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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH129211 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The study objectives are to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GYN Residency Training | Behavioral | The combined care model will be implemented and during months 5-14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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). | Up to 18 months (from month 5 to month 22) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of PrEP-eligible Participants Initiating PrEP at the LSU GYN Clinic Across the Two Implementation Time Periods | Up to 18 months (from month 5 to month 22) | |
| Difference in Number of Women Seen at LSU (Louisiana State University) GYN Clinic and UMC PrEP (Pre-exposure Prophylaxis) Clinic Combined Compared to the Number of Patients Seen at Tulane GYN & PrEP Clinics Combined |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Corneli, MPH, PhD | Duke University | Principal Investigator |
| Meredith Clement, MD | Louisiana State University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
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.
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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.
Patients were assessed by OBGYN residents for PrEP (pre-exposure prophylaxis) candidacy and initiated PrEP discussions with patients who may benefit from PrEP.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with whom OBGYN residents engaged in a conversation about PrEP.
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Care Model Only (Months 5-14) | GYN Residency Training (Phase I): The combined care model will be implemented and during months 5-14. |
| BG001 | Combined Care + Social Media (Months 15-22) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | All patients with whom GYN residents started a conversation about PrEP in each phase were included. | Posted | Count of Participants | Participants | Up to 18 months (from month 5 to month 22) |
|
Up to 18 months, during the intervention period (from month 5 to month 22)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Start the Conversation Package - Implementation Phase I | Implementation of the combined-care model at the LSU GYN residency clinic at UMCNO for 10 months (months 5-14). GYN Residency Training: The combined care model will be implemented and during months 5-14. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Corneli, Ph.D. | Duke University | 919-668-9238 | amy.corneli@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2025 | Oct 31, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Social Media Campaign | Behavioral | The social media campaign will be implemented along with the combined care model in months 15-18. |
|
| 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. | Up to 8 months (from month 15 to month 22) |
| Up to 18 months (from month 5 to month 22) |
| Difference in Number of Women Initiating PrEP at the LSU GYN Clinic During the Pre-implementation Period (Phase 1: Months 1-4) Compared to the Same Time Frame at the Tulane GYN Clinic. | Up to 18 months (from month 5 to month 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | 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). | All patients with whom GYN residents started a conversation about PrEP in each phase were included. | Posted | Count of Participants | Participants | Up to 18 months (from month 5 to month 22) |
|
|
|
| Secondary | 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 | Participants who started on PrEP. | Posted | Count of Participants | Participants | Up to 18 months (from month 5 to month 22) |
|
|
|
| Secondary | Overall Number of Women Who Initiated PrEP and Completed a Follow-up Appointment | Participants who made a follow-up appointment. | Posted | Count of Participants | Participants | Up to 18 months (from month 5 to month 22) |
|
|
|
| Secondary | 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. | Social Media Campaign participants. The social media campaign will be implemented along with the combined care model in months 15-22. | Posted | Number | clicks | Up to 8 months (from month 15 to month 22) | social media campaign pages | social media campaign pages |
|
|
|
| Other Pre-specified | Proportion of PrEP-eligible Participants Initiating PrEP at the LSU GYN Clinic Across the Two Implementation Time Periods | Not Posted | Up to 18 months (from month 5 to month 22) | Participants |
| Other Pre-specified | Difference in Number of Women Seen at LSU (Louisiana State University) GYN Clinic and UMC PrEP (Pre-exposure Prophylaxis) Clinic Combined Compared to the Number of Patients Seen at Tulane GYN & PrEP Clinics Combined | Not Posted | Up to 18 months (from month 5 to month 22) | Participants |
| Other Pre-specified | Difference in Number of Women Initiating PrEP at the LSU GYN Clinic During the Pre-implementation Period (Phase 1: Months 1-4) Compared to the Same Time Frame at the Tulane GYN Clinic. | Not Posted | Up to 18 months (from month 5 to month 22) | Participants |
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Start the Conversation Package - Implementation Phase II | Adding 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. GYN Residency Training: The combined care model will continue during months 15-22. Social Media Campaign: The social media campaign will be implemented along with the combined care model in months 15-22. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Declined to answer about ethnicity and race |
|