Cluster Randomized Control Trial 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**}

Effectiveness of the Systems Analysis and Improvement Approach to optimise outpatient mental, neurological, and substance-use disorder treatment cascades in Mozambique: a cluster-randomised trial

✪ 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

✪ 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**}

✪ Not getting better but not getting worse: A cluster randomized controlled pilot trial of a leadership implementation strategy

Abstract:

Background

Implementation of evidence-based practices (EBPs) in schools is fraught with challenges. Even when EBPs are initiated, deterioration of implementation efforts often hinders their long-term success. School leadership behaviors can influence teachers’ EBP implementation. Our study tested an implementation strategy called Helping Educational Leaders Mobilize Evidence (HELM), adapted from the Leadership and Organizational Change for Implementation strategy, to enhance EBP implementation through improvements in school leadership teams’ implementation leadership and climate to buffer against the deterioration of implementation efforts. This study explores the impact of HELM on theorized mechanisms of change (i.e., implementation leadership, climate), educator-level factors (i.e., implementation citizenship), and implementation outcomes (i.e., fidelity, initiative stability).

Method

One school district and 10 schools in Washington participated. Five of the schools were randomized to receive the HELM strategy and the remaining five schools received an alternative leadership training as an implementation attention control. Teachers at every school (n = 341) received training for an EBP called Positive Greetings at the Door that has been previously demonstrated to reduce student behavior problems. Principals and Assistant Principals (n = 18) received the HELM strategy or alternative leadership training. Three district Administrators also participated in HELM as part of the Organizational Strategy Development meetings.

Results

HELM significantly slowed the average decline of implementation leadership (perseverant leadership and communication), three dimensions of implementation climate (recognition, rewards, and existing supports) and total implementation climate, and one dimension of implementation citizenship (keeping informed). No significant effects were found with regard to implementation outcomes (i.e., fidelity, initiative stability).

Conclusions

HELM shows promise in buffering the deterioration of EBP implementation efforts in schools. HELM positively influenced implementation leadership and climate, which are the hypothesized mechanisms for promoting successful long-term implementation efforts. An appropriately powered trial is needed to determine the efficacy of HELM in the future.

Trial Registration Information

Name of the registry: clinicaltrials.gov
Trial registration number: NCT06340074
Date of registration: March 29, 2024. Retrospectively registered
URL of trial registry record: https://clinicaltrials.gov/study/NCT06340074?intr=helm&rank=

Plain Language Summary

Using practices that have been proven to work in research to support youth social, emotional, and behavioral well-being in schools is hard. Efforts to use these practices decrease across the school year. School leadership behaviors can influence educators’ use of these practices. Our study tested an implementation strategy or support designed to help educators use a research-backed practice called Helping Educational Leaders Mobilize Evidence (HELM). HELM was adapted from the Leadership and Organizational Change for Implementation (LOCI) strategy, to enhance school leadership teams’ specific leadership behaviors to protect against the decline in implementation effort. This study explores the impact of HELM on outcomes related to practice use. One school district and 10 schools in western Washington State participated. Five of the schools received the HELM strategy and the remaining five schools received an alternative leadership training. Teachers at every school (n = 341) received training in a practice called Positive Greetings at the Door (PGD) that has been shown to reduce student behavior problems. Principals and Assistant Principals (n = 18) received the HELM strategy or alternative leadership training. Three district administrators also participated in HELM. HELM unexpectedly slowed the average decline of implementation leadership (perseverant leadership and communication), three dimensions of implementation climate (recognition, rewards, and existing supports), total implementation climate, and one dimension of implementation citizenship (keeping informed). No significant effects were found with regard to use of the practice. The HELM strategy shows promise in slowing the deterioration of practice in schools and positively influenced implementation leadership behaviors.

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

✪ Integrating early child development into an existing health and nutrition program: evidence from a cluster-randomized controlled trial

Abstract:

Introduction

In low-resource settings, introducing child health programs into community services may compete for caregiver time. We analyzed the impact of a new early childhood development (ECD) program in rural Madagascar on family attendance at other health services and of adding at-home play materials on program attendance.

