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

December 8, 2025 updated by: Lynn T. Matthews, University of Alabama at Birmingham

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Behavioral: 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

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute of Mental Health (NIMH)

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Actual)

September 4, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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