Project Grant R44AA031393

USER-CENTERED DESIGN AND CLINICAL TESTING OF AN MHEALTH INTERVENTION TO REDUCE ALCOHOL-RELATED HARM - ABSTRACT ALCOHOL-RELATED DEATHS HAVE INCREASED BY 29% IN RECENT YEARS. IT IS THIS EVER-GROWING GLOBAL BURDEN OF ALCOHOL- RELATED HARM THAT HAS PROPELLED OUR TEAM TO CONDUCT OVER 15 YEARS OF RESEARCH TO DEVELOP AND SCIENTIFICALLY TEST A HIGHLY FLEXIBLE, PATIENT-DRIVEN, LOW-BARRIER, IN-PERSON TREATMENT KNOWN AS HARM AND RISK-REDUCTION TREATMENT FOR ALCOHOL (HART-A). HART-A MEETS PEOPLE WHERE THEY ARE AT TO HELP THEM CREATE GOALS TO REDUCE ALCOHOL-RELATED HARM AND IMPROVE HEALTH-RELATED QUALITY OF LIFE, EVEN IF THEY ARE NOT READY, WILLING OR ABLE TO STOP DRINKING. FINDINGS FROM OUR NIH-FUNDED RANDOMIZED CLINICAL TRIALS HAVE SHOWN THE EFFICACY OF LOW-BARRIER, IN-PERSON HART-A IN REDUCING HEAVY ALCOHOL USE AND ALCOHOL-RELATED HARM AND IN IMPROVING HEALTH-RELATED QUALITY OF LIFE, EVEN IN A POPULATION THAT IS SOCIALLY MARGINALIZED AND SEVERELY IMPACTED BY ALCOHOL USE DISORDER (AUD). HOWEVER, THE VAST MAJORITY OF PEOPLE WITH AUD-APPROXIMATELY 85% IN 2023-DO NOT SEEK IN-PERSON TREATMENT. COMMON BARRIERS INCLUDE THE TIME, TRAVEL, AND FINANCIAL BURDEN OF IN-PERSON TREATMENT SERVICES; THEIR LACK OF PATIENT-CENTEREDNESS; AND THE STIGMA ASSOCIATED WITH TREATMENT ATTENDANCE. AT THE SAME TIME, RECENT YEARS HAVE SEEN A GROWING ACCEPTANCE OF AND COMFORT WITH MOBILE HEALTH (MHEALTH) TECHNOLOGIES. TO LEVERAGE MHEALTH TECHNOLOGY TO REDUCE THE AFOREMENTIONED BARRIERS TO CARE, WE COLLABORATED WITH PEOPLE WITH AUD AND THE PROVIDERS WHO SERVE THEM TO CODEVELOP A MOBILE HEALTH VERSION OF HART-A (MHART-A). IN OUR SUCCESSFULLY COMPLETED STTR PHASE 1 PROJECT, OUR INITIAL HUMAN-CENTERED DESIGN AND TESTING OF THE MHART-A PROTOTYPE INDICATED STRONG LABORATORY-BASED USABILITY (N=11) AS WELL AS STRONG FIELD TESTS OF FEASIBILITY AND ACCEPTABILITY (N=31) AMONG PEOPLE WITH AUD. WE ARE THUS PROPOSING A FOLLOW-UP STTR PHASE 2 PROJECT, IN WHICH WE WILL REFINE AND OPTIMIZE THE MHART-A PLATFORM AND CONDUCT FINAL USABILITY AND FEASIBILITY TESTING (N=30) AIMED TOWARDS MAXIMIZING ITS SCALABILITY AND COMMERCIALIZATION POTENTIAL. THEN, WE WILL RIGOROUSLY TEST ITS EFFICACY IN A 2-MONTH RANDOMIZED CLINICAL TRIAL (N=215). WE HYPOTHESIZE THAT PARTICIPANTS RECEIVING MHART-A WILL SHOW SIGNIFICANT IMPROVEMENTS ON ALCOHOL OUTCOMES AND HEALTH-RELATED QUALITY OF LIFE COMPARED TO A NO-TREATMENT CONTROL GROUP. IF SUCCESSFUL, OUR COMBINED STTR PHASE 1 AND PHASE 2 PROJECTS WILL HAVE BUILT A STRONG EVIDENCE BASE TO PROPEL MHART-A TOWARDS WIDESPREAD ADOPTION AND COMMERCIAL VIABILITY. THIS NIH-FUNDED WORK WILL SUPPORT THE BROAD DISSEMINATION OF AN ACCESSIBLE AND EFFICACIOUS ALCOHOL INTERVENTION TO THE TENS OF MILLIONS OF PEOPLE WITH AUD WHO ARE NOT CURRENTLY RECEIVING HELP.