Friends Research Institute Inc

A COMPARATIVE EFFECTIVENESS TRIAL OF EXTENDED RELEASE NALTREXONE VERSUS EXTENDED-RELEASE BUPRENORPHINE WITH INDIVIDUALS LEAVING JAIL

FACILITATING THE IMPLEMENTATION OF INTERIM METHADONE TO INCREASE TREATMENT ACCESS: A MULTI-SITE IMPLEMENTATION TRIAL

BUPRENORPHINE FOR PROBATIONERS AND PAROLEES: BRIDGING THE GAP INTO TREATMENT

A RANDOMIZED CONTROLLED TRIAL AND COHORT STUDY OF HIV TESTING AND LINKAGE TO CARE

OPIOID USE DISORDER TREATMENT LINKAGE AT STD CLINICS USING BUPRENORPHINE (OUTLAST-B)

HEALTH SERVICES RESEARCH: EXTENDED RELEASE NALTREXONE FOR OPIOID-DEPENDENT YOUTH

A COMPARATIVE EFFECTIVENESS TRIAL OF SUBLINGUAL VERSUS EXTENDED-RELEASE BUPRENORPHINE WITH INDIVIDUALS LEAVING A CARCERAL SETTING - ABSTRACT ALTHOUGH PREVIOUS RESEARCH HAS DEMONSTRATED THE EFFECTIVENESS OF INITIATING MEDICATIONS FOR OPIOID USE DISORDER (MOUDS) DURING INCARCERATION, THERE HAS BEEN VERY LITTLE ADOPTION NATIONWIDE OF THIS PRACTICE. EXTENDED-RELEASE BUPRENORPHINE (XR-B) IS A PROMISING INTERVENTION FOR THE TREATMENT OF OUDS IN CARCERAL SETTINGS. INDIVIDUALS WITH OUDS RE-ENTERING THE COMMUNITY ARE AT AN ELEVATED RISK FOR OVERDOSE AND DEATH FROM RELAPSE TO OPIOID USE AMONG OTHER OPIOID-RELATED HARMS. THIS PROPOSAL BUILDS ON THE CURRENT INVESTIGATORS EXPERIENCE CONDUCTING CLINICAL TRIALS USING BOTH XR-B AND SUBLINGUAL-BUPRENORPHINE-NALOXONE (SL-B) WITH INDIVIDUALS IN JAIL AND PRISON. THIS PROPOSED STUDY IS A RANDOMIZED CONTROLLED TRIAL OF XR-B VS. SL-B IN A LARGE METROPOLITAN JAIL. AN OPEN-LABEL DESIGN WILL RANDOMLY ASSIGN 240 ADULTS WITH MODERATE-TO-SEVERE OUDS WHO ARE SOON-TO-BE-RELEASED FROM JAIL TO EITHER XR-B (N = 120) OR SL-B (N = 120) TREATMENT IN JAIL FOLLOWED BY 6-MONTHS OF POST-RELEASE BUPRENORPHINE TREATMENT, A 7-MONTH SAFETY VISIT, AND FINAL LONG-TERM FOLLOW-UP AT 12-MONTHS. THE STUDY HAS THREE AIMS: AIM 1. COMPARE THE EFFECTIVENESS OF XR-B VS. SL-B IN TERMS OF: PRIMARY OUTCOME. (A) ILLICIT OPIOID USE (I. URINE TOXICOLOGY; II. SELF-REPORTED DAYS OF OPIOID USE USING TIMELINE FOLLOWBACK; AND III. TIME TO OPIOID RELAPSE). SECONDARY OUTCOMES. (B) RETENTION IN BUPRENORPHINE TREATMENT (I. DAYS RECEIVING BUPRENORPHINE AND II. TIME TO TREATMENT DROPOUT); (C) OTHER ILLICIT SUBSTANCE USE (I. URINE TOXICOLOGY; II. SELF-REPORTED DAYS OF ILLICIT SUBSTANCE USE USING TIMELINE FOLLOWBACK; (D) OVERDOSE EVENTS (NON-FATAL AND FATAL); (E) QUALITY OF LIFE (I. PHYSICAL HEALTH; II. MENTAL HEALTH); (F) HIV RISK BEHAVIORS (I. SEXUAL RISK BEHAVIOR; II. NEEDLE USE OR SHARING); AND (G) CRIMINAL ACTIVITY (I. CRIME DAYS; II. RE-ARREST; III. TECHNICAL VIOLATIONS; IV. RE-INCARCERATION). AIM 2. TO CALCULATE THE COST TO THE STATE AND/OR JAIL/CITY HEALTH SYSTEM OF IMPLEMENTING XR-B AND SL-B, AND DETERMINE THE RELATIVE VALUE, INCLUDING THE COSTS ASSOCIATED WITH THE INTERVENTIONS IN THE COMMUNITY, FROM A COUNTY AND STATE-POLICYMAKER AND SOCIETAL PERSPECTIVE. AIM 3. EXPLORE BARRIERS AND FACILITATORS TO XR-B/SL-B IMPLEMENTATION IN JAIL: (1) DOSE INDUCTION; (2) DIVERSION AND PROCEDURES FOR REDUCING DIVERSION; (3) CONTINUITY OF CARE AFTER RELEASE OR TRANSFER TO ANOTHER FACILITY; (4) STAFFING (BOTH CUSTODY AND MEDICAL) NEEDS FOR DAILY VERSUS XR-B BUPRENORPHINE DOSING; AND (5) PATIENT PREFERENCE FOR XR-B VERSUS SL-B. THE PROPOSED STUDY WOULD BE INNOVATIVE BECAUSE IT WOULD BE THE FIRST LARGE SCALE RCT IN THE US ASSESSING EFFECTIVENESS AND COST EFFECTIVENESS OF XR-B VERSUS SL-B WITH INDIVIDUALS IN A JAIL WHO ARE RE-ENTERING COMMUNITY. UNDERSTANDING HOW TO EXPAND ACCEPTANCE OF BUPRENORPHINE IN JAILS, HAS FAR-REACHING IMPLICATIONS FOR EXPANDING TREATMENT ACCESS IN JAIL.

LONG-ACTING NALTREXONE FOR PRE-RELEASE PRISONERS: A RANDOMIZED TRIAL OF MOBILE TREATMENT

TREATING POLYSUBSTANCE USE IN METHADONE MAINTENANCE: APPLICATION OF NOVEL DIGITAL TECHNOLOGY - ABSTRACT METHADONE IS A HIGHLY EFFECTIVE TREATMENT FOR OPIOID USE DISORDER (OUD), BUT MANY PATIENTS LEAVE TREATMENT PREMATURELY, PLACING THEM AT HIGH RISK OF RELAPSE AND OVERDOSE. EXTENSIVE RESEARCH SHOWS THAT COMORBID COCAINE USE IS ASSOCIATED WITH POOR RETENTION IN METHADONE TREATMENT. THE PROPOSED STUDY WILL EXAMINE A NOVEL INTERVENTION DESIGNED TO IMPROVE METHADONE TREATMENT RETENTION AND OTHER OUTCOMES AMONG PEOPLE WITH OPIOID AND COCAINE POLYSUBSTANCE USE. THE DESIGN IS A 2-ARM RANDOMIZED CONTROLLED TRIAL CONDUCTED OVER A ONE- YEAR PERIOD FOLLOWING METHADONE TREATMENT ENTRY. RETENTION (PRIMARY) AND DRUG USE (SECONDARY) OUTCOMES FOR METHADONE TREATMENT AS USUAL (TAU, N=120) WILL BE COMPARED WITH THE ADDITION OF THE DYNAMICARE HEALTH CONTINGENCY MANAGEMENT APP (TAU+DCM, N=120). DCM IS A PERSONAL DIGITAL THERAPY TOOL PROVIDED AS AN APP ON THE PATIENT’S SMART PHONE. ITS CENTRAL FEATURE IS THE DELIVERY OF EVIDENCE-BASED CONTINGENCY MANAGEMENT THERAPY IN A CONVENIENT, REMOTE, AND FULLY AUTOMATED FASHION THAT ENSURES VALIDITY OF TARGET BEHAVIORS AND IMMEDIACY OF REWARD DELIVERY. TWO TARGET BEHAVIORS RELEVANT TO RETENTION WILL BE THE PRIMARY FOCUS OF THE DCM PROGRAM: 1) ABSTINENCE FROM OPIATES AND COCAINE AS VERIFIED VIA REMOTE ORAL FLUID TESTING, AND 2) MEDICATION PICKUP FROM THE METHADONE PROGRAM AS VERIFIED BY CLINIC RECORDS. PARTICIPANTS IN THE TAU+DCM ARM WILL RECEIVE FINANCIAL REWARDS FOR ACHIEVING THESE PRE-DETERMINED BEHAVIORAL TARGETS OVER A 48-WEEK INTERVENTION PERIOD. COMPREHENSIVE ASSESSMENT OF ALL PARTICIPANTS WILL BE CONDUCTED AT BASELINE, 3-, 6- AND 12-MONTHS. AIM 1: TO DETERMINE THE RELATIVE EFFECTIVENESS OF TAU+DCM COMPARED TO TAU ALONE IN IMPROVING METHADONE TREATMENT RETENTION THROUGH 12-MONTHS POST TREATMENT ENTRY. AIM 2: TO DETERMINE THE RELATIVE EFFECTIVENESS OF TAU+DCM COMPARED TO TAU ALONE IN TERMS OF [AIM 2A] REDUCING OPIOID USE AND COCAINE USE; AND [AIM 2B] IMPROVING OTHER SECONDARY OUTCOMES INCLUDING NON-TARGETED SUBSTANCE USE AND QUALITY OF LIFE THROUGH 12- MONTHS POST TREATMENT ENTRY. AIM 3: TO EXPLORE APP USE PATTERNS, ACCEPTABILITY, AND PERCEIVED VALUE OF THE PERSONALIZED TREATMENT INTERVENTION THROUGH 12-MONTHS POST TREATMENT ENTRY. INNOVATION LIES IN THE PLATFORM AND STRUCTURE OF CM DELIVERY THAT ENSURES TREATMENT FIDELITY WITH AUTOMATION OF REMOTE BEHAVIORAL MONITORING AND REWARD DELIVERY WITHOUT INVOLVEMENT OF CLINICAL STAFF. THIS PROJECT REPRESENTS A NOVEL APPLICATION OF DIGITAL THERAPEUTICS TO ENHANCE THE EFFECTIVENESS OF OUD TREATMENT WITH POLYSUBSTANCE USE. FINDINGS FROM THIS PROJECT CAN IMPROVE THE PUBLIC HEALTH IMPACT OF METHADONE TREATMENT BY IDENTIFYING AN EFFECTIVE AND SCALABLE APPROACH TO ADDRESS POLYSUBSTANCE USE AMONG PATIENTS AT HEIGHTENED RISK OF TREATMENT DROPOUT.

