Emily C. Williams, Madeline C. Frost, Olivia V. Fletcher, Carol E. Achtmeyer, Jessica A. Chen, Rachel L. Bachrach, E. Jennifer Edelman, Bryan J. Weiner, George N. Ioannou, and Judith I. Tsui
University of Washington affiliated authors are displayed in bold.
Published: August 2026
Seohyun Lee, Gohtbyeol Kim, SeYeon Kim, Narae Kim, Jihye Kim, Jieun Kim, Mohammad Sarwar Basher, Md. Atikur Rahman, Syeda Jamila Siddika, Jahanara Hridita, Golam Fakhruddin, Sharmin Sultana Urmi, Uzzal Kumar Roy & Golam Mothabbir
University of Washington affiliated authors are displayed in bold.
Published: April 2026
Maternal health service utilization remains low in Bangladesh, while maternal health outcomes are poor and adolescent pregnancy rates are high. In this context, targeted social and behavior change communication (SBCC) can be an effective approach. This targeted SBCC research was participatorily designed in collaboration with Bangladesh local partners and was funded as part of the 2023–27 KOICA Strategic Partnership Program (SPP)- Strengthening Maternal and Neonatal Health System in Rangpur, Bangladesh (No. 2023–0515). The study was informed by implementation and behavior change theories, engaging key family members in the intervention.
A hybrid effectiveness-implementation type II cluster-randomized study was designed to measure key maternal health service utilization outcomes as well as implementation outcomes. A total of 750 participants classified into four targeted groups-1) adolescent pregnant women, 2) adult pregnant women, 3) husbands and 4) mothers-in-law, will be invited to participate in group-based interactive community courtyard sessions. These 5-month curriculum targeted SBCC sessions cover maternal and newborn health topics such as antenatal care (ANC), safe delivery, postnatal care (PNC), and neonatal care. The primary outcomes include four or more ANC visits, facility delivery, Postnatal Care (PNC) and neonatal care within 48 h after delivery. Secondary outcomes are perceptions on early marriage, maternal health-seeking behaviors, family support, decision making, and satisfaction with the information gained from the targeted SBCC sessions. To assess the effectiveness, baseline and endline surveys, along with endline focus group discussions (FGDs) will be conducted before and after the 5-month curriculum. Additionally, implementation outcomes such as adoption, penetration, acceptability, coverage, feasibility, fidelity, and sustainability will be measured.
This study engages key decision-makers such as pregnant women, their husbands, and mothers-in-law, to enhance maternal health service utilization. As Bangladesh is a patriarchal society, men within households are often the primary decision-makers regarding marriage and reproductive matters. Moreover, the child marriage and adolescent pregnancy rates remain high, contributing to persistently elevated maternal and neonatal mortality. By applying implementation science frameworks and behavior change theories, this study aims to generate evidence to inform future scale-up efforts in similar contexts.
The protocol was registered with ISRCTN registry under registration ISRCTN12515877.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Aneth Dinis, Quinhas Fernandes, Orvalho Augusto, Bryan J. Weiner, Sarah Gimbel, Ermyas Birru, Dorlim Uetela, Grace John-Stewart, Stephen Gloyd, Isaias Ramiro & Kenneth Sherr
University of Washington affiliated authors are displayed in bold.
Published: December 2025
Assessing implementation fidelity—the degree to which a program is implemented as intended—is essential to understand whether poor outcomes are due to implementation problems or the design of an intervention. Few studies in health research have documented the association between implementation fidelity and effectiveness. The Integrated District Evidence-to-Action (IDEAs) is a multicomponent audit and feedback strategy designed to improve the implementation of maternal and child clinical guidelines in Mozambique. In a previous study, we found mixed results of IDEAs effectiveness. The objective of the present study is to understand how implementation fidelity may have influenced the effectiveness of the strategy.
IDEAs was implemented in 154 health facilities across 12 districts in Manica and Sofala provinces in Mozambique between 2016 and 2020. We used the conceptual framework for implementation fidelity to guide descriptive analysis of IDEAs adherence. Regression modeling was used to study patterns of the direction of association between measures of fidelity and effectiveness for ten service delivery outcomes and five service readiness outcomes.
We describe adherence on 15 measures of fidelity, of which 12 had high fidelity. Poor fidelity was found in conducting facility service readiness assessments and completing micro-interventions from action plans. Service delivery measures tended to be positively associated with participation and degree of micro-intervention completion and negatively associated with a higher number of action plans elaborated by participating teams. For the service readiness outcomes, delivery of essential care was positively associated with participation and micro-intervention completion, and staff availability was negatively associated with supervision.
