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Implementation Science at UW

Category: Funding News

Point-Of-Care Viral Load Testing to Enable Task Shifting for Chronic HIV Care

Funding has been awarded to principal investigator Dr. Paul Drain by the NIH National Institute of Allergy and Infectious Diseases for "Point-Of-Care Viral Load Testing to Enable Task Shifting for Chronic HIV Care".

 

Abstract:

Effective management of patients on antiretroviral therapy (ART) is essential to improve clinical outcomes and prevent HIV transmission, but monitoring life-long ART for over 13 million HIV-infected people has become a challenge, particularly in low- and middle-income countries (LMICs). As programs continue to focus on identifying HIV-infected people and starting ART at higher CD4 thresholds, HIV providers have been overburdened, which has resulted in poor retention rates. In addition, laboratories have been working to implement HIV viral load (VL) testing since the World Health Organization's recommendation to move away from routine CD4 count monitoring [WHO, HIV guidelines 2013]. As ART coverage scales up to include millions more people, additional strain will be placed on HIV clinicians and laboratories to manage stable patients on chronic ART. Implementing point-of-care HIV VL testing to enable task shifting to nurses for chronic HIV care may help mitigate these burdens. However, evidence for a combined implementation of point-of-care HIV VL testing and task shifting among healthcare workers as a novel and effective strategy for managing chronic HIV care in LMICs is needed.

The scientific objective of this project is to test the clinical equivalence and reduced cost of implementing a model for chronic HIV care that uses a point-of-care HIV VL assay to enable task shifting among healthcare workers at an urban clinic in South Africa. The central hypothesis is that rapid HIV VL testing, implemented by nurses, is an effective and cost-efficient strategy for management of chronic HIV infection in the majority of patients, thereby allowing more resources to be directed at the minority of patients who need greater attention. The plan to objectively test the central hypothesis will be completed by the following two specific aims: (1) to test the clinical equivalence of an implementation model for chronic HIV care using point-of-care HIV VL testing to enable task shifting in an urban South African clinic, and (2) 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. This work is innovative because it uses a randomized evaluation of an implementation model that combines a novel diagnostic point-of-care test with task shifting among healthcare workers compared to standard of care for chronic HIV care in a resource-limited setting.

This randomized trial will then form the basis of a larger, multi-country proposal to demonstrate the clinical equivalence and cost-effectiveness of implementing an integrated point-of-care HIV VL testing and task shifting model for chronic HIV care in LMICs. If nurses using clinic-based HIV VL testing were cost-effective for achieving both viral suppression and retention in care among patients on ART, then implementation of our chronic HIV care model would alleviate the strain on existing HIV providers and laboratories in LMICs.

Sponsor Award Number: 5R21AI124719-02

Women and HIV: Translation Of Research Into Practice

Funding has been awarded to principal investigator Dr. Carey Farquhar by the NIH Fogarty International Center for "Women and HIV: Translation Of Research Into Practice".

 

Abstract:

To provide optimal HIV treatment and prevent new infections among women and adolescent girls in Kenya, it is necessary to conduct locally relevant research that addresses the know-do gap and can be readily translated into national guidelines, clinical practice and policy. The proposed training program's primary goal is to build capacity at the Kenya Medical Research Institute (KEMRI) in implementation science focused on HIV, women and adolescents while creating bridges to other organizations responsible for healthcare practice and service delivery. KEMRI's strong commitment to conducting research that informs service delivery and improves national health outcomes in Kenya forms the foundation for the program. This foundation is strengthened by the University of Washington's (UW) long-term collaboration with KEMRI and other Kenyan institutions, such as the National AIDS and STD Control Program (NASCOP).

The program will be led by Dr. Carey Farquhar, UW Professor of Medicine, Epidemiology and Global Health, and Director of two large HIV training programs in Africa, and by Dr. Elizabeth Bukusi, an obstetrician-gynecologist with extensive research experience who is currently Deputy Director of Research and Training at KEMRI. The first aim of the proposed program will build implementation science research capacity at KEMRI and NASCOP by training 8 medical doctors in master's and doctoral programs offered by the UW School of Public Health. After 9 months of coursework in Seattle, trainees will return to Kenya for 9 months to conduct implementation science research projects focused on HIV treatment and prevention for women with guidance from a team of UW, KEMRI and NASCOP Core Faculty. During this period they will also complete an externship at the Kenya Ministry of Health, CDC-Kenya, or another governmental or non-governmental organization working in HIV care and prevention for women and adolescents. The program's second aim will further strengthen capacity at KEMRI by supporting medium-term training for 5 faculty who have excelled in teaching and research at the graduate school.

After 5 months at UW, faculty will return to KEMRI equipped to teach new courses in advanced research methods, implementation science and adolescent and women's health and having completed a grant proposal or manuscript related to women and HIV. The third aim will extend the reach of training to a greater number of KEMRI and NASCOP staff by providing 1-week workshops on implementation science, grant writing, and manuscript preparation; 1-day workshops for county medical directors will also be offered in collaboration with KEMRI staff to promote engagement of local care, treatment and prevention leaders in areas where women are hardest hit by the HIV epidemic. This three-tiered approach uses UW's well-established approaches to training, the proposed program to build greatly needed implementation science research capacity at KEMRI and its partner organization NASCOP and change the face of the HIV epidemic for women and adolescent girls in Kenya.

Sponsor Award Number: 5D43TW009783-04

Staff and School Factors Affecting Implementation of ASD Interventions in Schools

Funding has been awarded to principal investigator Jill Locke by the NIH National Institute of Mental Health for "Staff and School Factors Affecting Implementation of ASD Interventions in Schools".

