R01MH131415

COMPREHENSIVE, TAILORED, TECHNOLOGY-BASED INTERVENTION TO IMPROVE VIROLOGIC SUPPRESSION AMONG YOUTH AND YOUNG ADULTS LIVING WITH HIV - ABSTRACT/PROJECT SUMMARY:

IN THE US, YOUTH AND YOUNG ADULTS LIVING WITH HIV (YLWH) HAVE LOWER RATES OF ANTIRETROVIRAL THERAPY (ART) INITIATION, SUBOPTIMAL ART ADHERENCE AND RETENTION IN CARE, AND HIGHER RATES OF VIROLOGIC FAILURE, COMPARED TO OLDER AGE GROUPS.

ADDITIONALLY, THERE IS AN INCREASED RISK OF SUBSTANCE DEPENDENCE, PSYCHIATRIC DISORDERS, AND MORTALITY WITH INCREASED RISK OF SUBSTANCE USE AT A YOUNGER AGE.

MENTAL HEALTH (MH) AND SUBSTANCE USE (SU) IMPACT EVERY STEP OF THE HIV CARE CONTINUUM FROM DIAGNOSIS TO VIRAL SUPPRESSION AND EXACERBATE SOCIOECONOMIC CHALLENGES OF LINKAGE AND SUSTAINED ACCESS TO HEALTHCARE.

GIVEN THE STRONG EVIDENCE FOR THE INFLUENCE OF MH AND SU ON POOR HIV HEALTH OUTCOMES, THERE IS A CLEAR NEED FOR INCREASED ACCESS TO AND PROVISION OF THESE SERVICES.

DESPITE THE NEED TO ADDRESS THESE CRITICAL BARRIERS TO CARE IN YLWH, THERE IS A SEVERE SHORTAGE OF MH PROFESSIONALS NATIONWIDE AND A LACK OF INTERVENTIONS TAILORED TO THIS AGE GROUP.

IN COLLABORATION WITH THE NONPROFIT AIDS HEALTHCARE FOUNDATION (THE LARGEST PROVIDER OF HIV CARE) AND A YOUTH ADVISORY PANEL, THE PROPOSED STUDY AIMS TO ADDRESS THESE BARRIERS IN A TAILORED MANNER USING A DIFFERENTIATED CARE APPROACH THAT IS “YOUTH-FRIENDLY.”

OUR GOAL IS TO TEST THE EFFECT OF A TAILORED TECHNOLOGY-BASED INTERVENTION IN A RANDOMIZED CLINICAL TRIAL (RCT) WITH AN ADAPTIVE TREATMENT STRATEGY (ATS) AMONG 200 YLWH (18–29 YEARS OLD).

THE INTERVENTION INCLUDES: (1) BRIEF WEEKLY COUNSELING SESSIONS WITH A COUNSELOR TO DISCUSS MH, SU, HIV CARE ENGAGEMENT, AND OTHER BARRIERS TO CARE DELIVERED VIA A VIDEO-CHAT PLATFORM, AND (2) A MOBILE HEALTH APPLICATION DESIGNED AND DEVELOPED USING HUMAN-CENTERED DESIGN (HCD) WITH YLWH TO ADDRESS BARRIERS TO ENGAGEMENT IN CARE.

INDIVIDUALS WHO ARE NOT VIROLOGICALLY SUPPRESSED WILL BE RANDOMIZED TO VIDEO- COUNSELING+APP OR STANDARD OF CARE (SOC).

THROUGH THIS ENTIRELY REMOTELY-CONDUCTED STUDY, WE WILL BE ABLE TO:

AIM 1: TEST THE EFFICACY OF VIDEO-COUNSELING+APP VS SOC ON VIROLOGIC SUPPRESSION IN YLWH. WE WILL COMPARE HIV VIROLOGIC SUPPRESSION OF THOSE RANDOMIZED TO THE INTERVENTION VS CONTROL ARMS AT 16 WEEKS VIA AN RCT.

AIM 2: ASSESS THE IMPACT OF VIDEO-COUNSELING+APP VS SOC ON MH AND SU IN YLWH. WE WILL EVALUATE THE MH AND SU DIFFERENCES BETWEEN THE INTERVENTION VS CONTROL ARMS AT 16 WEEKS VIA AN RCT.

AIM 3: EXPLORE AN ATS TO INDIVIDUALIZE THE INTERVENTION BY ASSIGNING THE: (A) VIROLOGIC “NON-RESPONDERS” IN THE INTERVENTION ARM TO INTENSIFIED VIDEO-COUNSELING+APP FOR 16 MORE WEEKS, (B) VIROLOGIC “RESPONDERS” IN THE INTERVENTION ARM TO CONTINUE ONLY APP USE FOR 16 MORE WEEKS.

