PrEP Precriptions for Reproductive Aged WomenNCT07209722
PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare
An observational study of PrEP Precriptions for Reproductive Aged Women, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to learn more about health care providers' experiences and perspectives on prescribing HIV pre-exposure prophylaxis, also known as PrEP. Providers and patients in gynecology clinics were interviewed and completed surveys to measure the feasibility and preference of prescribing PrEP. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Precriptions for Reproductive Aged Women
- What is being tested?
- PrEP acronym (pre-exposure prophylaxis)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,377 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to 16 Aug 2025
- Phase
- Observational
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Reproductive aged women, 18-45, who attended their regular GYN clinic visit
Who may be able to join
- Patient of UAB GYN clinic
Who cannot join
- Not a patient of UAB GYN clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35222
About this study
The purpose of the study is to learn more about health care providers' experiences and perspectives on prescribing HIV pre-exposure prophylaxis, also known as PrEP. Providers and patients in gynecology clinics were interviewed and completed surveys to measure the feasibility and preference of prescribing PrEP.
- Being tested
- PrEP acronym (pre-exposure prophylaxis)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP acronym (pre-exposure prophylaxis)Behavioural
Tracked PrEP prescriptions over 8 months among patients who completed the survey
| Study group | Role | What they receive |
|---|---|---|
| Sexual Health-PRO | Patients seen during routine GYN clinic visit. Receives: Behavioral: PrEP acronym (pre-exposure prophylaxis) | |
| Post visit (fidelity) survey | Patients who completed the survey outside of clinic visit Receives: Behavioral: PrEP acronym (pre-exposure prophylaxis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Prescriptions
Number of participants receiving a new PrEP prescription during the recruitment period
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start22 Sep 2023
- Primary completion16 Aug 2025
- Study completion16 Aug 2025
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 PrEP Precriptions for Reproductive Aged WomenStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,377 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, Michael J Mugavero, MD, University of Alabama at Birmingham
- Investigators
- Michael Mugavero, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209722
- Sponsor's protocol ID
- IRB-300008345
- Other IDs
- 5R34MH128002
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare
- ClinicalTrials.gov ID
- NCT07209722
- Acronym / sponsor ID
- IRB-300008345
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,377 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 16 Aug 2025 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 7 Oct 2025 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn more about health care providers' experiences and perspectives on prescribing HIV pre-exposure prophylaxis, also known as PrEP. Providers and patients in gynecology clinics were interviewed and completed surveys to measure the feasibility and preference of prescribing PrEP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexual Health-PRO | – | Behavioral: PrEP acronym (pre-exposure prophylaxis)Patients seen during routine GYN clinic visit. |
| Post visit (fidelity) survey | – | Behavioral: PrEP acronym (pre-exposure prophylaxis)Patients who completed the survey outside of clinic visit |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive aged women, 18-45, who attended their regular GYN clinic visit
Key inclusion criteria (1 listed)
- Patient of UAB GYN clinic
Key exclusion criteria (1 listed)
- Not a patient of UAB GYN clinic
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 acronym (pre-exposure prophylaxis)Tracked PrEP prescriptions over 8 months among patients who completed the survey | Behavioural | Post visit (fidelity) survey, Sexual Health-PRO |
Primary outcome
PrEP Prescriptions
Time frame: 8 months
Number of participants receiving a new PrEP prescription during the recruitment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Michael Mugavero, MD 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?
An observational study of PrEP Precriptions for Reproductive Aged Women, 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 1 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 26 Jan 2026. 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 26 Jan 2026). 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?
PrEP Prescriptions (time frame: 8 months). 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 26 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.