Addressing Mental Health Barriers in HIV Care Coordination Is Crucial to Providing Optimal HIV/AIDS Care.

For people with HIV (PWH) who have psychological comorbidities, effective management of mental health issues is crucial to achieving and maintaining viral suppression. Care coordination programs (CCPs) have been shown to improve outcomes across the HIV care continuum, but little research has focused on the role of care coordination in supporting the mental health of PWH. This study reports qualitative findings from the Program Refinements to Optimize Model Impact and Scalability based on Evidence (PROMISE) study, which evaluated a revised version of an HIV CCP for Ryan White Part A clients in New York City. Semistructured interviews were conducted with 30 providers and 27 clients from 6 CCP-implementing agencies to elucidate barriers and facilitators of program engagement. Transcripts were analyzed for key themes related to clients' mental health needs and providers' successes and challenges in meeting these needs. Providers and clients agreed that insufficiently managed mental health issues are a common barrier to achieving and maintaining viral suppression. Although the CCP model calls for providers to address clients' unmet mental health needs primarily through screening and referrals to psychiatric and/or psychological care, both clients and providers reported that the routine provision of emotional support is a major part of providers' role that is highly valued by clients. Some concerns raised by providers included insufficient training to address clients' mental health needs and an inability to document the provision of emotional support as a delivered service. These findings suggest the potential value of formally integrating mental health services into HIV care coordination provision. ClinicalTrials.gov protocol number: NCT03628287.

Loss of Grp170 results in catastrophic disruption of endoplasmic reticulum function.

GRP170 (Hyou1) is required for mouse embryonic development, and its ablation in kidney nephrons leads to renal failure. Unlike most chaperones, GRP170 is the lone member of its chaperone family in the ER lumen. However, the cellular requirement for GRP170, which both binds nonnative proteins and acts as nucleotide exchange factor for BiP, is poorly understood. Here, we report on the isolation of mouse embryonic fibroblasts obtained from mice in which LoxP sites were engineered in the Hyou1 loci (Hyou1LoxP/LoxP). A doxycycline-regulated Cre recombinase was stably introduced into these cells. Induction of Cre resulted in depletion of Grp170 protein which culminated in cell death. As Grp170 levels fell we observed a portion of BiP fractionating with insoluble material, increased binding of BiP to a client with a concomitant reduction in its turnover, and reduced solubility of an aggregation-prone BiP substrate. Consistent with disrupted BiP functions, we observed reactivation of BiP and induction of the unfolded protein response (UPR) in futile attempts to provide compensatory increases in ER chaperones and folding enzymes. Together, these results provide insights into the cellular consequences of controlled Grp170 loss and provide hypotheses as to why mutations in the Hyou1 locus are linked to human disease.

Patient Education and Decision Support for Long-Acting Injectable HIV Antiretroviral Therapy: Protocol for Tool Development and Pilot Testing with Ryan White HIV/AIDS Program Medical Case Management Programs in New York.

BACKGROUND: Long-acting injectable (LAI) HIV antiretroviral therapy (ART) presents a major opportunity to facilitate and sustain HIV viral suppression, thus improving health and survival among people living with HIV and reducing the risk of onward transmission. However, realizing the public health potential of LAI ART requires reaching patients who face barriers to daily oral ART adherence and thus can clinically benefit from alternative treatment modalities. Ryan White HIV/AIDS Program Part A medical case management (MCM) programs provide an array of services to address barriers to HIV care and treatment among economically and socially marginalized people living with HIV. These programs have demonstrated effectiveness in improving engagement along the continuum of care, but findings of limited program impact on durable viral suppression highlight the need to further innovate and hone strategies to support long-term ART adherence. OBJECTIVE: This study aims to adapt and expand Ryan White MCM service strategies to integrate LAI ART regimen options, with the larger goal of improving health outcomes in the populations that could most benefit from alternatives to daily oral ART regimens. METHODS: In 3 phases of work involving patient and provider participants, this study uses role-specific focus groups to elicit perceptions of LAI versus daily oral ART; discrete choice experiment (DCE) surveys to quantify preferences for different ART delivery options and related supports; and a nonrandomized trial to assess the implementation and utility of newly developed tools at 6 partnering Ryan White HIV/AIDS Program Part A MCM programs based in urban, suburban, and semirural areas of New York. Findings from the focus groups and DCEs, as well as feedback from advisory board meetings, informed the design and selection of the tools: a patient-facing, 2-page fact sheet, including frequently asked questions and a side-by-side comparison of LAI with daily oral ART; a patient-facing informational video available on YouTube (Google Inc); and a patient-provider decision aid. Implementation outcomes, measured through provider interviews, surveys, and service reporting, will guide further specification of strategies to integrate LAI ART options into MCM program workflows. RESULTS: The study was funded in late April 2021 and received approval from the institutional review board in May 2021 under protocol 20-096. Focus groups were conducted in late 2021 (n=21), DCEs ran from June 2022 to January 2023 (n=378), and tools for piloting were developed by May 2023. The trial (May 2023 through January 2024) has enrolled >200 patients. CONCLUSIONS: This study is designed to provide evidence regarding the acceptability, feasibility, appropriateness, and utility of a package of patient-oriented tools for comparing and deciding between LAI ART and daily oral ART options. Study strengths include formative work to guide tool development, a mixed methods approach, and the testing of tools in real-world safety-net service settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT05833542; https://clinicaltrials.gov/study/NCT05833542. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56892.

Heterogeneity of provider preferences for HIV Care Coordination Program features: latent class analysis of a discrete choice experiment.

The PROMISE study assessed revisions designed to facilitate implementation of an HIV care coordination program (CCP) addressing gaps in care and treatment engagement among people living with HIV in New York City (NYC). Through latent class analysis (LCA) of a discrete choice experiment (DCE), we explored heterogeneity of provider preferences regarding CCP features. From January-March 2020, 152 NYC CCP providers completed a DCE with 3-4 levels on each of 4 program attributes: 1) Help with Adherence to Antiretroviral Therapy (ART), 2) Help with Primary Care Appointments, 3) Help with Issues Other than Primary Care, and 4) Where Program Visits Happen. We used LCA to assess patterns of preference, and choice simulation to estimate providers' endorsement of hypothetical CCPs. LCA identified three subgroups. The two larger subgroups (n = 133) endorsed more intensive individual program features, including directly observed therapy, home visits, and appointment reminders with accompaniment of clients to their appointments. The smallest subgroup (n = 19) endorsed medication reminders only, appointment reminders without accompaniment, and meeting at the program location rather than clients' homes. Choice simulation analysis affirmed the highest degree of endorsement (62%) for hypothetical programs combining the intensive features described above. Results indicated providers' preference for intensive program features and also reinforced the need for flexible service delivery options. Provider perspectives on service delivery approaches can inform program adjustments for successful long-term implementation, which in turn can improve patient outcomes.

Loss of Grp170 results in catastrophic disruption of endoplasmic reticulum functions.

GRP170, a product of the Hyou1 gene, is required for mouse embryonic development, and its ablation in kidney nephrons leads to renal failure. Unlike most chaperones, GRP170 is the lone member of its chaperone family in the ER lumen. However, the cellular requirement for GRP170, which both binds non-native proteins and acts as nucleotide exchange factor for BiP, is poorly understood. Here, we report on the isolation of embryonic fibroblasts from mice in which LoxP sites were engineered in the Hyou1 loci ( Hyou1 LoxP/LoxP ). A doxycycline-regulated Cre recombinase was also stably introduced into these cells. Induction of Cre resulted in excision of Hyou1 and depletion of Grp170 protein, culminating in apoptotic cell death. As Grp170 levels fell we observed increased steady-state binding of BiP to a client, slowed degradation of a misfolded BiP substrate, and BiP accumulation in NP40-insoluble fractions. Consistent with disrupted BiP functions, we observed reactivation of BiP storage pools and induction of the unfolded protein response (UPR) in futile attempts to provide compensatory increases in ER chaperones and folding enzymes. Together, these results provide insights into the cellular consequences of controlled Grp170 loss and insights into mutations in the Hyou1 locus and human disease.

Client preferences for HIV Care Coordination Program features in New York City: latent class analysis of a discrete choice experiment.

INTRODUCTION: The PROMISE study, launched in 2018, evaluates the implementation of revisions to the HIV Care Coordination Program (CCP) designed to minimize persistent disparities in HIV outcomes among high-need persons living with HIV in New York City. We conducted a discrete choice experiment (DCE) assessing the preferences of CCP clients to inform improvements to the program's design. METHODS: Clients chose between two hypothetical CCP options that varied across four program attributes: help with antiretroviral therapy (ART) adherence (directly observed therapy [DOT] vs. remind via phone/text vs. adherence assessment), help with primary care appointments (remind and accompany vs. remind and transport vs. remind only), help with issues other than primary care (coverage and benefits vs. housing and food vs. mental health vs. specialty medical care) and visit location (meet at home vs. via phone/video vs. program visit 30 or 60 minutes away). The latent class analysis identified different preference patterns. A choice simulation was performed to model client preferences for hypothetical CCPs as a whole. RESULTS: One hundred and eighty-one CCP clients from six sites implementing the revised CCP completed the DCE January 2020-March 2021. Most clients had stable housing (68.5%), reported no problem substance use in the last 3 months (72.4%) and achieved viral suppression (78.5) with only 26.5% receiving DOT within a CCP. 77.3% of responses were obtained before the COVID-19 pandemic. Preferences clustered into three groups. Visit location and ART adherence support were the most important attributes. Group 1 (40%) endorsed telehealth for visit location; telehealth for ART adherence support; and help with securing housing/food; Group 2 (37%) endorsed telehealth for visit location; telehealth for ART adherence support; and staff reminding/arranging appointment transportation; Group 3 (23%) endorsed staff meeting clients at program location and staff working with clients for medication adherence. In the choice simulation, Basic and Medium hypothetical CCPs were endorsed more than Intensive CCPs. CONCLUSIONS: This DCE revealed a strong preference for telehealth and a relatively low preference for intensive services, such as DOT and home visits; preferences were heterogeneous. The findings support differentiated care and remote service delivery options in the NYC CCP, and can inform improvements to CCP design.

Study protocol for data to suppression (D2S): a cluster-randomised, stepped-wedge effectiveness trial of a reporting and capacity-building intervention to improve HIV viral suppression in housing and behavioural health programmes in New York City.

INTRODUCTION: With progress in the 'diagnose', 'link' and 'retain' stages of the HIV care continuum, viral suppression (VS) gains increasingly hinge on antiretroviral adherence among people with HIV (PWH) retained in care. The Centers for Disease Control and Prevention estimate that unsuppressed viral load among PWH in care accounts for 20% of onward transmission. HIV intervention strategies include 'data to care' (D2C)-using surveillance to identify out-of-care PWH for follow-up. However, most D2C efforts target care linkage, not antiretroviral adherence, and limit client-level data sharing to medical (versus support-service) providers. Drawing on lessons learnt in D2C and successful local pilots, we designed a 'data-to-suppression' intervention that offers HIV support-service programmes surveillance-based reports listing their virally unsuppressed clients and capacity-building assistance for quality-improvement activities. We aimed to scale and test the intervention in agencies delivering Ryan White HIV/AIDS Programme-funded behavioural health and housing services. METHODS AND ANALYSIS: To estimate intervention effects, this study applies a cross-sectional, stepped-wedge design to the intervention's rollout to 27 agencies randomised within matched pairs to early or delayed implementation. Data from three 12-month periods (pre-implementation, partial implementation and full implementation) will be examined to assess intervention effects on timely VS (within 6 months of a report listing the client as needing follow-up for VS). Based on projected enrolment (n=1619) and a pre-implementation outcome probability of 0.40-0.45, the detectable effect size with 80% power is an OR of 2.12 (relative risk: 1.41-1.46). ETHICS AND DISSEMINATION: This study was approved by the New York City Department of Health and Mental Hygiene's institutional review board (protocol: 21-036) with a waiver of informed consent. Findings will be disseminated via publications, conferences and meetings including provider-agency representatives. TRIAL REGISTRATION NUMBER: NCT05140421.

Attitudes toward COVID-19 vaccine among pediatric patients with sickle cell disease and their caregivers.

OBJECTIVE: To evaluate attitudes toward vaccination and vaccine uptake regarding coronavirus disease 2019 (COVID-19) among pediatric patients with sickle cell disease (SCD) and their caregivers. PROCEDURE: Adolescent patients and caregivers of children with SCD were surveyed during routine clinic visits; we then conducted a logistic regression analysis to understand differences in vaccine status, while qualitative responses were coded thematically. RESULTS: Among respondents, the overall vaccination rate among adolescents and caregivers was 49% and 52%, respectively. Among the unvaccinated, 60% and 68% of adolescents and caregivers, respectively, preferred to remain unvaccinated, most commonly due to lack of perceived personal benefit from vaccination or mistrust in the vaccine. Multivariate logistic regression analysis showed that child's age (odds ratio [OR] = 1.1, 95% confidence interval [CI]: 1.0-1.2, p < .01) and caregiver education (measured by the Economic Hardship Index [EHI] score, OR = 0.76, 95% CI: 0.74-0.78, p < .05) were independent predictors of getting vaccinated. CONCLUSION: Despite the increased risk of severe illness due to COVID-19 in patients with SCD, vaccine hesitancy remains high in this population of families whose children have SCD. Fortunately, the reasons cited for deferring vaccination among those who are unvaccinated were largely due to barriers that may be overcome with quality communication around the utility of the vaccine and information about vaccine safety.

Gene therapy in sickle cell disease: Attitudes and informational needs of patients and caregivers.

BACKGROUND: Sickle cell disease (SCD) is an inherited blood disorder that results in serious morbidity and early mortality. Novel therapies for SCD, most notably genetic therapies (GTs) and HLA-mismatched donor hematopoietic cell transplantation, are in clinical trials. While potentially curative, these interventions are some of the most intensive treatments for SCD and are associated with serious and life-altering side effects, which may manifest several years after treatment. Little is known about knowledge, beliefs, and attitudes of individuals with SCD, or their caregivers, toward existing and these emerging therapies. METHODS: Patients with SCD at least 13 years of age (n = 66) and caregivers (n = 38) were surveyed about knowledge, attitudes, and beliefs surrounding treatments for SCD. RESULTS: Only 4.8% felt "extremely knowledgeable" about GT for SCD while the majority (63.4%) reported little knowledge. Overall, health literacy was low among respondents. Most respondents had a neutral attitude regarding the safety of GT for SCD, and whether it was a good treatment for the disorder (56.7% and 58.6%, respectively). Only a few respondents endorsed the idea that GT was "unsafe" or "not a good treatment" (5.8% and 4.8%, respectively). There was an association between increasing knowledge about GT and agreement that it is safe (p = .012) and a good treatment for SCD (p = .031). CONCLUSIONS: Given that very few patients with SCD feel knowledgeable about GT and a majority have neutral feelings about the safety and utility of this new approach, culturally appropriate patient-centered education is urgently needed as these treatments get regulatory approval and proceed to the clinic.

Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial.

