HIV InfectionsPrEP ProNCT06487390
Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South
A study testing PrEP Pro training intervention in people with HIV Infections and Sexually Transmitted Diseases, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- PrEP Pro training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2023to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
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
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
Read more
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
- Being tested
- PrEP Pro training intervention
- Keywords
- PrEP, HIV, HIV prevention, Adolescents, Young adults, Family Medicine, Residents, Physician Trainees, Training intervention, Sexual history, Sexual Health, Sexually Transmitted Infections
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Pro training interventionBehavioural
Training intervention adapted from evidence-based HIV epidemiology, sexual history taking, and PrEP prescription curricula.
| Study group | Role | What they receive |
|---|---|---|
| Resident Trainees | Experimental | Family medicine resident trainees who receive the PrEP Pro training intervention Receives: Behavioral: PrEP Pro training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (5)
HIV Epidemiology Knowledge Assessment
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.
Measured: 6 months
Sexual History Taking Practices
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.
Measured: 6 months
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
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.
Measured: 6 months
STI Screening Practices
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
Measured: 6 months
HIV Screening Practices
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start21 Apr 2023
- Primary completion4 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lynn T. Matthews, University of Alabama at Birmingham
- Investigators
- Latesha E. Elopre, MD, MSPH, Principal investigator, University of Alabama at BirminghamLynn T Matthews, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487390
- Sponsor's protocol ID
- IRB-300008567
- Other IDs
- R34MH128044-01
- Acronym
- PrEP Pro
- Status last verified
- Sep 2025
- First submitted
- 27 Jun 2024
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06487390
- Acronym / sponsor ID
- PrEP Pro / IRB-300008567
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- PrEP, HIV, HIV prevention, Adolescents, Young adults, Family Medicine, Residents, Physician Trainees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resident Trainees | Experimental | Behavioral: PrEP Pro training interventionFamily medicine resident trainees who receive the PrEP Pro training intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP Pro training interventionTraining intervention adapted from evidence-based HIV epidemiology, sexual history taking, and PrEP prescription curricula. | Behavioural | Resident Trainees |
Primary outcome
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
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
5 secondary outcomes
HIV Epidemiology Knowledge Assessment
Time frame: 6 months
Sexual History Taking Practices
Time frame: 6 months
PrEP Knowledge, Willingness to Prescribe, Prescribing Practices
Time frame: 6 months
STI Screening Practices
Time frame: 6 months
HIV Screening Practices
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- PrEP Pro Protocol PaperLink provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Latesha E. Elopre, MD, MSPH principal investigator
University of Alabama at Birmingham
Lynn T Matthews, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Pro training intervention in people with HIV Infections and Sexually Transmitted Diseases, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Implementation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.