Preexposure ProphylaxisNCT05909176

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

A study testing GYN Residency Training and Social Media Campaign in people with Preexposure Prophylaxis and HIV Infections, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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)… Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Preexposure Prophylaxis, HIV Infections
What is being tested?: GYN Residency Training and Social Media Campaign
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 30 May 2023to 30 Jun 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Not meeting above criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112

Other trials in United States

About this study

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

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.

Conditions: Preexposure Prophylaxis, HIV Infections
Being tested: GYN Residency Training, Social Media Campaign
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GYN Residency TrainingBehavioural
The combined care model will be implemented and during months 5-14.
Social Media CampaignBehavioural
The social media campaign will be implemented along with the combined care model in months 15-18.

Study groups in NCT05909176
Study group	Role	What they receive
Combined Care Model Only	Experimental	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 at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 8 months (months 15-22); 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. Receives: Behavioral: GYN Residency Training
Combined Care Model + Social Media	Experimental	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 at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 8 months (months 15-22); 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. Receives: Behavioral: GYN Residency Training; Behavioral: Social Media Campaign

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Women Engaged in Conversation
Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP (pre-exposure prophylaxis)
Measured: Up to 18 months (from month 5 to month 22)
Total Number of Women Initiating PrEP
Total number of women initiating PrEP (Pre-exposure Prophylaxis) at the LSU (Louisiana State University) GYN clinic (or after referral to a PrEP clinic).
Measured: Up to 18 months (from month 5 to month 22)

Secondary outcomes (3)

Number of Women Choosing Follow-up Care at the LSU (Louisiana State University) GYN Resident Clinic Versus Transition to a Local PrEP (Pre-exposure Prophylaxis) Provider
Measured: Up to 18 months (from month 5 to month 22)
Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment
Measured: Up to 18 months (from month 5 to month 22)
Total Number of Contacts With the LaHub Website
Measured by verifiable clicks to the LaHub Website from social media campaign pages. Data reflects the total number of "clicks" across all social media campaign pages.
Measured: Up to 8 months (from month 15 to month 22)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202330 Jun 2025

First posted18 Jun 2023
Study start30 May 2023
Primary completion31 Oct 2024
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Preexposure ProphylaxisStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05909176
Sponsor's protocol ID: PRO00113159
Other IDs: R34MH129211
Status last verified: Jun 2026
First submitted: 23 May 2023
Last updated: 10 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data sharing during study implementation: Implementation outcomes will be fed back in real-time to the gynecology residents and the Training Director to inform the residents of implementation fidelity and gain feedback into strategy adaptation. Data sharing will thus be part of the quality improvement process for providers. Data sharing after study implementation: Within two months of publication of any manuscript presenting major study findings, study investigators will make the study data available upon request. For the qualitative data, given its descriptive nature, sharing individual transcripts could potentially identify a participant. We will therefore provide de-identified, aggregated data summaries. De-identified implementation outcome data will be made available upon request following publication; we will ensure that data cannot be used to determine resident provider identities or patients. Our research will not produce patentable products or involve model organisms.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Enrolling by invitation
A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)
HIV Seropositivity
Active, not recruitingPhase 3
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Active, not recruiting
Clinical Decision Support for PrEP
HIV Infections, Preexposure Prophylaxis (PrEP)
Recruiting
The Collaborative Care PrTNER Study
HIV, Substance Use Disorders

All Preexposure Prophylaxis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in New Orleans, Louisiana
ClinicalTrials.gov ID: NCT05909176
Acronym / sponsor ID: PRO00113159
Conditions: Preexposure Prophylaxis, HIV Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Louisiana State University Health Sciences Center in New Orleans, National Institute of Mental Health (NIMH)
Study start: 30 May 2023 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 18 Jun 2023 (actual)
Results: Posted 10 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Combined Care Model Only	Experimental	Behavioral: GYN Residency TrainingThe 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 at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 8 months (months 15-22); 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.
Combined Care Model + Social Media	Experimental	Behavioral: GYN Residency Training, Behavioral: Social Media CampaignThe 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 at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 8 months (months 15-22); 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.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Not meeting above criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GYN Residency TrainingThe combined care model will be implemented and during months 5-14.	Behavioural	Combined Care Model + Social Media, Combined Care Model Only
Social Media CampaignThe social media campaign will be implemented along with the combined care model in months 15-18.	Behavioural	Combined Care Model + Social Media