 

Abstract:

The purpose of this K01 Mentored Research Scientist Development Award is to support the applicant in developing the skills necessary to become an independent researcher in the implementation and sustainment of autism-related interventions in school settings. Autism spectrum disorder (ASD) is a complex and lifelong developmental disability that affects 1 in 88 children in the United States. With the growing number of children with ASD enrolled in public schools, it is imperative that schools implement and sustain evidence- based interventions (EBIs) to improve children's academic, behavioral, and social outcomes. The 2012 Interagency Autism Coordinating Committee Strategic Plan for ASD Research states that successful implementation in community settings of EBIs is lacking, and there are no specific studies that examine these issues.

This K01 application capitalizes on an existing university-community partnership with the School District of Philadelphia to systematically examine implementation issues of a district-mandated autism EBI in urban public schools on a large scale. Under the mentorship of David Mandell, ScD, and a team of expert consultants, the proposed training and research activities will enable the applicant to: 1) understand which organizational factors affect implementation in schools; 2) develop expertise in mixed methods design to understand how organizational factors promote or impede implementation processes in public schools; and 3) acquire expertise in developing implementation interventions to address modifiable variables to improve the use and sustainment of autism EBIs in schools.

The research activities associated with these training goals include three aims that build upon each other. Aim 1 will use quantitative methods to examine staff- and school-level factors as predictors of implementation and sustainment of an EBI for children with ASD. Aim 2 will use qualitative methods to further explore the staff-and school-level factors uncovered in Aim 1 by closely examining the implementation processes for a subset of high and low performing classrooms implementing an EBI for children with ASD. Lastly, in Aim 3, the applicant will develop an implementation intervention to support schools in their use and sustainment of autism EBIs.

Findings from the proposed research projects have the potential to provide schools with the necessary supports to use EBIs and markedly improve the academic, behavioral, and social outcomes of children with ASD in public school settings.

Sponsor Award Number: 5K01MH100199-04

Clinic-Based Screening to Prevent HIV-Associated Cryptococcal Mortality

Funding has been awarded to principal investigator Dr. Paul Drain by the NIH National Institute of Allergy and Infectious Diseases for "Clinic-Based Screening to Prevent HIV-Associated Cryptococcal Mortality".

 

Abstract:

Cryptococcal meningitis is a leading cause of AIDS-related mortality worldwide. Circulating cryptococcal antigens can be detected weeks before the onset of neurological symptoms, and pre-emptive anti-fungal therapy can prevent cryptococcal meningitis and death. Unfortunately, most clinics in cryptococcal endemic regions do not have access to laboratory-based testing for cryptococcal antigens. A newly-approved, rapid cryptococcal antigen test can facilitate implementing a clinic-based screening strategy in any resource-limited setting, which, when coupled with oral anti-fungal therapy, could save thousands of lives each year worldwide. However, evidence on the feasibility and impact of conducting point-of-care testing for cryptococcal antigens in a clinic-based setting is needed.

My career goal is to become an independent investigator in clinical research with a focus on implementation science to improve clinical diagnosis and treatment of cryptococcal infections and prevention of cryptococcal meningitis in resource-limited settings. I will draw upon the methodological training of the K23 award and leverage the existing research infrastructure of my co-mentors and collaborators in Durban, South Africa to accomplish my scientific objective: to better understand the value of point-of-care testing, clinic-based screening, and implementation science for cryptococcal disease among HIV-infected adults in resource-limited settings.

My hypothesis is that clinic-based, nurse-driven, point-of-care screening for cryptococcal antigens at the time of initial HIV diagnosis will be feasible and will improve patient outcomes. I will test this hypothesis through the following four specific aims: (1) To estimate CD4-specific prevalence of cryptococcal antigenemia and cumulative incidence of cryptococcal meningitis and mortality for those with and without cryptococcal antigenemia within 12 months of HIV diagnosis in a standard-of-care, lab-based serum CrAg screening program, (2) To evaluate a rapid point-of-care LFA CrAg test by measuring test characteristics of whole blood and urine samples, compared with gold-standard serum-based tests, (3) To estimate cumulative incidence of cryptococcal meningitis and mortality within 12 months of HIV diagnosis when implementing an active, clinic-based screening program for CrAg in urine and/or whole blood among newly- diagnosed HIV-infected adults, and to compare cumulative incidence of cryptococcal meningitis and mortality to the standard-of-care, lab-based serum CrAg screening program (measured in Aim #1), and (4) To assess the long-term clinical outcomes, cost, and cost-effectiveness of intensified CrAg screening, compared to lab- based CrAg screening, among newly-diagnosed HIV-infected adults in South Africa.

I am well positioned to accomplish these aims, based on my educational and mentorship plans, as well as my experience conducting a clinic-based, nurse-driven evaluation of a point-of-care diagnostic test for tuberculosis. I will draw upon the guidance of my renowned mentors and collaborators, who have extensive experience in HIV care, cryptococcal disease, clinical research, evaluating screening strategies, and cost-effectiveness analysis, while also developing my own distinct research trajectory. My approach is innovative by: (1) validating a point-of-care test in a clinical setting by nurses, (2) evaluating the impact of clinic-based screening on patient outcomes, and (3) use of a novel, rapid cryptococcal antigen testing platform. The proposed research is significant because it will provide the tools to implement clinic-based screening for cryptococcus, a common and fatal disease in resource-limited settings, and provide a platform to launch my career as an independent investigator.

Sponsor Award Number: 5K23AI108293-06