Nurse-Led PrEP Initiation Among Incarcerated Individuals (SWIFT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Prevention Program; Pre-Exposure Prophylaxis (PrEP)
• Intervention / Treatment: Behavioral: Nurse-Led Intervention; Behavioral: Patient Navigation Intervention; Behavioral: Standard-of-care (SoC)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Ramsey, PhD; Phone Number: 401-444-7831; Email: sramsey@brownhealth.org
• Study Contact Backup: Name: Evan Ames; Phone Number: 401-444-2474; Email: evan.ames@brownhealth.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
      • Contact: Evan Ames; Phone Number: 401-444-2474; Email: evan.ames@brownhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm	Behavioral: Nurse-Led Intervention; 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.; Behavioral: 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.
Experimental: Experimental Arm	Behavioral: Nurse-Led Intervention; 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.; Behavioral: Patient Navigation Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6-Month Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1, 3, & 6-Month Follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use assessed with the Timeline Followback	The number of standard drinks consumed per day will be assessed with the Timeline Followback (TLFB) interview. The TLFB is a calendar-assisted structured interview which provides a way to cue memory and enhance recall. This data collection method has excellent reliability and validity.	Baseline, 1, 3, & 6-Month Follow-up
Drug Use assessed with the Timeline Followback	The class of drugs used each day will be assessed with the Timeline Followback (TLFB) interview. The TLFB is a calendar-assisted structured interview which provides a way to cue memory and enhance recall. This data collection method has excellent reliability and validity.	Baseline, 1, 3, & 6-Month Follow-up
HIV-Related Risk Behavior assessed with the HIV Risk Assessment Battery	The HIV Risk Assessment Battery (RAB) will be administered at each assessment period to capture participants' overall HIV acquisition risk. The RAB is a standardized measure with strong psychometric properties. Total scores range from 0 to 40, with higher scores representing greater HIV risk.	Baseline, 1, 3, & 6-Month Follow-up
Depressive Symptoms assessed with the Center for Epidemiologic Studies Depression Scale	The Center for Epidemiologic Studies Depression Scale (CES-D) will be used to assess depressive symptoms at baseline and follow-ups. This 20-item measure is widely used and has strong psychometric properties. Total scores range from 0 to 60, with higher scores representing greater depressive symptoms.	Baseline, 1, 3, & 6-Month Follow-up
Knowledge Regarding PrEP assessed with a PrEP Knowledge Questionnaire	PrEP knowledge will be assessed with a slightly-adapted 5-item measure that was developed to assess knowledge regarding PrEP. Scores range from 0 to 13, with higher scores representing greater PrEP knowledge.	Baseline, 1, 3, & 6-Month Follow-up
Attitudes and Beliefs Regarding PrEP Use assessed with PrEP Attitudes Survey	Attitudes and beliefs (norms, self-efficacy, and stigma) related to PrEP will be assessed with an adapted 9-item survey utilized in previous PrEP research. Scores range from 0 to 27, with higher scores representing greater stigmatizing attitudes related to PrEP.	Baseline, 1, 3, & 6-Month Follow-up
Treatment Received assessed with the Treatment Services Review	Receipt of case management, HIV/STI risk reduction counseling, mental health, substance use, and other treatment services will be assessed with the Treatment Services Review (TSR). This is a semi-structured method of assessing different types of treatment received. The number of times different types of treatment were utilized will be captured for each time period.	Baseline, 1, 3, & 6-Month Follow-up
Use of Medications assessed with semi-structured interview	Participants will be asked to provide information regarding their use of medications for medical, psychiatric, or substance use indications. The number of medications for each category (medical, psychiatric, and substance use indications) will be captured at each time point.	Baseline, 1, 3, & 6-Month Follow-up
Pregnancies assessed with semi-structured interview	Participants will also be asked about any pregnancies they have experienced.	Baseline, 1, 3, & 6-Month Follow-up
Reasons for PrEP Care Linkage/Non-Linkage assessed with qualitative exit interview	Brief qualitative exit interviews will be conducted with NAV participants (n = 60). These participants will be asked to reflect on factors that impacted their use or non-use of PrEP while incarcerated and after release and about other HIV risk reduction strategies used. Participants who linked with a community-based PrEP care provider will be asked about the decision process for their PrEP formulation choice (daily oral vs. long acting). Lastly, we will ask about perceived utility of the nurse-led and NAV intervention components and suggested changes.	6-Month Follow-up
Mistrust of Medial Organizations assessed with the Medical Mistrust Index	Mistrust of medical organizations will be assessed with the Medical Mistrust Index (MMI) The MMI is well suited for assessing medical mistrust of organizations and has been validated among various racial and ethnic groups. Scores range from 7 to 28, with higher scores representing greater mistrust of medical organizations.	Baseline, 1, 3, & 6-Month Follow-up
Mistrust of Medical Personnel assessed with the Group Based Medical Mistrust Scale	Mistrust of medical personnel will be assessed with the Group Based Medical Mistrust Scale (GBMMS). The GBMMS boasts strong psychometric properties and has been validated in various racial and ethnic groups. Scores range from 12 to 60, with higher scores representing greater mistrust of medical personnel.	Baseline, 1, 3, & 6-Month Follow-up

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Principal Investigator: Susan Ramsey, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Nurse-Led; Criminal-Legal Involvement; Patient Navigatioin
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: R34DA061656 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No