Protocol Archives - Implementation Science at UW

✪ Targeted social and behavior change communication (SBCC) in a high adolescent pregnancy setting of Bangladesh: a cluster-randomized study protocol engaging key family members

Abstract:

Background

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.

Methods

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.

Discussion

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.

Trial registration

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**}

✪ Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study

Authors:

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.}

✪ Open Access

Published: November 2025

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

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.

Methods and analysis

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**}

✪ Strategies to improve healthcare team communication structure and quality in resource-variable childhood cancer hospitals (TeamTalk): a study protocol

Abstract:

Background

Healthcare team communication is essential to high-quality childhood cancer care, especially during high-acuity events such as clinical deterioration and in resource-variable settings, where supportive interventions to resolve deterioration are less available. Communication quality has traditionally been understudied in these settings, and there is a notable lack of communication interventions that are appropriate and feasible in settings across resource levels. We propose addressing this challenge in this study protocol, which will co-develop and pilot a multi-level intervention to improve communication and outcomes for children receiving cancer treatment.

Methods/design

This study leverages systems and implementation science methodologies to evaluate and improve communication quality in the care of hospitalized children with cancer. We will use a newly developed reliable and multilingual measure of communication quality during clinical deterioration (CritCom). In this study, we will: 1) evaluate the relationship between healthcare team communication structures (using social network analysis) and quality (using CritCom) in the care of children with cancer, with a specific focus on the impact of hierarchy and modifiable communication determinants. We will then: 2) co-develop a multilevel intervention to address challenges in communication quality across variably resourced settings, using semi-structured interviews among clinicians working in these settings and intervention mapping with a global expert panel. Finally, we will 3) test the feasibility, acceptability, appropriateness, and preliminary efficacy of this novel intervention using a cluster-randomized wait list control pilot trial in eight resource-variable hospitals providing childhood cancer care with poor team communication quality.

Discussion

This project identifies modifiable determinants of communication before co-developing and testing interventions with clinicians. When completed, this study will produce an evidence-informed, multilevel intervention to improve healthcare team communication during clinical deterioration, advancing the science of team communication during cancer care, and ultimately improving survival for children with cancer.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya

Abstract:

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Protocol amendments

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**}

Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations

✪ Optimizing healthcare for blood donors at risk of transfusion-transmissible infections: pre-implementation mixed methods protocol

Abstract:

In the Peruvian Amazon, a significant proportion of replacement blood donors test reactive for HIV, HTLV-1/2, and other transfusion-transmissible infections but often receive no subsequent care. Optimizing healthcare for these individuals can mitigate adverse outcomes by enabling early diagnosis and management. Effective coordination between Blood Bank and Infectious Diseases services is essential to provide comprehensive care. To address this challenge, this study applies an Implementation Science approach to design and assess an innovation that enhances healthcare for blood donors affected by transfusion-transmissible infections. A pre-implementation mixed methods study will be conducted at two hospitals in the Peruvian Amazon, employing the Consolidated Framework for Implementation Research (CFIR) and a systems engineering tool (mapping). The study will focus on the inner setting domain of CFIR and map the care continuum to identify contextual determinants that may influence implementation. It has three specific aims planned for the future: first, to use a convergent mixed methods approach to examine the care continuum of blood donors and the inner settings; second, to co-design an innovation through qualitative and participatory methods, integrating Blood Bank and Infectious Diseases services via the hospital information management system; and third, to evaluate the feasibility, appropriateness, and acceptability of the co-designed innovation through a pilot. Replacement blood donation and fragmented healthcare systems are common challenges in other low- and middle-income countries. The findings of this study can inform future implementation research and policy in similar settings.

Paper context

Main findings: This study will co-design and pilot an innovation to improve how blood donors at risk of transfusion-transmissible infections receive screening results, confirmatory testing, and care, by integrating Blood Bank and Infectious Diseases services through digital tools.

Added knowledge: This study employs a participatory, mixed-methods implementation science approach to systematically assess and address gaps in blood donor healthcare, providing a scalable methodology while ensuring context-specific, actionable interventions for resource-limited settings.