Methods

We randomized 75 communities where community health workers (CHWs) implement an existing child health and nutrition program (Projet d’Amélioration des Résultats Nutritionnels or PARN), the status quo. We offered two 6-month cycles of 12 ECD sessions to eligible caregiver-child dyads (6–30 months) in 25 sites [T]; we added take-home play materials in Cycle 2 to 25 sites [T+]. We used differences-in-differences with administrative data to analyze the effect of offering ECD sessions on monthly PARN attendance (T+/T vs. C) among age-eligible children and the impact of toy boxes/libraries on monthly ECD session attendance (T + vs. T). We used random intercept models to analyze characteristics associated with program registration.

Results

We analyzed data for 9,408 dyads; 30% and 32% registered for the program in Cycle 1 and 2 (respectively). On average, CHWs delivered 11.4 sessions (SD: 1.5). Children from wealthier households who already attended PARN sessions were more likely to register, and we found no effect of T or T + on PARN attendance. Adding play materials did not affect monthly ECD session attendance. Children from more populated sites were less likely to participate in both ECD and PARN sessions.

Conclusions

Integrating new services for ECD into the health system was feasible and did not reduce dyad participation in existing services. Investment in health services in more populated areas is needed to provide coverage to all eligible children. Novel strategies should be explored to engage the most vulnerable children in new and existing health services.

Trial registration

AEA Social Science Registry (AEARCTR-0004704) on November 15, 2019 (prospective registration) and ClinicalTrials.gov (NCT05129696) on November 22, 2021 (retrospective registration).

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

✪ Implementation of collaborative care for depression in VA HIV clinics: Translating Initiatives for Depression into Effective Solutions (HITIDES): protocol for a cluster-randomized type 3 hybrid effectiveness-implementation trial

Abstract:

Background

Depression is the most diagnosed mental health condition among people living with HIV. Collaborative care is an effective intervention for depression, typically delivered in primary care settings. The HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) clinical intervention involves a depression care team housed off-site that supports depression care delivery by HIV care providers. In a randomized controlled trial, HITIDES significantly improved depression symptoms for veterans living with HIV and delivered cost savings. However, no HIV clinics in the Veterans Health Administration (VHA) have implemented HITIDES; as such, it is unclear what implementation strategies are necessary to launch and sustain this intervention.

Methods

This hybrid type-3 effectiveness-implementation trial examines the implementation and effectiveness of HITIDES in 8 VHA HIV clinics randomly assigned to one of two implementation arms. Each arm uses a different implementation strategy package. Arm 1 includes an intervention operations guide; an on-site clinical champion who, with the help of a peer community of practice, will work with local clinicians and leadership to implement HITIDES at their site; and patient engagement in implementation tools. Arm 2 includes all strategies from Arm 1 with assistance from an external facilitator. The primary implementation outcomes is reach; secondary outcomes include adoption, implementation dose, depressive symptoms, and suicidal ideation. We will conduct a budget impact analysis of the implementation strategy packages. We hypothesize that Arm 2 will be associated with greater reach and adoption and that Arm 1 will be less costly.

Discussion

Preliminary work identified implementation strategies acceptable to veterans living with HIV and HIV care providers; however, the effectiveness and cost of these strategies are unknown. While the depression care team can deliver services consistently with high quality, the ability of the depression care team to engage with HIV care providers at sites is unknown. Findings from this study will be used to inform selection of implementation strategies for a broad rollout to enhance depression and suicide care for people living with HIV.

Trial registration

ClinicalTrials.gov ID: NCT05901272, Registered 10 May 2023, https://clinicaltrials.gov/study/NCT05901272

Contributions to the literature

It is well-recognized that those with HIV infections need greater access to mental healthcare for depression. But it is not known how best to support deployment of evidence-based mental healthcare to them.
This paper describes an implementation trial to roll out depression care in HIV clinics.
With the fragmentation of care among so many subspecialties, understanding how to roll out mental health support across specialty medical settings is crucial.
Results will be relevant to mental health and suicide support not only for those with HIV but across many sectors of care for adults receiving care in specialty medical settings.