IDENTIFYING SUSPECTED DRUG OVERDOSE DEATHS IN NEAR REAL-TIME USING DATA COLLECTED BY DEATH INVESTIGATORS - THIS STUDY IS PART OF THE NIH’S HELPING TO END ADDICTION LONG-TERM (HEAL) INITIATIVE TO SPEED SCIENTIFIC SOLUTIONS TO THE NATIONAL OPIOID PUBLIC HEALTH CRISIS. THE NIH HEAL INITIATIVE BOLSTERS RESEARCH ACROSS NIH TO IMPROVE TREATMENT FOR OPIOID MISUSE AND ADDICTION. DRUG OVERDOSE DEATH RATES HAVE REACHED A RECORD HIGH. EFFECTIVE RESPONSES TO THE OVERDOSE EPIDEMIC REQUIRE ACCURATE AND TIMELY DRUG OVERDOSE SURVEILLANCE DATA. DEATH CERTIFICATES ARE THE FOUNDATION OF OVERDOSE MORTALITY SURVEILLANCE; HOWEVER, LONG TURNAROUND TIMES FOR ISSUING FINALIZED DEATH CERTIFICATES IN SUSPECTED DRUG-RELATED DEATHS HINDERS SURVEILLANCE ACTIVITIES AND PREVENTS RAPID RESPONSES BY PUBLIC HEALTH PROGRAMS. CORONERS AND MEDICAL EXAMINERS (C/MES) PLAY A CRITICAL ROLE IN GENERATING DATA FOR THE MEDICAL CERTIFICATION SECTION OF DEATH CERTIFICATES. THESE DATA ARE ROUTINELY COLLECTED IMMEDIATELY AFTER THE OVERDOSE FATALITY OCCURS AND PROVIDE AN OPPORTUNITY TO RAPIDLY EXAMINE THE CIRCUMSTANCES OF DEATH AND INFORM TIME-SENSITIVE ACTIVITIES IN RESPONSE TO FATAL OVERDOSES. THE NEW YORK CITY (NYC) OFFICE OF CHIEF MEDICAL EXAMINER (OCME) DEVELOPED A TOOL THAT USES DATA GENERATED DURING DEATH INVESTIGATIONS TO IDENTIFY DRUG OVERDOSE DEATHS IN NEAR REAL-TIME. THIS TOOL, NAMED THE SUSPECTED POTENTIAL OVERDOSE TRACKER (SPOT), USES A SMALL NUMBER OF VARIABLES ROUTINELY COLLECTED BY DEATH INVESTIGATORS IN A RIGOROUS AND REPRODUCIBLE ALGORITHM TO RAPIDLY PREDICT WHETHER A DEATH WAS AN UNINTENTIONAL DRUG OVERDOSE. WHILE PRELIMINARY FINDINGS SHOW THAT SPOT IS HIGHLY PROMISING FOR IDENTIFYING FATAL OVERDOSES IN NEAR REAL-TIME, THERE IS A NEED TO FURTHER ENHANCE THE TOOL, EXAMINE ITS PERFORMANCE ACROSS DIFFERENT SUBPOPULATIONS, AND ASSESS ITS PERFORMANCE AND USABILITY OUTSIDE OF NYC. THUS, THIS STUDY AIMS TO (1) OPTIMIZE SPOT THROUGH ADDITIONAL DATA FROM THE NYC OCME TO IMPROVE PERFORMANCE OF THE TOOL AND DEVELOP ADVANCED FEATURES USING NATURAL LANGUAGE PROCESSING; (2) ASSESS BARRIERS AND FACILITATORS OF ADOPTING SPOT IN PREPARATION FOR ITS DEPLOYMENT THROUGH SEMI-STRUCTURED INTERVIEWS WITH PRIMARY AND SECONDARY USERS OF SPOT DATA; AND (3) EVALUATE THE USABILITY AND PERFORMANCE OF SPOT IN C/ME OFFICES ACROSS NEW YORK STATE, INCLUDING COUNTIES INVOLVED IN THE NIDA-FUNDED HEALING COMMUNITIES STUDY. THE PUBLIC HEALTH IMPLICATIONS OF ADOPTING THIS TOOL ARE SIGNIFICANT: 1) IT ALLOWS FOR NEAR REAL-TIME MONITORING OF OVERDOSE FATALITY LEVELS AND DETECTION OF ATYPICAL PATTERNS; 2) IT PROVIDES A MECHANISM FOR EXPEDITED OUTREACH TO FAMILY AND FRIENDS OF OVERDOSE DECEDENTS WHO MAY BE AT HIGH RISK FOR OVERDOSE; 3) IT ALLOWS FOR IDENTIFICATION OF GAPS IN OVERDOSE RESPONSE PREPAREDNESS AND DATA-DRIVEN DECISION MAKING OF PUBLIC HEALTH AND PUBLIC SAFETY AGENCIES; AND 4) IT AFFORDS OPPORTUNITIES FOR EVALUATION AND CONSISTENT INFORMATION EXCHANGE OF OVERDOSE PREVENTION INTERVENTIONS, PROGRAMS AND POLICIES. IF FOUND SUCCESSFUL, THE SPOT METHODOLOGY CAN BE READILY DISSEMINATED TO OTHER STATES TO ENHANCE SURVEILLANCE OF DRUG OVERDOSE MORTALITY. THIS PROJECT IS HIGHLY RESPONSIVE TO A TOP NIDA RESEARCH PRIORITY, AND DIRECTLY ADDRESSES ONE OF THE NATION’S MOST CHALLENGING PUBLIC HEALTH CRISES.

ENTRY AND ENGAGEMENT IN METHADONE MAINTENANCE TREATMENT

SCOPE AND IMPACT OF METHADONE TAKE-HOME AND TELEHEALTH PRACTICE CHANGES DURING THE COVID-19 PANDEMIC - ABSTRACT METHADONE IS AN EFFECTIVE TREATMENT FOR OPIOID USE DISORDER (OUD) THAT IS DELIVERED IN THE U.S. THROUGH SPECIALIZED OPIOID TREATMENT PROGRAMS (OTPS). SINCE THE INCEPTION OF THE OTP SYSTEM MANY DECADES AGO, FEDERAL REGULATIONS HAVE REQUIRED FREQUENT CLINIC ATTENDANCE TO MONITOR PATIENTS’ RESPONSE TO TREATMENT AND REDUCE THE RISKS OF METHADONE DIVERSION. PATIENTS CAN ONLY ‘EARN’ TAKE-HOME METHADONE AFTER SIGNIFICANT TIME IN TREATMENT WHILE DEMONSTRATING RIGID STANDARDS FOR ADHERENCE AND STABILITY. HOWEVER, THESE CLASSIC REGULATIONS ARE NOT GROUNDED IN STRONG EMPIRICAL EVIDENCE. THE COVID-19 PANDEMIC TRANSFORMED SERVICE DELIVERY PRACTICES AT OTPS. TO REDUCE CROWDING IN CLINICS, SAMHSA REGULATORS SWIFTLY ISSUED REGULATORY EXEMPTIONS THAT GAVE OTPS UNPRECEDENTED DISCRETION TO PROVIDE TAKE-HOME METHADONE DOSES AND DELIVER COUNSELING VIA TELEHEALTH. OTPS WERE SUDDENLY PERMITTED TO DISPENSE UP TO 14 DAYS OF TAKE-HOME METHADONE FOR ‘LESS STABLE’ PATIENTS, AND 28 DAYS FOR ‘STABLE’ PATIENTS. MORE RECENTLY, SAMHSA REAFFIRMED THE REGULATORY EXEMPTIONS AND ANNOUNCED INTENTIONS TO PURSUE PERMANENT REGULATORY REFORM FOR OTPS. HOWEVER, RESEARCH IS NEEDED TO EXAMINE THE SCOPE AND IMPACT OF THESE MAJOR CHANGES TO CARE DELIVERY. THIS STUDY WILL (1) CHARACTERIZE PRACTICE CHANGES AT OTPS FOLLOWING THE COVID-19 PANDEMIC AND THE ISSUANCE OF REGULATORY EXEMPTIONS, (2) EXAMINE THE RELATIONSHIP OF TWO MAJOR PRACTICE CHANGES (EXPANDED TAKE-HOME METHADONE AND TELEHEALTH PRACTICES) AND PATIENT OUTCOMES, (3) DEVELOP A PREDICTION MODEL TO INFORM DECISION- MAKING ABOUT WHEN PATIENTS CAN SAFELY RECEIVE TAKE-HOMES WITHOUT INCREASING RISK OF NEGATIVE OUTCOMES, AND (4) EXAMINE THE RELATIONSHIP BETWEEN EXPANDED TAKE-HOME METHADONE AND METHADONE OVERDOSE DEATHS AT A POPULATION LEVEL. THE STUDY WILL USE CLINICAL AND ADMINISTRATIVE DATA FROM BAYMARK HEALTH SERVICES, THE LARGEST PROVIDER OF OUTPATIENT OUD TREATMENT IN THE U.S., WITH 100 OTPS IN 23 STATES. ADVANCED ANALYTICAL METHODS WILL BE APPLIED TO ANSWER THE RESEARCH QUESTIONS, INCLUDING MULTILEVEL GENERALIZED LINEAR MIXED MODELING, PREDICTIVE MODELING AND SIMULATION METHODS, AND INTERRUPTED TIME SERIES. ALL ANALYSES WILL CONSIDER BEHAVIORAL HEALTH EQUITY AND EXAMINE DISPARITIES WITH RESPECT TO PATIENTS’ SEX, RACE, AND ETHNICITY. THIS STUDY WILL PROVIDE CRITICAL DATA FOR REGULATORS, OTP ADMINISTRATORS, AND PRACTITIONERS. IT WILL YIELD HIGHLY NOVEL DATA TO SUPPORT EVIDENCE-DRIVEN REGULATORY REFORM, AND COULD SHAPE METHADONE TREATMENT DELIVERY OVER THE NEXT DECADE AND BEYOND. THE COVID-19 PANDEMIC AND ASSOCIATED FEDERAL EXEMPTIONS OFFER AN UNPRECEDENTED OPPORTUNITY TO EVALUATE LONG-HELD ASSUMPTIONS ABOUT HOW METHADONE TREATMENT SHOULD BE STRUCTURED TO MAXIMIZE ITS BENEFITS WHILE SAFEGUARDING PATIENTS AND THE PUBLIC FROM UNINTENDED HARM.

