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Implementation Science at UW

Category: Funding News

Evaluating the Scale-Up of HIV Partner Services in Mozambique

Funding has been awarded to principal investigator Matthew Golden by the National Institutes of Health (NIH) and the US Department of Health and Human Services (DHHS) for "Evaluating the Scale-Up of HIV Partner Services in Mozambique".

 

Abstract:

New World Health Organization guidelines recommend that all persons diagnosed with HIV receive partner notification services (PNS) and the President’s Emergency Program for AIDS Relief (PEPFAR) now requires all PEPFAR supported countries to implement PNS programs. How to implement PNS and whether PNS programs will prove safe and effective as they go to scale is uncertain. The University of Washington International Training and Education Center for Health (I-TECH) has worked with the Mozambican Ministry of Health and PEPFAR since 2016 to implement PNS programs in 29 clinics in Mozambique, providing PNS to over 16,000 persons newly diagnosed with HIV infection. The team implemented PNS using two models, a high-intensity support model that included new, dedicated PNS staff and supervisors in 3 facilities, and a low intensity support model that provided training and quarterly supervision to existing staff in 26 sites.

This application proposes secondary analyses of data collected through PNS scale-up in Mozambique. Specific aim 1 will assess the reach and effectiveness of PNS programs in 29 clinics in Mozambique, comparing outcomes in high and low intensity clinics. Analyses will assess the proportion of persons diagnosed with HIV who received PNS (reach) and will evaluate conventional PNS indices related to partner notification, testing and HIV case-finding. Aim 2 will assess the impact of PNS on the total number of HIV cases identified in 29 clinics in Mozambique, an approach that will overcome many of the biases inherent in more traditional PNS evaluations. This aim will include a stepped-wedge analysis to assess the impact of PNS program implementation on the total number of HIV cases identified in each clinic, comparing high and low-intensity clinics and evaluating reach as a mediator of PNS effectiveness. Finally, aim 3 will evaluate how often disclosure of HIV status to a sex partner was associated with intimate partner violence or loss of financial support from a partner, and will identify factors associated with these adverse outcomes. The results of the proposed analyses will inform how PNS programs are implemented and evaluated in Mozambique and elsewhere around the world.

Sponsor Award Number: 1R03MH123285-01

Field Studies on Feasibility of Elimination of Soil Transmitted Helminths

Funding has been awarded to principal investigator Judd Walson (Global Health) by the London Natural History Museum for "Field Studies on Feasibility of Elimination of Soil Transmitted Helminths".

 

Abstract:

While the NHM is a leader in many areas, the NHM does not have strong core expertise in clinical epidemiology, trial management, biostatistics, implementation science or clinical medicine. All of these are incredible strengths of the University of Washington. The University of Washington START Center will provide background research and analytic support in direct support of several activities supported by this investment. In addition, the Clinical Trials and Implementation Support Unit will provide access to expertise to help develop, guide and manage the proposed investment most effectively. This will include assistance in the design of the proposal and analysis plan, development of SOPs and training of the field sites (in close collaboration with the OT), analysis of data and reporting of results. Each sub-awardee will provide some level of data oversight for their trial site but it is critical that there is a unified harmonized approach to the study and data that can only be provided at a more central level.

Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia

Sub-award funding has been granted to Christopher Kemp (Global Health) by the Center for Infectious Disease Research in Zambia to lead project activities for the NIMH award "Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia" (Principal Investigator: Izukanji Sikazwe).

 

Abstract:

Parent Award

The overall objective of this study is to evaluate implementation strategies that can reduce the science-to- practice gap of evidence-based treatments (EBT) for mental health. Although evidence suggests that mental health treatments are acceptable and efficacious in low-and-middle income countries (LMIC) for the treatment of common mental disorders, there remains a gap in our understanding of how to bring these interventions to scale. A significant challenge is training and sustaining counselors in EBT. We will conduct implementation research evaluating the effectiveness of two Train-the-Trainer (TTT) implementation strategies to increase and sustain the number of counselors in a non-inferiority design.

One TTT strategy is the gold-standard of utilizing expert trainers to conduct in-person training and coaching to produce local trainers. The second strategy is technology based with no experts needed on-site, utilizing phones that function both on and offline and allow for pre-recorded teachings. Trainers (6-8) will be randomized to one of the TTT strategies, and subsequently complete two Common Elements Treatment Approach (CETA) trainings with local lay counselors. A total of 100 lay counselors trained in CETA will serve at least 5 adolescents or young adults under supervision of the local trainers. The transdiagnostic treatment being scaled up, CETA, was effective in two randomized clinical trials in LMIC settings with lay providers.

