CompletedNot Applicable

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

United States56 participantsStarted 2023-05-30

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

Trial details

NCT IDNCT05909176

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Preexposure Prophylaxis trials

Plain-language summary

What they're measuring

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

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

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