SBIRT IN NEW MEXICO

A RANDOMIZED CLINICAL TRIAL OF SBIRT SERVICES IN SCHOOL-BASED HEALTH CENTERS

A RANDOMIZED TRIAL OF INTERIM METHADONE AND PATIENT NAVIGATION INITIATED IN JAIL

NAVIGATION SERVICES TO AVOID REHOSPITALIZATION (NAVSTAR) AMONG SUBSTANCE ABUSERS

GETTING OFF: A THEORY-BASED MHEALTH INTERVENTION FOR METHAMPHETAMINE-USING MSM

BUPRENORPHINE FOR PRISONERS

THEORY-BASED TEXT MESSAGING TO REDUCE METHAMPHETAMINE USE AND HIV RISKS AMONG MSM

SBIRT IMPLEMENTATION FOR ADOLESCENTS IN URBAN FEDERALLY QUALIFIED HEALTH CENTERS

OPTIMIZING PREP IMPLEMENTATION AND COST-EFFECTIVENESS AMONG SEXUAL AND GENDER MINORITY INDIVIDUALS WITH A SUBSTANCE USE DISORDER - ABSTRACT IN THE US MOST (~70%) ANNUAL NEWLY DIAGNOSED HIV INFECTIONS ARE AMONG SUBSTANCE-USING SEXUAL MINORITY CISGENDER MEN (MSM) AND GENDER MINORITY TRANSGENDER WOMEN (TW).1 TW/MSM ARE MORE LIKELY TO REPORT OR BE DIAGNOSED WITH A SUBSTANCE USE DISORDER (SUD) THAN THEIR CISGENDER OR HETEROSEXUAL COUNTERPARTS2-5 AND THE PRESENCE OF A SUD SUBSTANTIALLY INCREASES RISK OF HIV INFECTION IN BOTH GROUPS.6-16ALTHOUGH PREP IS HIGHLY EFFECTIVE, INITIATION, ADHERENCE, AND PERSISTENCE ARE EXCLUSIVELY BEHAVIORAL OUTCOMES, AND THE BIOMEDICAL BENEFITS OF PREP ARE ABROGATED BY SUBSTANCE USE. SUD IS ALSO ASSOCIATED WITH REDUCED QUALITY-OF-LIFE, AND INCREASED OVERDOSE DEATHS, UTILIZATION OF HIGH-COST HEALTHCARE SERVICES, ENGAGEMENT IN A STREET ECONOMY, AND CYCLES OF INCARCERATION.17-26 THIS APPLICATION BUILDS UPON THE HIGHLY PROMISING FINDINGS FROM OUR OPEN-LABEL PHASE I A.S.K.- PREP (ASSISTANCE SERVICES KNOWLEDGE-PREP) PILOT, WHICH UTILIZED PREP NAVIGATION WITH TEXT MESSAGE (SMS) SUPPORT TO INCREASE PREP INITIATION AMONG TW/MSM. THE PHASE II STUDY WILL IMPLEMENT A RCT WITH A STEPPED CARE DESIGN OF ASK-PREP VS. STANDARD OF CARE (SOC) TO DETERMINE OPTIMAL INTERVENTION RESPONSE AMONG TW/MSM WITH A SUD (N=285; N=95 TW; N=190 MSM) FOR ADVANCEMENT ALONG THE PREP CARE CONTINUUM. PARTICIPANTS WILL BE RANDOMIZED (3:1) TO STEPPED CARE (N=214) OR SOC (N=71). PARTICIPANTS IN THE STEPPED CARE ARM WILL RECEIVE THE SAME ASK-PREP INTERVENTION THAT WAS DELIVERED IN THE PILOT STUDY AND WILL BE ASSESSED AT 3- MONTHS FOR INTERVENTION RESPONSE; RESPONDERS WILL BE MAINTAINED IN ASK-PREP, WHILE NON-RESPONDERS WILL RECEIVE ADDED ATTENTION TO THEIR SUD VIA CONTINGENCY MANAGEMENT (CM). NON-RESPONDERS WILL BE RE-RANDOMIZED (1:1) TO EITHER A) RECEIVE ASK-PREP + CM, OR B) SHIFT THE PRIMARY FOCUS TO THEIR SUD (CM ALONE). THE ASK-PREP NAVIGATION INTERVENTION IS BASED ON MECHANISMS OF THE REASONED ACTION APPROACH, SMS SUPPORT IS BASED IN SOCIAL SUPPORT THEORY, AND CM IS BASED ON BEHAVIORAL ECONOMICS. THE SPECIFIC AIMS ARE TO: 1) EVALUATE A STEPPED CARE APPROACH PROMOTING ADVANCEMENT ALONG THE PREP CARE CONTINUUM (INITIATION, ADHERENCE, PERSISTENCE), AND REDUCTIONS IN SUBSTANCE USE AMONG TW/MSM WITH A SUD; 2) ESTIMATE THE COST OF IMPLEMENTING AND SUSTAINING EACH INTERVENTION AND CONDUCT A COST-EFFECTIVENESS ANALYSIS TO DETERMINE THE VALUE OF EACH INTERVENTION RELATIVE TO SOC, AND TO EACH OTHER, FROM THE HEALTHCARE-SECTOR, STATE-POLICYMAKER, AND SOCIETAL PERSPECTIVES; SECONDARY AIM 1) DETERMINE THE INDIVIDUAL EFFECTS OF SPECIFIC SUBSTANCES, ROUTES OF ADMINISTRATION, SEVERITY OF SUD, SOCIAL AND STRUCTURAL DETERMINANTS OF HEALTH, AND DIFFERING INDIVIDUAL-LEVEL CHARACTERISTICS AS MODERATORS OF OUTCOMES; AND EXPLORATORY AIM) EVALUATE INTERVENTION ENGAGEMENT AND RESPONSE BY CHOSEN PREP MODALITY (ORAL DAILY OR LONG-ACTING INJECTABLE). THE “INTENT-TO-TREAT” RCT USES REPEATED ASSESSMENTS AT BASELINE AND AT 3-, 6-, 9-, AND 12-MONTHS POST ENROLLMENT. THE STUDY WILL BE CONDUCTED IN LOS ANGELES COUNTY, AN EHE PRIORITY COUNTY.27, 28 THIS STUDY COULD HAVE SIGNIFICANT PUBLIC HEALTH IMPACT BY IDENTIFYING SCALABLE AND EFFECTIVE PREP INTERVENTIONS THAT MATCH INTENSITY AND PARTICIPANT NEEDS TO MAXIMIZE EFFICACY WHILE MINIMIZING COSTS.

HUMAN IMMUNODEFICIENCY VIRUS (HIV) PREVENTION PROJECTS FOR COMMUNITY-BASED ORGANI

SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE

TREATMENT STUDY USING DEPOT NALTREXONE(5/6)BALTIMORE PROTOCOL TREATMENT SITE

A PATIENT PREFERENCE TRIAL OF SUBLINGUAL VERSUS EXTENDED-RELEASE BUPRENORPHINE TELEMEDICINE AND PHARMACY LINKAGE FOR INDIVIDUALS RE-ENTERING THE COMMUNITY FROM JAIL - ABSTRACT THIS PROPOSED STUDY IS A PATIENT PREFERENCE TRIAL (PPT) OF XR-B VS. SL-B IN 8 RURAL JAILS IN MARYLAND. A TOTAL OF 500 ADULTS WITH MODERATE/SEVERE OUD SOON-TO-BE-RELEASED FROM JAIL WILL BE RECRUITED AND WILL CHOOSE TO RECEIVE XR-B OR SL-B TREATMENT IN JAIL VIA TELEMEDICINE FOLLOWED BY 6-MONTHS OF POST-RELEASE XR-B/SL-B TREATMENT VIA TELEMEDICINE AT COMMUNITY PHARMACIES, A 7-MONTH SAFETY VISIT, AND 12-MONTH FOLLOW-UP. ALL INDIVIDUALS RECEIVING XR-B WILL HAVE THEIR INJECTION ADMINISTERED BY A PHARMACIST, ALLOWING THE TELEMEDICINE TREATMENT TO BE FULLY REMOTE AND EQUIVALENT TO THAT OF SL-B WHICH WILL ALSO BE FILLED AT A LOCAL PHARMACY. IN ADDITION, THE CONSOLIDATED FRAMEWORK FOR IMPLEMENTATION RESEARCH (CFIR) AND REACH, EFFECTIVENESS, ADOPTION, IMPLEMENTATION, AND MAINTENANCE (RE-AIM) FRAMEWORK WILL BE UTILIZED TO UNDERSTAND IMPLEMENTATION OF TELEMEDICINE OF XR-B AND SL-B IN JAILS AND CONTINUED AT COMMUNITY PHARMACIES. AIM 1. COMPARE THE EFFECTIVENESS OF XR-B VS. SL-B IN TERMS OF: PRIMARY OUTCOME. (A) RETENTION IN BUPRENORPHINE TREATMENT (I. DAYS RECEIVING BUPRENORPHINE AND II. TIME TO TREATMENT DROPOUT). SECONDARY OUTCOMES. (B) ILLICIT OPIOID USE (I. URINE TOXICOLOGY; II. SELF-REPORTED DAYS OF OPIOID USE; AND III. TIME TO OPIOID RELAPSE); (C) OTHER ILLICIT SUBSTANCE USE (I. URINE TOXICOLOGY; II. SELF-REPORTED DAYS OF ILLICIT SUBSTANCE USE; (D) OVERDOSE EVENTS (NON-FATAL AND FATAL); (E) HEALTH-RELATED QUALITY OF LIFE (I. PHYSICAL HEALTH; II. MENTAL HEALTH); (F) HIV RISK BEHAVIORS (I. SEXUAL RISK BEHAVIOR; II. NEEDLE USE OR SHARING); AND (G) CRIMINAL ACTIVITY (I. CRIME DAYS; II. RE-ARREST; III. TECHNICAL VIOLATIONS; IV. RE-INCARCERATION). AIM 2A. DOCUMENT FACTORS RELEVANT TO IMPLEMENTATION AND SUSTAINABILITY OF THE TELEMEDICINE BUPRENORPHINE INTERVENTION IN JAILS AND PHARMACY SETTINGS. GUIDED BY CFIR AND RE-AIM WE WILL GAUGE 1) HOW TO OPTIMIZE KEY INTERVENTION COMPONENTS (E.G., DOSE INDUCTION, TELEMEDICINE PROCEDURES, MEDICATION PREFERENCES, CONTINUITY OF CARE, INNER AND OUTER CONTEXT FACTORS, STIGMA, PHARMACY PROCEDURES, IMPROVEMENT OF THE CASCADE OF CARE FOR OUD) AND 2) THE RE-AIM OF KEY IMPLEMENTATION FACTORS. TO ACHIEVE THIS AIM, WE WILL CONDUCT INTERVIEWS WITH STAKEHOLDERS (N = 10, E.G., PHARMACISTS, TELEMEDICINE PROVIDERS, JAIL STAFF PER SITE; TOTAL N = 80). AIM 2B. WE WILL CONTACT AND ATTEMPT TO CONDUCT QUALITATIVE INTERVIEWS WITH THE CHIEF EXECUTIVE OFFICER (CEO) OR A DESIGNATED REPRESENTATIVE FROM STATE PHARMACY ASSOCIATIONS IN EACH OF THE 50 STATES TO: 1) UNDERSTAND STATE-LEVEL POLICIES AND REGULATORY REQUIREMENTS REGARDING THE PROVISION OF BUPRENORPHINE IN PHARMACIES; 2) INFORM STATE-LEVEL IMPLEMENTATION STRATEGIES AMONG BOTH BIG BOX AND INDEPENDENT PHARMACIES RELEVANT TO THE FEDERAL 2025-SUPPORT ACT, WHICH EXPLICITLY AUTHORIZES PHARMACISTS TO PRESCRIBE BUPRENORPHINE; AND 3) UNDERSTAND HOW BEST TO OPTIMIZE IMPLEMENTATION OF AN XR-B/SL-B COLLABORATIVE CARE MODEL IN THE PHARMACY SETTING. FINDINGS FROM THESE INTERVIEWS, COMBINED WITH QUALITATIVE DATA FROM INTERVIEWS WITH OUR LOCAL MD PHARMACIES, WILL INFORM THE DEVELOPMENT OF THE FOLLOWING DELIVERABLES: 1) BEST-PRACTICES TOOLKIT/GUIDE TO SUPPORT PHARMACIES NATIONWIDE IN IMPLEMENTING INJECTABLE BUPRENORPHINE (XR-B) FOR OPIOID USE DISORDER, EXPANDING ACCESS TO SL-B, AND ESTABLISHING COLLABORATIVE CARE MODELS WITH OTHER PROVIDERS FOR BUPRENORPHINE TREATMENT; AND 2) IMPLEMENTATION GUIDE TO SUPPORT COORDINATION BETWEEN JAILS (MEDICAL STAFF) AND COMMUNITY PHARMACIES, ENABLING INITIATION OF BUPRENORPHINE IN CORRECTIONAL SETTINGS AND CONTINUITY OF CARE THROUGH POST-RELEASE TREATMENT AT LOCAL PHARMACIES. THE STUDY WILL BE INNOVATIVE FOR TWO REASONS: 1) IT WOULD BE THE FIRST LARGE SCALE PPT OF XR-B/SL-B USING TELEMEDICINE AMONG INDIVIDUALS LEAVING JAIL; AND 2) IT WOULD BE THE FIRST STUDY CONTINUING XR-B INJECTIONS WITH A RE-ENTRY POPULATION AT PHARMACIES. THE STUDY WILL BE HIGHLY SIGNIFICANT BECAUSE MOST INDIVIDUALS WITH OUD DO NOT RECEIVE TREATMENT WHILE IN JAIL, THEREBY S

