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Implementation Science at UW

Category: Funding News

A differentiated care model to improve the efficiency of PrEP delivery in Kenya

Funding has been awarded to principal investigator Dr. Kenneth Mugwanya by the National Institute of Mental Health for "A differentiated care model to improve the efficiency of PrEP delivery in Kenya".

 

Abstract:

PrEP is a potent HIV prevention strategy but maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact. Kenya, with the 4th largest HIV epidemic in the world, officially launched PrEP in May 2017, making it the first African national PrEP program. In collaboration with the Kenyan Ministry of Health, since 2017 we have been conducting a large step-wedge randomized roll-out of PrEP in 24 high-volume (the Partners Scale- Up Project, R01MH095507).The project uses implementation science methods to document the process of PrEP delivery at scale in a national public health model. Our preliminary data show high enthusiasm and uptake for PrEP delivered in HIV clinics, with good continuation and high adherence – but also highlighted inefficiencies including frequent and lengthy visits that burden the health system. For PrEP clients, long waiting times and frequent clinic visits endanger PrEP continuation because of opportunity costs.

In African HIV treatment programs, differentiated care services – i.e., patient-centered strategies that simplify care for most patients, through task shifting or refill-only visits – have been successfully implemented, with improved adherence and viral suppression. For PrEP, similar approaches to streamline patient flow to promote access to and continuation on PrEP need to be clearly defined. We propose to evaluate the feasibility and acceptability of a facility pharmacy-based PrEP refill care pathway (a differentiated care intervention). The core components are: 1) 3-monthly refills, 2) direct-topharmacy refill visits, and 3) HIV self-testing (HIVST) while waiting for refills. We hypothesize that the intervention could streamline client flow in busy HIV care clinics, freeing providers to concentrate on urgent services, reducing client waiting time, minimizing stigma, and improving retention.

In this pilot implementation study, four clinics of comparable patient volume will be randomly allocated to implement either current PrEP patient flow or intervention; primary outcome assessments will at the patient-level. The Specific Aims are: 1) To evaluate whether a differentiated care intervention improves the efficiency of PrEP delivery while resulting in equivalent or better, patient waiting time, PrEP continuation, and adherence; 2) Conduct a mixed methods study to explore acceptability and how HIVST and pharmacy refill visits fit into PrEP provision; and 3) Assess the cost and cost-effectiveness of differentiated delivery of PrEP. We will conduct novel process flow mapping and time and motion studies to define optimal client flow. Relevant constructs of the Consolidated Framework for Implementation
Science Research will be used to explore contextual information on factors important for acceptability, adoption, and maintenance, as well as quality and fidelity of the proposed intervention. Key outcomes will be patient visit time (measure of efficiency), patient satisfaction, PrEP continuation, and PrEP adherence.

The proposed work will advance PrEP delivery in innovative ways, aiming for greater efficiency, reduced workload, diminished client burden, and better outcomes – allowing human and financial resources to be directed to those in most need.

Sponsor Award Number: 4R00MH118134-02

Health Promotion and Disease Prevention Research Centers

Funding has been awarded to principal investigator Dr. Margaret (Peggy) Hannon by the National Center for Chronic Disease Prevention and Health Promotion to renew the "Health Promotion and Disease Prevention Research Centers."

 

Abstract:

In the past three decades, we have learned much about how to prevent and control chronic diseases including cancer and depression; yet stark disparities remain, particularly among low-income adults and adults of color. The Health Promotion Research Center (HPRC) at the University of Washington seeks to eliminate these disparities. Our work focuses on cancer prevention and control, mental health and physical activity of older adults, and workplace health promotion. HPRC’s three evidence-based programs are collectively implemented in more than 45 states, in partnership with strategic translation partners who reach and serve populations experiencing health disparities.

The three programs are EnhanceFitness, a group-based physical activity program for older adults that has been implemented in 46 states and reached more than 80,000 older adults; Workplace Solutions, a suite of workplace health promotion programs that has been delivered to employers in more than 40 states and reached more than 8,000,000 employees and dependents; and the Program to Encourage Active and Rewarding Lives (PEARLS), a depression management program for older adults and the focus of our Core Research Project, which has reached more than 6,200 older adults in 25 states.

In this proposal, we address six interrelated specific aims, three for our Center and three for our Core Research Project. Our Center aims include reducing health disparities through translation of HPRC’s evidence-based programs into practice in new settings reaching underserved populations; building local, state, and national capacity in applied prevention research; and conducting a community-engaged Core Research Project aimed at large-scale implementation of PEARLS in two states. The proposed Center aims will improve health equity among middle-aged and older adults through translating HPRC’s programs with partners and settings that reach populations experiencing health disparities.

