The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.
Adults (age 18) at a participating carceral site;
Eligible for release within 120 days (sentenced and/or pretrial). Individuals who might be sentenced to federal prison will be excluded;
History of OUD (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration);
HIV negative (as confirmed by a HIV rapid test);
Liver function test levels greater than four times normal (if we are unable to obtain labs, a determination by our site partner physicians will be made to allow inclusion);
Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);
Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrhythmics, antipsychotics and antidepressants);
Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);
Parallel
Cabotegravir Injection
DrugLong-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Cabotegravir Pill
DrugOral PrEP + SL-B treatment initiated in jail or prison.
Buprenorphine injection
DrugLong-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Buprenorphine Pill
DrugOral PrEP + SL-B treatment initiated in jail or prison.
PrEP adherence, time to dropout
Dropout is defined as missing treatment for 7 consecutive days.
Buprenorphine adherence, time to dropout
Dropout is defined as missing treatment for 7 consecutive days.
Substance use as measured by number of participants with positive Urine Drug Test (UDT)
Number of participants with a fatal or non-fatal overdose
Number of participants engaging in HIV risk behaviors
Number of participants with past criminal system engagement
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Friends Research Institute, Inc.
Collaborator
The Miriam Hospital
Collaborator
University of Arkansas
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
