Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South (PrEP Pro)
PrEP Pro: Adapting a Multi-component Intervention to Train and Support Providers to Promote PrEP for Adolescent Girls and Young Women in the Deep South
The goal of this study is to adapt evidence-based curriculum on HIV epidemiology and PrEP prescription to train family medicine physician trainees to take a thorough sexual history and discuss HIV/STI prevention and PrEP options with adolescent patients in Alabama. The primary outcomes of the study are:
- Feasibility of the PrEP Pro training intervention
- Acceptability of the PrEP Pro training intervention
Secondary outcomes include:
- Behavioral changes in sexual history taking performed by physician trainees
- PrEP knowledge and prescribing practices
- HIV and STI screening practices
Participants will receive training on sexual history taking and HIV prevention options, including PrEP prescription and management. They will complete a pre-training survey (enrollment) and post-training survey (6 months post enrollment) to understand differences in knowledge and practice before and after receiving the training intervention. The post training survey will also assess acceptability and feasibility of the intervention. A subset of participants will complete qualitative in-depth interviews to further discuss their experiences with the program and suggestions for future adaptations.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- licensed HCP (MD, DO) trainee
- providing medical care to AGYW in AL
- working in a clinic setting where at least 20% of the population is Black
- able/willing to provide informed consent
Exclusion Criteria:
(a) unable or unwilling to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resident Trainees
Family medicine resident trainees who receive the PrEP Pro training intervention
|
Training intervention adapted from evidence-based HIV epidemiology, sexual history taking, and PrEP prescription curricula.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Intervention Implementation
Time Frame: 6 months
|
Feasibility of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning more feasible to implement
|
6 months
|
|
Acceptability
Time Frame: 6 months
|
Acceptability of Intervention: 4 items, 5-point Likert scale, scale values range from 1-5 with higher score meaning the intervention is more acceptable to participants
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV Epidemiology Knowledge Assessment
Time Frame: 6 months
|
Measured by baseline and 6-month (pre- and post-training) surveys; scores range from 0-100% based on the percentage of participants who answered all five questions related to HIV epidemiology correctly; higher percentages indicate that more participants knew the correct answer to all 5 HIV epidemiology questions.
|
6 months
|
|
Sexual History Taking Practices
Time Frame: 6 months
|
Measured by baseline survey. Sexual history taking knowledge, attitudes, and beliefs. 23 questions split into four subscales on 3-point Likert scale; each subscale score is the mean of the scores from the questions in the scale. Subscales: Attitudes (4 items), Skills (14), Barriers (2), Training (3). Strongly agree/Somewhat agree = 3, Neither agree nor disagree = 2, Strongly disagree/Somewhat disagree = 1 Higher score on 1-3 range indicates more positive attitude towards sexual history assessment, higher skill, more barriers, and better training. |
6 months
|
|
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
Time Frame: 6 months
|
measured by baseline and 6-month (pre- and post-training) surveys, qualitative interviews, EMR data. The score ranges for each subscale varied (PrEP knowledge=0-20, attitudes=0-28, and beliefs=0-8), with high values on each subscale representing good knowledge or positive attitudes toward PrEP, respectively. |
6 months
|
|
STI Screening Practices
Time Frame: 6 months
|
Percent of participants (providers) who reported they assessed sexual history and/or tested clients for STIs in the past week at least some of the time, by group (AGYW/ABYM). "At least some of the time" = answering "some, many, most, or all" (vs "none") to questions formatted like: Among the [AGYW/ABYM] seen last week, for about how many did you [assess sex Hx/test for STIs]? measured by BL and 6-month surveys, IDIs, EMR data; BL=baseline; AGYW=adolescent girls and young women (ages 14-24); ABYM=adolescent boys and young men (ages 14-24); sex Hx=assessed for sexual history; past wk=past 7 days |
6 months
|
|
HIV Screening Practices
Time Frame: 6 months
|
Percent of participants (providers) who reported they tested clients for HIV in the past week at least some of the time, by group (AGYW/ABYM). "At least some of the time" = answering "some, many, most, or all" (vs "none") to questions formatted like: Among the [AGYW/ABYM] seen last week, for about how many did you [test for HIV]? measured by BL and 6-month surveys, IDIs, EMR data; BL=baseline; AGYW=adolescent girls and young women (ages 14-24); ABYM=adolescent boys and young men (ages 14-24); sex Hx=assessed for sexual history; past wk=past 7 days |
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Latesha E. Elopre, MD, MSPH, University of Alabama at Birmingham
- Principal Investigator: Lynn T Matthews, MD, MPH, University of Alabama at Birmingham
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Disease Attributes
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Pathological Conditions, Signs and Symptoms
- HIV Infections
- Sexually Transmitted Diseases
Other Study ID Numbers
- IRB-300008567
- R34MH128044-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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