Our Core Research Project aims are to develop a community-engaged PEARLS translation strategy that meets the needs of organizations that that serve older adults experiencing disparities related to race/ethnicity, socioeconomic status, rural area of residence, and lack of access to depression care; test the translation strategy in a stepped-wedge, cluster randomized controlled trial in two states; and collaborate with CDC and the PRC Network to disseminate and translate our findings. If successful, our approaches have the potential to improve health equity for middle-aged and older adults experiencing health disparities, and to generate replicable implementation and translation strategies that public health practitioners and researchers can apply to other evidence-based programs.

Sponsor Award Number: 6U48DP006398-01

Population Management for Hereditary Cancer Prevention: Implementation, Effectiveness, and Acceptability Within A Learning Health System

Career development funding has been awarded to Dr. Sarah Knerr by the National Human Genome Research Institute for “Population Management for Hereditary Cancer Prevention: Implementation, Effectiveness, and Acceptability Within a Learning Health System.”

 

Abstract:

The objective of this Mentored Clinical Scientist Research Career Development Award (K08) is to provide Dr. Sarah Knerr with training, mentoring, research experience, and protected time to transition her career into genomic medicine and develop into an independent academic researcher. Dr. Knerr has an MPH in public health genetics and a PhD in health services research. She is currently Acting Assistant Professor, University of Washington Department of Health Services. Her career goals include: (1) conducting health services research that increases the generalizability and relevance of the genomic medicine literature, (2) becoming an expert in evaluating genomic health care delivery interventions, (3) using implementation science tools to accelerate genomic translation, and (4) obtaining funding to support an interdisciplinary research career.

The didactic and experiential training activities outlined in this three-year K08 award will thus provide her with essential skills in leading pragmatic research within learning health care systems, evaluating health care programs using quasi-experimental designs, applying implementation science theories and methods to genomic health care delivery, and developing competitive grant applications. The complementary research project leverages the launch of a hereditary breast and ovarian cancer (HBOC) population management program within the Kaiser Permanente Washington (KPWA) health system. Building on Dr. Knerr’s prior work studying BRCA test utilization trends within KPWA, and through the following specific aims, the proposed study will generate novel data about the implementation, effectiveness, and acceptability of population-focused health care delivery programs in hereditary cancer genomics.

Aim 1 will identify program implementation barriers and facilitators using ethnographic observation, document review, and key informant interviews. Aim 2 will use interviews to investigate patient experiences, satisfaction, and informational needs in the context of a clinical HBOC population management program. Aim 3 will determine program effects on genetic counseling referral and genetic services utilization within the KPWA population using routinely collected administrative data and an interrupted time series study design. This work supports current national priorities in genomic medicine and hereditary cancer prevention and control. Study findings can inform the implementation of genomic screening programs across disease areas, developing the clinical infrastructure needed to translate genomic advances into population-level health improvements.

An outstanding team of mentors and advisors with expertise in genomic medicine, cancer prevention and control, implementation science, health program evaluation, and interrupted time series analysis will support Dr. Knerr in her training and research goals. The K08 activities lay the foundation for future R-level applications focused on refining and testing implementation strategies and supports for HBOC population management programs as well as follow-up studies of long-term program outcomes (e.g., risk management uptake, quality of life, costs) within the KPWA system.

Sponsor Award Number: 1K08HG010488

Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa

Funding has been awarded to principal investigator Dr. Paul Drain (Global Health, Medicine – Infectious Diseases) and co-investigators Dr. Ruanne Barnabas (Global Health, Medicine – Infectious Diseases) and Jane Simoni (Psychology – Global Mental Health) by the National Institute of Allergy and Infectious Diseases for “Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa.”

 

Abstract:

For over 20 million people living with HIV (PLHIV) who are receiving antiretroviral therapy (ART), maintaining adequate ART adherence and receiving routine HIV viral load monitoring are critical to achieving virologic suppression. Management of life-long ART has been challenging for both providers and PLHIV in low- and middle-income countries (LMICs), particularly with respect to poor self-estimation of ART adherence and delays with lab-based testing. Since providers have limited access to drug resistance and ART testing, PLHIV are often switched unnecessarily to more costly second- or third-line ART regimens. In addition, delays in lab-based HIV viral load monitoring can result in prolonged HIV viremia, onward transmission, and poor treatment outcomes. We have completed a pilot study of clinic-based HIV viral load monitoring to demonstrate the initial feasibility, acceptability, and improved clinical outcomes for HIV management in South Africa. We have recently developed a point-of-care (POC) tenofovir adherence assay as a rapid urine dipstick test for improve ART management and adherence in LMICs. As several LMICs, including South Africa, are adopting dolutegravir, tenofovir, and lamivudine (TLD) as a first-line ART regimen, evaluated newer models of HIV care will be critical to maintaining virologic suppression. We propose a study to determine the clinical impact and cost-effectiveness of implementing an integrated model of clinic-based HIV viral load monitoring (time to results in <2 hours) and POC tenofovir adherence testing to improve HIV virological suppression and retention in care among PLHIV in South Africa.

Our long-term goal is to improve clinical HIV diagnosis and management to prevent HIV transmission and reduce AIDS-related mortality in LMICs. Our objective in this application is to test the clinical efficacy and cost of implementing an integrated model for HIV care and ART management that uses clinic-based HIV viral load monitoring and POC tenofovir adherence testing to maintain durable HIV virological suppression among PLHIV in urban and rural South Africa clinics. Our central hypothesis is to prove that clinic-based HIV viral load monitoring and POC tenofovir adherence testing will improve virological suppress and retention in
care, while being preferable and a cost-efficient strategy, for ART management in South Africa. We are well-qualified to answer this question because we have over 10 years of experience conducting clinic-based implementation science research in this HIV-endemic setting, we have a completed a smaller pilot study at the proposed clinical site, and we have established strong partnerships with the South African National Health Laboratory Service (NHLS) and Department of Health.

We will objectively test our central hypothesis with the following specific aims:

Aim #1. To determine if implementing an integrated model for HIV care, using a clinic-based HIV viral load monitoring or a POC tenofovir adherence assay, will improve viral suppression and retention.
Hypothesis: We hypothesize that a model of clinic-based HIV viral load monitoring or POC tenofovir adherence testing will achieve a higher rate of virological suppression and retention, as compared to the standard-of-care (adherence counseling without testing and laboratory-based HIV viral load monitoring).
Approach: At ART initiation, participants will be randomized (1:1:1) into either (1) routine POC adherence testing and counseling; (2) clinic-based HIV viral load monitoring and POC adherence testing and counseling; (3) standard-of-care ART management (adherence counseling without objective testing and laboratory based HIV viral load monitoring). All participants will be followed for 24 months, and we will determine and compare a primary composite outcome of retention and HIV virological suppression on first-line ART.

Aim #2. To determine the feasibility, acceptability, and preferences of using real-time POC adherence testing and HIV viral load monitoring among both patients and providers in South Africa.
Hypothesis: We hypothesize that POC tenofovir adherence testing and HIV viral load monitoring will feasible, acceptable for delivering more efficient HIV care, and will be preferable by both PLHIV and providers.
Approach: We will assess attitudes on POC tenofovir and viral load testing using a mixed-methods approach. We will use semi-structured questionnaires and interview guides to complete serial interviews with participants (weeks 4, 12, 24) and informal small group discussions with PLHIV and providers before and after the study.

Aim #3. To assess the costs, both incurred and averted, of implementing the proposed model in Aim #1, and the cost per HIV-positive person virally suppressed on ART and retained in care.
Hypothesis: We hypothesize that POC adherence testing and HIV viral load monitoring will minimize the costs per PLHIV virally suppressed and retained in care, as compared to the current standard-of-care.
Approach: We will use an activity-based, micro-costing approach to estimate the cost per HIV-positive person virally suppressed and retained in care, as compared to the Standard-of-Care Group.

This innovative work uses a randomized implementation trial of POC testing for both ART adherence and viral load to compare outcomes against the standard of care. At the end of this project we expect to know the clinical effect, acceptability, and cost-effectiveness for implementing an integrated POC testing model for HIV care, which will inform global policy for using POC adherence testing and clinic-based viral load monitoring in LMICs.

Sponsor Award Number: 1R01AI147752

Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury

Funding has been awarded to principal investigator Dr. Monica Vavilala (University of Washington Departments of Anesthesiology and Pain Medicine, Pediatrics) by the National Institute of Neurological Disorders and Stroke (NINDS) for “Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury”.

Abstract:

Traumatic brain injury (TBI) is a public health crisis for children in the US and worldwide. There are no proven therapies to treat TBI, and evidenced-based guidelines have been developed over the past two decades to guide inform the community of best current practices. In prior work, we found that adherence to the TBI guidelines was associated with 6% better outcomes in five leading U.S. academic centers. However, TBI guideline adherence remains low and the guidelines have limitations related to recommendation applicability across health care systems and across countries.

In response, we developed and pilot tested an innovative multilevel Pediatric Guideline Adherence and Outcomes (PEGASUS) program to increase TBI guideline adherence worldwide. Preliminary data show that barriers to TBI guideline adherence are remediable, TBI guideline based intensive care benefits outcomes, and there is organizational readiness to implement and evaluate the PEGASUS program. This proposal is an established collaboration between U.S. and Argentine TBI clinical investigators dedicated to understanding TBI guideline adherence.

The overarching aim of this proposal is to conduct a pragmatic randomized comparative effectiveness trial that directly informs national stakeholders, and targets best practice for the care of children with severe TBI. Specifically, we propose to test the implementation and outcomes of the PEGASUS program (intervention) and to improve TBI guideline adherence (main outcome) in severe pediatric TBI across six Argentine study sites. We propose three Specific Aims: 1) implement and examine the relationship between PEGASUS program implementation and TBI guideline adherence, 2) determine value added process of care associated with TBI guideline adherence, and 3) use computer simulation to develop and disseminate a real world best practice blueprint for adherence to the Pediatric Guidelines. This is a necessary advance and a step towards implementing guideline-based TBI care for children who suffer from TBI.

Sponsor Award Number: 1R01NS106560-01A1

Modeling approaches to prioritize TB prevention among people with HIV in Uganda

Career development funding has been awarded to Dr. Jennifer Ross by the National Institute of Allergy and Infectious Diseases for “Modeling approaches to prioritize TB prevention among people with HIV in Uganda.”

 

Abstract:

The goal of this proposed K01 mentored career development award is to support Dr. Jennifer Ross’s research training in the advanced epidemiologic methods of geospatial and mathematical modeling of HIV and tuberculosis (TB) to further her goal of developing targeting strategies for prevention of TB among people living with HIV (PLHIV). Dr. Ross is currently a senior infectious disease fellow at the University of Washington (UW). This award will support her development in modeling methods and implementation science to facilitate her transition to becoming an independent investigator. She will receive mentorship from Dr. Ruanne Barnabas, Professor Simon Hay, Dr. David Dowdy, and Dr. Judith Wasserheit for this award.

The research goal of the award is to maximize the public health impact of isoniazid preventive therapy (IPT) for TB prevention in HIV-infected individuals using cutting-edge geospatial models that integrate existing epidemiologic information. Tuberculosis (TB) is the leading cause of death among PLHIV in sub-Saharan Africa, including those recently started on antiretroviral (ART) therapy in Uganda. IPT prevents tuberculosis and TB associated mortality among PLHIV, but fewer than 5% of eligible Ugandans receive IPT due to limited resources to successfully implement IPT programs. This award will marry the expanding sources of TB and HIV surveillance data in Uganda with the expertise at UW and the Institute for Health Metrics and Evaluation (IHME) in spatiotemporal and mathematical modeling to produce novel tools that guide IPT implementation.

This K01 proposal will inform the prioritization of IPT through three research aims. In the first aim, Dr. Ross will examine the relationship between ART coverage and geographic predictors of TB with TB-associated mortality among PLHIV using geospatial and mathematical models. In the second aim, Dr. Ross will estimate the impact of IPT implementation on HIV-TB mortality using mathematical models of a regionally-targeted implementation strategy versus uniform roll-out. Finally, in the third aim, Dr. Ross will engage stakeholders to inform model development, evaluate the effect of engagement with the model on stakeholder support of modeling, and facilitate implementation of targeted TB prevention.

This award will support Dr. Ross to dedicate more than 75% of her effort to research as she furthers her learning in the methods and application of state-of-the-art geospatial and mathematical modeling techniques. Acquiring these advanced skills will facilitate her future R01 proposals. With her clinical training in infectious disease, her outstanding mentorship, and the support of this award to further develop her expertise, Dr. Ross will be well-positioned to contribute to the control of TB and HIV epidemics in sub-Saharan Africa.

Sponsor Award Number: 1K01AI138620

Leveraging routing science to optimize ART delivery for efficient scale-up, high ART coverage, and viral suppression in South Africa

Principal investigator Dr. Ruanne Barnabas (Global Health) and co-investigator Dr. Adam Szpiro (Biostatistics) have received funding from the National Institutes of Health for "Leveraging routing science to optimize ART delivery for efficient scale-up, high ART coverage, and viral suppression in South Africa."

 

Abstract:

Globally, half of the world’s 37 million people living with HIV are on antiretroviral therapy (ART) representing immense and encouraging success with access to HIV care. ART prevents disease, death and HIV transmission and HIV-positive persons can expect to live as long as their HIV-negative peers. However, the burden of supplying ART is enormous. In South Africa alone, seven million HIV-positive persons will require ART for life and only 3.3 million are currently on ART. Prescription refills consume 70% of current pharmacy load, contributing to the overcrowding of clinics. Further, over four years, a third of HIV-positive persons are lost from care due to barriers of collecting ART at clinic pharmacies including long waits and inconvenient hours. To address this resupply gap, efforts are underway to support medication refills outside the clinic, including private pharmacy pick-up, but in rural communities without pharmacies and a formal address
system, this has been challenging. How ART delivery will be scaled up and distributed for life to millions of people is a critical question for sustainable HIV treatment.

Decentralized ART delivery, i.e. ART resupply outside the clinic, can increase the number of persons receiving safe ART resupply and monitoring. Specifically, community-based mobile vans are increasingly being tested as a venue for ART resupply and monitoring. Tools are needed to determine where mobile vans should be stationed, the optimal delivery time, and the number clients served. Amazon.com is the largest internet-based retailer in the world with experience delivering goods on time to persons in diverse settings, including rural areas. We will collaborate with Amazon’s routing science scientists and adapt their algorithms to optimize delivery to efficiently meet ART demand. Further, for participants who are willing to pay a delivery fee, home ART delivery can simplify their resupply (the Amazon Prime model). A fee for home delivery of ART could increase engagement in care and offset costs of home delivery. Data driven ART delivery algorithms have the potential to sustain 90% viral suppression among persons on ART.

Working closely with Amazon, we propose to develop and test a software application (Deliver Health) that uses spatial GPS data on where HIV-positive clients live, distance from mobile van potential locations, street maps, and client needs and preferences to inform an objective algorithm. The Deliver Health algorithm uses these data to maximizes the number of clients served by the mobile van location at a specific time. We will compare algorithm and study coordinator determined mobile van placement for ART delivery in a cluster randomized study (N=600). Separately, we will test a fee for home delivery service in a randomized pilot study (N=120) compared to mobile van ART resupply and monitoring. The study outcomes are the proportion of HIV-positive persons virally
suppressed and the number of missed ART refills. We will also assess costs and conduct participatory research to support implementation of decentralized strategies for ART resupply.

Sponsor Award Number: 1R21MH115770-01A1

Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families

Funding has been awarded to principal investigator Dr. J. Randall Curtis by the NIH National Institute of Nursing Research for "Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families".

 

Abstract:

The impact of critical illness is increasing due to our aging population as well as advances in effectiveness and availability of critical care. Critically ill patients and their families suffer a high burden of symptoms of depression, anxiety, and post-traumatic stress due, in part, to fragmented medical care that is often poorly aligned with their goals. Fragmented care includes numerous transitions for patients and families across clinicians and across settings, starting in the ICU and extending to acute care, skilled nursing facilities, or home. As illness progresses, patients and families struggle to navigate the spectrum of goals of care, to match their values and goals with treatments, to communicate their goals to their clinicians, and to make difficult medical decisions without letting unmet emotional needs interfere. Poor communication exacerbated by these transitions compounds an already stressful experience, causing distress to patients and their families. Taken together, these issues lead to ineffective communication during and after the ICU which can often result in high intensity “default” care that may be unwanted.

Using a randomized trial, this application proposes to evaluate an innovative model of care in which ICU nurse facilitators support, model, and teach communication strategies that enable patients and families to secure care in line with their goals over an illness trajectory, beginning in the ICU and continuing into the community. Facilitators will use communication skills, attachment theory, and mediation to improve: 1) patients' and families' self-efficacy to communicate with clinicians within and across settings; 2) patients' and families' outcome expectation that communication with clinicians can improve their care; and 3) patients' and families' behavioral capability through skill building to resolve barriers to effective communication and mediate conflict.

Facilitators will work with seriously ill patients (n=376) and their families (n=564) beginning with a critical care unit stay and following them over the course of 3 months. The intervention's effectiveness will be measured with patient- and family-centered outcomes including symptoms of depression, anxiety, and post-traumatic stress, as well as quality of life and assessments of goal- concordant care, at 1, 3, and 6 months post-randomization. The primary outcome will be family members' burden of symptoms of depression over the 6 months. We will also evaluate whether the intervention improves the value of healthcare by reducing healthcare costs while improving patient and family outcomes. Finally, we will use qualitative methods to explore implementation factors (intervention, settings, individuals, processes) associated with improved implementation outcomes (acceptability, fidelity, penetration) to inform dissemination of this type of intervention to support patients and their families.

This application will address key knowledge gaps while evaluating a methodologically rigorous intervention to improve outcomes for patients with serious illness and their families across the trajectory of care and the spectrum of goals of care.

Sponsor Award Number: 1R01NR018161-01