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

Study Overview
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Brief Summary
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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.

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

Conditions
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Preexposure Prophylaxis, HIV Infections

Intervention / Treatment
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* Behavioral: GYN Residency Training
* Behavioral: Social Media Campaign


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Start the Conversation Package<br>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<br>* The combined care model will be implemented and during months 5-8.<br>Behavioral: Social Media Campaign<br>* The social media campaign will be implemented along with the combined care model in months 9-12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of women choosing follow-up care at the LSU GYN resident clinic versus transition to a local PrEP provider. |  | Up to 12 months | 
| 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 | 
| Number of contacts with the LDH navigator |  | Up to 12 months | 
| Number of appointments made through the LDH navigator |  | Up to 12 months |