An interventional study of Patient participant screening and Physician participant training in HIV and PrEP, sponsored by Women and Infants Hospital of Rhode Island. Recruiting at 1 site in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Screening
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:
Patient participants:
Physician participants:
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:
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.
This study will include patient participants who:
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.
Behavioral: Patient participant screening
Behavioral: Physician participant training
Patient participants will be provided with the standardized PrEP screening and initiation protocol.
Physician participants will be trained in the investigators' standardized PrEP screening and initiation protocol.
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to hour 6 for patient participants; Up to month 12 for physician participants
Plan to share: No
No publications or documents are linked to this record.
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Women and Infants Hospital of Rhode Island