Participation in audit and feedback meetings, the number of action plans elaborated, and the degree of completion of micro-interventions seem to be related to the effectiveness results. IDEAs should be adapted to reduce the number of action plans elaborated and promote better micro-intervention completion. Additionally, combining audit and feedback strategies with other strategies might enhance effectiveness in service outcomes. This study examines how to analyze the link between fidelity and effectiveness of a strategy to inform better design and recommend context-specific improvements.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Mariana Murea, Kristie L Foley, Samir C Gautam, Jennifer E Flythe , Jochen G Raimann, Emaad Abdel-Rahman, Alaa S Awad, Vandana Dua Niyyar, Cassandra Kovach, Glenda V Roberts, Nicole M Jefferson, Paul T Conway, Laura M Rosales, Jobira Woldemichael, Hiba I Sheikh, Gaurav Raman, Anne M Huml, Daphne H Knicely, Irtiza Hasan, Bhaktidevi Makadia , Janice Lea, John T Daugirdas, Nihan Gencerliler, Jasmin Divers, Peter Kotanko, TwoPlus Research Consortium & Ucheoma C Nwaozuru
University of Washington affiliated authors are displayed in bold.
Published: November 2025
Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.
We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Patty B. Kuo, Amber Calloway, Max A. Halvorson & Torrey A. Creed
University of Washington affiliated authors are displayed in bold.
Published: September 2025
Cognitive behavioral therapy (CBT), an umbrella term for therapeutic techniques guided by cognitive behavioral theory, is an evidence-based approach for many psychiatric conditions in youth. A stronger dose of CBT delivery is thought to improve youth clinical outcomes. While a critical indicator of care quality, measuring the use of CBT techniques feasibly and affordably is challenging. Certain CBT techniques (e.g., more concrete and observable) may be easier to measure than others using low-cost methods, such as clinician self-report; however, this has not been studied.
To assess the concordance of three methods of measuring CBT technique use with direct observation (DO), clinicians from 27 community agencies (n = 126; Mage = 37.7 years, SD = 12.8; 76% female) were randomized 1:1:1 to a self-report, chart-stimulated recall (CSR; semistructured interviews with the chart available), or behavioral rehearsal (BR; simulated role-plays) condition. In previous work using a global score aggregating 12 CBT techniques, only BR produced scores that did not differ from DO. This secondary analysis examined the concordance of these alternate methods with DO for each discrete CBT technique, testing for differential concordance across cognitive techniques (e.g., cognitive education) compared to behavioral techniques (e.g., behavioral activation).
Results of three-level mixed effects regression models indicated that BR scores did not differ significantly from DO for any techniques, and for nine techniques, neither did CSR (all ps > .05). Contrastingly, self-report scores differed from DO for all but one technique, with greater concordance for behavioral than cognitive techniques (z = −3.29, p < .001).
Unlike previous findings using an aggregate score, we found that both BR and CSR did not differ significantly from DO for most techniques tested. These findings have implications within implementation research and usual care settings; they support multiple viable measurement methods that are less resource-intensive than DO.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Simone H Schriger, Steven C Marcus, Emily M Becker-Haimes, Shannon Dorsey, David S Mandell, Bryce D McLeod, Sonja K Schoenwald & Rinad S Beidas
University of Washington affiliated authors are displayed in bold.
Published: September 2025
Cognitive behavioral therapy (CBT), an umbrella term for therapeutic techniques guided by cognitive behavioral theory, is an evidence-based approach for many psychiatric conditions in youth. A stronger dose of CBT delivery is thought to improve youth clinical outcomes. While a critical indicator of care quality, measuring the use of CBT techniques feasibly and affordably is challenging. Certain CBT techniques (e.g., more concrete and observable) may be easier to measure than others using low-cost methods, such as clinician self-report; however, this has not been studied.
To assess the concordance of three methods of measuring CBT technique use with direct observation (DO), clinicians from 27 community agencies (n = 126; Mage = 37.7 years, SD = 12.8; 76% female) were randomized 1:1:1 to a self-report, chart-stimulated recall (CSR; semistructured interviews with the chart available), or behavioral rehearsal (BR; simulated role-plays) condition. In previous work using a global score aggregating 12 CBT techniques, only BR produced scores that did not differ from DO. This secondary analysis examined the concordance of these alternate methods with DO for each discrete CBT technique, testing for differential concordance across cognitive techniques (e.g., cognitive education) compared to behavioral techniques (e.g., behavioral activation).