A PATIENT PREFERENCE TRIAL OF SUBLINGUAL VERSUS EXTENDED-RELEASE BUPRENORPHINE TELEMEDICINE AND PHARMACY LINKAGE FOR INDIVIDUALS RE-ENTERING THE COMMUNITY FROM JAIL - ABSTRACT THIS PROPOSED STUDY IS A PATIENT PREFERENCE TRIAL (PPT) OF XR-B VS. SL-B IN 8 RURAL JAILS IN MARYLAND. A TOTAL OF 500 ADULTS WITH MODERATE/SEVERE OUD SOON-TO-BE-RELEASED FROM JAIL WILL BE RECRUITED AND WILL CHOOSE TO RECEIVE XR-B OR SL-B TREATMENT IN JAIL VIA TELEMEDICINE FOLLOWED BY 6-MONTHS OF POST-RELEASE XR-B/SL-B TREATMENT VIA TELEMEDICINE AT COMMUNITY PHARMACIES, A 7-MONTH SAFETY VISIT, AND 12-MONTH FOLLOW-UP. ALL INDIVIDUALS RECEIVING XR-B WILL HAVE THEIR INJECTION ADMINISTERED BY A PHARMACIST, ALLOWING THE TELEMEDICINE TREATMENT TO BE FULLY REMOTE AND EQUIVALENT TO THAT OF SL-B WHICH WILL ALSO BE FILLED AT A LOCAL PHARMACY. IN ADDITION, THE CONSOLIDATED FRAMEWORK FOR IMPLEMENTATION RESEARCH (CFIR) AND REACH, EFFECTIVENESS, ADOPTION, IMPLEMENTATION, AND MAINTENANCE (RE-AIM) FRAMEWORK WILL BE UTILIZED TO UNDERSTAND IMPLEMENTATION OF TELEMEDICINE OF XR-B AND SL-B IN JAILS AND CONTINUED AT COMMUNITY PHARMACIES. AIM 1. COMPARE THE EFFECTIVENESS OF XR-B VS. SL-B IN TERMS OF: PRIMARY OUTCOME. (A) RETENTION IN BUPRENORPHINE TREATMENT (I. DAYS RECEIVING BUPRENORPHINE AND II. TIME TO TREATMENT DROPOUT). SECONDARY OUTCOMES. (B) ILLICIT OPIOID USE (I. URINE TOXICOLOGY; II. SELF-REPORTED DAYS OF OPIOID USE; AND III. TIME TO OPIOID RELAPSE); (C) OTHER ILLICIT SUBSTANCE USE (I. URINE TOXICOLOGY; II. SELF-REPORTED DAYS OF ILLICIT SUBSTANCE USE; (D) OVERDOSE EVENTS (NON-FATAL AND FATAL); (E) HEALTH-RELATED QUALITY OF LIFE (I. PHYSICAL HEALTH; II. MENTAL HEALTH); (F) HIV RISK BEHAVIORS (I. SEXUAL RISK BEHAVIOR; II. NEEDLE USE OR SHARING); AND (G) CRIMINAL ACTIVITY (I. CRIME DAYS; II. RE-ARREST; III. TECHNICAL VIOLATIONS; IV. RE- INCARCERATION). AIM 2. DOCUMENT FACTORS RELEVANT TO IMPLEMENTATION AND SUSTAINABILITY OF THE TELEMEDICINE BUPRENORPHINE INTERVENTION IN JAILS AND PHARMACY SETTINGS. GUIDED BY CFIR AND RE-AIM WE WILL GAUGE 1) HOW TO OPTIMIZE KEY INTERVENTION COMPONENTS (E.G., DOSE INDUCTION, TELEMEDICINE PROCEDURES, MEDICATION PREFERENCES, CONTINUITY OF CARE, INNER AND OUTER CONTEXT FACTORS, STIGMA, PHARMACY PROCEDURES, IMPROVEMENT OF THE CASCADE OF CARE FOR OUD) AND 2) THE RE-AIM OF KEY IMPLEMENTATION FACTORS. TO ACHIEVE THIS AIM, WE WILL CONDUCT INTERVIEWS WITH STAKEHOLDERS (N = 10, E.G., PHARMACISTS, TELEMEDICINE PROVIDERS, JAIL STAFF PER SITE; TOTAL N = 80). THE STUDY WILL BE INNOVATIVE FOR TWO REASONS: 1) IT WOULD BE THE FIRST LARGE SCALE PPT OF XR-B/SL-B USING TELEMEDICINE AMONG INDIVIDUALS LEAVING JAIL; AND 2) IT WOULD BE THE FIRST STUDY CONTINUING XR-B INJECTIONS WITH A RE-ENTRY POPULATION AT PHARMACIES. THE STUDY WILL BE HIGHLY SIGNIFICANT BECAUSE MOST INDIVIDUALS WITH OUD DO NOT RECEIVE TREATMENT WHILE IN JAIL, THEREBY SUBSTANTIALLY RAISING THEIR LIKELIHOOD OF RELAPSE TO DRUG USE, OVERDOSE DEATH, AND RE-INCARCERATION WHEN THEY ARE RELEASED. A TELEMEDICINE PROGRAM MAY IMPROVE THE CONTINUITY OF CARE BETWEEN INCARCERATION AND RE-ENTRY WHICH IS THE PERIOD IN WHICH INDIVIDUALS WITH AN OUD ARE MOST VULNERABLE. FINALLY, UNDERSTANDING HOW TO EXPAND ACCEPTANCE OF MOUDS IN JAILS USING TELEMEDICINE AND PHARMACY ADMINISTRATION OF XR-B, HAS FAR-REACHING IMPLICATIONS FOR EXPANDING TREATMENT ACCESS.

ENTRY INTO COMPREHENSIVE METHADONE TREATMENT VIA INTERIM MAINTENANCE

SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE

IMPLEMENTING A PATIENT NAVIGATION INTERVENTION ACROSS A HEALTH SYSTEM TO IMPROVE OUTCOMES FOR PATIENTS WITH OPIOID USE DISORDER - OPIOID AGONIST TREATMENT (OAT) IS PROTECTIVE AGAINST OVERDOSE, YET LESS THAN 20% OF PEOPLE WITH OPIOID USE DISORDER (OUD) ENGAGE IN SUCH TREATMENT. HOSPITAL UTILIZATION IS HIGH AMONG PEOPLE WITH OUD AND CAN BE A ‘REACHABLE MOMENT’ TO INITIATE OAT. HOWEVER, MOST HOSPITALS LACK THE CAPACITY TO FOLLOW UP WITH PATIENTS AFTER DISCHARGE. PATIENT NAVIGATOR (PN) INTERVENTIONS FOLLOWING HOSPITAL DISCHARGE CAN HELP PATIENTS ENGAGE IN OAT AND NAVIGATE COMPLEX SYSTEMS OF CARE. HOWEVER, CHALLENGES PERSIST IN IMPLEMENTING PN INTERVENTIONS ON A WIDE SCALE, AS THEY REQUIRE COORDINATION ACROSS ORGANIZATIONS, DATA SHARING, DEDICATED PERSONNEL, AND RESOURCES. TO BRING THESE INTERVENTIONS TO SCALE, STRATEGIES ARE NEEDED TO DETERMINE FEASIBILITY, REACH, AND SUSTAINABILITY. TESTING INNOVATIVE IMPLEMENTATION STRATEGIES FOR PN INTERVENTIONS HAS THE POTENTIAL FOR SIGNIFICANT IMPACT, AS IT WILL DEMONSTRATE IMPLEMENTATION SUCCESS OF AN INTERVENTION THAT CAN ADDRESS THE OPIOID EPIDEMIC IN REAL-WORLD SETTINGS AND CLOSE THE RESEARCH-TO-PRACTICE TRANSLATION GAP. THE PROPOSED STUDY IS A TYPE II HYBRID IMPLEMENTATION-EFFECTIVENESS TRIAL OF NAVIGATION SERVICES TO AVOID REHOSPITALIZATION (NAVSTAR). OUR RESEARCH TEAM SHOWED IN A SINGLE-SITE RANDOMIZED TRIAL WITH 400 PARTICIPANTS THAT NAVSTAR SIGNIFICANTLY IMPROVED OAT ENTRY, REDUCED READMISSIONS, AND WAS HIGHLY COST-EFFECTIVE COMPARED TO TREATMENT AS USUAL. THE PRESENT STUDY WILL TEST AN IMPLEMENTATION FACILITATION (IF) STRATEGY TO PROVIDE TRAINING, RESOURCES, AND PERFORMANCE FEEDBACK TO IMPLEMENT NAVSTAR IN FOUR HOSPITALS IN PHILADELPHIA. WE HYPOTHESIZE THAT ENGAGING STAKEHOLDERS IN AN IF STRATEGY WILL YIELD AN IMPLEMENTATION PROCESS THAT IS FEASIBLE, ACCEPTABLE, AND EFFECTIVE IN IMPROVING OUTCOMES FOR PATIENTS WITH OUD. THE R61 PHASE WILL CONDUCT PROCESS MAPPING TO IDENTIFY EXISTING HOSPITAL WORKFLOW AND THEN REFINE AN IF STRATEGY THROUGH SEQUENTIAL PILOT TRIALS AT 4 HOSPITAL SITES. R61 MILESTONES INCLUDE THE CREATION OF AN IMPLEMENTATION TOOLKIT AND DATA SHARING AGREEMENTS. DURING THE R33 PHASE, WE WILL CONDUCT A TYPE II HYBRID-IMPLEMENTATION-EFFECTIVENESS TRIAL (N=720) OF NAVSTAR USING A RANDOMIZED STEPPED-WEDGE DESIGN.

