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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05909176
• Other study ID #: PRO00113159
• Secondary ID: R34MH129211
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 414
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• LSU GYN residents

• Black cisgender women eligible for PrEP per CDC guidelines

Related Conditions & MeSH terms

• HIV Infections
• Preexposure Prophylaxis

Intervention

Behavioral:
• GYN Residency Training
The combined care model will be implemented and during months 5-14.
• Social Media Campaign
The social media campaign will be implemented along with the combined care model in months 15-18.

Locations

Country	Name	City	State
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Louisiana State University Health Sciences Center in New Orleans, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP.		Up to 12 months
Primary	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
Primary	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
Primary	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	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
Secondary	Proportion of women choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider.		Up to 12 months
Secondary	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
Secondary	Number of contacts with the LDH navigator		Up to 12 months
Secondary	Number of appointments made through the LDH navigator		Up to 12 months