BACKGROUND: To address challenges with delivery of an evidence-based HIV care coordination program (CCP), the New York City Health Department initiated a CCP redesign. We conducted a site-randomized stepped-wedge trial to evaluate effectiveness of the revised versus the original model. SETTING: The CCP is delivered in New York City hospitals, community health centers, and community-based organizations to people experiencing or at risk for poor HIV outcomes. METHODS: The outcome, timely viral suppression (TVS), was defined as achievement of viral load <200 copies/mL within 4 months among enrollees with unsuppressed viral load (≥200 copies/mL). Seventeen original-CCP provider agencies were randomized within matched pairs to early (August 2018) or delayed (May 2019) starts of revised-model implementation. Data from 3 periods were examined to compare revised versus original CCP effects on TVS. The primary analysis of the intervention effect applied fully conditional maximum likelihood estimation together with an exact, conditional P -value and an exact test-based 95% CI. We assigned each trial enrollee the implementation level of their site (based on a three-component measure) and tested for association with TVS, adjusting for period and study arm. RESULTS: Over 3 nine-month periods, 960 individuals were eligible for trial inclusion (intention to treat). The odds ratio of TVS versus no TVS comparing revised with original CCP was 0.88 (95% CI: 0.45, 1.7). Thus, the revised program yielded slightly lower TVS, although the effect was statistically nonsignificant. TVS was not significantly associated with revised-CCP implementation level. CONCLUSION: Program revisions did not increase TVS, irrespective of the implementation level.

Characterizing Ryan White Part A-funded support service utilization patterns and their association with viral suppression among people with HIV in New York City.

Use of HIV-related support services has been demonstrated to improve outcomes for people living with HIV. Further exploring patterns of use could help identify how and in what settings additional HIV care and treatment adherence support could be provided. We aimed to identify support service utilization patterns and examine their association with viral load suppression (VLS). Our sample comprised 6,581 people with HIV who received Ryan White Part A support services for basic needs (food and nutrition, legal, harm reduction, housing services) in New York City from 1/2013 to 12/2016, but had not received services specifically targeting HIV care and treatment adherence. Five support service utilization classes were identified using latent class analysis, the majority of which were characterized by the predominant use of concrete services (e.g., food assistance). Compared with the low-intensity, sporadic concrete service use class, clients in all other classes had lower odds of VLS in a 365-day follow-up period, but this disadvantage disappeared with adjustment for confounding variables indicative of need. Our findings underscore the impact of need-related barriers on VLS and suggest that long-term service utilization beyond the one year period of this study may be required to diminish their negative effect on HIV outcomes.

Provider preferences for delivery of HIV care coordination services: results from a discrete choice experiment.

INTRODUCTION: The PROMISE study was launched in 2018 to assess and document the implementation of changes to an existing HIV Care Coordination Programme (CCP) designed to address persistent disparities in care and treatment engagement among persons with HIV in New York City. We evaluated provider endorsement of features of the CCP to understand drivers of engagement with the programme. METHODS: We used a discrete choice experiment to measure provider endorsement of four CCP attributes, including: (1) how CCP helps with medication adherence, (2) how CCP helps with primary care appointments, (3) how CCP helps with issues other than primary care and (4) where CCP visits take place (visit location). Each attribute had three to four levels. Our primary outcomes were relative importance and part-worth utilities, measures of preference for the levels of the four CCP program attributes, estimated using a hierarchical-Bayesian multinomial logit model. All non-medical providers in the core CCP positions of patient navigator, care coordinator and programme director or other administrator from each of the 25 revised CCP-implementing agencies were eligible to participate. RESULTS: We received responses from 152 providers, 68% of whom identified as women, 49% identified as Latino/a, 34% identified as Black and 60% were 30-49 years old. Visit location (28.6%, 95% confidence interval [CI] 27.0-30.3%) had the highest relative importance, followed by how staff help with ART adherence (24.3%, 95% CI 22.4-26.1%), how staff help with issues other than primary care (24.2%, 95% CI 22.7-25.7%) and how staff help with primary care appointments (22.9%, 95% CI 21.7-24.1%). Within each of the above attributes, respectively, the levels with the highest part-worth utilities were home visits 60 minutes from the program or agency (utility 19.9, 95% CI 10.7-29.0), directly observed therapy (utility 26.1, 95% CI 19.1-33.1), help with non-HIV specialty medical care (utility 26.5, 95% CI 21.5-31.6) and reminding clients about and accompanying them to primary care appointments (utility 20.8, 95% CI 15.6-26.0). CONCLUSIONS: Ongoing CCP refinements should account for how best to support and evaluate the intensive CCP components endorsed by providers in this study.