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

✪ Using FRAME to characterize provider-identified adaptations to a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach

Abstract:

Introduction

The Data-informed Stepped Care (DiSC) study is a cluster-randomized trial implemented in 24 HIV care clinics in Kenya, aimed at improving retention in care for adolescents and youth living with HIV (AYLHIV). DiSC is a multi-component intervention that assigns AYLHIV to different intensity (steps) of services according to risk. We used the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) to characterize provider-identified adaptations to the implementation of DiSC to optimize uptake and delivery, and determine the influence on implementation outcomes.

Methods

Between May and December 2022, we conducted continuous quality improvement (CQI) meetings with providers to optimize DiSC implementation at 12 intervention sites. The meetings were guided by plan-do-study-act processes to identify challenges during early phase implementation and propose targeted adaptations. Meetings were audio-recorded and analysed using FRAME to categorize the level, context and content of planned adaptations and determine if adaptations were fidelity consistent. Providers completed surveys to quantify perceptions of DiSC acceptability, appropriateness and feasibility. Mixed effects linear regression models were used to evaluate these implementation outcomes over time.

Results

Providers participated in eight CQI meetings per facility over a 6-month period. A total of 65 adaptations were included in the analysis. The majority focused on optimizing the integration of DiSC within the clinic (83%, n = 54), and consisted of improving documentation, addressing scheduling challenges and improving clinic workflow. Primary reasons for adaptation were to align delivery with AYLHIV needs and preferences and to increase reach among AYLHIV: with reminder calls to AYLHIV, collaborating with schools to ensure AYLHIV attended clinic appointments and addressing transportation challenges. All adaptations to optimize DiSC implementation were fidelity-consistent. Provider perceptions of implementation were consistently high throughout the process, and on average, slightly improved each month for intervention acceptability (β = 0.011, 95% CI: 0.002, 0.020, p = 0.016), appropriateness (β = 0.012, 95% CI: 0.007, 0.027, p<0.001) and feasibility (β = 0.013, 95% CI: 0.004, 0.022, p = 0.005).

Conclusions

Provider-identified adaptations targeted improved integration into routine clinic practices and aimed to reduce barriers to service access unique to AYLHIV. Characterizing types of adaptations and adaptation rationale may enrich our understanding of the implementation context and improve abilities to tailor implementation strategies when scaling to new settings.

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

✪ Scaling up a brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial

Authors:

Sophia M. Bartels, Huong T. T. Phan, Heidi E. Hutton, Do T. Nhan, Teerada Sripaipan, Jane S. Chen, Sarah L. Rossi, Olivia Ferguson, Ha T. T. Nong, Ngan T. K. Nguyen, Le Minh Giang, Hao T. M. Bui, Geetanjali Chander, Hojoon Sohn, Sol Kim, Ha V. Tran, Minh X. Nguyen, Byron J. Powell, Brian W. Pence, William C. Miller & Vivian F. Go

^{University of Washington affiliated authors are displayed in bold.}

✪ Open Access

Published: June 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians’ attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians’ knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use.

Methods

Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians’ alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI.

Participants: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months.

Outcomes: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff’s alcohol use and clinic-level alcohol expectations in the EBAI arm.

Discussion

This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases.

Trial Registration

NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885.

Contributions to the literature

This study tests a novel implementation strategy to educate ART providers and address their attitudes and knowledge about alcohol use and treatment in Vietnam. Few implementation strategies are grounded in an experiential approach to changing provider attitudes and behaviors in contexts where these behaviors are pervasive.
It uses mixed-methods to determine mechanisms influencing scale-up of the brief alcohol intervention (BAI) to inform future implementation of alcohol interventions for people with HIV across settings where alcohol is normalized.
It assesses resource-related costs associated with the experiential BAI (EBAI) and EBAI implementation, which can inform policymakers working to prevent HIV transmission.

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

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✪ Open Access

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Read the full text in the open access journal BMJ Open

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Methods and analysis

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

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✪ Open Access

Read the full text in the open access journal Implementation Research and Practice

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Plain Language Summary

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✪ Open Access

Read the full text in the open access journal BMC Public Health

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✪ Open Access

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

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Methods

Discussion

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✪ Open Access

Read the full text in the open access journal Journal of the International AIDS Society

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Introduction

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Results

Conclusions

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