About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
able to provide written informed consent in English or Spanish;
living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);
willing to have HIV testing to determine negative or positive status;
Disqualifiers
severe medical or psychiatric disability making participation unsafe;
unable to provide consent.
persons self-reporting pregnancy
Trial design
Parallel
Treatments tested in this trial
Standard PN
BehavioralStandard of care
Patient Choice
BehavioralParticipants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.
Treatment groups
Trial outcomes
Primary outcomes
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
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
Secondary outcomes
Percentage of participants that adhere to PrEP
Percentage of participants that adhere to PrEP
Percentage of participants retaining on PrEP
Percentage of participants retaining on PrEP
HIV incidence
HIV incidence \[binary\] for those testing negative using rapid point of care (POC) test over time
Percentage of participants that adhere to ART
Percentage of participants that adhere to ART
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator