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

AbstractIntroductionGrowing evidence supports combining social, behavioral 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 maximize uptake, engagement and effectiveness. In New York City (NYC), a multi-component Ryan White-funded medical case management intervention called the Care Coordination Program (CCP) was launched at 28 agencies in 2009 to address barriers to care and treatment. Effectiveness estimates based on >7,000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over ‘usual care’ for short- and long-term viral suppression, with substantial room for improvement.Methods and analysisIntegrating 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 randomized within matched pairs to immediate or delayed CCR implementation. Data from three nine-month periods (pre-implementation, partial implementation and full implementation) will be examined to compare CCR versus CCP effects on timely viral suppression (TVS, within four months of enrollment) among individuals with unsuppressed HIV viral load newly enrolling in the CCR/CCP. Based on estimated enrollment (n=824) and the pre-implementation outcome probability (TVS=0.45), the detectable effect size with 80% power is an odds ratio of 2.90 (relative risk: 1.56).Ethics and disseminationThis 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 registrationRegistered with ClinicalTrials.gov under identifier: NCT03628287, Version 2, 25 September 2019; pre-results.ARTICLE SUMMARYStrengths and limitations of this studyThe PROMISE trial, conducted in real-world service settings, leverages secondary analyses of programmatic and surveillance data to assess the effectiveness of a revised (CCR) versus original HIV care coordination program to improve viral suppression.To meet stakeholder expectations for rapid completion of the CCR rollout, the study applies a stepped-wedge design with a nine-month gap between implementation phases, prompting use of a short-term (four-month) outcome and a brief (five-month) lead-in time for enrollment accumulation.Randomization is performed at the agency level to minimize crossover between the intervention conditions, since service providers would otherwise struggle logistically and ethically with simultaneously delivering the two different intervention models to different sets of clients, especially given common challenges related to reaching agreement on clinical equipoise.1–3The use of agency matching, when followed by randomization within matched pairs, offers advantages akin to those of stratified random assignment: increasing statistical power in a situation where the number of units of randomization is small, by maximizing equivalency between the intervention and control groups on key observable variables, thus helping to isolate the effects of the intervention.3In addition, nuisance parameters are removed through the conditional analytic approach, which accounts and allows for the unavoidably imperfect matching of agencies and arbitrary variation of period effects across agency pairs.4

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

AIDS Education and Prevention ◽

10.1521/aeap.2020.32.4.296 ◽

2020 ◽

Vol 32 (4) ◽

pp. 296-310

Author(s):

Lydia O'Donnell ◽

Mary K. Irvine ◽

Aisha L. Wilkes ◽

Julie Rwan ◽

Athi Myint-U ◽

...

Keyword(s):

New York ◽

Care Coordination ◽

Viral Suppression ◽

Lessons Learned ◽

Hiv Care ◽

Coordinated Care ◽

Team Coordination ◽

Practice Improvement ◽

Ryan White ◽

Wide Scale

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.

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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

BMJ Open ◽

10.1136/bmjopen-2019-034624 ◽

2020 ◽

Vol 10 (7) ◽

pp. e034624

Author(s):

Mary K Irvine ◽

Bruce Levin ◽

McKaylee M Robertson ◽

Katherine Penrose ◽

Jennifer Carmona ◽

...

Keyword(s):

New York ◽

Care Coordination ◽

Viral Suppression ◽

Treatment Effectiveness ◽

Scale Up ◽

Hiv Care ◽

Detectable Effect ◽

Hiv Viral Load ◽

Ryan White ◽

White Part

IntroductionGrowing 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 analysisIntegrating 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 disseminationThis 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 numberRegistered with ClinicalTrials.gov under identifier: NCT03628287, V.2, 25 September 2019; pre-results.

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1311. Ryan White HIV Care Continuum Model Doubled the Rate of Community HIV Viral Suppression for Newly Diagnosed Patients: A 10-Year Review

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.1174 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S473-S473

Author(s):

Christina Rizk ◽

Alice Zhao ◽

Janet Miceli ◽

Portia Shea ◽

Merceditas Villanueva ◽

...

