Robert H. Remien - US grants

This is a revised proposal for the project, Promoting Antiviral Medication Adherence in HIV Clinics, which will test the effectiveness of an intervention to promote medication adherence and improve clinical outcome for patients about to initiate combination anti-retroviral therapy. The study will be conducted in three large adult HIV outpatient clinics, treating predominantly ethnic minority men and women n Medicaid, at two major teaching hospitals in New York City (Columbia-Presbyterian and New York Hospital/Cornell University Medical Centers). "Combination therapy," with at least two anti-retroviral drugs, and usually including a protease inhibitor, has become the standard of care and is demonstrably effective in reducing HIV viral load for many patients. However, these exciting therapeutic advances bring with them major challenges with respect to medication adherence. Since patients can develop resistance and cross- resistance (to all other protease inhibitors) after only a week of missed medication, irregular use, or incomplete doses, there are serious consequences for the individual and potential public health consequences as well, since resistant viral strains can be transmitted to others. All patients in these clinics who have agreed with their doctor's recommendation to start (or switch to) combination therapy that includes a protease inhibitor will be eligible. Participants will be randomized to either the intervention of control ("usual care") arm of the study, and all will have assessments at baseline and Weeks 4, 12, and 26. The cognitive-behavioral intervention is structured and theory-driven. Delivered by a nurse educator, it focuses on maximizing accurate understanding of the medical and practical aspects of combination treatment an resolving practical barriers to adherence, maximizing belief in person control or self-efficacy, and maximizing perceived and practical social support. There will be four acute phase sessions during the first month of initiating combination therapy ("hit hard, hit early") and four maintenance sessions at successive monthly intervals. Major outcome measures include behavioral adherence and clinical effect in terms of decline in HIV RNA viral load. The primary goal of the study is to test the effectiveness of our intervention; secondary goals are to examine the relationship between adherence and clinical outcome and to identify psychiatric, psychosocial, medical, and situational predictors of adherence and clinical outcome.

sex partner; therapy compliance; antiAIDS agent; AIDS therapy; disease /disorder proneness /risk; HIV infections; dyadic interaction; nursing intervention; patient monitoring device; AIDS education /prevention; outpatient care; health services research tag; behavioral /social science research tag; human subject; serology /serodiagnosis; clinical research;

DESCRIPTION (provided by applicant): This is a revised application for the Community Collaboration Core (CCC). Community-research collaborations involving academia, community-based organizations (CBOs), clinical care settings, and health departments can ensure high-quality HIV prevention science and address health disparities among diverse underserved groups. These "research-practice" collaborations make it possible to target interventions to the needs of well-defined groups; tailor approaches to address culturally specific beliefs about gender, sexuality, and health; and promote healthy lifestyles through enduring community ties. However, many questions about undertaking and evaluating collaborations remain unanswered and require systematic scientific inquiry. The CCC will integrate scientific and community responses to the HIV epidemic by providing technical assistance to foster and support research partnerships and by developing theoretical models to advance scientific understanding of the collaborative process. Building on the HIV Center's 15 year history of promoting "community-informed research" and "research-informed services in the community," the aims of the CCC are (1) to initiate and sustain successful partnerships to conduct HIV prevention and treatment research and program activities related to sexuality, gender, and mental health that are of mutual interest and benefit to communities; and (2) to develop and disseminate theoretical models and methods that will advance the science of the collaborative process in the field of HIV prevention and treatment and may then be applied to other areas of health behavior research. Risk-determinant studies and development of effective interventions in diverse populations are facilitated through community-academic partnerships and are central to the mission of the HIV Center. Drawing on existing relationships and expertise at the Center and in the community, we have assembled an interdisciplinary group of behavioral scientists, representatives from key CBOs, primary care clinics, and New York State and City governmental planning and policy bodies to support and strengthen community-research collaborations and advance the scientific basis for understanding partnership. To achieve these objectives, the Core will engage in the following key activities: community outreach; triage and formation of consultation teams; ongoing consultations, technical assistance, and case conference reviews; and model building in the study of partnerships and the collaborative process.

[unreadable] DESCRIPTION (provided by applicant): HIV is a major threat to the health and psychosocial well-being of infected people, particularly in low-resource countries that have had limited access to antiretroviral treatment (ART). South Africa (SA) has one of the highest HIV prevalence rates in the world. Recently, a national plan was initiated to make ART widely available in SA which will result in a growing population of people living with HIV who survive and must live with HIV disease as a chronic, stigmatizing, and transmittable illness, with the potential for significant public health consequences. The goal of this application is to adapt and pilot test a counselor- and multimedia-driven social support intervention to promote optimal medical care adherence for adult patients accessing ART in SA community based clinics. The original intervention (SMART Couples) was developed and tested in the US with HIV+ adults and their serodiscordant partners. This curriculum will be modified in two primary ways: (1) we will modify the approach so that it can be used with all adult patients on ART, allowing them to include any member of their social network (not just a serodiscordant partner); and (2) we will translate the intervention into a multimedia computer-based format so that it can be used effectively by lay counselors, with minimal training, supervision, and cost. In Phase 1, we will adapt the SMART curriculum for SA adult men and women using a Social Action Theory (SAT) model of behavioral health. We will use community-based participatory research methods (CBPR) to modify the existing curriculum and to specify procedures for intervention and assessment delivery. A series of consumer consultant meetings with health care staff (e.g., nurses, physicians, psychologists, and HIV counselors) and patients accessing HIV services will focus on adapting the intervention for the local setting. Content from the existing SMART manual and newly developed media will be reviewed by theses key stakeholders and the research team. We will examine intervention implementation issues, with attention not only to logistics, but also to attitudes about psychosocial interventions, HIV stigma, and provider roles, particularly those of nurses and adherence counselors. Through the use of CBPR, we will build consensus about which components of the existing SMART intervention are relevant to the SA context and add local techniques that are deemed more relevant, but that also allow us to retain fidelity to core intervention components and our theoretical framework. In Phase 2, 66 HIV+ adult patients at three clinics in the South Peninsula District of the Western Cape (False Bay, Victoria Hospital, and Retreat Clinic) will participate in a pilot randomized controlled trial of the intervention. They will be randomized either to the active intervention or to "standard of care." Participants will be assessed at three time-points (pre- and post-test intervention and 3-month follow-up) on adherence and other behavioral health outcomes, social support processes, and other self-regulation and contextual variables - guided by the SAT model. Process variables, including barriers and facilitators of feasibility and acceptability will be collected from patients and clinic staff. The findings can be used to inform larger-scale effectiveness studies in similar settings. [unreadable] [unreadable] [unreadable]

AIDS; AIDS Virus; AIDS/HIV; AIDS/HIV problem; Academia; Acquired Immune Deficiency; Acquired Immune Deficiency Syndrome; Acquired Immune Deficiency Syndrome Virus; Acquired Immuno-Deficiency Syndrome; Acquired Immunodeficiency Syndrome; Acquired Immunodeficiency Syndrome Virus; Adherence; Adherence (attribute); Affect; Appendix; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior or Life Style Modifications; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Research; Behavioral Therapy; Behavioral Treatment; Brazil; Caring; Case Study; China; Collaborations; Commit; Communities; Community Developments; Community Healthcare; Community Services; Conditioning Therapy; Country; Development; Developments, Community; Doctor of Philosophy; Dominican Republic; Ensure; Epidemic; Faculty; Family; Fostering; Funding Mechanisms; Geography; Government; Government Agencies; HIV; HIV/AIDS; HIV/AIDS problem; HTLV-III; Health; Health Care, Community; Healthcares, Community; Home; Home environment; Hour; Human Immunodeficiency Viruses; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Immunologic Deficiency Syndrome, Acquired; India; Individual; Institution; Interdisciplinary Research; Interdisciplinary Study; International; Intervention; Intervention Strategies; Investigators; Journals; Knowledge; LAV-HTLV-III; Leadership; Life; Life Style Modification; Location; Low income; Lymphadenopathy-Associated Virus; Magazine; Mainland China; Maintenance; Maintenances; Mexico; Modeling; Multidisciplinary Collaboration; Multidisciplinary Research; Multinational Perspectives; New York City; On-Line Systems; Online Systems; Perspectives, International; Ph.D.; PhD; Policy Research; Prevention; Prevention program; Process; Programs (PT); Programs [Publication Type]; Public Health Schools; Public Policy; Publications; Republic of South Africa; Research; Research Personnel; Research Priority; Research Resources; Researchers; Resource Development; Resources; Risk; SCHED; Schedule; Schools, Public Health; Science; Scientific Publication; Scientist; South Africa; Study, Interdisciplinary; Translating; Translatings; Union of South Africa; Universities; Vermiform Appendix; Viet Nam; Vietnam; Vietnam, Republic of; Virus-HIV; antiretroviral therapy; base; behavior intervention; behavioral intervention; case report; community based participatory research; community organizations; experience; health practice; interest; international center; interventional strategy; language translation; member; online computer; programs; response; scale up; social organization; success; tool; treatment program; web based

DESCRIPTION (provided by applicant): South Africa (SA) has the largest number of HIV infections in the world. Although initial reports suggested that rates of ART adherence in sub-Saharan Africa were high, recent data indicate that adherence may be a major obstacle to actualizing the full benefits of ART. Inadequate adherence and associated drug resistance are factors contributing to high rates of treatment failure often observed within the first 12 months of ART initiation. Patient understanding of HIV disease and the necessity for high ART adherence, as well as the social support for maintenance of adherence are key to the long-term success of ART. Given the ratio of physicians/nurses to patients, ART adherence counseling in SA is conducted mostly by lay counselors with varied expertise and skills, and minimal supervision. Lack of standardization and variability in quality of counseling has prompted urgent calls for an effective adherence intervention that can be delivered by trained lay staff (with fidelity) to establish optimal adherence among patients initiating ART. With the support of an NIMH R34 grant, we developed Masivukeni, an innovative, multi-media computer-based intervention developed by our US-SA research team with SA patients and care providers using community based participatory research methods. Based on Social Action Theory, Masivukeni addresses contextual factors that may promote or impede adherence, and self-regulation and social support factors that can improve behavioral and biological outcomes. The utilization of computer-based technology by counselors working with patients and their treatment support partners enables lay counselors with minimal training and supervision to teach complex medical information and problem-solving skills, with culturally relevant, interactive imagery. The intervention also enhances counselor capacity for screening and making referrals for mental health and substance use problems among patients initiating ART. Our pilot study demonstrated high acceptability and feasibility, as well as promising effects on key primary and secondary outcomes. Through a collaboration among City and Provincial DOHs in Cape Town, research and clinical partners in SA (University of Cape Town) and the US (HIV Center for Clinical and Behavioral Studies at NYS Psychiatric Institute/RFMH and CCNMTL at Columbia University), we propose to compare Masivukeni to standard care by randomly assigning 360 patients initiating ART to one of the two study conditions in two publicly financed medical clinics serving predominantly poor communities with high HIV prevalence. Patients will be followed over the course of one year. Assessments will be administered to patients at baseline, 6 months and 12 months post baseline. Through partnership with clinicians and DOH policy-makers, the intervention will be quickly available for wide-scale dissemination if shown to be efficacious. Further, an efficacious intervention of this modality could readily be culturally tailored and implemented in other regions of the world, including the US where long-term adherence remains a challenge, particularly for patients with low literacy and mental health and substance use problems.

DESCRIPTION (provided by applicant): Acute HIV Infection (AHI) - the 10-week period after HIV-infection before antibodies are produced but when viral load is extremely high - plays a critical role in HIV transmission: as many as half of all new HIV infections may be attributable to transmission from an acutely infected person. Current policy and practice for routine HIV testing uses the HIV-antibody test, thus providing negative test results to acutely infected individuals precisely when they are at least 10 times as infectious as at later stages. Yet, those diagnosed with AHI often reduce their risk behaviors, thereby reducing rapid HIV transmission;and early treatment for AHI has short- and long-term individual clinical benefit. Test-and-Treat approaches to HIV prevention are based on expanded HIV-antibody testing combined with antiretroviral therapy to lower viral load. This strategy will be compromised if measures are not taken to improve detection of AHI. Yet, primary (non-HIV) care providers are often not aware of AHI or trained to screen for risk status and order diagnostic tests. Similarly, HIV test counselors are not trained to screen for AHI symptoms or to make warranted referrals for testing. Finally, primary healthcare clinics do not have the tools necessary to adopt structural changes necessary to optimize detection of AHI. To address this evolving public health challenge, this study proposes to develop and evaluate an innovative multi-level, multi-component, structural intervention (implemented at the level of the clinic) to promote routine screening and appropriate testing for AHI by medical care providers HIV-test counselors, and among their patients. The study will compare a "Basic Intervention" to an "Enhanced Intervention" to determine how intensive the intervention needs to be and what resources would be needed for widespread scale-up and dissemination. The study will be conducted in areas of high HIV incidence and prevalence in Bronx, NY by three collaborating partners: The HIV Center for Clinical and Behavioral Studies at the NY State Psychiatric Institute, the NY State Department of Health, AIDS Institute, and the NYC Department of Health and Mental Hygiene. There will also be involvement of local clinical and community stakeholders. Thus this innovative structural intervention has the potential to influence policy at the level of medical care clinics and in directives and guidance from national, state, and local Institutes and Departments of Health, which can in turn, have a large impact on HIV epidemiology, particularly in settings of high HIV incidence, domestically and internationally. PUBLIC HEALTH RELEVANCE: There is compelling evidence that acute HIV infection (AHI) plays a critical role in HIV transmission, because it is a period of time after infection when a person is highly infectious but before antibodies can be detected. As many as half of all new cases of HIV may be due to transmission during this period when the person does not know he/she is infected, and when the person can benefit from early treatment. Thus, increasing detection of AHI in communities of high HIV prevalence and incidence carries significant potential benefits for both the public and individual health.