CONTINUING CARE APP FOR JUSTICE-INVOLVED INDIVIDUALS WITH SUBSTANCE USE DISORDERS - ABSTRACT SUBSTANCE USE DISORDERS (SUDS) CONTINUE TO BE ONE OF THE MOST SERIOUS PUBLIC HEALTH PROBLEMS IN THE US.1 STUDIES HAVE CONSISTENTLY DOCUMENTED A SUBSTANTIALLY HIGHER PREVALENCE OF SUDS AMONG ADULTS UNDER JUSTICE SUPERVISION IN THE COMMUNITY (I.E., PROBATION/PAROLE) AS COMPARED TO THE GENERAL POPULATION.2-4 CONTINUING CARE INITIATIVES FOR INDIVIDUALS WITH SUDS HAVE GAINED INCREASED ATTENTION WITH THE RECOGNITION THAT SUBSTANCE USE TREATMENT REQUIRES LONG-TERM CARE.15, 46, 47, 54-58 STUDIES SHOW THAT CONTINUING CARE INTERVENTIONS CAN PROVIDE ONGOING SUPPORT OR EXTEND PRIMARY TREATMENT GAINS WITH RESPECT TO REDUCTIONS IN SUBSTANCE USE, RELAPSE, AND CRIMINAL ACTIVITY.12, 52, 55, 56, 61-63 RECENT DIFFUSION OF INTERNET AND SMARTPHONE TECHNOLOGIES AMONG DISADVANTAGED POPULATIONS NOW OFFERS UNPRECEDENTED OPPORTUNITIES FOR INCREASING ACCESS TO QUALITY CONTINUING CARE INTERVENTIONS AS WELL AS CHRONIC DISEASE SELF-MANAGEMENT TOOLS. PROBATIONERS AND PAROLEES AT HIGH RISK FOR DRUG ABUSE RELAPSE AND INVOLVEMENT IN HEALTH COMPROMISING BEHAVIORS ARE AN IMPORTANT POPULATION THAT STANDS TO BENEFIT FROM CONTINUING CARE TECHNOLOGIES. BUILDING ON OUR TEAM’S EXTENSIVE EXPERIENCE IN THE FIELDS OF CRIMINOLOGY AND SUBSTANCE USE, WE PROPOSE TO FINALIZE THE DEVELOPMENT OF A CONTINUING CARE MOBILE APPLICATION (APP) BY ENHANCING APP CAPABILITIES AND CONDUCTING A RANDOMIZED CONTROLLED TRIAL TO ASSESS ITS EFFECTIVENESS AMONG CLIENTS ON PROBATION OR PAROLE WHO ARE ENROLLED IN OUTPATIENT SUBSTANCE USE TREATMENT. THE APP IS DESIGNED TO MEET THE RECOVERY AND PERSONAL SUPPORT NEEDS OF PROBATIONERS AND PAROLEES WITH SUDS WHO ARE AT ELEVATED RISK OF RELAPSE, TREATMENT DISCONTINUATION, RE-ARREST, AND INCARCERATION. IT IS GUIDED BY THE PRINCIPLES OF THE TRANSTHEORETICAL MODEL OF BEHAVIOR CHANGE,24 AND APP CONTENT IS DERIVED FROM THE YOUR OWN REINTEGRATION SYSTEM (YOURS) PROGRAM,25 AN EMPIRICALLY-SUPPORTED26 INTERVENTION THAT FOCUSES ON SUBSTANCE USE RECOVERY, REDUCING CRIMINAL THINKING AND BEHAVIOR, AND CULTIVATING SUPPORT SYSTEMS. IF PROVEN TO BE EFFECTIVE, THE CC APP COULD BE DEPLOYED ACROSS THE NATIONAL NETWORK OF OUTPATIENT TREATMENT PROVIDERS AND BE HIGHLY SIGNIFICANT IN ITS DIRECT IMPACT ON PUBLIC HEALTH.

LEVERAGING SOCIAL DETERMINANTS VIA ARTIFICIAL INTELLIGENCE AND PEER COACHING TO ADDRESS RACIAL DISPARITIES IN PRIMARY CARE AMONG PEOPLE WHO USE OPIOIDS - PROJECT SUMMARY BLACK AND LATINX PEOPLE WHO USE OPIOIDS (PWUO) BEAR A DISPROPORTIONATE BURDEN OF OPIOID OVERDOSE DEATHS. THE ECONOMIC BURDEN FACED BY BLACK AND LATINX PWUO HAS ALSO RISEN DUE TO COSTS ASSOCIATED WITH EXCESS MORTALITY AND UTILIZATION OF HIGH-COST HEALTHCARE SERVICES. COMPARED TO WHITE PWUO, BLACK AND LATINX PWUO ARE LESS LIKELY TO BE INITIATED ON BUPRENORPHINE IN EMERGENCY DEPARTMENT (ED) SETTINGS AND ESTABLISH CARE IN PRIMARY CARE FOR THE TREATMENT OF OPIOID USE DISORDER (OUD). RACIAL DISPARITIES AMONG PWUO IN PRIMARY CARE ARE DRIVEN BY SOCIAL DETERMINANTS OF HEALTH (SDH; E.G., LACK OF PEER SUPPORT OR HEALTH INSURANCE) AND MAY BE PARTIALLY ADDRESSED BY ADOPTING INNOVATIVE MOBILE HEALTH AND PEER COACHING STRATEGIES. WITH NIH SUPPORT, WE HAVE VALIDATED A THEORY-DRIVEN, ARTIFICIAL INTELLIGENCE (AI)-DRIVEN TEXTING TOOL USING NATURAL LANGUAGE PROCESSING TO FACILITATE REAL-TIME TEXT RESPONSES TO PATIENT QUERIES COMBINED WITH AUTOMATED TEXTS FACILITATING RECEIPT OF BUPRENORPHINE IN OFFICE-BASED OPIOID TREATMENT (OBOT) AND SOCIAL SERVICES THAT ADDRESS SOCIAL DETERMINANTS OF HEALTH (SDH). THIS OPEN SOURCE TEXTING TOOL OFFERS PASSIVE REMINDERS, INFORMATIONAL CONTENT, AND INTERACTIVE TWO- WAY RESPONSE ALGORITHMS WITHOUT PERSONAL STAFF CONTACT. IN ADDITION, WE HAVE ADAPTED AN EFFICACIOUS CULTURAL AND STRUCTURAL HUMILITY TRAINING FOR PRCS THAT GOES BEYOND SDH TO ALSO ADDRESS STIGMA REDUCTION, DISCRIMINATION, HEALTH HABITUS, AND PATIENT NAVIGATION TO ENHANCE UPTAKE OF PRIMARY CARE AND SOCIAL SERVICES FOR PWUO. USING A THREE-ARM, COMPARATIVE EFFECTIVENESS TRIAL DESIGN, OUR SPECIFIC AIMS ARE TO: (1) ASSESS THE EFFICACY OF PRC- SUPPORTED TEXT-BASED CARE/SERVICES COORDINATION WITH PWUO + AI-DRIVEN SDH-ENHANCED TEXT MESSAGING (INTERVENTION ARM-1) VS. AI-DRIVEN SDH-ENHANCED TEXT MESSAGING ONLY (INTERVENTION ARM-2) VS. TAU OR PRINTED SOCIAL/MEDICAL SERVICES REFERRALS (CONTROL) TO ENHANCE THE RECEIPT OF BUPRENORPHINE IN OBOT AMONG ED-ENROLLED BLACK / LATINX PWUO (N=252); (2) EVALUATE THE IMPLEMENTATION OF THE MULTIMODAL INTERVENTION (ARM-1) GUIDED BY THE RE-AIM AND CFIR FRAMEWORKS USING IN-DEPTH INTERVIEWS AMONG 3 STAKEHOLDER GROUPS: (1) FRONTLINE PROVIDERS (N=10); (2) ADMINISTRATORS (N=10); AND (3) A SUBSET OF THE BLACK AND LATINX PWUO FROM THE MULTIMODAL INTERVENTION ARM-1 (N=30); AND (3) IDENTIFY THE RESOURCES AND ESTIMATE THE ASSOCIATED COST OF IMPLEMENTING AND SUSTAINING THE MULTIMODAL INTERVENTION AND INCORPORATE THIS INFORMATION INTO A CUSTOMIZABLE BUDGET-IMPACT TOOL AND CONDUCT A COMPREHENSIVE ECONOMIC EVALUATION TO CALCULATE THE RELATIVE ECONOMIC VALUE (E.G., COST-PER QUALITY-ADJUSTED LIFE YEARS, COST-PER OUD TREATMENT DAYS) OF EACH STUDY ARM FROM THE HEALTHCARE SECTOR, STATE- POLICYMAKER, AND SOCIETAL PERSPECTIVES WHICH WILL ALSO INFORM IMPLEMENTATION FRAMED BY RE-AIM. OUR TEAM IS POISED TO CONDUCT THIS STUDY GIVEN EXPERTISE IN NOVEL CULTURAL & STRUCTURAL HUMILITY TRAINING DESIGNED FOR PEERS, IN OPEN SOURCE AI-DRIVEN MOBILE HEALTH INNOVATIONS, AND WAS INSTRUMENTAL IN INTEGRATING MHEALTH AND TELEMEDICINE SOLUTIONS FOR PATIENTS INITIATING BUPRENORPHINE IN PRIMARY CARE. IF SUCCESSFUL, A MULTISITE EFFECTIVENESS-IMPLEMENTATION HYBRID TYPE 1 TRIAL WILL FOLLOW. .