THEREFORE, IN AN ERA OF SEVERE SHORTAGES OF MH PROVIDERS WHEN MH AND SU CHALLENGES OF YLWH ARE CRITICAL BARRIERS TO CARE, EXAMINING AN INNOVATIVE INTERVENTION DEVELOPED USING HCD WITH A DIFFERENTIATED CARE APPROACH DIRECTED SPECIFICALLY TO YLWH, GROUNDED IN A WELL-ESTABLISHED THEORETICAL MODEL OF CARE AND FORMATIVE RESEARCH, AND WITH COMMUNITY PARTNERSHIP IS NECESSARY FOR “GETTING TO ZERO” AND ENDING THE HIV EPIDEMIC.

San Francisco Regents Of The University Of California

THE MISSION OF THE NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) IS TO TRANSFORM THE UNDERSTANDING AND TREATMENT OF MENTAL ILLNESSES THROUGH BASIC AND CLINICAL RESEARCH, PAVING THE WAY FOR PREVENTION, RECOVERY, AND CURE. IN MAY 2020, NIMH RELEASED ITS NEW STRATEGIC PLAN FOR RESEARCH. THE NEW STRATEGIC PLAN BUILDS ON THE SUCCESSES OF PREVIOUS NIMH STRATEGIC PLANS BY PROVIDING A FRAMEWORK FOR SCIENTIFIC RESEARCH AND EXPLORATION, AND ADDRESSING NEW CHALLENGES IN MENTAL HEALTH. THE NEW STRATEGIC PLAN OUTLINES FOUR HIGH-LEVEL GOALS: GOAL 1: DEFINE THE BRAIN MECHANISMS UNDERLYING COMPLEX BEHAVIORS GOAL 2: EXAMINE MENTAL ILLNESS TRAJECTORIES ACROSS THE LIFESPAN GOAL 3: STRIVE FOR PREVENTION AND CURES GOAL 4: STRENGTHEN THE PUBLIC HEALTH IMPACT OF NIMH-SUPPORTED RESEARCH THESE FOUR GOALS FORM A BROAD ROADMAP FOR THE INSTITUTE'S RESEARCH PRIORITIES OVER THE NEXT FIVE YEARS, BEGINNING WITH THE FUNDAMENTAL SCIENCE OF THE BRAIN AND BEHAVIOR, AND EXTENDING THROUGH EVIDENCE-BASED SERVICES THAT IMPROVE PUBLIC HEALTH OUTCOMES. THE INSTITUTE'S OVERALL FUNDING STRATEGY IS TO SUPPORT A BROAD SPECTRUM OF INVESTIGATOR-INITIATED RESEARCH IN FUNDAMENTAL SCIENCE, WITH INCREASING USE OF INSTITUTE-SOLICITED INITIATIVES FOR APPLIED RESEARCH WHERE PUBLIC HEALTH IMPACT IS A SHORT-TERM MEASURE OF SUCCESS. THE NEW STRATEGIC PLAN ALSO ADDRESSES A NUMBER OF CROSS-CUTTING THEMES THAT ARE RELEVANT TO ALL RESEARCH SUPPORTED BY NIMH, THESE THEMES HIGHLIGHT AREAS WHERE NIMH-FUNDED SCIENCE MAY HAVE THE GREATEST IMPACT, BRIDGE GAPS, AND OFFER NOVEL APPROACHES TO ACCELERATE ADVANCES IN MENTAL HEALTH RESEARCH. FOR EXAMPLE, NIMH VALUES A COMPREHENSIVE RESEARCH AGENDA THAT TAKES AN INCLUSIVE APPROACH THAT ENSURES RESEARCH INTERESTS ARE VARIED, MAINTAIN DIVERSE PARTICIPATION AND PARTNERSHIPS, AND ACHIEVE RESEARCH GOALS ACROSS MULTIPLE TIMEFRAMES. THIS INCLUDES DIVERSE METHODOLOGIES, TOOLS, AND MODELS, RESEARCH ADDRESSING COMPLEX BASIC, TRANSLATIONAL, AND APPLIED QUESTIONS, RESEARCH INCLUDING BOTH SEXES AND, AS APPROPRIATE, GENETIC BACKGROUND, AND, PARTICIPANTS FROM DIVERSE RACIAL AND ETHNIC BACKGROUNDS, AND ACROSS GENDER IDENTITIES, GEOGRAPHICAL CONTEXT, SOCIOECONOMIC STATUS, NEUROTYPE, AND AGE