Clinical trial NCT06487390: Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: PrEP
HIV
HIV prevention
Adolescents
Young adults
Family Medicine
Residents
Physician Trainees
Training intervention
Sexual history
Sexual Health
Sexually Transmitted Infections
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. licensed HCP (MD, DO) trainee
2. providing medical care to AGYW in AL
3. working in a clinic setting where at least 20% of the population is Black
4. able/willing to provide informed consent

Exclusion Criteria:

(a) unable or unwilling to provide informed consent

Primary outcomes:
measure: Feasibility (proportion of participants ranking feasibility high on 5-point Likert scale)
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
Secondary outcomes:
measure: HIV epidemiology knowledge assessment
timeFrame: 6 months
measure: Sexual history taking practices
timeFrame: 6 months
measure: PrEP knowledge, willingness to prescribe, prescribing practices
timeFrame: 6 months
measure: STI screening practices
timeFrame: 6 months
measure: HIV screening practices
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Latesha E. Elopre, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Lynn T Matthews, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isehunwa OO, Hill SV, Menninger AT, Hubner B, Krakower D, Long DM, Pratt MC, Clement ME, Wagoner NV, Lanzi RG, Simpson T, Elopre L, Matthews LT. A Multicomponent Intervention to Train and Support Family Medicine Providers to Promote Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in the Deep South: Protocol for the PrEP-Pro Study. JMIR Res Protoc. 2023 Mar 21;12:e44908. doi: 10.2196/44908.