Mortality among clients in the New York city HIV Care Coordination Program (CCP): incidence and associated clinical factors.

PURPOSE: We examined psychosocial factors (housing, drug use, incarceration history or mental health) and care factors (comorbidities and acute care) associated with all-cause and HIV-related mortality while enrolled in the New York City Ryan White HIV Care Coordination Program (CCP), an intensive case management program for people with barriers to HIV care and treatment. METHODS: We used hazards regression (HR) to understand factors associated with mortality. RESULTS: 8,135 people (13,479.4 person years [PY]) enrolled in the CCP from March 2011 to December 2016. The all-cause mortality rate while enrolled was 28.8 per 1000 PY (N = 388), with 43% of deaths (N = 167) related to HIV (12.4 per 1000 PY). Controlling for demographics and clinical status, the variables associated with increased hazards of all-cause mortality included hospitalizations or emergency-department visits prior to enrollment (aHRHospitalizations: 2.54; 95% Confidence Interval 2.07-3.11 and aHRED: 1.54; 1.24-1.92) or a diabetes or Hepatitis C diagnosis at enrollment (aHRDiabetes: 1.80; 1.36-2.37 and aHRHCV: 1.78; 1.37-2.30). These factors also increased the hazards of HIV-related mortality. CONCLUSIONS: CCP and similar case management programs should systematically screen enrolling clients for a history of acute care and comorbidities, as they may be important markers of need for more intensive engagement and follow-up to prevent death.

HIV Care Coordination promotes care re-engagement and viral suppression among people who have been out of HIV medical care: an observational effectiveness study using a surveillance-based contemporaneous comparison group.

BACKGROUND: Medical care re-engagement is critical to suppressing viral load and preventing HIV transmission, morbidity and mortality, yet few rigorous intervention studies address this outcome. We assessed the effectiveness of a Ryan White Part A-funded HIV Care Coordination Program relative to 'usual care,' for short-term care re-engagement and viral suppression among people without recent HIV medical care. METHODS: The Care Coordination Program was launched in 2009 at 28 hospitals, health centers, and community-based organizations in New York City. Designed for people with HIV (PWH) experiencing or at risk for poor HIV outcomes, the Care Coordination Program provides long-term, comprehensive medical case management utilizing interdisciplinary teams, structured health education and patient navigation. The intervention was implemented as a safety-net services program, without a designated comparison group. To evaluate it retrospectively, we created an observational, matched cohort of clients and controls. Using the HIV surveillance registry, we identified individuals meeting program eligibility criteria from December 1, 2009 to March 31, 2013 and excluded those dying prior to 12 months of follow-up. We then matched clients to controls on baseline status (lacking evidence of viral suppression, consistently suppressed, inconsistently suppressed, or newly diagnosed in the past 12 months), start of follow-up and propensity score. For this analysis, we limited to those out of care at baseline (defined as having no viral load test in the 12 months pre-enrollment) and still residing within jurisdiction (defined as having a viral load or CD4 test reported to local surveillance and dated within the 12-month follow-up period). Using a GEE model with binary error distribution and logit link, we compared odds of care re-engagement (defined as having ≥ 2 laboratory events ≥ 90 days apart) and viral suppression (defined as having HIV RNA ≤ 200 copies/mL on the most recent viral load test) at 12-month follow-up. RESULTS: Among 326 individuals out of care at baseline, 87.2% of clients and 48.2% of controls achieved care re-engagement (Odds Ratio: 4.53; 95%CI 2.66, 7.71); 58.3% of clients and 49.3% of controls achieved viral suppression (Odds Ratio: 2.05; 95%CI 1.30, 3.23). CONCLUSIONS: HIV Care Coordination shows evidence of effectiveness for care and treatment re-engagement.

