Bringing Medicines for HIV Prevention to a Family Planning Clinic

NCT06930508 | Not Yet Recruiting

• 1 other identifier: 2282543-1
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic?
2. 2.What things make it easier or harder to ask about PrEP in a family planning clinic setting?
3. 3.What things make it easier or harder to begin PrEP in a family planning clinic setting?
4. 4.Will receive standardized counseling about PrEP.
5. 5.Will have the opportunity to begin PrEP as part of their routine, ongoing care.
6. 6.Will be asked to complete a survey about their experiences.
7. 7.Will receive standardized education about PrEP.
8. 8.Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP.
9. 9.Will be asked to complete pre-and post-study surveys about their experiences.
10. 10.May be asked to complete a post-study in-depth interview about their experiences.

Conditions

HIV; PrEP

Keywords

HIV PrEP screening; HIV PrEP initiation; ob/gyn

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Patient Participant

EXPERIMENTAL

Behavioral: Patient participant screening

Physician Participant

EXPERIMENTAL

Behavioral: Physician participant training

Interventions

Patient participant screening BEHAVIORAL

Patient participants will be provided with the standardized PrEP screening and initiation protocol.

Patient Participant

Physician participant training BEHAVIORAL

Physician participants will be trained in the investigators' standardized PrEP screening and initiation protocol.

Physician Participant

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Advance RI CTR: collaborator

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Central Study Contacts

Benjamin P Brown, MD, MS

CONTACT

401-274-1122; benjamin_brown@brown.edu

Erica J Hardy, MD, MMSc, MA

CONTACT

401-453-7950; erica_hardy@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be no between-group comparison in this trial. However, the investigators will simultaneously recruit both patient participants and physician participants. Study procedures will be different for these two groups, as described in the protocol section.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 16, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)