HIVNCT06930508
Bringing Medicines for HIV Prevention to a Family Planning Clinic
A study testing Patient participant screening and Physician participant training in people with HIV and PrEP, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- What is being tested?
- Patient participant screening and Physician participant training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Benjamin P Brown, MD, MS, 401-274-1122 ext. 41501, benjamin_brown@brown.edu
Erica J Hardy, MD, MMSc, MA, 401-453-7950, erica_hardy@brown.edu
About this study
Official title: 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:
- Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic?
- What things make it easier or harder to ask about PrEP in a family planning clinic setting?
- What things make it easier or harder to begin PrEP in a family planning clinic setting?
Read more
Patient participants:
- Will receive standardized counseling about PrEP.
- Will have the opportunity to begin PrEP as part of their routine, ongoing care.
- Will be asked to complete a survey about their experiences.
Physician participants:
- Will receive standardized education about PrEP.
- Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP.
- Will be asked to complete pre-and post-study surveys about their experiences.
- May be asked to complete a post-study in-depth interview about their experiences.
Read the 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:
- Evaluate the patient acceptability of HIV pre-exposure prophylaxis (PrEP) eligibility screening and initiation in an ob/gyn-staffed family planning clinic.
- Assess the barriers, facilitators, and feasibility of PrEP eligibility screening in an ob/gyn-staffed family planning clinic.
- 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.
- Being tested
- Patient participant screening, Physician participant training
- Keywords
- HIV PrEP screening, HIV PrEP initiation, ob/gyn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient participant screeningBehavioural
Patient participants will be provided with the standardized PrEP screening and initiation protocol.
Physician participant trainingBehavioural
Physician participants will be trained in the investigators' standardized PrEP screening and initiation protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patient Participant | Experimental | Not described Receives: Behavioral: Patient participant screening |
| Physician Participant | Experimental | Not described Receives: Behavioral: Physician participant training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to hour 6 for patient participants; Up to month 12 for physician participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start28 May 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Advance RI CTR
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930508
- Sponsor's protocol ID
- 2282543-1
- Status last verified
- May 2026
- First submitted
- 1 Apr 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing HIV Pre-Exposure Prophylaxis in a Family Planning Clinic: A Study of Feasibility and Acceptability (Aka The Pilot Fish Study)
- ClinicalTrials.gov ID
- NCT06930508
- Acronym / sponsor ID
- 2282543-1
- Keywords
- HIV PrEP screening, HIV PrEP initiation, ob/gyn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Advance RI CTR
- Study start
- 28 May 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic?
- What things make it easier or harder to ask about PrEP in a family planning clinic setting?
- What things make it easier or harder to begin PrEP in a family planning clinic setting?
Patient participants:
- Will receive standardized counseling about PrEP.
- Will have the opportunity to begin PrEP as part of their routine, ongoing care.
- Will be asked to complete a survey about their experiences.
Physician participants:
- Will receive standardized education about PrEP.
- Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP.
- Will be asked to complete pre-and post-study surveys about their experiences.
- May be asked to complete a post-study in-depth interview about their experiences.
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:
- Evaluate the patient acceptability of HIV pre-exposure prophylaxis (PrEP) eligibility screening and initiation in an ob/gyn-staffed family planning clinic.
- Assess the barriers, facilitators, and feasibility of PrEP eligibility screening in an ob/gyn-staffed family planning clinic.
- 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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient Participant | Experimental | Behavioral: Patient participant screening |
| Physician Participant | Experimental | Behavioral: Physician participant training |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient participant screeningPatient participants will be provided with the standardized PrEP screening and initiation protocol. | Behavioural | Patient Participant |
| Physician participant trainingPhysician participants will be trained in the investigators' standardized PrEP screening and initiation protocol. | Behavioural | Physician Participant |
Primary outcome
Acceptability of Intervention Measure
Time frame: Up to hour 6 for patient participants; Up to month 12 for physician participants
A validated measure of acceptability, administered via questionnaire. 4 Likert scale items. Item score range 1-5. Higher scores reflect higher acceptability.
Feasibility of Intervention Measure
Time frame: Up to hour 6 for patient participants; Up to month 12 for physician participants
A validated measure of feasibility, administered via questionnaire. 7-12 Likert scale items. Item score range 1-5. Higher scores reflect higher feasibility.
Intervention Appropriateness Measure
Time frame: Up to hour 6 for patient participants; Up to month 12 for physician participants
A validated measure of appropriateness, administered via questionnaire. 4 Likert scale items. Item score range 1-5. Higher scores reflect higher appropriateness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient participant screening and Physician participant training in people with HIV and PrEP, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin P Brown, MD, MS (401-274-1122 ext. 41501, benjamin_brown@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (time frame: Up to hour 6 for patient participants; Up to month 12 for physician participants). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.