Service utilization and HIV outcomes among transgender women receiving Ryan White Part A services in New York City.

BACKGROUND: Prior research has found evidence of gender disparities in U.S. HIV healthcare access and outcomes. In order to assess potential disparities in our client population, we compared demographics, service needs, service utilization, and HIV care continuum outcomes between transgender women, cisgender women, and cisgender men receiving New York City (NYC) Ryan White Part A (RWPA) services. METHODS: The analysis included HIV-positive clients with an intake assessment between January 2016 and December 2017 in an NYC RWPA services program. We examined four service need areas: food and nutrition, harm reduction, mental health, and housing. Among clients with the documented need, we ascertained whether they received RWPA services targeting that need. To compare HIV outcomes between groups, we applied five metrics: engagement in care, consistent engagement in care, antiretroviral therapy (ART) use, point-in-time viral suppression, and durable viral suppression. RESULTS: All four service needs were more prevalent among transgender women (N = 455) than among cisgender clients. Except in the area of food and nutrition services, timely (12-month) receipt of RWPA services to meet a specific assessed need was not significantly more or less common in any one of the three client groups examined. Compared to cisgender women and cisgender men, a lower proportion of transgender women were durably virally suppressed (39% versus 52% or 50%, respectively, p-value < 0.001). CONCLUSIONS: Compared with cisgender women and cisgender men, transgender women more often presented with basic (food/housing) and behavioral-health service needs. In all three groups (with no consistent between-group differences), assessed needs were not typically met with the directly corresponding RWPA service category. Targeting those needs with RWPA outreach and services may support the National HIV/AIDS Strategy 2020 goal of reducing health disparities, and specifically the objective of increasing (to ≥90%) the percentage of transgender women in HIV medical care who are virally suppressed.

STEPS to Care: Translating an Evidence-Informed HIV Care Coordination Program Into a Field-Tested Online Practice Improvement Toolkit.

Increasing care engagement is essential to meet HIV prevention goals and achieve viral suppression. It is difficult, however, for agencies to establish the systems and practice improvements required to ensure coordinated care, especially for clients with complex health needs. We describe the theory-driven, field-informed transfer process used to translate key components of the evidence-informed Ryan White Part A New York City Care Coordination Program into an online practice improvement toolkit, STEPS to Care (StC), with the potential to support broader dissemination. Informed by analyses of qualitative and quantitative data collected from eight agencies, we describe our four phases: (1) review of StC strategies and key elements, (2) translation into a three-part toolkit: Care Team Coordination, Patient Navigation, and HIV Self-Management, (3) pilot testing, and (4) toolkit refinement for national dissemination. Lessons learned can guide the translation of evidence-informed strategies to online environments, a needed step to achieve wide-scale implemention.

PROMISE (Program Refinements to Optimize Model Impact and Scalability based on Evidence): a cluster-randomised, stepped-wedge trial assessing effectiveness of the revised versus original Ryan White Part A HIV Care Coordination Programme for patients with barriers to treatment in the USA.