COMPARATIVE- AND COST-EFFECTIVENESS RESEARCH DETERMINING THE OPTIMAL INTERVENTION FOR ADVANCING TRANSGENDER WOMEN LIVING WITH HIV TO FULL VIRAL SUPPRESSION - ABSTRACT TRANS WOMEN (TW) ACHIEVE SUBOPTIMAL ADVANCEMENT THROUGH THE HIV CARE CONTINUUM,1-7 INCLUDING POOR HIV HEALTHCARE UTILIZATION,8,9 RETENTION IN HIV MEDICAL CARE,10-12 AND RATES OF VIRAL SUPPRESSION.3,4,6,7,13,14 THESE ISSUES ARE EXACERBATED BY COMORBID CONDITIONS, SUCH AS SUBSTANCE USE DISORDER (SUD),15-22 WHICH IS ALSO ASSOCIATED WITH REDUCED QUALITY-OF-LIFE, AND INCREASED OVERDOSE DEATHS, UTILIZATION OF HIGH-COST HEALTHCARE SERVICES, ENGAGEMENT IN A STREET ECONOMY, AND CYCLES OF INCARCERATION.23,24 DRUG USE AMONG TW HAS BEEN DEMONSTRATED TO BE A BARRIER TO HIV CARE AND ADVANCEMENT ALONG THE HIV CARE CONTINUUM.16 THUS, IT IS CRITICAL THAT EFFORTS TO END THE HIV EPIDEMIC (EHE) INCLUDE EFFECTIVE INTERVENTIONS TO LINK AND RETAIN TW IN HIV CARE THROUGH FULL VIRAL SUPPRESSION.25-27 THIS STUDY BUILDS ON THE PROMISING FINDINGS FROM OUR TWO HRSA-FUNDED DEMONSTRATION PROJECTS, THE ALEXIS PROJECT28 AND TEXT ME, GIRL!,29 WHICH UTILIZED PEER HEALTH NAVIGATION (PHN) AND SMS (I.E., TEXT MESSAGING), RESPECTIVELY, FOR ADVANCING TW LIVING WITH HIV TO FULL VIRAL SUPPRESSION. THOUGH THE EFFECTIVENESS OF BOTH INTERVENTIONS HAS BEEN ESTABLISHED, THEIR COMPARATIVE-EFFECTIVENESS, REQUIRED RESOURCES/COSTS, COST-EFFECTIVENESS, AND HETEROGENEOUS EFFECTS ON SUBGROUPS, INCLUDING THOSE WITH SUD, HAVE NOT BEEN EVALUATED. GIVEN THE MANY NEGATIVE PERSONAL- AND PUBLIC-HEALTH CONSEQUENCES OF UNTREATED/UNDERTREATED HIV, AND THAT HIV SERVICES FOR TW ARE FREQUENTLY DELIVERED IN RESOURCE-LIMITED, COMMUNITY-BASED SETTINGS,30-33 A COMPREHENSIVE ECONOMIC EVALUATION IS CRITICAL TO INFORM DECISIONS OF STAKEHOLDERS, SUCH AS PROVIDERS, INSURERS, AND POLICYMAKERS. THE “INTENT-TO-TREAT” RCT WILL RANDOMIZE PARTICIPANTS (N=225) INTO: PHN ALONE (N=75), SMS ALONE (N=75), OR PHN+SMS (N=75). USING THE SAME TIME POINTS AS THE HRSA PROJECTS, THE REPEATED-MEASURES DESIGN WILL ASSESS PARTICIPANTS AT BASELINE, 3-, 6-, 12-, AND 18-MONTHS POST-RANDOMIZATION. THE SPECIFIC AIMS ARE: 1) CONDUCT A COMPARATIVE EFFECTIVENESS RESEARCH TRIAL TO DETERMINE THE RELATIVE EFFECTIVENESS OF PHN VS. SMS VS. PHN+SMS IN TERMS OF: PRIMARY (A) VIROLOGIC SUPPRESSION; AND SECONDARY OUTCOMES (B) HIV TREATMENT ADHERENCE SELF-EFFICACY SCALE SCORES; (C) THE AIDS HEALTH BELIEF SCALE SCORES; (D) THE INVENTORY OF SOCIALLY SUPPORTIVE BEHAVIORS SCORES; AND (E) URINE DRUG SCREEN RESULTS; 2) IDENTIFY THE RESOURCES REQUIRED TO PREPARE FOR, IMPLEMENT, AND SUSTAIN EACH INTERVENTION, AND ESTIMATE THE ASSOCIATED COSTS; 3) CONDUCT A COMPREHENSIVE COST-EFFECTIVENESS ANALYSIS TO DETERMINE THE RELATIVE VALUE OF EACH INTERVENTION FROM THE HEALTHCARE-SECTOR, STATE-POLICYMAKER, AND SOCIETAL PERSPECTIVES; AND, A SECONDARY AIM TO DETERMINE HETEROGENEOUS INTERVENTION EFFECTS ACROSS INTERVENTIONS DUE TO SOCIAL AND STRUCTURAL DETERMINANTS OF HEALTH AND INDIVIDUAL-LEVEL CHARACTERISTICS. TW ARE A HIGH-PRIORITY POPULATION FOR REACHING EHE25-27 GOALS AND LOS ANGELES COUNTY (THE STUDY LOCATION) IS AN EHE PRIORITY COUNTY.34,35 FINDINGS HAVE THE POTENTIAL TO IMPROVE INDIVIDUAL AND POPULATION HEALTH OUTCOMES BY GENERATING SIGNIFICANT IMPROVEMENTS IN VIRAL SUPPRESSION AMONG TW AND GUIDING SERVICE PROVISION AND PUBLIC POLICY.

INTENSIVE OUTPATIENT V. OUTPATIENT TREATMENT WITH BUPRENORPHINE AMONG AFRICAN AME

IMPLEMENTING TREATMENT INITIATIVES FOR CRIMINAL JUSTICE CLIENTS

IMPLEMENTING A PATIENT NAVIGATION INTERVENTION ACROSS A HEALTH SYSTEM TO ADDRESS TREATMENT ENTRY INEQUITIES - PROJECT SUMMARY/ABSTRACT OPIOID AGONIST TREATMENT (OAT) IS PROTECTIVE AGAINST OVERDOSE, YET LESS THAN 20% OF PEOPLE WITH OPIOID USE DISORDER (OUD) ENGAGE IN SUCH TREATMENT. HOSPITAL UTILIZATION IS HIGH AMONG PEOPLE WITH OUD AND CAN BE A ‘REACHABLE MOMENT’ TO INITIATE OAT. HOWEVER, MOST HOSPITALS LACK THE CAPACITY TO FOLLOW UP WITH PATIENTS AFTER DISCHARGE. THEORY-BASED, EMPIRICALLY SUPPORTED PATIENT NAVIGATOR (PN) INTERVENTIONS FOLLOWING HOSPITAL DISCHARGE REDUCE INEQUITIES IN ACCESSING COMMUNITY-BASED OAT BY HELPING PATIENTS NAVIGATE COMPLEX SYSTEMS OF CARE. HOWEVER, CHALLENGES PERSIST IN IMPLEMENTING PN INTERVENTIONS ON A WIDE SCALE, AS THEY REQUIRE COORDINATION ACROSS INSTITUTIONS, DATA SHARING, DEDICATED PERSONNEL, AND COMMUNITY RESOURCES. THIS IS ESPECIALLY TRUE IN SETTINGS THAT REACH DIVERSE, RESOURCE-CHALLENGED COMMUNITIES. TO BRING THESE INTERVENTIONS TO SCALE, STRATEGIES ARE NEEDED TO ASSESS FACTORS THAT INFLUENCE PN IMPLEMENTATION IN HOSPITALS TO INCREASE FEASIBILITY, REACH, AND SUSTAINABILITY. TESTING INNOVATIVE IMPLEMENTATION STRATEGIES FOR PN INTERVENTIONS HAS THE POTENTIAL FOR SIGNIFICANT IMPACT, AS IT WILL DEMONSTRATE IMPLEMENTATION SUCCESS OF AN INTERVENTION THAT CAN ADDRESS THE OPIOID EPIDEMIC IN REAL-WORLD SETTINGS AND CLOSE THE RESEARCH-TO-PRACTICE TRANSLATION GAP. THE PROPOSED STUDY IS A TYPE II HYBRID IMPLEMENTATION-EFFECTIVENESS TRIAL OF NAVIGATION SERVICES TO AVOID REHOSPITALIZATION (NAVSTAR). OUR RESEARCH TEAM SHOWED IN A SINGLE-SITE RANDOMIZED TRIAL WITH 400 PARTICIPANTS THAT NAVSTAR SIGNIFICANTLY INCREASED OAT ENTRY, REDUCED READMISSIONS, AND WAS HIGHLY COST- EFFECTIVE COMPARED TO TREATMENT AS USUAL. THE PRESENT STUDY WILL TEST AN IMPLEMENTATION FACILITATION (IF) STRATEGY FOLLOWING PROCTOR’S CONCEPTUAL MODEL USING AN EXTERNAL FACILITATOR AND AN INTERNAL LOCAL CLINICAL CHAMPION TO PROVIDE TRAINING, RESOURCES, AND PERFORMANCE FEEDBACK TO IMPLEMENT NAVSTAR IN FOUR HOSPITALS. WE HYPOTHESIZE THAT ENGAGING STAKEHOLDERS (INCLUDING PATIENTS, CLINICIANS, AND COMMUNITY LEADERS) IN AN IF STRATEGY WILL CREATE AND TEST AN IMPLEMENTATION PROCESS THAT IS FEASIBLE, ACCEPTABLE, AND EFFECTIVE IN EXPANDING ACCESS TO OAT POST-DISCHARGE. THE R61 PHASE WILL CONDUCT PROCESS MAPPING TO IDENTIFY EXISTING HOSPITAL WORKFLOW AND THEN REFINE AN IF STRATEGY THROUGH SEQUENTIAL PILOT TRIALS AT 4 HOSPITAL SITES IN PREPARATION FOR THE R33 PHASE. THE TEAM’S NAVSTAR OPERATIONS MANUAL WILL BE ADAPTED TO THE SITES TO TRAIN THE EXISTING STAFF. R61 MILESTONES INCLUDE THE CREATION OF AN IMPLEMENTATION TOOLKIT AND DATA SHARING AGREEMENTS. DURING THE R33 PHASE, WE WILL CONDUCT A TYPE II HYBRID-IMPLEMENTATION-EFFECTIVENESS TRIAL (N=720) OF NAVSTAR USING A RANDOMIZED STEPPED-WEDGE DESIGN WITH AUGMENTED INVERSE PROBABILITY WEIGHTING TO COMPARE OUTCOMES PRE- AND POST-IMPLEMENTATION. THIS STUDY WILL DEVELOP AN EFFECTIVE IF STRATEGY TO INCREASE THE REACH AND SUSTAINABILITY OF NAVSTAR AND PROVIDE A PATH TO SCALE-UP THIS INTERVENTION TO ADDRESS THE OPIOID EPIDEMIC.

