Bringing Medicines for HIV Prevention to a Family Planning Clinic

Implementing HIV Pre-Exposure Prophylaxis in a Family Planning Clinic: A Study of Feasibility and Acceptability (Aka The Pilot Fish Study)

The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP. The main questions to answer are:

1. Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic?
2. What things make it easier or harder to ask about PrEP in a family planning clinic setting?
3. What things make it easier or harder to begin PrEP in a family planning clinic setting?

Patient participants:

1. Will receive standardized counseling about PrEP.
2. Will have the opportunity to begin PrEP as part of their routine, ongoing care.
3. Will be asked to complete a survey about their experiences.

Physician participants:

1. Will receive standardized education about PrEP.
2. Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP.
3. Will be asked to complete pre-and post-study surveys about their experiences.
4. May be asked to complete a post-study in-depth interview about their experiences.

Study Overview

• Status: Recruiting
• Conditions: PrEP; HIV
• Intervention / Treatment: Behavioral: Patient participant screening; Behavioral: Physician participant training

Detailed Description

In the proposed pilot study, the investigators' goal is to improve community health resources available to Rhode Islanders to lower their risk of HIV acquisition, via the following specific aims:

1. Evaluate the patient acceptability of HIV pre-exposure prophylaxis (PrEP) eligibility screening and initiation in an ob/gyn-staffed family planning clinic.
2. Assess the barriers, facilitators, and feasibility of PrEP eligibility screening in an ob/gyn-staffed family planning clinic.
3. Assess the barriers, facilitators, and feasibility of delivery and uptake of PrEP in an ob/gyn-staffed family planning clinic.

Overall, the investigators' expected outcome is to have exploratory data to inform a scalable intervention to implement PrEP access, which can be deployed in family planning clinic settings, and which is designed in accordance with acceptability and feasibility data from patients and providers. Since the existing data suggest that ob/gyn-staffed family planning clinics are an ideal site both as a catchment area for patients who are at higher risk for HIV acquisition, and in terms of technical capacity and provider skill set, the next step to expand PrEP service delivery in these settings is to assess the barriers and facilitators to such care, in order to meet patients where they are, with the care they need. The goal is to situate the protocol to fit into the usual clinical workflow of a busy family planning clinic.

The investigators will develop and implement a standardized PrEP eligibility screening instrument and initiation protocol, based on CDC guidelines. The investigators will survey patient and physician participants about feasibility and acceptability of study procedures. Patient participants will be approached by a research assistant, who will inform eligible individuals about the purpose, risks, and benefits of the study. The research assistant will obtain informed consent from participants. Physicians will then screen participants for PrEP eligibility per protocol, and will offer initiation of PrEP. These medications are not investigational, are part of standard of care STI prevention, and are not themselves the primary subject of this study.

The investigators' primary data collection will be via survey. Patient participants will receive a $25 gift card for completing the post-intervention survey. Physician participants will receive pre- and post-study surveys, and a subgroup will participate in focused interviews.

There is no control arm in this study. The alternative to participation in this study is to simply undergo (or provide) routine care in the investigators' Family Planning Clinic, which does not currently include PrEP provision - though, as described above, such care is within the scope of routine care in ob/gyn settings.

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin P Brown, MD, MS; Phone Number: 41501 401-274-1122; Email: benjamin_brown@brown.edu
• Study Contact Backup: Name: Erica J Hardy, MD, MMSc, MA; Phone Number: 401-453-7950; Email: erica_hardy@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Women and Infants Hospital of Rhode Island
      • Contact: Benjamin P Brown, MD, MS; Phone Number: 41501 401-274-1122; Email: benjamin_brown@brown.edu
      • Contact: Erica J Hardy, MD, MMSc, MA; Phone Number: 401-453-7950; Email: erica_hardy@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

This study will include patient participants who:

• Are age 16 or older
• Are presenting for care at the Women and Infants Hospital of Rhode Island Family Planning Clinic
• Speak English or Spanish
• Have decisional capacity

This study will exclude patient participants who:

- Are currently seeking abortion care

This study will include physician participants who:

- Provide care at the Women and Infants Hospital of Rhode Island Family Planning Clinic

This study will not have any specific exclusion criteria for physician participants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Participant	Behavioral: Patient participant screening; Patient participants will be provided with the standardized PrEP screening and initiation protocol.
Experimental: Physician Participant	Behavioral: Physician participant training; Physician participants will be trained in the investigators' standardized PrEP screening and initiation protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure	A validated measure of acceptability, administered via questionnaire. 4 Likert scale items. Item score range 1-5. Higher scores reflect higher acceptability.	Up to hour 6 for patient participants; Up to month 12 for physician participants
Feasibility of Intervention Measure	A validated measure of feasibility, administered via questionnaire. 7-12 Likert scale items. Item score range 1-5. Higher scores reflect higher feasibility.	Up to hour 6 for patient participants; Up to month 12 for physician participants
Intervention Appropriateness Measure	A validated measure of appropriateness, administered via questionnaire. 4 Likert scale items. Item score range 1-5. Higher scores reflect higher appropriateness.	Up to hour 6 for patient participants; Up to month 12 for physician participants

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews	A subgroup of physician participants will be engaged in qualitative interviews to further contextualize their survey responses.	Once at the completion of physician participation in the study (maximum anticipated timeframe, 1 year)

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborators: Advance RI CTR

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: HIV PrEP screening; HIV PrEP initiation; ob/gyn
• Other Study ID Numbers: 2282543-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No