INTRODUCTION: Growing evidence supports combining social, behavioural and biomedical strategies to strengthen the HIV care continuum. However, combination interventions can be resource-intensive and challenging to scale up. Research is needed to identify intervention components and delivery models that maximise uptake, engagement and effectiveness. In New York City (NYC), a multicomponent Ryan White Part A-funded medical case management intervention called the Care Coordination Programme (CCP) was launched at 28 agencies in 2009 in order to address barriers to care and treatment. Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement. METHODS AND ANALYSIS: Integrating evaluation findings and CCP service-provider and community-stakeholder input on modifications, the NYC Health Department packaged a Care Coordination Redesign (CCR) in a 2017 request for proposals. Following competitive re-solicitation, 17 of the original CCP-implementing agencies secured contracts. These agencies were randomised within matched pairs to immediate or delayed CCR implementation. Data from three 9-month periods (pre-implementation, partial implementation and full implementation) will be examined to compare CCR versus CCP effects on timely viral suppression (TVS, within 4 months of enrolment) among individuals with unsuppressed HIV viral load newly enrolling in the CCR/CCP. Based on current enrolment (n=933) and the pre-implementation outcome probability (TVS=0.54), the detectable effect size with 80% power is an OR of 2.75 (relative risk: 1.41). ETHICS AND DISSEMINATION: This study was approved by the NYC Department of Health and Mental Hygiene Institutional Review Board (IRB, Protocol 18-009) and the City University of New York Integrated IRB (Protocol 018-0057) with a waiver of informed consent. Findings will be disseminated via publications, conferences, stakeholder meetings, and Advisory Board meetings with implementing agency representatives. TRIAL REGISTRATION NUMBER: Registered with ClinicalTrials.gov under identifier: NCT03628287, V.2, 25 September 2019; pre-results.

Social Vulnerabilities and Reported Discrimination in Health Care Among HIV-Positive Medical Case Management Clients in New York City.

We aimed to investigate the extent to which social vulnerabilities correlated with lifetime experience of discrimination in healthcare among people with HIV (PWH) receiving services to improve treatment adherence and viral suppression. Individuals (N=687) enrolled in a Ryan White Part A medical case management program were surveyed about discrimination experienced in healthcare settings, reasons for any discrimination faced, and self-reported health. We merged data from the survey with data from the New York City HIV Surveillance Registry and a programmatic database to obtain client sociodemographic and clinical characteristics and reported history of social vulnerabilities. Thirty-nine percent of participants reported lifetime experience of discrimination in healthcare settings; individuals with a history of at least three social vulnerabilities (mental health diagnosis, incarceration, substance use, and/or housing instability) had more than twice the odds of reporting discrimination than individuals who did not report any of these social vulnerabilities (aOR, 2.33 [95% CI, 1.43 - 3.83]). Among individuals who reported discrimination in healthcare, those who cited HIV status or substance use as reasons for discrimination were significantly more likely to report a higher number of social vulnerabilities (p=0.04 and p=0.009, respectively), with discrimination due to HIV status most strongly associated with a mental health diagnosis. These findings underscore the importance of acknowledging life experience and psychosocial barriers in provider interactions with PWH. They also highlight a need for monitoring provider attitudes and behaviors regarding intersectional stigmas related not only to factors such as race and sexual orientation, but also to social vulnerabilities.

Impact of an HIV Care Coordination Program on the Timeliness of Viral Suppression and Immune Recovery Among Clients Newly Diagnosed with HIV.

We compared the time to immune recovery and viral suppression (VS) among people newly diagnosed with HIV who enrolled in the HIV Care Coordination Program (CCP), a comprehensive medical case management program, with a propensity matched group of newly diagnosed people who did not enroll. CCP enrollees had more rapid VS (≤ 200 copies/mL) [hazards ratio (HR) 1.17; 95% confidence interval 1.02-1.34] but no more rapid immune recovery (≥ two successive CD4 counts > 500 cells/mm3) (HR 0.98; 0.84-1.13). Relative to usual care, the CCP may expedite VS (though not immune recovery) for newly diagnosed HIV patients and therefore lower forward transmission risk.