HIV Infections, Preexposure Prophylaxis
Conditions
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.
Interventions
BEHAVIORALGYN Residency Training
The combined care model will be implemented and during months 5-14.
BEHAVIORALSocial Media Campaign
The social media campaign will be implemented along with the combined care model in months 15-18.
Sponsors
Duke University
Louisiana State University Health Sciences Center in New Orleans
National Institute of Mental Health (NIMH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* LSU GYN residents * Women eligible for PrEP per CDC guidelines including Black cisgender women
Exclusion criteria
* Not meeting above criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Engaged in Conversation | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 18 months (from month 5 to month 22) | — |
| Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment | Up to 18 months (from month 5 to month 22) | — |
| Total Number of Contacts With the LaHub Website | Up to 8 months (from month 15 to month 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy Corneli, MPH, PhD
Duke University
PRINCIPAL_INVESTIGATORMeredith Clement, MD
Louisiana State University Health Sciences Center
Participant flow
Recruitment details
Patients were assessed by OBGYN residents for PrEP (pre-exposure prophylaxis) candidacy and initiated PrEP discussions with patients who may benefit from PrEP.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.80 years STANDARD_DEVIATION 11.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 51 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 10 |
| other Total, other adverse events | 0 / 41 | 0 / 10 |
| serious Total, serious adverse events | 0 / 41 | 0 / 10 |
Outcome results
None listed