The Administrative Core provides the coordinating mechanisms for strategic planning and scientific review that continually improves the quality and impact of HIV Center research, while enabling us to open new frontiers in HIV/AIDS research. Effective leadership is critical to forging new scientific and community partnerships that advance HIV/AIDS research. The scientific and programmatic PSO ARC leadership provided through the Administrative Core ensures that the HIV Center's overall scientific vision is realized through our proposed Research Cores and our associated research projects. Under the leadership of Ehrhardt, we established an evolving system of innovations to ensure strategic planning and scientific review. These have included a rotating set of multidisciplinary Senior Scientific Advisors from throughout the US; a Strategic Planning Group of leaders from the US, Africa, Latin America, and Asia; and one of the first Performance and Safety Monitoring Boards for behavioral science research, which has become a model in the field (see SED Core). PSO Center leadership thus receives input to evaluate both Core function and Center research progress from multiple sources, including external advisors, individual Core leadership, and Center investigators (see Section 5.1).

DESCRIPTION (provided by applicant): The New York City-based HIV Center for Clinical and Behavioral Studies is dedicated to multidisciplinary research that will advance the implementation of the US National HIV/AIDS Strategy - to prevent new infections, improve health outcomes for people living with HIV, and reduce health disparities. In 2011, we are at a defining moment in the HIV epidemic with the emergence of effective biomedical approaches to HIV prevention. Yet, without rigorous behavioral and social science research to ensure uptake and adherence, these approaches will not realize their potential. In this renewal application, we propose important reconceptualizations and reconfigurations mobilizing a diverse and multidisciplinary cadre of senior scientists, early stage investigators, practitioners, and policy-makers from multiple academic, community and public health venues to (1) advance the science of HIV prevention, treatment, and care, providing the building blocks for combination prevention, (2) realize the full potential of biomedical HIV prevention and treatment strategies through the application of behavioral and social science theory and research, and (3) apply principles of implementation science to maximize our public health impact. We propose the following six Cores, reflecting our commitment to breaking new ground while building on documented strengths and accomplishments: (1) the Administrative Core to provide leadership that stimulates and manages innovative research through strategic planning, ensuring the highest scientific standards and ethical integrity, and efficient fiscal operations; (2) the Development Core to promote science innovation, provide internal peer review, and nurture early stage investigators; (3) the Intervention Science Core to provide expertise on intervention development and assessment, stimulate the integration of biomedical and behavioral approaches, and advise on the use of community-based participatory research methodologies; (4) the Statistics, Epidemiology and Data Management Core to provide a centralized resource for innovative research designs, statistical analysis, and data management; (5) the Public Health Practice and Policy Core to apply implementation science and ethical and policy analysis to close the gaps among science, public health practice, and policy; and (6) the New Media Core, to integrate new media and information technologies into HIV research and focus on these environments as areas in need of study. The HIV Center provides a rich, value-added resource to a large number of investigators, practitioners, and policy-makers, while attracting and training new investigators and making innovative, scientific, programmatic, and policy contributions that respond to the evolving HIV/AIDS epidemic on a national and international level.

