Clinical trial NCT05909176: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preexposure Prophylaxis
HIV Infections
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
name: National Institute of Mental Health (NIMH)
First posted: 2023-06-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP.
timeFrame: Up to 12 months
measure: 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.
timeFrame: Up to 12 months
measure: 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.
timeFrame: Up to 12 months
measure: 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
timeFrame: Up to 12 months
Secondary outcomes:
measure: 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.
timeFrame: Up to 12 months
measure: Proportion of women choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider.
timeFrame: Up to 12 months
measure: 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).
timeFrame: Up to 12 months
measure: Number of contacts with the LDH navigator
timeFrame: Up to 12 months
measure: Number of appointments made through the LDH navigator
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
Study officials:
affiliation: Duke University
name: Amy Corneli, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University Health Sciences Center
name: Meredith Clement, MD
role: PRINCIPAL_INVESTIGATOR
References: