HIV Prevention ProgramSWIFTNCT07781423
Nurse-Led PrEP Initiation Among Incarcerated Individuals
A study testing Nurse-Led Intervention, Patient Navigation Intervention and Standard-of-care (SoC) in people with HIV Prevention Program and Pre-Exposure Prophylaxis (PrEP), run by Rhode Island Hospital at 1 site in United States.
Trial summary
PrEP is a medication that can help prevent the spread of HIV, but many who might benefit from PrEP do not take it. Individuals experiencing incarceration are interested in starting PrEP while incarcerated, but there are challenges that make it difficult for them to start this medication when they return to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention Program, Pre-Exposure Prophylaxis (PrEP)
- What is being tested?
- Nurse-Led Intervention, Patient Navigation Intervention and Standard-of-care (SoC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Apr 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently incarcerated at the Rhode Island Department of Corrections
- At least 18 years of age
- Not currently pregnant
- Eligible for PrEP
- No PrEP use in the 90 days prior to incarceration
- Interested in starting PrEP
Show all 9Show fewer
- Report any criminalized drug use or at least one heavy drinking day in the 90 days prior to incarceration
- Likely to be incarcerated for more than a week but less than 6 months
- Able to understand and speak English and provide written and verbal informed consent
Who cannot join
None listed.
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
Rhode Island Hospital
Providence, Rhode Island, 02903
Evan Ames, 401-444-2474, evan.ames@brownhealth.org
About this study
Official title: Nurse-Led Rapid Initiation of HIV Pre-Exposure Prophylaxis Care Among Incarcerated Individuals With Continuation of Care Services Post-Incarceration
PrEP is a medication that can help prevent the spread of HIV, but many who might benefit from PrEP do not take it. Individuals experiencing incarceration are interested in starting PrEP while incarcerated, but there are challenges that make it difficult for them to start this medication when they return to the community. This study will test to see if a nurse-led, same-day PrEP start program can help individuals experiencing incarceration start and stay on PrEP. To do this, N = 90 PrEP-eligible patients during their incarceration will test the nurse-led program. Everyone will receive access to a nurse-led behavioral intervention during incarceration and information about PrEP services available in the community. Then, N = 60 participants will receive patient navigation support to help them link with PrEP care in the community and N = 30 participants will receive a list of community resources. Research interviews will be conducted with participants while they are incarcerated and 1, 3, and 6 months after they re-enter the community. Participants are offered compensation for each of the research interviews.
- Being tested
- Nurse-Led Intervention, Patient Navigation Intervention, Standard-of-care (SoC)
- Keywords
- Criminal-Legal Involvement, Patient Navigatioin, Nurse-Led
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led InterventionBehavioural
All participants will receive the nurse-led intervention. The study nurse will meet with participants twice during incarceration and deliver behavioral sessions focused on motivational interviewing and psychoeducation related to PrEP. The aim of these sessions is to enhance motivation to start PrEP following community re-entry. Anyone expressing interest in starting PrEP will be provided information about how to access PrEP care in the community with our study nurse and other community-based providers.
The study nurse will deliver same-day PrEP care services at a outpatient clinic. In this setting, the nurse will perform all of the necessary activities required to initiate a patient on same-day PrEP. These activities include, HIV testing and any other remaining recommended testing that was not performed while the participant was at RIDOC and placing an order for a PrEP prescription. All clinical activities will be supervised by a physician or a nurse-practitioner.
Patient Navigation InterventionBehavioural
Participants randomly assigned to the experimental arm will receive a warm handoff from the study nurse to the patient navigator (PN), in which they will be introduced by the nurse to the PN prior to discharge. NAV participants will receive 6 monthly phone calls, or alternate means of contact (texts, emails, HIPAA compliant videoconferencing) if preferred by participant, from the PN and access to navigation services for 6 months. Navigation services include: assistance with health insurance issues, facilitating transfer of medical records, scheduling PrEP care appointments, and facilitating linkage to substance use treatment and mental health services as appropriate. In addition, the PN will remind participants of PrEP care appointments, arrange transportation to appointments as needed, and attend the first PrEP care appointment if desired by participant. The PN can also provide information regarding other community-based resources.
Standard-of-care (SoC)Behavioural
SOC will consist of a brochure regarding how to receive PrEP care in the community after discharge from RIDOC, which SOC participants will receive from the study nurse prior to discharge.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Behavioral: Nurse-Led Intervention; Behavioral: Patient Navigation Intervention |
| Control Arm | Active comparator | Not described Receives: Behavioral: Nurse-Led Intervention; Behavioral: Standard-of-care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to Community-Based PrEP Care assessed with medical record review
Operationalized as receipt of prescription from a community-based provider within 6 months of release from incarceration. This will be verified through medical record review.
Measured: 1, 3, & 6-Month Follow-ups
Intervention Feasibility assessed with Exit Interviews
Participant eligibility rate, enrollment rate, rate of recruitment, and follow-up completion rate will serve as indices of intervention feasibility and will be compiled at the conclusion of the study. In exit interviews with NAV participants, feedback will be solicited regarding the feasibility of the intervention.
Measured: 6-Month Follow-up
Intervention Acceptability assessed with the Client Satisfaction Questionnaire-Revised
The 8-item Client Satisfaction Questionnaire-Revised will be administered to participants to assess intervention acceptability. Total scores range from 8 to 32, with higher scores representing greater intervention acceptability.
Measured: 6-Month Follow-up
Secondary outcomes (2)
PrEP Care Retention
Retention in care is defined as attending a clinical appointment 3 months (+/- 1 month) after an initial PrEP care appointment. These data will be captured via medial record review.
