Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South

NCT06487390 | Completed Results

• 2 other identifiers: IRB-300008567R34MH128044-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intervention Implementation

  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

  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 Outcomes (5)

• HIV Epidemiology Knowledge Assessment

  6 months

• Sexual History Taking Practices

  6 months

• PrEP Knowledge, Willingness to Prescribe, Prescribing Practices

  6 months

• STI Screening Practices

  6 months

• HIV Screening Practices

  6 months

Study Arms (1)

Resident Trainees

EXPERIMENTAL

Family medicine resident trainees who receive the PrEP Pro training intervention

Behavioral: PrEP Pro training intervention

Interventions

PrEP Pro training intervention BEHAVIORAL

Training intervention adapted from evidence-based HIV epidemiology, sexual history taking, and PrEP prescription curricula.

Resident Trainees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (a) unable or unwilling to provide informed consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Related Links

• PrEP Pro Protocol Paper

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study is limited by small sample size, short follow-up, and sampling bias from clinics that opted in. Effectiveness in improving PrEP prescribing could not be assessed. The intervention did not address provider stigma or restrictive state laws.

Results Point of Contact

• Title: Dr. Lynn Matthews
• Organization: University of Alabama at Birmingham

lynnmatthews@uabmc.edu

2059348148

Study Officials

• Latesha E. Elopre, MD, MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Lynn T Matthews, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: April 21, 2023
• Primary Completion: September 4, 2024
• Study Completion: September 15, 2024
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-09

Locations

US (1)