Global health impact for policy and action: This study will drive digital innovations in blood donor healthcare to strengthen blood safety and infectious disease control, while framing a pragmatic, adaptable approach for integrating fragmented healthcare systems in resource-limited settings.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Comparing the effectiveness of implementation strategies to improve liver and colon cancer screening for Veterans: protocol for a large cluster-randomized implementation study

Abstract:

Background

Screening for gastrointestinal (GI) cancers, specifically colorectal cancer (CRC) and hepatocellular carcinoma (HCC), is often inadequately and inequitably implemented, leading to preventable morbidity and mortality. This protocol paper describes a study designed to compare the effectiveness of external facilitation with patient navigation across hospitals in the Veterans Health Administration (VA).

Methods

Two hybrid type 3, cluster-randomized trials will compare the effectiveness of patient navigation versus external facilitation for supporting HCC and CRC screening completion. Twenty-four sites will be included in the HCC trial and 32 in the CRC trial, cluster-randomizing Veterans by their site of primary care. The primary outcome of reach of cancer screening completion will be measured after intervention and during sustainment. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants.

Discussion

Comparing findings in the two trials will allow researchers to understand how implementation barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC).

Trial registration

This project was registered at ClinicalTrials.Gov (NCT06458998) on 6/13/24.

Contributions to the literature

This comparative effectiveness trial will compare two evidence-based implementation strategies to improve cancer screening reach.
Comparing a patient-facing to a clinician-facing approach will offer novel insights into what works and for whom.
This trial will assess mechanisms and heterogeneity of treatment effects to inform the science of implementation.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Advancing implementation of single session interventions in schools: a protocol for a qualitative study

Abstract:

Background

Schools are one of the most common settings in which youth seek mental health services, yet existing school-based mental health interventions are often difficult to implement due to time, cost, and staffing limitations. Digital, self-administered Single Session Interventions (SSIs) are evidence-based supports that are intentionally structured to deliver a clinically-meaningful dosage of evidence-based content within one session. Although multiple studies have demonstrated the clinical effectiveness of school-based SSIs, there have been no systemic efforts to understand how SSIs can be practically implemented in schools. The goal of this project is to partner with students, parents, and school staff to identify factors that impact the implementation of SSIs and understand how SSIs can be sustainably integrated as mental health supports into school mental health infrastructure.

Methods

We will conduct focus groups (five groups, total n = 35–45) among community members (i.e., students, parents/caregivers, teachers, school administrators, and school mental health providers) to assess perceived facilitators and barriers to the effective implementation of evidence-based SSIs in schools (Aim 1). We will then work in partnership with community members (n = 10–15) to co-design multi-level implementation strategies (i.e., student-directed, staff-directed, system-directed) for increasing uptake and promoting sustainability of school-based SSIs (Aim 2). We will use inductive coding to thematically analyze qualitative data from group sessions. This study is being conducted within the Lake Washington School District in the Seattle, Washington region.

Discussion

The proposed project will be the first to investigate facilitators and barriers to real-world implementation of SSIs in schools and strategies to improve implementation. Future studies may test the effectiveness of the generated implementation strategies on outcomes such as SSI uptake over time.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Study protocol for testing the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in elementary schools: a hybrid type 3 effectiveness-implementation randomized controlled trial

Abstract:

Background

Schools need to implement universal student supports that prevent social, emotional, and behavioral difficulties; minimize associated risks; and promote social, emotional, and behavioral competencies. The purpose of this study is to examine the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy for promoting school-level implementation leadership, implementation climate, and high-fidelity delivery of an evidence-based practice. We will test HELM with an exemplar EBP, Positive Behavioral Interventions and Supports (PBIS). The specific aims of the study are to: 1) experimentally evaluate the effects of HELM versus PBIS training and technical assistance only (control condition); and 2) explore for whom, under what conditions, how equitably, and through which processes HELM works to improve outcomes, as well as its cost-effectiveness.

Methods

This study will use a hybrid type 3 effectiveness-implementation trial to provide a rigorous test of the effects of HELM in elementary schools. Schools will be randomly assigned to HELM + PBIS training and technical assistance (n = 21 schools; n = 210 educators) or PBIS training and technical assistance only (n = 21 schools; n = 210 educators) in a 1:1 ratio within cohorts using covariate constrained randomization that accounts for degree of prior PBIS exposure (measured using the Tiered Fidelity Inventory at baseline) and school size. A series of mixed effects models (time within educator, educator within school) will test within-subject/between-subject interactions across three timepoints (12 months total) to examine whether HELM will show steeper gains than the control on implementation leadership (primary outcome), implementation climate, PBIS fidelity, and student outcomes. Mediational analyses will test hypothesized mechanisms of change (i.e., implementation leadership and climate) of HELM on PBIS fidelity. Sequential mixed-methods data collection and analyses will further explore how organizational mechanisms are linked to implementation outcomes. Cost-effectiveness analyses will compare costs and outcomes of PBIS training and technical assistance only versus PBIS implementation with HELM.