? DESCRIPTION (provided by applicant): In response to RFA-AI-14-071, we propose to determine the utility of assay of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) as an objective measure of adherence to antiretroviral treatment (ART) in South Africa. Measurement of this active antiretroviral medication (ARV) anabolite quantifies medication ingestion, may provide early warning of viremia, and may be used to provide motivating and actionable feedback to patients and providers. Feedback that motivates adherence has additional importance as more patients begin ART earlier in their disease course when they are feeling healthy and, as a result, may have problems sustaining long-term adherence. Routine (often only annual) viral load measurement often misses the opportunity to prevent viremia and/or development of resistant virus. Objective adherence measures could provide timely feedback for earlier intervention, however, existing measures have problems with validity; patient/provider burden; and expense and acceptability. None indicates if a dose is actually ingested. Co-Investigator, Anderson, developed an assay of TFV-DP in DBS that reflects drug ingestion over past weeks/months; research likely to lead to a point- of-care application of this assay is under development. Although the assay has been characterized in HIV- adults, our proposed project would examine its utility for treatment rather than prevention in real-world settings in Sub Saharan Africa. This research will provide critical information without which the effective roll-out of such technologies would be significantly compromised - especially in low-resource settings, such as South Africa. Following our recent pilot study (Remien et al.) using Anderson's DBS TFV-DP assay among HIV+ patients in SA, we propose research on the use of this assay to assess and manage ART adherence in this low-resource setting through two Specific Aims. Aim 1: Among 250 HIV+ adults on ART containing TFV for ?12 months, we will determine the ability of this assay to provide an objective, clinically relevant, and actionable measure of adherence by using monthly drug anabolite and VL assays along with continuous Wisepill output over 12 months. We will compare the abilities of the DBS TFV-DP assay and Wisepill to predict viremia; determine the magnitude of decrease in DBS TFV-DP - in real-world use - that predicts viremia and by how long; and document the range of DBS TFV-DP levels in patients who remain virally suppressed. Aim 2: We will develop messages and procedures for giving patients and providers monthly feedback from the assay and, in a small pilot study (N=60), examine provider and patient behaviors in response to receiving this information. Findings will inform the field and provide pilot data for a future larger trial to establish the imact of such feedback on patients' adherence-related behaviors and on medical management by providers. The proposed research represents an ongoing, innovative, and productive multidisciplinary partnership among behavioral scientists, pharmacologists, and clinicians in the US and South Africa.

Promising new tools for HIV prevention and treatment have stimulated global initiatives to ?End the HIV Epidemic? and reach the ?End of AIDS;? however, significant challenges to ending the global HIV epidemic remain. Biomedical advances for prevention and treatment will not reach their full potential without rigorous behavioral and social science research to optimize uptake, adherence, and equitable and effective implementation and scale-up. Thus, we propose a renewed HIV Center for Clinical and Behavioral Studies that expands on our history of conducting interdisciplinary HIV research and leverages new partnerships to maximize the potential of biomedical advances, addressing their availability and acceptability to the most vulnerable populations. The HIV Center is unique among NIMH AIDS Research Centers (ARCs) in being based in New York City (NYC), a continuing US AIDS epicenter in a state that has the greatest number of people living with HIV (PLWH) in the US, including ethnic/racial minority populations coping with extreme economic, health, and social disparities. In 2014, HIV Center investigators and other academicians, providers, advocates, and policy-makers joined the Office of the Governor of New York State (NYS) to develop a NYS Blueprint for Ending the Epidemic (EtE). The Blueprint provides the HIV Center with the unique opportunity to use our home city and state as a ?laboratory? to study implementation of EtE initiatives and apply lessons learned to US and global epidemics. Thus, in the next five years, the HIV Center will be guided by the theme, The Science of Ending the HIV/AIDS Epidemic (EtE): Efficacy to Effectiveness at Scale, and its emphasis on implementation research and research at the intersection of behavioral, social, and biomedical sciences. The HIV Center brings together a cadre of investigators at the forefront of multiple disciplines to address three Specific Aims: (1) to catalyze intervention and implementation science research necessary to achieve EtE goals; (2) to translate research into culturally and structurally competent practice and policy for maximum public health impact; and (3) to increase the capacity of current and future generations of scientists, service providers, and community and policy leaders to create and implement biomedical, behavioral, social, and structural HIV prevention and treatment interventions to meet EtE goals. Our Cores ensure methodological and theoretical rigor, identify and rapidly respond to new trends in the epidemic, support critical research- practice partnerships, and train new scientists. We complement the Administrative and Development Cores with three Research Cores: (1) Statistics, Assessment, and Data Management (StAD) Core, focused on innovative analytic, assessment, and data management strategies; (2) Bio-Behavioral Core, focused on research at the interface of the biomedical and the behavioral and social sciences; and (3) Implementation Science and Health Outcomes (ISHO) Core focused on effective, sustained, and equitable achievement of HIV prevention and care outcomes at scale.