A PATIENT NAVIGATION TRIAL FOR HOUSING AND HEALTH (PATHH): A RANDOMIZED CONTROLLED TRIAL - NEARLY ONE IN THREE WOMEN HAVE EXPERIENCED PHYSICAL OR SEXUAL VIOLENCE. WOMEN WHO HAVE SURVIVED VIOLENCE (WSV) DEMONSTRATE HIGH RATES OF HOUSING INSTABILITY AND HEALTH PROBLEMS, INCLUDING INCREASED MORBIDITY AND MORTALITY RELATED TO SUBSTANCE USE, DEPRESSION, AND HIV. HOUSING INFLUENCES LONG-TERM WELL-BEING AND CONTRIBUTES TO DIFFERENCES IN HEALTH OUTCOMES THAT CAN PERSIST OVER TIME. HEALTHCARE ENGAGEMENT FOR WSV IS OFTEN LIMITED BY FACTORS SUCH AS FRAGMENTED SERVICES, COMPLEX ELIGIBILITY REQUIREMENTS, AND INCONSISTENT FOLLOW-UP SYSTEMS. DESPITE THE ESTABLISHED LINK BETWEEN HOUSING AND HEALTH, THERE IS A LACK OF EVIDENCE-BASED INTERVENTIONS DESIGNED TO DIRECTLY IMPROVE HOUSING INSTABILITY WHILE SIMULTANEOUSLY SUPPORTING IMPROVED CONNECTION TO HEALTHCARE SERVICES. THERE IS AN URGENT NEED FOR APPROACHES THAT PROMOTE HOUSING STABILITY AND IMPROVE ENGAGEMENT IN CARE FOR WSV TO REDUCE PREVENTABLE NEGATIVE HEALTH OUTCOMES. PATIENT NAVIGATION (PN) IS AN EVIDENCE-BASED INTERVENTION SHOWN TO SUPPORT ENGAGEMENT IN SOCIAL AND HEALTHCARE SERVICES AMONG POPULATIONS FACING COMPLEX NEEDS. BUILDING ON OUR PRIOR RESEARCH AND ADAPTING THE CORE COMPONENTS OF THE NAVIGATION SERVICES TO AVOID RE-HOSPITALIZATION (NAVSTAR) INTERVENTION, WE PROPOSE TO DEVELOP AND TEST PATHH (PATIENT NAVIGATION TRIAL FOR HOUSING AND HEALTH), A PN MODEL FOCUSED ON IMPROVING HOUSING STABILITY AND HEALTH SELF-EFFICACY FOR WSV. GUIDED BY A COMMUNITY ADVISORY BOARD, WE WILL ADAPT PN TO SUPPORT PATHH’S IMPLEMENTATION ACROSS INDIVIDUAL, ORGANIZATIONAL, AND COMMUNITY LEVELS (AIM 1). PATHH WILL THEN BE EVALUATED AS AN AUGMENTATION TO EXISTING SERVICES IN PARTNERSHIP WITH COMMUNITY ORGANIZATIONS (AIMS 2 AND 3). TO ASSESS EFFECTIVENESS, WE WILL CONDUCT A PARALLEL, TWO-ARM RANDOMIZED CONTROLLED TRIAL (N=300), RANDOMLY ASSIGNING WSV 1:1 TO PATHH (N=150) OR TREATMENT-AS-USUAL (N=150). PRIMARY OUTCOMES WILL INCLUDE HOUSING STABILITY AND HEALTH SELF-EFFICACY; SECONDARY OUTCOMES INCLUDE SUBSTANCE USE, MENTAL HEALTH, AND PHYSICAL HEALTH. WE WILL ALSO EVALUATE IMPLEMENTATION OUTCOMES AT THE TRIAL’S CONCLUSION. THIS STUDY IS SIGNIFICANT IN TESTING A SCALABLE PN APPROACH DESIGNED TO IMPROVE HOUSING STABILITY AND HEALTH FOR WSV, AND INNOVATIVE IN EXTENDING PN BEYOND TRADITIONAL HEALTHCARE SETTINGS INTO COMMUNITY-BASED PARTNERSHIPS, WHILE ALSO GENERATING EVIDENCE TO GUIDE FUTURE IMPLEMENTATION OF PN MODELS.

RISK FACTORS FOR HIV AMONG URBAN AFRICAN AMERICAN YOUTH

INTERVENTION TO REDUCE INTERNALIZED STIGMA (IRIS) AMONG PEOPLE LIVING WITH HIV WHO USE SUBSTANCES - ABSTRACT DIFFERENT FACETS OF STIGMA (ANTICIPATED, ENACTED, INTERNALIZED) ASSOCIATED WITH SUBSTANCE USE DISORDER (SUD) AND WITH HIV POSITIVE STATUS IMPEDE CESSATION OF SUBSTANCE USE AND HIV HEALTH OUTCOMES INCLUDING ANTIRETROVIRAL THERAPY ADHERENCE AND VIRAL LOAD SUPPRESSION.1-6 ALTHOUGH PUBLIC STIGMA IS PERVASIVE SURROUNDING BOTH, INDIVIDUALS CAN LEARN TO REDUCE ITS INTERNALIZATION AND MITIGATE STIGMA’S NEGATIVE IMPACTS ON THEIR HEALTH. HOWEVER, INTERVENTIONS PROMOTING THIS ARE NON-EXISTENT IN THE PUBLISHED LITERATURE. TO THIS END, WE PROPOSE TO ADAPT AN EVIDENCE-BASED STIGMA-IMPACT REDUCTION INTERVENTION, ENDING SELF- STIGMA (ESS) TO REDUCE STIGMA AND ITS NEGATIVE IMPACTS ON HEALTH. ESS HAS SHOWN EFFICACY IN REDUCING INTERNALIZED AND ANTICIPATED STIGMA IN POPULATIONS EXPERIENCING MENTAL HEALTH CONDITIONS.7 THE 9-SESSION GROUP-BASED INTERVENTION, WHICH USES COGNITIVE BEHAVIORAL THERAPY STRATEGIES AND SOCIAL COGNITIVE THEORY CONSTRUCTS, EMPLOYS DIDACTIC LEARNING AND INTERACTIVE ACTIVITIES TO FACILITATE REDUCTIONS IN INTERNALIZED AND ANTICIPATED STIGMA. THE PURPOSE OF THE PROPOSED STUDY IS TO ADAPT THE ESS INTERVENTION FOR PEOPLE LIVING WITH HIV (PLWH) WHO ALSO HAVE OPIOID USE DISORDER (OUD) AND/OR COCAINE USE DISORDER (CUD). IN THE FIRST YEAR, WE WILL USE AN ITERATIVE PROCESS THAT STARTS WITH FORMATIVE INTERVIEWS WITH SERVICE DELIVERY KEY INFORMANTS AND PEOPLE LIVING WITH PLWH WITH OUD AND/OR CUD, AND ENDS WITH TWO SUCCESSIVE PILOT STUDIES WITH THE STUDY POPULATION. THROUGH THIS PROCESS, INTERVENTION CONTENT WILL BE ADAPTED FOR THIS POPULATION AND INTERVENTION DELIVERY WILL BE ADAPTED FOR A VIRTUAL FORMAT VIA A WEB-BASED PLATFORM. THEN, IN YEARS 2-3, A SMALL RANDOMIZED CLINICAL TRIAL OF THE RESULTING ENDING SELF-STIGMA INTERVENTION ADAPTED FOR PLWH WITH SUBSTANCE USE DISORDER (ESS-HSU) WILL BE CONDUCTED WITH 70 PARTICIPANTS TO DETERMINE ITS FEASIBILITY AND ACCEPTABILITY IN ADDITION TO COLLECTING DATA ON PROXIMAL OUTCOMES INCLUDING INTERNALIZED AND ANTICIPATED STIGMA, DEPRESSIVE SYMPTOMS, ANXIETY AND PERCEIVED STRESS ASSOCIATED WITH STIGMA. WE WILL ALSO MEASURE DISTAL OUTCOMES INCLUDING ART ADHERENCE, VIRAL LOAD AND SUBSTANCE USE (SU) AT 6-MONTH FOLLOW-UP. THE ESS-HSU INTERVENTION HAS THE POTENTIAL FOR HIGH PUBLIC HEALTH IMPACT BY REDUCING THE NEGATIVE EFFECTS OF INTERNALIZED AND ANTICIPATED STIGMA RESULTING FROM THE PERVASIVE PUBLIC STIGMATIZATION OF HIV SEROPOSITIVE STATUS AND SUD ON HIV HEALTH OUTCOMES AND CESSATION OF SU. ESS-HSU WOULD BE THE FIRST VIRTUAL INTERVENTION OF THIS TYPE TO BE EVALUATED IN A RANDOMIZED CLINICAL TRIAL. IF RESULTS ARE PROMISING, WE WILL SEEK R01 FUNDING FOR A FULL-SCALE TEST OF THIS INNOVATIVE INTERVENTION TO DETERMINE ITS EFFECTS ON A RANGE OF HEALTH OUTCOMES AND CHARACTERIZE MECHANISMS OF INTERVENTION EFFECTS.

SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE

COGNITIVE BEHAVIORAL THERAPY FOR SOUTH AFRICA

PREVENTING SUBSTANCE ABUSE, HIV/AIDS, AND HEPATITIS IN NATIVE AMERICANS

EMPOWERING SUPPORT PERSONS TO ENHANCE THE RECOVERY CAPITAL OF POSTPARTUM WOMEN WITH OPIOID USE DISORDER - PROJECT SUMMARY/ABSTRACT OPIOID AGONIST TREATMENT (OAT) IS HIGHLY EFFECTIVE IN PREVENTING MORBIDITY AND MORTALITY RELATED TO OPIOID USE DISORDER (OUD), BUT LONG-TERM ENGAGEMENT IS COMPLICATED BY PHYSICAL, SOCIAL, AND STRUCTURAL FACTORS, ESPECIALLY FOR WOMEN. POSTPARTUM WOMEN WITH OUD FACE THE CHALLENGING TRANSITION FROM HOSPITAL CARE TO THE COMMUNITY, BOTH FOR THEMSELVES AND THEIR NEWBORNS. FEAR OF JUDGMENT FROM HEALTHCARE PROVIDERS MAY DISCOURAGE WOMEN FROM ASKING FOR HELP OR ACCESSING NECESSARY SUPPORT SERVICES. THE PRESENCE OF SUPPORTIVE INDIVIDUALS—SUCH AS FAMILY OR FRIENDS—CAN INCREASE RECOVERY CAPITAL; HOWEVER, SUPPORT PEOPLE MAY REQUIRE ADDITIONAL EDUCATION AND SKILLS TO EFFECTIVELY ASSIST THEIR LOVED ONES, REPRESENTING A CRITICAL GAP IN THEIR ABILITY TO INFLUENCE TREATMENT OUTCOMES. THEORY-BASED, EVIDENCE-SUPPORTED PATIENT NAVIGATION (PN) INTERVENTIONS IMPROVE OAT ENGAGEMENT BY ADDRESSING SOCIAL, STRUCTURAL, AND INTERNAL BARRIERS (E.G. MISTRUST) USING MOTIVATIONAL TECHNIQUES AND PROVIDING TANGIBLE RESOURCES. THIS STUDY AIMS TO LEVERAGE THE STRENGTHS OF BOTH PN AND SUPPORTIVE FAMILY OR FRIEND INVOLVEMENT TO ENHANCE RECOVERY CAPITAL AND, SECONDARILY, IMPROVE RETENTION IN COMMUNITY-BASED OAT. WE HYPOTHESIZE THAT TRAINING AND ENGAGING SUPPORT PERSONS WILL PROMOTE RECOVERY CAPITAL BY TARGETING SOCIAL CAPITAL (BY FOSTERING STRONGER RELATIONSHIPS), HUMAN CAPITAL (THROUGH INCREASING SELF-EFFICACY), AND CULTURAL CAPITAL (BY PROMOTING NORMS AND VALUES THAT SUPPORT RECOVERY). THIS PROJECT ALIGNS WITH THE OBJECTIVES OF RFA- DA-26-024, WHICH EMPHASIZES INNOVATIVE STRATEGIES TO IMPROVE CARE TRANSITIONS AND ENHANCE RECOVERY CAPITAL. THE PROPOSED STUDY IS A RANDOMIZED CONTROLLED TRIAL OF A PN INTERVENTION CALLED SUPPORTING TREATMENT FOR OPIOIDS AND RECOVERY CAPITAL (STORC) THAT BLENDS PN WITH AN ADDED COMPONENT DESIGNED TO ENHANCE RECOVERY CAPITAL FOR POSTPARTUM WOMEN THROUGH ADDITIONAL TRAINING FOR CHOSEN SUPPORT PERSONS. THIS INTERVENTION WILL PROVIDE PATIENTS WITH CARE COORDINATION AND RESOURCE REFERRALS, AND WILL PROVIDE SUPPORT PERSONS WITH COMPREHENSIVE TOOLS, INCLUDING KNOWLEDGE ABOUT OUD TREATMENT, EFFECTIVE COMMUNICATION STRATEGIES, AND EMOTIONAL SUPPORT. PATIENT NAVIGATION, COMBINED WITH TARGETED TRAINING FOR SUPPORT PERSONS, EQUIPS FAMILY AND FRIENDS WITH THE SKILLS AND KNOWLEDGE TO OFFER MORE EFFECTIVE, IMPACTFUL SUPPORT FOR THEIR LOVED ONES IN RECOVERY. THIS PROJECT IS SIGNIFICANT TO PUBLIC HEALTH BECAUSE IT EMPLOYS A RECOVERY CAPITAL FRAMEWORK TO EXPLORE HOW SUPPORT PERSONS CAN PLAY A CRITICAL ROLE IN THE RECOVERY EFFORTS OF NEW MOTHERS AT HIGH RISK OF OVERDOSE.