Measured: 3 & 6-Month Follow-up
PrEP Adherence assessed with 3-item adherence measure
PrEP adherence will be assessed via Wilson et al.'s 3-item adherence measure. This assessment is widely used and boasts favorable psychometric properties. Scores range from 0 to 30, with higher scores representing greater PrEP adherence.
Measured: 1, 3, & 6-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Prevention ProgramStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Ramsey, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781423
- Sponsor's protocol ID
- R34DA061656
- Acronym
- SWIFT
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Rapid Initiation of HIV Pre-Exposure Prophylaxis Care Among Incarcerated Individuals With Continuation of Care Services Post-Incarceration
- ClinicalTrials.gov ID
- NCT07781423
- Acronym / sponsor ID
- SWIFT / R34DA061656
- Keywords
- Criminal-Legal Involvement, Patient Navigatioin, Nurse-Led
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 24 Aug 2026 (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.
PrEP is a medication that can help prevent the spread of HIV, but many who might benefit from PrEP do not take it. Individuals experiencing incarceration are interested in starting PrEP while incarcerated, but there are challenges that make it difficult for them to start this medication when they return to the community. This study will test to see if a nurse-led, same-day PrEP start program can help individuals experiencing incarceration start and stay on PrEP. To do this, N = 90 PrEP-eligible patients during their incarceration will test the nurse-led program. Everyone will receive access to a nurse-led behavioral intervention during incarceration and information about PrEP services available in the community. Then, N = 60 participants will receive patient navigation support to help them link with PrEP care in the community and N = 30 participants will receive a list of community resources. Research interviews will be conducted with participants while they are incarcerated and 1, 3, and 6 months after they re-enter the community. Participants are offered compensation for each of the research interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: Nurse-Led Intervention, Behavioral: Patient Navigation Intervention |
| Control Arm | Active comparator | Behavioral: Nurse-Led Intervention, Behavioral: Standard-of-care (SoC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Currently incarcerated at the Rhode Island Department of Corrections
- At least 18 years of age
- Not currently pregnant
- Eligible for PrEP
- No PrEP use in the 90 days prior to incarceration
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nurse-Led InterventionAll participants will receive the nurse-led intervention. The study nurse will meet with participants twice during incarceration and deliver behavioral sessions focused on motivational interviewing and psychoeducation related to PrEP. The aim of these sessions is to enhance motivation to start PrEP following community re-entry. Anyone expressing interest in starting PrEP will be provided information about how to access PrEP care in the community with our study nurse and other community-based providers. The study nurse will deliver same-day PrEP care services at a outpatient clinic. In this setting, the nurse will perform all of the necessary activities required to initiate a patient on same-day PrEP. These activities include, HIV testing and any other remaining recommended testing that was not performed while the participant was at RIDOC and placing an order for a PrEP prescription. All clinical activities will be supervised by a physician or a nurse-practitioner. | Behavioural | Control Arm, Experimental Arm |
| Patient Navigation InterventionParticipants randomly assigned to the experimental arm will receive a warm handoff from the study nurse to the patient navigator (PN), in which they will be introduced by the nurse to the PN prior to discharge. NAV participants will receive 6 monthly phone calls, or alternate means of contact (texts, emails, HIPAA compliant videoconferencing) if preferred by participant, from the PN and access to navigation services for 6 months. Navigation services include: assistance with health insurance issues, facilitating transfer of medical records, scheduling PrEP care appointments, and facilitating linkage to substance use treatment and mental health services as appropriate. In addition, the PN will remind participants of PrEP care appointments, arrange transportation to appointments as needed, and attend the first PrEP care appointment if desired by participant. The PN can also provide information regarding other community-based resources. | Behavioural | Experimental Arm |
| Standard-of-care (SoC)SOC will consist of a brochure regarding how to receive PrEP care in the community after discharge from RIDOC, which SOC participants will receive from the study nurse prior to discharge. | Behavioural | Control Arm |
Primary outcome
Linkage to Community-Based PrEP Care assessed with medical record review
Time frame: 1, 3, & 6-Month Follow-ups
Operationalized as receipt of prescription from a community-based provider within 6 months of release from incarceration. This will be verified through medical record review.
Intervention Feasibility assessed with Exit Interviews
Time frame: 6-Month Follow-up
Participant eligibility rate, enrollment rate, rate of recruitment, and follow-up completion rate will serve as indices of intervention feasibility and will be compiled at the conclusion of the study. In exit interviews with NAV participants, feedback will be solicited regarding the feasibility of the intervention.
Intervention Acceptability assessed with the Client Satisfaction Questionnaire-Revised
Time frame: 6-Month Follow-up
The 8-item Client Satisfaction Questionnaire-Revised will be administered to participants to assess intervention acceptability. Total scores range from 8 to 32, with higher scores representing greater intervention acceptability.
2 secondary outcomes
PrEP Care Retention
Time frame: 3 & 6-Month Follow-up
PrEP Adherence assessed with 3-item adherence measure
Time frame: 1, 3, & 6-Month Follow-up
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 24 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for HIV Prevention Program
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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.
Susan Ramsey, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Intervention, Patient Navigation Intervention and Standard-of-care (SoC) in people with HIV Prevention Program and Pre-Exposure Prophylaxis (PrEP), run by Rhode Island Hospital 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?
The sponsor lists 9 inclusion and 0 exclusion criteria. 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: opening soon, as of the sponsor's last update on 24 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 Susan Ramsey, PhD (401-444-7831, sramsey@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to Community-Based PrEP Care assessed with medical record review (time frame: 1, 3, & 6-Month Follow-ups). 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 24 Aug 2026.