Keyword(s):

Viral Suppression ◽

Linkage To Care ◽

Hiv Care ◽

Hiv Care Continuum ◽

Newly Diagnosed ◽

New Haven ◽

Care Continuum ◽

Art Initiation ◽

Ryan White ◽

Hiv Viral Suppression

Abstract Background It is estimated that 1,295 per 100,000 are people living with HIV (PLWH) in New Haven, which is the second highest rate of HIV prevalence in Connecticut. Since 2009, New Haven has established the Ryan White (RW) HIV Care Continuum. The main goals of HIV care are early linkage to care, ART initiation, and HIV viral suppression. This study is designed to understand the trends and outcomes in newly diagnosed PLWH in New Haven County. Methods This study is a retrospective medical record review of all newly diagnosed RW eligible PLWH from January 1, 2009 to December 31, 2018. The data were collected in REDCap database and included demographics, HIV risk factor, presence of mental health and/or substance abuse disorder, date of diagnosis, date of initial visit, and ART initiation. Health outcomes such as AIDS at diagnosis and rate of viral suppression were evaluated. The data were then analyzed to show the trends over 10 years. Results From January 1, 2009 to December 31, 2018 there were 420 newly diagnosed RW PLWH. Sixty-seven percent of those were male, 56% were non-white, 47% self-identified as Men who have Sex with Men (MSM), and 41% were heterosexual. Twenty-nine percent had AIDS-defining condition at the time of the diagnosis. Thirty-four percent of the 420 patients had a mental health and/or substance use disorder; 53% of those were MSM and 51% were non-white. Over the 10-year period, it was noted that the duration between date of HIV diagnosis and linkage to care as well as ART initiation decreased. This decline was associated with a substantial increase in viral suppression. The average time between the dates of HIV diagnosis and initial visit decreased from 269 days in 2009 to 13 days in 2018. Moreover, the average time between the dates of diagnosis and ART initiation dropped from 308 days in 2009 to 15 days in 2018. The 1-year HIV viral suppression rate subsequently doubled from 44% in 2009 to 87% in 2018 (P < 0.01). Conclusion The Ryan White HIV Care Continuum Model with emphasis on early linkage to care and ART initiation can have a significant impact on HIV viral suppression at a community level for newly diagnosed patients. Another important observation in this study was the alarming high rate of AIDS at diagnosis, which highlights the need for universal HIV testing, and early diagnosis. Disclosures All authors: No reported disclosures.

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High Rates of Retention and Viral Suppression in the US HIV Safety Net System: HIV Care Continuum in the Ryan White HIV/AIDS Program, 2011

Clinical Infectious Diseases ◽

10.1093/cid/ciu722 ◽

2014 ◽

Vol 60 (1) ◽

pp. 117-125 ◽

Cited By ~ 66

Author(s):

R. K. Doshi ◽

J. Milberg ◽

D. Isenberg ◽

T. Matthews ◽

F. Malitz ◽

...

Keyword(s):

Viral Suppression ◽

Safety Net ◽

Hiv Care ◽

Hiv Care Continuum ◽

Care Continuum ◽

Ryan White ◽

The Us ◽

Aids Program ◽

Hiv Aids

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Patients’ perspectives on the development of HIV services to accommodate ageing with HIV: a qualitative study

International Journal of STD & AIDS ◽

10.1177/0956462417735723 ◽

2017 ◽

Vol 29 (5) ◽

pp. 483-490 ◽

Cited By ~ 4

Author(s):

Alex Pollard ◽

Carrie Llewellyn ◽

Vanessa Cooper ◽

Memory Sachikonye ◽

Nicky Perry ◽

...

