Nurse-Led PrEP Initiation Among Incarcerated Individuals

NCT07781423 | Not Yet Recruiting DMC

• 1 other identifier: R34DA061656
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

HIV Prevention Program; Pre-Exposure Prophylaxis (PrEP)

Keywords

Criminal-Legal Involvement; Patient Navigatioin; Nurse-Led

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• PrEP Care Retention

  3 & 6-Month Follow-up

• PrEP Adherence assessed with 3-item adherence measure

  1, 3, & 6-Month Follow-up

Other Outcomes (12)

• Alcohol Use assessed with the Timeline Followback

  Baseline, 1, 3, & 6-Month Follow-up

• Drug Use assessed with the Timeline Followback

  Baseline, 1, 3, & 6-Month Follow-up

• HIV-Related Risk Behavior assessed with the HIV Risk Assessment Battery

  Baseline, 1, 3, & 6-Month Follow-up

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Behavioral: Nurse-Led Intervention; Behavioral: Patient Navigation Intervention

Control Arm

ACTIVE COMPARATOR

Behavioral: Nurse-Led Intervention; Behavioral: Standard-of-care (SoC)

Interventions

Nurse-Led Intervention BEHAVIORAL

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.

Control Arm; Experimental Arm

Patient Navigation Intervention BEHAVIORAL

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.

Experimental Arm

Standard-of-care (SoC) BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Susan Ramsey, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Ramsey, PhD

CONTACT

401-444-7831; sramsey@brownhealth.org

Evan Ames

CONTACT

401-444-2474; evan.ames@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)