guidelines

Contacts and Locations

Locations

Site City State Country Postal Code
1 Louisiana State University Health Sciences Center New Orleans Louisiana United States 70112

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Amy Conelli, MPH, PhD, Duke University
  • Principal Investigator: Meredith Clement, MD, Louisiana State University Health Sciences Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05909176
Other Study ID Numbers:
  • PRO00113159
  • R34MH129211
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023