PROJECT SUMMARY. HIV pre-exposure prophylaxis (PrEP) is a highly effective method to decrease HIV transmission that remains underutilized. This submission is a planning project to engage a Community Collaborative of providers and users of ED services, community-based organization (CBO) staff, and policymakers to develop a set of strategies to incorporate PrEP services in Emergency Departments (EDs) in the four most highly burdened counties in New York State. We will address the ?Prevent Pillar? of the Ending the HIV Epidemic by using an intersectional lens to address key social and structural determinants of HIV. Specifically, offering PrEP in the ED will broaden access to this prevention tool to populations experiencing intersecting vulnerabilities affecting access to health care (e.g., racism, homophobia/transphobia, unstable housing), as these individuals frequently present in EDs for non-emergent care. The proposed work is framed by the Consolidated Framework for Implementation Research (CFIR) and addresses early steps in the PrEP cascade (screening/identification, education/offer of PrEP, PrEP uptake, linkage to primary care). The Specific Aims are to form and work together with a Community Collaborative to: 1) Use data from 40 interviews we will conduct with a wide network of stakeholders (ED staff/clinicians and patients, CBO program staff, and ED administrators that have successfully integrated PrEP in other US hospitals) to identify implementation strategies to address challenges to offering PrEP in urban EDs in high HIV prevalence settings serving sizable populations of vulnerable individuals, and 2) Develop a Toolkit of PrEP service delivery implementation strategies for EDs informed by the Collaborative?s deliberations and review of the stakeholder data. Aims are informed by pilot interviews with ED leaders in our target counties, who described EDs as appropriate sites to identify individuals who could benefit from PrEP but do not have access to it. Yet, despite the potential of EDs to integrate PrEP and promote its uptake, multiple institutional, provider and patient-level challenges need to be addressed. The Collaborative will work with the investigators to iteratively identify what is known and not known (in order to guide the stakeholder interviews), draw on data being collected through these interviews, apply their own knowledge, experience, and expertise, and then formulate a set of strategies to address the challenges associated with providing PrEP in the ED and linking users to ongoing primary care. The primary product(s) of the collaborative are a set of ED-based PrEP implementation strategies, tailored to the needs of individuals with intersecting vulnerabilities. As no single approach will work in all EDs, we will ?package? each strategy, describing its implementation elements (core components, critical resources, staffing, institutional commitments, protocols/workflows) to create a comprehensive Toolkit from which facilities can select to use in their setting. In a future study, we will evaluate these strategies in a diverse set of NYC EDs that serve economically and socially disadvantaged individuals in high HIV prevalence areas.

PROJECT SUMMARY HIV-related stigma is driving suboptimal HIV-related care, thwarting efforts to end the HIV epidemic. Available evidence must be leveraged on how to mitigate HIV-related stigma by implementing evidence-based approaches within healthcare settings. This requires an empirical understanding of how such interventions can best be implemented in real-world environments. Building on the outcomes from our EHE planning supplement ?Building a Coalition to Overcome Intersecting Stigmas and Improve HIV Prevention, Care Access, and Health Outcomes in New York City? and ongoing activities, this study will investigate whether ?Getting To Outcomes? (GTO) ? an evidence-based implementation model that guides institutions through the adoption, implementation, and evaluation of evidence-based intervention programs ? is a feasible and acceptable implementation strategy for addressing HIV-related stigma in a healthcare setting in New York City. By focusing on healthcare, this supplement primarily addresses the EHE pillar Treat and indirectly Diagnose and Prevent. GTO is grounded in implementation theory by integrating all major domains that influence implementation according to the Consolidated Framework for Implementation Research. Three research questions will be answered: (1) Is GTO an acceptable, feasible, and appropriate implementation strategy in healthcare settings for the planning, delivery, and evaluation of an evidence-informed multilevel intervention to reduce HIV-related stigma? (2) Which specific implementation determinants and strategies facilitate engagement in GTO? and (3) Which specific implementation determinants and strategies are associated with the quality of the planning, delivery, and evaluation of an evidence- informed stigma intervention? We will collaborate with the Ryan Chelsea-Clinton Community Health Center (RCC) by training a multidisciplinary Clinic Team in GTO and supporting this team through stigma intervention selection, implementation, and evaluation. As a healthcare clinic, RCC has identified the need to address stigma at the provider and system levels to enhance client engagement and retention, including for the promotion of viral suppression. The GTO process is facilitated by: (1) adapted tools; (2) training of the Clinic Team in using GTO; and (3) technical assistance by an Implementation Coach (IC). To answer research questions, data will be informed by the Consolidated Framework for Implementation Research; Expert Recommendations for Implementing Change; and the Stages of Implementation Completion, and will be collected from a variety of sources over the course of the project including interviews, the IC?s log, meeting minutes, and GTO tools.