CETA provides the basis for feasible scale-up through the use a single therapy to treat multiple common mental disorders with varying severities, an approach that is more cost-effective than implementing multiple single-disorder focused psychotherapy treatments in LMIC. Outcomes will include: 1) trainer and counselor competency, knowledge and fidelity through tests, behavioral rehearsal, and audio/video recordings, 2) client mental health symptomatology, and 3) implementation constructs of reach, acceptability, appropriateness, feasibility, and scale-up potential. The cost-effectiveness of the two TTT strategies will also be evaluated. The project will specifically strengthen the capacity of: 1) study staff to conduct mental health implementation science research, 2) counselor and trainers in CETA training, supervision and delivery, and 3) policy and decision makers to interpret and appropriately utilize the scientific evidence to improve mental health policies and programs.

At 15+ organizations with CETA providers, we will set up monitoring systems to assess quality, reach and cost going beyond the study. These aims will contribute to developing dynamic sustainable Learning Health Care Systems in LMIC. This proposal leverages previous studies and strong collaborations in Zambia with the Ministry of Health and numerous local organizations. Results from this trial will produce effectiveness and costing data on 2 TTT strategies that could inform the scale-up potential of diverse EBT in LMIC across and beyond mental health. This research study ultimately addresses both the treatment and implementation gaps in lower-resource settings globally.

 

Sub-Award

Dr. Kemp’s contribution to this study will consist of taking the lead on overall project activities. Over the 3 years of the study, this will include:

  • Recruitment of expert panel
  • Facilitation of modified Delphi process
  • Adaptation of instruments based on Delphi recommendations
  • Development of online data-sharing platform
  • Training Zambia staff on validation study protocol and data collection activities
  • Exploratory data analysis, interpretation, and results write-up
  • Making annual trips to U01 GACD hub meetings to meet with the other program staff

The research assistant (Kristen Danforth)’s contribution to this study will consist of taking the supporting Dr. Kemp’s role as project director and co-investigator. Over the 3 years of the study, this will include:

  • Coordinating and communicating with expert panel
  • Production of study progress reports
  • Troubleshooting online data-sharing platform
  • Development of standard operating procedures for Zambia validation study
  • Data cleaning
  • Support in manuscript write-up

 

Principal Investigator: Izukanji Sikazwe (Center for Infectious Disease Research in Zambia)

Sponsor Award Number: 3R01MH115495-02S1

Digital treatments for opioids and other substance use disorders (DIGITS) in primary care: A hybrid type-III implementation trial

Funding has been awarded to principal investigator Edwin Wong by Kaiser Permanente Washington Health Research Institute for "Digital treatments for opioids and other substance use disorders (DIGITS) in primary care: A hybrid type-III implementation trial".

 

Abstract:

The proposed study addresses a critical gap: how to best implement digital treatments for opioids and other substance use disorders (SUDs) in primary care (PC). In late 2017, the US FDA approved the first ever digital therapeutic for any medical condition, which happens to be for SUD. Pear Therapeutics reSET is a smartphone-based, FDA-approved version of a computerized cognitive-behavioral treatment for SUD, the Therapeutic Educational System (TES). A new version reSET-O is currently under expedited FDA review that can be used with buprenorphine treatment. Therefore, reSET could address a significant barrier to
buprenorphine prescribing in PC: the lack of access to psychosocial treatment. Despite their promise, digital treatments have failed to gain traction in real-world health care. There is a lack of knowledge about how to implement them well.

Our delivery system partners in Kaiser Permanente Washington are committed to collaborating with us to study four approaches to implementing reSET and reSET-O in 25 PC clinics in Washington State using a randomized 2x2 factorial design. These four approaches are (1) “standard implementation”, an evidence-based implementation strategy previously used by our delivery system partners; (2) “standard implementation plus external facilitation”; (3) “standard implementation with a patient coach” to support patient engagement; and (4) “standard implementation with both”. These strategies are proven in PC and address common barriers to addiction interventions and digital treatments.

Specific Aims are to (1) compare implementation outcomes of reach and fidelity of these four approaches for implementing digital treatments in 23 PC clinics, and (2) compare the population-level cost-effectiveness of each implementation approach in achieving reach, fidelity, and abstinence.