Keyword(s):

Care Coordination ◽

Service Providers ◽

Hiv Care ◽

Framework Analysis ◽

Hiv Knowledge ◽

Specialist Service ◽

Knowledge And Skills ◽

Hiv Services ◽

Levels Of Care ◽

Patient Confidence

The objective of this study was to identify the aspects of healthcare that are most valued by people with HIV and to describe their concerns and preferences for the future delivery of services for non-HIV-related illness. Twelve focus groups of people receiving HIV care were conducted in community settings in South-East England. Groups were quota sampled based on age, gender, sexual orientation and ethnicity. Data were analysed using Framework Analysis. The results showed that among the 74 respondents (61% male), a preference for maintaining all care within specialist HIV clinics was commonplace, but was highest among participants with more extensive histories of HIV and comorbidities. Participants valued care-coordination, inter-service communication and timely updates to medical notes. There were high levels of concern around HIV skills in general practices and the capacity of general practitioners to manage patient confidentiality or deal appropriately with the emotional and social challenges of living with HIV. Participants valued, and had an overall preference for, the specialist knowledge and skills of HIV services, suggesting that non-HIV-specialist services will need to build their appeal if they are to have a greater future role in the care of people with HIV. Particular concerns that should be addressed include: patient confidence in the HIV knowledge and skills of non-specialist service providers; clear processes for prescribing and referrals; improved levels of care-coordination and communication between services and increased patient confidence in the capacity of primary care to maintain confidentiality and to appreciate the stigma associated with HIV.

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Implementation and evaluation of the ‘Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)’ provider education pilot

BMC Medical Education ◽

10.1186/s12909-021-02991-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Ashley Lacombe-Duncan ◽

Carmen H. Logie ◽

Yasmeen Persad ◽

Gabrielle Leblanc ◽

Kelendria Nation ◽

...

Keyword(s):

Hiv Prevention ◽

Social Service ◽

Service Providers ◽

Scale Up ◽

Hiv Care ◽

Provider Education ◽

Post Intervention ◽

Link Type ◽

Trans Women ◽

Score Range

Abstract Background Transgender (trans) women face constrained access to gender-affirming HIV prevention and care. This is fueled in part by the convergence of limited trans knowledge and competency with anti-trans and HIV-related stigmas among social and healthcare providers. To advance gender-affirming HIV service delivery we implemented and evaluated ‘Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)’. This theoretically-informed community-developed intervention aimed to increase providers’ gender-affirming HIV prevention and care knowledge and competency and reduce negative attitudes and biases among providers towards trans women living with and/or affected by HIV. Methods Healthcare and social service providers and providers in-training (e.g., physicians, nurses, social workers) working with trans women living with and/or affected by HIV (n = 78) participated in a non-randomized multi-site pilot study evaluating TEACHH with a pre-post-test design. Pre- and post-intervention surveys assessed participant characteristics, intervention feasibility (e.g., workshop completion rate) and acceptability (e.g., willingness to attend another training). Paired sample t-tests were conducted to assess pre-post intervention differences in perceived competency, attitudes/biases, and knowledge to provide gender-affirming HIV care to trans women living with HIV and trans persons. Results The intervention was feasible (100% workshop completion) and acceptable (91.9% indicated interest in future gender-affirming HIV care trainings). Post-intervention scores indicated significant improvement in: 1) knowledge, attitudes/biases and perceived competency in gender-affirming HIV care (score mean difference (MD) 8.49 (95% CI of MD: 6.12–10.86, p < 0.001, possible score range: 16–96), and 2) knowledge, attitudes/biases and perceived competency in gender-affirming healthcare (MD = 3.21; 95% CI of MD: 1.90–4.90, p < 0.001, possible score range: 9–63). Greater change in outcome measures from pre- to post-intervention was experienced by those with fewer trans and transfeminine clients served in the past year, in indirect service roles, and having received less prior training. Conclusions This brief healthcare and social service provider intervention showed promise in improving gender-affirming provider knowledge, perceived competency, and attitudes/biases, particularly among those with less trans and HIV experience. Scale-up of TEACHH may increase access to gender-affirming health services and HIV prevention and care, increase healthcare access, and reduce HIV disparities among trans women. Trial registration ClinicalTrials.gov (NCT04096053).

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

PLoS ONE ◽

10.1371/journal.pone.0253444 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0253444

Author(s):

Jacinthe A. Thomas ◽

Mary K. Irvine ◽

Qiang Xia ◽

Graham A. Harriman

Keyword(s):

New York ◽

New York City ◽

Service Utilization ◽

York City ◽

Viral Suppression ◽

Transgender Women ◽

Service Needs ◽

Engagement In Care ◽

Ryan White ◽

Food And Nutrition

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.

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