Discussion

The nature of leadership support in schools can make the difference between successful and unsuccessful EBP implementation. Testing HELM within the context of PBIS implementation will provide rigorous evidence about whether and how HELM can equitably address important EBP and student outcomes.

Trial Registration

Clinical Trials ID: NCT06586723. Date of Registration: August 27, 2024. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06586723?intr=helm&rank=1

Contributions to the Literature

Few effective strategies to enhance evidence-based practice implementation in schools address implementation leadership and climate, and those that do have only been evaluated qualitatively.
Schools have unique organizational characteristics, and it is important to test whether organizational implementation strategies developed in other contexts can be effective in improving implementation outcomes in schools.
This study will evaluate the effects of a tailored adaptation of the Leadership and Organizational Change for Implementation (LOCI) strategy for schools, entitled Helping Educational Leaders Mobilize Evidence (HELM), on implementation mechanisms (implementation leadership and implementation climate), PBIS fidelity, and student outcomes.
This study also will explore for whom, under what conditions, and how equitably HELM demonstrates its effects, providing critical information about influence on – and the limitations of – the impact of this organizational implementation strategy.
Finally, the study will evaluate the processes through which HELM works to improve outcomes, contributing to the emerging literature on implementation mechanisms, as well as its cost-effectiveness.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

Name of the registry
clinicaltrials.gov.

Peer Review reports

✪ Mental health policy implementation in low- and middle-income countries: a realist review protocol

Abstract:

Introduction

Formulating and implementing mental health policy is foundational to public mental health. The implementation of mental health policy varies in low- and middle-income countries (LMICs), with some countries having better implementation outcomes than others. Low implementation poses challenges relating to addressing the high burden and wide treatment gaps of mental health conditions. While different implementation strategies are applied to implement mental health policy in different contexts, there is little knowledge of what category of strategies are being used and how and why their implementation produces varied outcomes. To this end, we propose to conduct a realist synthesis to explain how, why, for whom, and under what health system conditions certain policy implementation strategies work or not in LMICs.

Methods and analysis

This paper will detail the protocol on conducting a realist review of the literature on mental health policy implementation in LMICs. Realist reviews/syntheses are theory-driven reviews designed to formulate and test (confirm, refute, or refine) initial programme theories to explain how, why, for whom and under what contexts a programme, intervention or policy works as intended or not. Theory is built by exploring and abstracting context-mechanism-outcome (CMO) configurations in the data. These CMO configurations are identified through retroductive theorizing, a mechanism-centred approach to theory development. We will adopt these steps to guide the process of realist synthesis: i) identify the research question, clarifying the scope of the review and formulating the initial programme theory (ii) conducting background searches in PubMed, PsycINFO, Africa-Wide Information, African Index Medicus (AIM), CINAHL and Scopus databases, and grey literature (iii) appraising the quality of studies and data extraction and (iv) synthesising data.

Registration

The review is part of a realist evaluation exploring mental health policy implementation in LMICs and is registered under PROSPERO (registration number: CRD42024580312). Findings will inform the development of initial mental health policy implementation programme theories explaining why and how mental health policy implementation in LMICs works.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration

Authors:

✪ Open Access

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Methods and analysis

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science Communication

Abstract:

Background

Methods/design

Discussion

Authors:

✪ Open Access

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Methods and analysis

Ethics and dissemination

Protocol amendments

Authors:

Subscription Required for Full Text Access

Read the full text in the subscription access journal Contemporary Clinical Trials

Authors:

✪ Open Access

Read the full text in the open access journal Global Health Action

Abstract:

Paper context

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration

Contributions to the literature

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Methods

Discussion

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial Registration

Contributions to the Literature

Authors:

✪ Open Access

Read the full text in the open access journal PLOS One

Abstract:

Introduction

Methods and analysis

Registration