IMPACT: Researchers and health systems do not know how to reach large numbers of patients with opioid and other SUDs. Digital treatments are promising, but there is no evidence to guide their implementation. Costly implementation strategies are not always superior. The current study will provide health system leaders with data on how to best implement digital treatments.

PrEP optimized for mothers (PrOM): Efficient PrEP integration in MCH clinics

Funding has been awarded to principal investigator Grace John Stewart and co-principal investigator Pamela Kohler, by the Eunice Kennedy Shriver National Institute of Child Health & Human Development for "PrEP optimized for mothers (PrOM): Efficient PrEP integration in MCH clinics".

 

Abstract:

Women are at increased risk for HIV acquisition during pregnancy and postpartum and pre-exposure prophylaxis (PrEP) could prevent this risk. Thus, maternal child health (MCH) clinics are an important setting for PrEP provision because of high attendance, increased HIV risk during pregnancy/postpartum, existing supply chain for serial HIV testing and drug delivery, lower stigma than accessing PrEP through HIV treatment centers, and in-built follow-up. In regions with high fertility, women spend appreciable time either pregnant or lactating. PrEP integration in MCH clinics not only protects women, it also contributes to elimination of mother-to-child HIV transmission (EMTCT). Postpartum women access family planning at FP clinics after they exit MCH clinics.

Our team pioneered PrEP implementation in MCH and family planning (FP) clinics in Kenya in a PEPFAR-supported DREAMS Innovation Challenge. We screened >20,000 women, of whom 4,378 initiated PrEP. We demonstrated that PrEP was acceptable to women in these clinics and uptake aligned with potential HIV risk. To pilot this concept, new nurses were added to work with MCH and FP clinics to include PrEP provision and to train MCH/FP clinic nurses to sustain PrEP services. In our ongoing R01 (PrEP in adolescent girls and young women (AGYW): a multi-dimensional evaluation), we aim to evaluate adherence in these MCH-PrEP and FP-PrEP clinics and to assess and improve PrEP counseling. For this revision supplement to the parent R01, we seek to identify ways to improve efficiency of PrEP integration within MCH and FP clinics.

Aim 1a. To determine stakeholder views on innovations for effective PrEP integration in MCH and FP clinics, we will conduct in-depth interviews and focus group discussions with policy-makers, program implementers, AGYW (15-24 yrs old), women (25-45 yrs old), and health care workers (HCW).

Aim 1b. To identify health systems issues that enhance or challenge MCH-PrEP and FP-PrEP integration, we will conduct surveys with clinics to assess PrEP integration practices. To identify bottlenecks to PrEP integration, we will conduct flow mapping and time-and-motion of PrEP services in MCH and FP clinics.

Aim 2. To pilot an optimized MCH-PrEP approach (PrEP optimized for mothers- PrOM) that decreases HCW workload and enhances client experience. The PrOM model will combine video-education for PrEP, HIV self-testing at clinic, and optimized dispensing. We will conduct an interrupted time series analysis to compare client and HCW satisfaction and time, as well proportion of clients screened for and initiated on PrEP, and PrEP knowledge before and after implementation of the PrOM approach.

Aim 3. To review evidence and findings from Aims 1 and 2 in a workshop with relevant stakeholders and develop a guide for best practices in MCH-PrEP and FP-PrEP integration.

This supplement will provide Kenya, other high HIV burden countries, and PEPFAR with a model for efficient and effective MCH-PrEP and FP-PrEP integration.

Sponsor Award Number: 3R01HD094630-03S1

Pre-post study of an audit and feedback intervention to reduce intrapartum stillbirth in Mombasa, Kenya

Post-doctoral fellowship funding has been awarded to Dr. Jess Long by the National Institutes of Health to work with mentor Dr. Scott McLelland on "Pre-post study of an audit and feedback intervention to reduce intrapartum stillbirth in Mombasa, Kenya".

 

Abstract:

Stillbirth disproportionately affects those in low-resource settings, with 10-fold higher stillbirth rates in low-income countries compared to high-income countries. This disparity is due in part to gaps in health care delivery; even facilities that are equipped to provide comprehensive emergency obstetric and newborn care (CEmONC) often fail to delivery care quickly and effectively. A third of intrapartum stillbirths (those occurring after the onset of labor) could be prevented through improved labor and delivery management and use of interventions that are known to be efficacious (e.g. cesarean sections).

