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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34MH128002 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of the study is to learn more about health care providers' experiences and perspectives on prescribing HIV pre-exposure prophylaxis, also known as PrEP. Providers and patients in gynecology clinics were interviewed and completed surveys to measure the feasibility and preference of prescribing PrEP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sexual Health-PRO | Patients seen during routine GYN clinic visit. |
| |
| Post visit (fidelity) survey | Patients who completed the survey outside of clinic visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP acronym (pre-exposure prophylaxis) | Behavioral | Tracked PrEP prescriptions over 8 months among patients who completed the survey |
|
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Prescriptions | Number of participants receiving a new PrEP prescription during the recruitment period | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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Reproductive aged women, 18-45, who attended their regular GYN clinic visit
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| Name | Affiliation | Role |
|---|---|---|
| Michael Mugavero, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35222 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sexual Health-PRO | Patients seen during routine GYN clinic visit. PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey |
| FG001 | Post Visit (Fidelity) Survey | Patients who completed the survey outside of clinic visit PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sexual Health-PRO | Patients seen during routine GYN clinic visit. PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey |
| BG001 | Post Visit (Fidelity) Survey |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | PrEP Prescriptions | Number of participants receiving a new PrEP prescription during the recruitment period | All women who received care at the GYN clinic during the study period received the PrEP4Her intervention as a component of their routine standard of gynecologic care. | Posted | Count of Participants | Participants | 8 months |
|
8 months
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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 | Sexual Health-PRO | Patients seen during routine GYN clinic visit. PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernadette Johnson | UAB | 205-934-7329 | bajohnson@uabmc.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 | Aug 1, 2022 | Dec 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065129 | Pre-Exposure Prophylaxis |
| ID | Term |
|---|---|
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Patients who completed the survey outside of clinic visit
PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 1,135 |
| 0 |
| 1,135 |
| 0 |
| 1,135 |
| EG001 | Post Visit (Fidelity) Survey | Patients who completed the survey outside of clinic visit PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey | 0 | 242 | 0 | 242 | 0 | 242 |
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| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |