An interventional study of Standard PN and Patient Choice in Substance Use Disorders, sponsored by Yale University. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.
The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.
Exclusion Criteria:
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling.
Behavioral: Standard PN
PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment.
Behavioral: Standard PN · Behavioral: Patient Choice
Standard of care
Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.
Percentage of participants who initiate or re-initiate PrEP
Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report
Time frame: 6 months
Percentage of participants who initiate or re-initiate ART
Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report
Time frame: 6 months
Percentage of participants that adhere to PrEP
Percentage of participants that adhere to PrEP
Time frame: 6 and 12 months
Percentage of participants retaining on PrEP
Percentage of participants retaining on PrEP
Time frame: 6 and 12 months
HIV incidence
HIV incidence \[binary\] for those testing negative using rapid point of care (POC) test over time
Time frame: 6 and 12 months
Percentage of participants that adhere to ART
Percentage of participants that adhere to ART
Time frame: 6 and 12 months
ART retention
For persons living with HIV (PLH), ART retention \[binary\]
Time frame: 6 and 12 months
Substance use treatment
Percentage of participants engaged in substance use disorder (SUD) treatment
Time frame: 6 and 12 months
HIV viral suppression
For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load \< 200 copies/mL at 6 months
Time frame: 6 months
Retention in HIV PrEP/ART
Retention in HIV PrEP/ART care \[binary\]: defined as attending 2 or more visits in 6-months
Time frame: 6 months
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior
Number of Participants Who Had Any Needle Sharing Activity
Time frame: 6 and 12 months
Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior
Number of Participants Who Had Vaginal or Anal Sex Without a Condom
Time frame: 6 and 12 months
Days of using opioids
Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use
Time frame: 6 and 12 months
Number of participants with with overdose events
Number of participants with non-fatal and fatal overdose events
Time frame: 6 and 12 months
Percentage of participants with retention in SUD treatment
Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD)
Time frame: 6 and 12 months
Quality of Life assessed using PROMIS-PROPr
PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health.
Time frame: 6 and 12 months
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.
Time frame: 6 and 12 months
Recidivism: Reasons
Number of participants per reason for arrest/ incarceration/return-to-custody
Time frame: 6 and 12 months
Recidivism: Mean days in custody/incarcerated
Mean days in custody/incarcerated
Time frame: 6 and 12 months
Recidivism: Mean days to return
Mean days to return to custody/incarcerated
Time frame: 6 and 12 months
HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)
Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma
Time frame: 6 and 12 months
Percentage of participants diagnosed with SUD
Percentage of participants diagnosed with SUD using DSM-5
Time frame: Baseline and 12 months
Plan to share: No
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Yale University