PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare

NCT ID: NCT07209722

Last Updated: 2026-01-26

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1377 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-22

Study Completion Date

2025-08-16

Brief Summary

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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.

Detailed Description

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Conditions

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PrEP Precriptions for Reproductive Aged Women

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Sexual Health-PRO

Patients seen during routine GYN clinic visit.

PrEP acronym (pre-exposure prophylaxis)

Intervention Type BEHAVIORAL

Tracked PrEP prescriptions over 8 months among patients who completed the survey

Post visit (fidelity) survey

Patients who completed the survey outside of clinic visit

PrEP acronym (pre-exposure prophylaxis)

Intervention Type BEHAVIORAL

Tracked PrEP prescriptions over 8 months among patients who completed the survey

Interventions

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PrEP acronym (pre-exposure prophylaxis)

Tracked PrEP prescriptions over 8 months among patients who completed the survey

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patient of UAB GYN clinic

Exclusion Criteria

* Not a patient of UAB GYN clinic
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael J Mugavero, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Mugavero, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R34MH128002

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300008345

Identifier Type: -

Identifier Source: org_study_id

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