Results of three-level mixed effects regression models indicated that BR scores did not differ significantly from DO for any techniques, and for nine techniques, neither did CSR (all ps > .05). Contrastingly, self-report scores differed from DO for all but one technique, with greater concordance for behavioral than cognitive techniques (z = −3.29, p < .001).
Unlike previous findings using an aggregate score, we found that both BR and CSR did not differ significantly from DO for most techniques tested. These findings have implications within implementation research and usual care settings; they support multiple viable measurement methods that are less resource-intensive than DO.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Benn Kwach, Josephine B Odoyo, Amber R Lauff, Victor Omollo, Bernard Rono, Vallery Ogello, Victoria Mann, Zachary Kwena, Katherine Thomas, Monisha Sharma, Jennifer F Morton, Kenneth Ngure, Elizabeth Bukusi, Kenneth K Mugwanya & One-Stop PrEP Care Team
University of Washington affiliated authors are displayed in bold.
Published: September 2025
Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.
We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.
Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.
Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.
Protocol version V. 2.0 dated 21 May 2024.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Shumenghui Zhai, Weichao Yuwen, Tiffany L. Zyniewicz, Jennifer Sonney, Jonika Hash, Maida Chen, & Teresa M Ward
University of Washington affiliated authors are displayed in bold.
Published: June 2025
Behavioral intervention technologies (BITs) offer scalable, cost-effective healthcare solutions but often show reduced impacts in community settings and are rarely sustained. Human-centered design (HCD) enhances usability by tailoring BITs to stakeholder needs, while implementation science (IS) identifies contextual barriers and strategies to promote uptake and sustainability. Both HCD and IS aim to improve BIT usability and implementation through iterative, user-focused processes but are rarely integrated.
We introduced the user-centered and sustainable implementation science (USIS) model, a novel and systematic framework that combines HCD and IS principles to enhance BIT effectiveness and sustainability. We aimed to (1) synthesize the HCD and IS outcomes and integrate them into a USIS framework; (2) apply USIS to a case study: the sleep shared-management intervention for children with juvenile idiopathic arthritis and their parents (SLEEPSMART).
We conducted a narrative literature review on HCD and IS outcomes for BITs from the PubMed, CINAHL, and Web of Science databases. Articles were selected based on their focus on usability, implementation outcomes, and evidence-based healthcare practices. This synthesis informed the development of the USIS model.
The USIS model incorporates five domains: (1) user-centeredness (empathy, engagement, and equity), (2) efficiency (cost, timeliness, and rapidity), (3) feasibility (learnability, memorability, error reduction, and low cognitive load), (4) satisfaction (acceptability and appropriateness), and (5) fidelity (adoption, penetration, and sustainability). We applied the USIS model to evaluate the SLEEPSMART project to demonstrate the application of the USIS model in guiding BIT design and refinement. Insights from the review informed the design principles applied during the development and testing stages of SLEEPSMART.
The USIS model serves as a practical and theoretical guide to improve BIT design and evaluation. By emphasizing implementation considerations early and centering user needs, USIS provides a pathway to bridge HCD and IS approaches to enhance the real-world impact and sustainability of digital health innovations.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Shari S. Rogal, Brittney Neely, Monica Merante, Karen Slazinski, Lorenzo McFarland, Christina Brodkorb, Jada Cooper, Carolyn Lamorte, Sandra Gibson, Emily Comstock, Jamie Morano, Marissa Maier, Lauren A. Beste, Karine Rozenberg, Maggie Chartier, Matthew J. Chinman, David Ross & Vera Yakovchenko
University of Washington affiliated authors are displayed in bold.
Published: June 2025
Pre-Exposure Prophylaxis (PrEP) dramatically reduces the likelihood of acquiring human immunodeficiency virus (HIV), yet it remains under-prescribed, particularly for people in communities with high HIV incidence. While implementation science and health services researchers aim to address disparities in care, few interventions have proven effective in doing so. We aimed to identify implementation strategies associated with higher PrEP prescribing rates and pilot test a tailored intervention as a proof-of-concept in a single Veterans Health Administration (VA) facility.
VA clinicians were surveyed using an instrument derived from the Evidence-based Recommendations for Implementing Change taxonomy to assess the use of various strategies for PrEP in fiscal years 2019–2021. Correlational analyses identified the strategies associated with the frequency of PrEP prescribing and semi-structured interviews with personnel from 11 VA medical facilities with high PrEP prescribing refined and manualized these strategies into the Getting to Implementation (GTI)-PrEP playbook. The playbook was subsequently pilot tested in a VA facility with high new HIV diagnosis rates and low PrEP prescribing rates.
