An interventional study of Nurse-Led Intervention and Patient Navigation Intervention in HIV Prevention Program and Pre-Exposure Prophylaxis (PrEP), sponsored by Rhode Island Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Treatment
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.
Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Nurse-Led Intervention · Behavioral: Patient Navigation Intervention
Behavioral: Nurse-Led Intervention · Behavioral: Standard-of-care (SoC)
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 6-Month Follow-up
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.
Time frame: 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.
Time frame: 1, 3, & 6-Month Follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1, 3, & 6-Month Follow-up
Pregnancies assessed with semi-structured interview
Participants will also be asked about any pregnancies they have experienced.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1, 3, & 6-Month Follow-up
Plan to share: No
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Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
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