Primary outcome

Number of Women Engaged in Conversation
Time frame: Up to 18 months (from month 5 to month 22)
Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP (pre-exposure prophylaxis)
Total Number of Women Initiating PrEP
Time frame: Up to 18 months (from month 5 to month 22)
Total number of women initiating PrEP (Pre-exposure Prophylaxis) at the LSU (Louisiana State University) GYN clinic (or after referral to a PrEP clinic).

3 secondary outcomes

Number of Women Choosing Follow-up Care at the LSU (Louisiana State University) GYN Resident Clinic Versus Transition to a Local PrEP (Pre-exposure Prophylaxis) Provider
Time frame: Up to 18 months (from month 5 to month 22)
Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment
Time frame: Up to 18 months (from month 5 to month 22)
Total Number of Contacts With the LaHub Website
Time frame: Up to 8 months (from month 15 to month 22)

Results and safety

Results posted to the registry on 10 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combined Care Model Only (Months 5-14)	41	41
Combined Care + Social Media (Months 15-22)	10	10

Primary outcome: Number of Women Engaged in Conversation

Time frame: Up to 18 months (from month 5 to month 22). Count of participants. Unit: Participants

Measure	Combined Care Only (Months 5-14) n = 41	Combined Care + Social Media (Months 15-22) n = 10
All women	41	10
Black cisgender women	22	6

Population analysed: All patients with whom GYN residents started a conversation about PrEP in each phase were included.

Primary outcome: Total Number of Women Initiating PrEP

Time frame: Up to 18 months (from month 5 to month 22). Count of participants. Unit: Participants

Measure	Combined Care Model Only (Months 5-14) n = 41	Combined Care + Social Media (Months 15-22) n = 10
Latina ethnicity	1	1
Black race	3	2
Declined to answer about ethnicity and race	0	1

Population analysed: All patients with whom GYN residents started a conversation about PrEP in each phase were included.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 18 months, during the intervention period (from month 5 to month 22). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Start the Conversation Package - Implementation Phase I	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Start the Conversation Package - Implementation Phase II	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data sharing during study implementation: Implementation outcomes will be fed back in real-time to the gynecology residents and the Training Director to inform the residents of implementation fidelity and gain feedback into strategy adaptation. Data sharing will thus be part of the quality improvement process for providers. Data sharing after study implementation: Within two months of publication of any manuscript presenting major study findings, study investigators will make the study data available upon request. For the qualitative data, given its descriptive nature, sharing individual transcripts could potentially identify a participant. We will therefore provide de-identified, aggregated data summaries. De-identified implementation outcome data will be made available upon request following publication; we will ensure that data cannot be used to determine resident provider identities or patients. Our research will not produce patentable products or involve model organisms.

Related trials for Preexposure Prophylaxis

RecruitingPhase 3
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Enrolling by invitation
A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)
HIV Seropositivity
Active, not recruitingPhase 3
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Active, not recruiting
Clinical Decision Support for PrEP
HIV Infections, Preexposure Prophylaxis (PrEP)
Recruiting
The Collaborative Care PrTNER Study
HIV, Substance Use Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Corneli, MPH, PhD principal investigator

Duke University

Meredith Clement, MD principal investigator

Louisiana State University Health Sciences Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GYN Residency Training and Social Media Campaign in people with Preexposure Prophylaxis and HIV Infections, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Women Engaged in Conversation (time frame: Up to 18 months (from month 5 to month 22)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05909176.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.