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

NCT ID: NCT06487390

Last Updated: 2025-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2024-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Sexually Transmitted Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resident Trainees

Family medicine resident trainees who receive the PrEP Pro training intervention

Group Type EXPERIMENTAL

PrEP Pro training intervention

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PrEP Pro training intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lynn T. Matthews

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Latesha E. Elopre, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Lynn T Matthews, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R34MH128044-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300008567

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Women-Focused PrEP Intervention
NCT03699722 COMPLETED PHASE1
Information Seeking About Pre-exposure Prophylaxis
NCT05728034 ACTIVE_NOT_RECRUITING NA
Making ART Work Among Brazilian Youth
NCT06056037 RECRUITING NA