OFFERING THE BEST POSSIBLE REPRESENTATION, FOR THE BROADEST NUMBER OF INDIVIDUALS WHO MAY ULTIMATELY BENEFIT FROM THESE SCIENTIFIC ADVANCES. TO ACCOMPLISH THE GOALS OUTLINED IN THE NEW STRATEGIC PLAN, NIMH WILL SUPPORT RESEARCH THAT AIMS: TO CHARACTERIZE THE GENOMIC, MOLECULAR, CELLULAR, AND CIRCUIT COMPONENTS CONTRIBUTING TO BRAIN ORGANIZATION AND FUNCTION, TO IDENTIFY THE DEVELOPMENTAL, FUNCTIONAL, AND REGULATORY MECHANISMS RELEVANT TO COGNITIVE, AFFECTIVE, AND SOCIAL DOMAINS, ACROSS UNITS OF ANALYSIS, AND, TO GENERATE AND VALIDATE NOVEL TOOLS, TECHNIQUES, AND MEASURES TO QUANTIFY CHANGES IN THE ACTIVITY OF MOLECULES, CELLS, CIRCUITS, AND CONNECTOMES. TO DISCOVER GENE VARIANTS AND OTHER GENOMIC ELEMENTS THAT CONTRIBUTE TO THE DEVELOPMENT OF MENTAL ILLNESSES IN DIVERSE POPULATIONS, TO ADVANCE OUR UNDERSTANDING OF THE COMPLEX ETIOLOGY OF MENTAL ILLNESSES USING MOLECULAR EPIDEMIOLOGIC APPROACHES THAT INCORPORATE INDIVIDUAL GENETIC INFORMATION IN LARGE COHORTS, TO ELUCIDATE HOW HUMAN GENETIC VARIATION AFFECTS THE COORDINATION OF MOLECULAR, CELLULAR, AND PHYSIOLOGICAL NETWORKS SUPPORTING HIGHER-ORDER FUNCTIONS AND EMERGENT PROPERTIES OF NEUROBIOLOGICAL SYSTEMS, AND, TO DEVELOP NOVEL TOOLS AND TECHNIQUES FOR THE ANALYSIS OF LARGE-SCALE GENETIC, MULTI-OMIC DATA AS IT APPLIES TO MENTAL HEALTH. TO UTILIZE CONNECTOMIC APPROACHES TO IDENTIFY BRAIN NETWORKS AND CIRCUIT COMPONENTS THAT CONTRIBUTE TO VARIOUS ASPECTS OF MENTAL FUNCTION AND DYSFUNCTION, TO DETERMINE THROUGH BRAIN-WIDE ANALYSIS HOW CHANGES IN THE PHYSIOLOGICAL PROPERTIES OF MOLECULES, CELLS, AND CIRCUITS CONTRIBUTE TO MENTAL ILLNESSES, TO DEVELOP MOLECULAR, CELLULAR, AND CIRCUIT-LEVEL BIOMARKERS OF IMPAIRED NEURAL FUNCTION IN HUMANS, AND, TO DEVELOP INNOVATIVE TECHNOLOGIES, INCLUDING NEW IMAGING, COMPUTATIONAL, PHARMACOLOGICAL, AND GENETIC TOOLS TO INTERROGATE AND MODULATE CIRCUIT ACTIVITY AND STRUCTURE ALTERED IN MENTAL ILLNESSES. TO ELUCIDATE THE MECHANISMS CONTRIBUTING TO THE TRAJECTORIES OF BRAIN DEVELOPMENT AND BEHAVIOR, AND, TO CHARACTERIZE THE EMERGENCE AND PROGRESSION OF MENTAL ILLNESSES, AND IDENTIFYING SENSITIVE PERIODS FOR OPTIMAL INTERVENTION. TO DETERMINE EARLY RISK AND PROTECTIVE FACTORS, AND RELATED MECHANISMS, TO SERVE AS NOVEL INTERVENTION GROUPS, AND, TO DEVELOP RELIABLE AND ROBUST BIOMARKERS AND ASSESSMENT TOOLS TO PREDICT ILLNESS ONSET, COURSE, AND ACROSS DIVERSE POPULATIONS. TO DEVELOP NOVEL INTERVENTIONS USING A MECHANISM-INFORMED, EXPERIMENTAL THERAPEUTICS APPROACH, AND, TO DEVELOP AND IMPLEMENT MEASUREMENT STRATEGIES TO FACILITATE MECHANISM-BASED INTERVENTION DEVELOPMENT AND TESTING. TO INVESTIGATE PERSONALIZED INTERVENTION STRATEGIES ACROSS DISEASE