Recruiting

PrEP

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT06930508

Conditions

HIV

PrEP

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Patient participant screening

Physician participant training

Study Details

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. 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.

Conditions

HIV

PrEP

Study ID

NCT06930508

Start date

May 28, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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 Design

Enrollment

83 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Patient Participant

experimental: Physician Participant

Interventions

Patient participant screening

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

Physician participant training

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

Primary outcome measure

  • Acceptability of Intervention Measure [ Time Frame: Up to hour 6 for patient participants; Up to month 12 for physician participants ]
  • Feasibility of Intervention Measure [ Time Frame: Up to hour 6 for patient participants; Up to month 12 for physician participants ]
  • Intervention Appropriateness Measure [ Time Frame: Up to hour 6 for patient participants; Up to month 12 for physician participants ]

Central Contacts and Locations

Central contacts

Erica J Hardy, MD, MMSc, MA

401-453-7950erica_hardy@brown.edu

Locations

Women and Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Erica J Hardy, MD, MMSc, MA

401-453-7950erica_hardy@brown.edu

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Aug 6, 2026

Last verified

May, 2026

Keywords

  • HIV PrEP screening
  • HIV PrEP initiation
  • ob/gyn

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2026-08-06.