Nurse-Led PrEP Initiation Among Incarcerated Individuals
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhode Island Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently incarcerated at the Rhode Island Department of Corrections
At least 18 years of age
Not currently pregnant
Eligible for PrEP
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-Led Intervention
BehavioralAll 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 Intervention
BehavioralParticipants 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)
BehavioralSOC 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Experimental ArmExperimental treatment 2 interventions
Group B: Control ArmActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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-ups2
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-up3
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-upSecondary outcomes
1
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-up2
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-upOther outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov
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