In this proposal, we aim to assess if an audit and feedback intervention designed to improve quality of care can reduce the rate of intrapartum stillbirth in a CEmONC hospital in a low-resource setting. The aims of this proposal are: 1) to identify health systems factors associated with intrapartum stillbirth that could be addressed by modifying provider behavior; 2) to conduct a pre-post study using interrupted time series analysis to determine if rates of stillbirth are reduced after implementation of an audit and feedback intervention; and 3) to determine the incremental cost and budget impact of the audit and feedback intervention.

The proposed research will use both quantitative and qualitative methods to assess the impact of the audit and feedback intervention on both process indicators (e.g. changes in care delivery) and intrapartum stillbirth rates. Audit and feedback is a flexible approach that allows for context-specific factors to be considered and addressed. If found to be effective and low-cost, this approach could be expanded to other CEmONC facilities in sub-Saharan Africa as a cost-effective means of lowering stillbirth rates.

To conduct this work, the candidate will receive training at the University of Washington, which is a world leader in implementation science research. Her training plan will include a combination of field experience, coursework, supplementary training, and mentorship in implementation science, interrupted time series analysis, and cost analysis. The fellowship will also provide ample opportunities for the candidate to publish original research, present work at international conferences, develop a professional network, and gain experience with grant writing. This set of skills will put her on a path toward a career as an independent investigator.

Sponsor Award Number: 1F32HD100070-01

A pilot one-stop service model to streamline the efficiency of PrEP implementation in public health facilities in Kenya

Funding has been awarded to principal investigator Dr. Jared Baeten by the National Institute of Mental Health for "A pilot one-stop service model to streamline the efficiency of PrEP implementation in public health facilities in Kenya".

 

Abstract:

Maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV-1 prevention. In Africa, PrEP will be added to an already-burdened health infrastructure and the ability of the health systems to maximize PrEP access will necessitate finding novel delivery strategies. Since 2017, in collaboration with the Kenyan Ministry of Health, we have been conducting a large step-wedge randomized roll-out of PrEP delivery in 24 high-volume, PEPFAR-supported, public HIV care facilities in Kenya and use implementation science methods (including the RE-AIM framework) to document the process of PrEP delivery at scale in a national public health model (The Partners Scale Up Project).

Preliminary assessments we done show high enthusiasm and uptake, continuation, and adherence for PrEP delivered in HIV clinics but also highlighted major barriers including lengthy visits with multiple stops (i.e., separate rooms for triage, HIV testing, counseling, clinical review, dispensing, and prescription) that burden the health system. We hypothesize that a nurse-led one-stop delivery model of PrEP could streamline patient flow and improve delivery efficiency in busy HIV care clinics, freeing providers to concentrate on urgent services, reducing client waiting time, minimizing stigma, and improving retention. In the context of our ongoing project, we have assembled a multidisciplinary team, to expand this work to identify more efficient and cost-effective strategies to deliver PrEP at scale by evacuating the feasibility of a highly novel care pathway: nurse-led one-stop PrEP delivery model.

We will conduct this pilot research to develop a nurse-led one-stop PrEP delivery model at 4 PEPFAR supported HIV care clinics in in Kenya. In this pilot study, will enroll up to 200 PrEP users during two serial, four-month periods (100 per period): 1) an observational period with standard patient flow to serve as a contemporaneous control and 2) an observation study period with one-stop-PrEP provision. In the one-stop phase (intervention), all PrEP services (i.e., HIV testing, risk assessment, PrEP prescription, dispensing, and follow-up) will be done in a VCT room by a nurse-counselor. We will conduct novel process flow mapping and time and motion studies during the two periods to identify points of inefficiency and bottlenecks to optimal client flow. Key outcomes will be patient visit time, early PrEP continuation and adherence (quantified by tenofovir levels in dried blood spots). We will use causal inference methods to compare outcomes in the one-stop vs standard practice periods. We will also measure participants’ and providers experiences with nurse-led one stop PrEP delivery using qualitative interviews and patient satisfaction using quantitative exit surveys.

We have already demonstrated in our project that PrEP can be delivered in PEPFAR clinics, by PEPFAR staff; this supplement would extend further, aiming for greater efficiency, reduced workload, diminished client burden, and better outcomes.

Sponsor Award Number: 3R01MH095507-09S1