The clinician survey collected 157 responses from 95 unique VA facilities on implementation strategy use. Analysis identified eight strategies significantly associated with PrEP prescribing, including: networking, clinician education, clinical support tools, dashboard utilization, telehealth, pharmacist involvement, direct patient engagement, and enhanced sexual health history taking. In the pilot study, the site completed the GTI-PrEP Playbook with high fidelity and newly implemented seven of the eight strategies, achieving a 363% increase in PrEP prescribing rates among Black Veterans over the one-year period.
This multi-year national evaluation identified a core subset of effective implementation strategies for increasing PrEP prescribing. The process of empirically specifying these strategies and pilot testing them through the GTI-PrEP playbook demonstrates a promising, data-driven approach to improve PrEP prescribing rates and reduce racial disparities in HIV prevention.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Shannon Dorsey, Rashed AlRasheed, Suzanne EU Kerns, Rosemary D Meza, Noah Triplett, Esther Deblinger, Nathaniel Jungbluth, Lucy Berliner, Lavangi Naithani, and Michael D Pullmann
University of Washington affiliated authors are displayed in bold.
Published: May 2025
Clinicians need supports beyond training to deliver evidence-based treatments with fidelity. Workplace-based clinical supervision often is a commonly provided support in community mental health, yet too few studies have empirically examined supervision and its impact on clinician fidelity and treatment delivery.
Building on a Washington State-funded evidence-based treatment initiative (CBT+), we conducted a randomized controlled trial (RCT), testing two supervision conditions delivered by workplace-based supervisors (supervisors employed by community mental health organizations). The RCT followed a supervision-as-usual (SAU) phase for comparison. The treatment of focus was trauma-focused cognitive behavioral therapy (TF-CBT). Clinicians (N = 238) from 25 organizations participated in the study across the SAU baseline and RCT phases. In the RCT phase, clinicians were randomized to either symptom and fidelity monitoring (SFM) or SFM and behavioral rehearsal (SFM + BR). For BR, clinicians engaged in a short role play of an upcoming treatment element. Supervisors delivered both conditions, with regular study monitoring for drift. Clinicians audiorecorded therapy sessions with enrolled clients, and masked coders coded a subset of recordings for adherence to TF-CBT. One hundred and thirty-three clinicians had recorded TF-CBT session data for 258 youth. We examined six adherence outcomes, including potential moderators.
Results of generalized estimating equations indicated that there were no real differences on adherence outcomes for experimental conditions (SFM, SFM + BR) compared to SAU. Adherence scores in the baseline SAU phase and the RCT conditions were high. Only one interaction was significant.
Contrary to our hypotheses, we did not see improvements in adherence with the RCT conditions. However, nonsignificant findings seem best explained by clinicians’ acceptable/high adherence in SAU. This study was conducted within the context of a long-standing, state-funded EBT initiative, in which clinicians and their supervisors receive training and support, and in which participating community mental health organizations have adopted and supported TF-CBT.
ClinicalTrials.gov ID: NCT01800266
Clinicians often receive training in evidence-based treatments (EBTs), but training alone is not enough for clinicians to deliver EBTs well. They need other supports. One of the necessary supports is clinical supervision. In public community mental health organizations, which are often resource-constrained, routine clinical supervision is a commonly available support. However, its potential for supporting high-quality EBT delivery is not well understood. This study looked at supervision and clinicians’ delivery of trauma-focused cognitive behavioral therapy (TF-CBT), an EBT for youth who have mental health problems subsequent to trauma. We found that clinicians who received workplace-based supervision on TF-CBT from TF-CBT-trained supervisors, within the context of a state-funded EBT initiative, delivered TF-CBT well. This initiative supported delivery by providing training and supervisor-specific supports. In a second phase of the study, we rigorously tested supervisors’ use of two specific technique packages. These packages included having supervisors review: (a) graphed client mental health symptoms across treatment and clinicians’ report of TF-CBT elements delivered each session or (b) these plus having clinicians do a brief demonstration of how they would deliver an upcoming TF-CBT element to their client, so supervisors could “see” clinicians’ skill and provide feedback. Contrary to expectations, we did not see important differences in clinicians’ TF-CBT delivery. This may be because the clinicians enrolled in our study were already delivering TF-CBT well and, therefore, there was less opportunity for changes. Future studies should explore if these techniques are more helpful for specific situations or clinicians.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**