PROGRESSION AND DEVELOPMENT, AND, TO DEVELOP AND REFINE COMPUTATIONAL APPROACHES AND RESEARCH DESIGNS THAT CAN BE USED TO INFORM AND TEST PERSONALIZED INTERVENTIONS. TO DEVELOP AND TEST APPROACHES FOR ADAPTING, COMBINING, AND SEQUENCING INTERVENTIONS TO ACHIEVE THE GREATEST IMPACT ON THE LIVES AND FUNCTIONING OF PERSONS SEEKING CARE, TO CONDUCT EFFICIENT PRAGMATIC TRIALS THAT EMPLOY NEW TOOLS TO RAPIDLY IDENTIFY, ENGAGE, ASSESS, AND FOLLOW PARTICIPANTS IN THE CONTEXT OF ROUTINE CARE, AND, TO ENHANCE THE PRACTICAL RELEVANCE OF EFFECTIVENESS RESEARCH VIA DEPLOYMENT-FOCUSED, HYBRID, EFFECTIVENESS-IMPLEMENTATION STUDIES. TO EMPLOY ASSESSMENT PLATFORMS WITHIN HEALTHCARE SYSTEMS TO ACCURATELY ASSESS THE DISTRIBUTION AND DETERMINANTS OF MENTAL ILLNESSES AND TO INFORM STRATEGIES FOR IMPROVED SERVICES, TO OPTIMIZE REAL-WORLD DATA COLLECTION SYSTEMS TO IDENTIFY STRATEGIES FOR IMPROVING ACCESS, QUALITY, EFFECTIVENESS, AND CONTINUITY OF MENTAL HEALTH SERVICES, AND, TO COMPARE ALTERNATIVE FINANCING MODELS TO PROMOTE EFFECTIVE AND EFFICIENT CARE FOR INDIVIDUALS WITH SERIOUS EMOTIONAL DISTURBANCES AND SERIOUS MENTAL ILLNESSES. TO STRENGTHEN PARTNERSHIPS WITH KEY STAKEHOLDERS TO DEVELOP AND VALIDATE STRATEGIES FOR IMPLEMENTING, SUSTAINING, AND CONTINUOUSLY IMPROVE EVIDENCE-BASED PRACTICES, TO BUILD MODELS TO SCALE-UP EVIDENCE-BASED PRACTICES FOR USE IN PUBLIC AND PRIVATE PRIMARY CARE, SPECIALTY CARE AND OTHER SETTINGS, AND, TO DEVELOP DECISION-SUPPORT TOOLS AND TECHNOLOGIES THAT INCREASE THE EFFECTIVENESS AND CONTINUOUS IMPROVEMENT OF MENTAL HEALTH INTERVENTIONS IN PUBLIC AND PRIVATE PRIMARY CARE, SPECIALTY CARE, AND OTHER SETTINGS. TO ADAPT, VALIDATE, AND SCALE-UP PROGRAMS CURRENTLY IN USE THAT IMPROVE MENTAL HEALTH SERVICES FOR UNDERSERVED POPULATIONS, TO DEVELOP AND VALIDATE SERVICE DELIVERY MODELS THAT PROVIDE EVIDENCE-BASED CARE FOR INDIVIDUALS THROUGHOUT THE COURSE OF MENTAL ILLNESS, TO DEVELOP AND VALIDATE SYSTEMS-LEVEL STRATEGIES USING TECHNOLOGY AND OTHER APPROACHES, TO IDENTIFY, SUPPORT, AND MONITOR THE EFFECTIVENESS OF EVIDENCE-BASED CARE THROUGHOUT THE COURSE OF ILLNESS, AND, TO DEVELOP AND VALIDATE DECISION-MAKING MODELS THAT BRIDGE MENTAL HEALTH, MEDICAL, AND OTHER CARE SETTINGS TO INTEGRATE THE APPROPRIATE CARE FOR PEOPLE WITH SERIOUS MENTAL ILLNESSES AND COMORBID MEDICAL CONDITIONS.

93.242 - Mental Health Research Grants

National Institute of Mental Health (NIMH) [HHS - NIH]

California United States

State-Wide

Expanding Differentiated Care Approaches for Adolescents Living with HIV (R01 Clinical Trial Optional) (RFA-MH-22-105)

Amendment Since initial award the total obligations have increased 354% from $856,189 to $3,886,971.