Trial Outcomes & Findings for Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in Nola (NCT NCT05909176)
NCT ID: NCT05909176
Last Updated: 2026-07-10
Results Overview
Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP (pre-exposure prophylaxis)
COMPLETED
NA
51 participants
Up to 18 months (from month 5 to month 22)
2026-07-10
Participant Flow
Patients were assessed by OBGYN residents for PrEP (pre-exposure prophylaxis) candidacy and initiated PrEP discussions with patients who may benefit from PrEP.
Participants in the pre-intervention phase were not considered enrolled. Participants are not randomized into study arms; instead, there are two distinct study populations. Group 1 includes patients from OB/GYN resident clinics, with activities divided into two phases: Phase 1 (months 5-14) and Phase 2 (months 15-22). Patients who were determined by OBGYN residents to not benefit from PrEP were excluded. Group 2 consists of individuals engaged through a social media campaign during months 15-22.
Participant milestones
| Measure |
Combined Care Model Only (Months 5-14)
Phase 1 includes implementation of the combined-care model: training for GYN residents to (1) start a conversation about PrEP with patients at the LSU GYN residency clinic at UMCNO, and (2) have a discussion about PrEP follow-up at either the LSU GYN residency clinic at UMCNO or a PrEP clinic, for 10 months (months 5-14).
|
Combined Care + Social Media (Months 15-22)
Phase 2 includes the addition of social media campaign about Black women and PrEP in the NOLA area for 8 months (months 15-22) plus the continued implementation of the combined-care model at LSU GYN residency clinic at UMCNO (months 15-22).
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
10
|
|
Overall Study
COMPLETED
|
41
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Start the Conversation: Evaluating Implementation of a Multi-level PrEP Initiative for Black Cisgender Women in Nola
Baseline characteristics by cohort
| Measure |
Combined Care Model Only (Months 5-14)
n=41 Participants
GYN Residency Training (Phase I): The combined care model will be implemented and during months 5-14.
|
Combined Care + Social Media (Months 15-22)
n=10 Participants
Social Media Campaign + GYN Residency Training (Phase II): The social media campaign will be implemented along with the combined care model in months 15-22.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.29 years
STANDARD_DEVIATION 10.11 • n=9 Participants
|
33.80 years
STANDARD_DEVIATION 11.45 • n=27 Participants
|
33.39 years
STANDARD_DEVIATION 10.26 • n=267 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
51 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
51 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Up to 18 months (from month 5 to month 22)Population: All patients with whom GYN residents started a conversation about PrEP in each phase were included.
Total number of women overall and number of Black cisgender women with whom GYN residents start the conversation about PrEP (pre-exposure prophylaxis)
Outcome measures
| Measure |
Combined Care Only (Months 5-14)
n=41 Participants
GYN Residency Training (Phase I): The combined care model will be implemented and during months 5-14.
|
Combined Care + Social Media (Months 15-22)
n=10 Participants
Social Media Campaign + GYN Residency Training (Phase II): The social media campaign will be implemented along with the combined care model in months 15-22.
|
|---|---|---|
|
Number of Women Engaged in Conversation
All women
|
41 Participants
|
10 Participants
|
|
Number of Women Engaged in Conversation
Black cisgender women
|
22 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 18 months (from month 5 to month 22)Population: All patients with whom GYN residents started a conversation about PrEP in each phase were included.
Total number of women initiating PrEP (Pre-exposure Prophylaxis) at the LSU (Louisiana State University) GYN clinic (or after referral to a PrEP clinic).
Outcome measures
| Measure |
Combined Care Only (Months 5-14)
n=41 Participants
GYN Residency Training (Phase I): The combined care model will be implemented and during months 5-14.
|
Combined Care + Social Media (Months 15-22)
n=10 Participants
Social Media Campaign + GYN Residency Training (Phase II): The social media campaign will be implemented along with the combined care model in months 15-22.
|
|---|---|---|
|
Total Number of Women Initiating PrEP
Latina ethnicity
|
1 Participants
|
1 Participants
|
|
Total Number of Women Initiating PrEP
Black race
|
3 Participants
|
2 Participants
|
|
Total Number of Women Initiating PrEP
Declined to answer about ethnicity and race
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 18 months (from month 5 to month 22)Population: Participants who started on PrEP.
Outcome measures
| Measure |
Combined Care Only (Months 5-14)
n=8 Participants
GYN Residency Training (Phase I): The combined care model will be implemented and during months 5-14.
|
Combined Care + Social Media (Months 15-22)
Social Media Campaign + GYN Residency Training (Phase II): The social media campaign will be implemented along with the combined care model in months 15-22.
|
|---|---|---|
|
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
PrEP clinic
|
2 Participants
|
—
|
|
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
GYN clinic
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 18 months (from month 5 to month 22)Population: Participants who made a follow-up appointment.
Outcome measures
| Measure |
Combined Care Only (Months 5-14)
n=8 Participants
GYN Residency Training (Phase I): The combined care model will be implemented and during months 5-14.
|
Combined Care + Social Media (Months 15-22)
Social Media Campaign + GYN Residency Training (Phase II): The social media campaign will be implemented along with the combined care model in months 15-22.
|
|---|---|---|
|
Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 8 months (from month 15 to month 22)Population: Social Media Campaign participants. The social media campaign will be implemented along with the combined care model in months 15-22.
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.
Outcome measures
| Measure |
Combined Care Only (Months 5-14)
n=14 social media campaign pages
GYN Residency Training (Phase I): The combined care model will be implemented and during months 5-14.
|
Combined Care + Social Media (Months 15-22)
Social Media Campaign + GYN Residency Training (Phase II): The social media campaign will be implemented along with the combined care model in months 15-22.
|
|---|---|---|
|
Total Number of Contacts With the LaHub Website
|
392 clicks
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months (from month 5 to month 22)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months (from month 5 to month 22)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months (from month 5 to month 22)Outcome measures
Outcome data not reported
Adverse Events
Start the Conversation Package - Implementation Phase I
Start the Conversation Package - Implementation Phase II
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place