PEOPLE PREFERRING FENTANYL (PPF): CHARACTERISTICS, OUTCOMES, AND PERSPECTIVES

ENGAGING DETOXIFICATION CLIENTS INTO LONG-TERM TREATMENT

LEVERAGING A TIME-LIMITED OPPORTUNITY TO STUDY THE IMPACT OF AN INTERVENTION FOR INDIVIDUALS BEREAVED BY DRUG OVERDOSE - THE ONGOING OPIOID EPIDEMIC HAS CREATED A LARGE NUMBER OF PEOPLE WHO HAVE LOST FAMILY, FRIENDS, OR OTHER CLOSE PEERS TO DRUG OVERDOSE. PEOPLE BEREAVED BY OVERDOSE OFTEN EXPERIENCE PSYCHOLOGICAL STRESSORS AND DISRUPTIONS TO LIFE, AND ARE AT GREATER RISK OF EXPERIENCING MORE SEVERE GRIEF SYMPTOMS, SUBSTANCE MISUSE, AND SERIOUS HEALTH PROBLEMS COMPARED TO PEOPLE BEREAVED BY OTHER TYPES OF DEATHS. THE NEW YORK CITY OFFICE OF THE CHIEF MEDICAL EXAMINER (OCME) ROUTINELY ENCOUNTERS SOCIAL NETWORKS OF OVERDOSE DECEDENTS DURING DEATH INVESTIGATIONS AND RECENTLY IMPLEMENTED A SOCIAL WORKER OUTREACH AND RESOURCE DELIVERY (SWORD) INTERVENTION TO REDUCE RISKS AFTER LOSS. SWORD IS DELIVERED BY A TRAINED SOCIAL WORKER AND INTEGRATES EVIDENCE- BASED STRATEGIES FOR MITIGATING HEALTH RISKS, INCLUDING MOTIVATIONAL INTERVIEWING, SOCIAL SUPPORT, AND LINKAGE TO SERVICES/RESOURCES. THE SWORD SERVICE MODEL IS STRUCTURED INTO FIVE MODULES: BEREAVEMENT LOGISTICS, GRIEF AND EMOTIONAL SUPPORT, SUBSTANCE USE SUPPORT, PHYSICAL AND MENTAL HEALTH SUPPORT, AND SOCIAL SERVICES. DUE TO INSUFFICIENT RESOURCES, THE OCME HAS NOT HAD THE CAPACITY TO OFFER THE INTERVENTION UNIVERSALLY. IMPORTANTLY, THE OCME HAS USED A RANDOM SELECTION PROCESS TO DETERMINE WHO IS OFFERED THE SERVICE. FOLLOWING SUCCESS OF THE SWORD PILOT, THE OCME RECENTLY RECEIVED FUNDING AS PART OF THE NATIONAL OPIOID SETTLEMENT TO EXPAND THIS INNOVATIVE SERVICE TO NETWORK MEMBERS OF ALL OVERDOSE DECEDENTS. AS THE SWORD SERVICE EXPANDS AND ACCESS IS NO LONGER RATIONED, THERE IS A TIME-LIMITED OPPORTUNITY TO COMPARE OUTCOMES OF SWORD WITH A NATURAL CONTROL GROUP THAT WAS SELECTED AT RANDOM WITHIN THE NATION’S LARGEST MEDICAL EXAMINER OFFICE. DESPITE ABUNDANT EVIDENCE DEMONSTRATING THAT PEOPLE BEREAVED BY OVERDOSE ARE AT HIGHER RISK OF POOR HEALTH OUTCOMES THAN PEOPLE BEREAVED BY OTHER TYPES OF DEATHS, HEALTH INTERVENTIONS SPECIFICALLY DESIGNED FOR PEOPLE WHO EXPERIENCE LOSS TO OVERDOSE HAVE NOT BEEN SCIENTIFICALLY STUDIED. IN THIS STUDY, WE WILL LEVERAGE THE OCME’S RANDOM SELECTION FOR SWORD BY CONDUCTING SURVEYS WITH 300 OVERDOSE BEREAVED INDIVIDUALS (150 SWORD, 150 CONTROL) 6 MONTHS POST-LOSS TO EXAMINE THE EFFECT OF SWORD ON GRIEF SEVERITY, SUBSTANCE USE, AND OTHER MEASURES OF BEREAVEMENT-RELATED FUNCTIONING (ANXIETY, DEPRESSION, PTSD, COPING). WE WILL ALSO CHARACTERIZE THE NEEDS OF OVERDOSE-BEREAVED INDIVIDUALS AND IDENTIFY HIGH-NEED SUBGROUPS AND GAPS IN SWORD SERVICES USING THE SURVEY DATA AND THROUGH QUALITATIVE INTERVIEWS WITH 30 OVERDOSE BEREAVED ADULTS. THE PROJECT HAS BEEN STRATEGICALLY DESIGNED IN PARTNERSHIP WITH THE OCME TO SUPPORT INTERVENTION SUSTAINABILITY AND OPPORTUNITIES FOR SCIENTIFIC INNOVATION. GIVEN THE PROPOSAL’S INNOVATION AND HIGH POTENTIAL TO REDUCE GRIEF AND RISKY SUBSTANCE USE AND IMPROVE BEREAVEMENT-RELATED FUNCTIONING, IT IS CRITICAL TO LEVERAGE THIS TIME-LIMITED OPPORTUNITY TO STUDY THE IMPACT OF THIS INTERVENTION. FINDINGS FROM THIS R21 STUDY WILL BE USED TO MAKE ENHANCEMENTS TO THE SWORD INTERVENTION AND DESIGN A FUTURE LARGE-SCALE RCT OF SWORD THAT ENSURES OPTIMAL INTERVENTION DESIGN AND TARGETS THE MOST VULNERABLE PEOPLE BEREAVED BY OVERDOSE. THIS STUDY IS PART OF THE NIH’S HELPING TO END ADDICTION LONG-TERM (HEAL) INITIATIVE TO SPEED SCIENTIFIC SOLUTIONS TO THE NATIONAL OPIOID PUBLIC HEALTH CRISIS. THE NIH HEAL INITIATIVE BOLSTERS RESEARCH ACROSS NIH TO IMPROVE TREATMENT FOR OPIOID MISUSE AND ADDICTION

FACILITATING THE IMPLEMENTATION OF INTERIM METHADONE TO INCREASE TREATMENT ACCESS: A MULTI-SITE IMPLEMENTATION TRIAL

VOUCHER-BASED INCENTIVES IN A PREVENTION SETTING

DEVELOPMENT AND TESTING OF AN IDENTITY MEASURE FOR TRANSGENDER AND GENDER DIVERSE PERSONS - ABSTRACT EVIDENCE DEMONSTRATES THAT TRANSGENDER AND GENDER DIVERSE (TGD) PERSONS ARE AT DRAMATICALLY ELEVATED RISK FOR HIV AND A NUMBER OF OTHER DETRIMENTAL HEALTH OUTCOMES LARGELY AS A RESULT OF PERVASIVE EXPOSURE TO GENDER- BASED STIGMA AND DISCRIMINATION. SUCH PREJUDICIAL TREATMENT IS INTERNALIZED BY TGD PERSONS AS “IDENTITY NON- VERIFICATION,” A WELL-ESTABLISHED BEHAVIORAL MECHANISM IN IDENTITY THEORY WHICH HAS YET TO BE BROADLY ADOPTED BY RESEARCHERS STUDYING TGD POPULATIONS. THIS STUDY WOULD DEVELOP THE FIRST MULTIDIMENSIONAL MEASURE OF TGD PERSONS' GENDER IDENTITIES USING IDENTITY THEORY'S ESTABLISHED METRICS (E.G., IDENTITY STANDARDS, REFLECTED APPRAISALS, SALIENCE / PROMINENCE / COMMITMENT RATINGS) AND MECHANISMS (E.G., IDENTITY NON-VERIFICATION, IDENTITY CORRECTIVE RESPONSES). THE STUDY WOULD OCCUR IN TWO STAGES, BEGINNING WITH A DEVELOPMENT STAGE IN WHICH IN-DEPTH INTERVIEWS ARE CARRIED OUT WITH A PURPOSIVELY SAMPLED GROUP OF TGD PERSONS EVENLY SPLIT BY AGE, HIV STATUS, AND GENDER IDENTITY (N = 24 PARTICIPANTS EACH) OVER THE COURSE OF SIX MONTHS FOLLOWED BY A PERIOD OF SIX WEEKS TO ANALYZE THE INTERVIEW DATA AND FORMULATE INITIAL DIMENSIONS OF THE GENDER IDENTITY MEASURE. SIX WEEKS OF COGNITIVE DEBRIEFING INTERVIEWS (N = 6) WOULD THEN CONFIRM THE FACE VALIDITY OF THE NEW MEASURE AND ALLOW FOR FINE-TUNING OF ITEMS. THIS WOULD CONCLUDE THE DEVELOPMENT STAGE AND WOULD COMMENCE THE TESTING STAGE (N = 150), IN WHICH THE RELIABILITY AND VALIDITY OF THE NEW MEASURE COULD BE ESTABLISHED, AND A TEST OF HOW IDENTITY NON-VERIFICATION IS ASSOCIATED WITH CRITICAL HEALTH OUTCOMES CAN BE CARRIED OUT. A DEEPER AND MORE GRANULAR UNDERSTANDING OF HOW TGD PERSONS SEE THEMSELVES, HOW THEY BELIEVE OTHER PEOPLE SEE THEM, AND HOW DIFFERENCES BETWEEN THESE TWO CONSTRUCTS ARE ASSOCIATED WITH HIV-RELATED OUTCOMES AND RISKS (INCLUDING EXPOSURE TO HIV AND UPTAKE/ADHERENCE TO ART OR PEP/PREP) COULD GENERATE NEW HYPOTHESES, BETTER RESEARCH QUESTIONS, AND NEW METHODS OF INTERVENING IN ONE OF THE POPULATIONS MOST AFFECTED BY HIV IN THE US.

SOCIAL NETWORKS AND TECHNOLOGY USE OF TRANSGENDER WOMEN WITH/AT HIGH RISK FOR HIV

NEXT GEN NRT PHARMACOKINETICS AND PHARMACODYNAMICS

SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE

A CBT-BASED TEXT MESSAGING INTERVENTION FOR METHAMPHETAMINE DEPENDENCE

RISK FACTORS FOR HIV AMONG URBAN AFRICAN AMERICAN YOUTH

ADX71441, A GABA B POSITIVE ALLOSTERIC MODULATOR, FOR TREATMENT OF COCAINE USE DISORDER - INITIAL HUMAN STUDIES

SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE