Protocol Archives - Page 4 of 7 - Implementation Science at UW

✪ Enhancing the Introduction and Scale Up of Self-Administered Injectable Contraception (DMPA-SC) in Health Systems (the EASIER Project): Protocol for Embedded Implementation Research

Abstract:

Background

The introduction of self-administered injectable contraception presents an opportunity to address the unmet need for family planning. As ministries of health scale up self-administered injectable contraception, there is a scarcity of knowledge on the implementation practices and contextual conditions that help and hinder these efforts. The World Health Organization has launched the “enhancing self-administered family planning through embedded research project” (EASIER) to address this challenge.

Objective

EASIER’s objectives are to: (1) assess the coverage of self-injectable contraception, and the readiness of health systems to integrate it into the contraceptive method mix; (2) document strategies used to introduce and scale up self-injectable contraception and understand practices that have led to success and challenges; (3) identify the contextual factors that affect the adoption and implementation of self-injectable contraception throughout health systems; (4) understand whether implementation addresses users’ preferences and needs; (5) strengthen collaboration between decision makers, researchers, and implementers; support and build capacity to use evidence.

Methods

EASIER developed a global protocol that implementation research (IR) teams in Burkina Faso, Ghana, and Kenya adapted into country-level embedded IR projects. In all countries (1) at the national level, IR teams evaluate the policy environment for scaling up by conducting a desk review and in-depth interviews; (2) at the local level, IR teams implement quantitative questionnaires on structural and organizational readiness to integrate self-injection into the method mix; (3) in “case study” localities, IR teams conduct in-depth interviews and focus group discussions with implementers, method users, and community members; and (4) IR teams use participatory action research to elicit stakeholder participation and translate findings into programmatic decisions.

Results

EASIER has been launched in all 3 countries. Preliminary findings are available from Burkina Faso and Kenya. In Burkina Faso, IR teams identified the need to strengthen health worker training approaches to ensure that family planning providers at primary health care facilities are adequately oriented to depo-medroxyprogesterone acetate subcutaneous (DMPA-SC) and self-injection and capacitated to initiate women to the method. In addition, they report the need for service communication strategies that reach potential users of the method with knowledge about self-injection and how to initiate the practice. In Kenya, the findings illuminate the need for practice guidelines that county health teams can use to coordinate the rollout of self-administered DMPA-SC. In addition, Kenya’s findings underscore the importance of addressing logistical bottlenecks to help avoid stock-outs.

Conclusions

EASIER presents a strategy to embed IR in contraceptive method introduction and scale-up, address local knowledge needs, devise ways to maximize the impact of new technologies in health systems, and build capacity for using evidence in programmatic decisions. Adaptation and implementation of country-level IR studies will advance the use of IR to strengthen family planning programs.

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

✪ HPV vaccination in Kenya: a study protocol to assess stakeholders’ perspectives on implementation drivers of HPV vaccination and the acceptability of the reduced dose strategy among providers

Abstract:

Background:

Cervical cancer is the leading cause of cancer-related deaths among Kenyan women. Persistent infection with high-risk oncogenic Human papillomavirus (HPV) genotypes is a necessary cause of cervical cancer. HPV vaccines are safe, durable, and efficacious in preventing incident HPV infections. In Kenya, despite efforts to increase HPV vaccination, coverage remains low. We sought to assess: (1) barriers and facilitators of HPV vaccination from the perspective of adolescent girls and young women (AGYW), their guardians as well as stakeholders involved in HPV vaccine delivery, and (2) the acceptability of the single dose of the HPV vaccination among healthcare providers (HCPs).

Methods:

Our study is nested within the KENya Single-dose HPV-vaccine Efficacy study (KEN SHE) that sought to test the efficacy of single-dose bivalent (HPV 16/18) and single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) vaccination. We are conducting this study in Kiambu, Nairobi, and Kisumu counties. In these counties, we are interviewing stakeholders (n = ∼25), selected based on their role in HPV vaccination at the county and national levels. Interviews are audio recorded and conducted in English or Swahili. The semi-structured interview guides were designed based on: (1) the Theoretical Domains Framework (TDF) for AGYW and guardians and (2) the Consolidated Framework for Implementation Research (CFIR) for other stakeholders. The Theoretical Framework of Acceptability (TFA) was leveraged to design the survey administered to HCPs (n = ∼309) involved in HPV vaccination. We will develop a codebook based on emerging codes from the transcripts and constructs from the TDF and CFIR. Emerging themes will be summarized highlighting similarities and differences between and within the different stakeholder groups and counties. Descriptive statistics and a χ2 test will be used to assess the distribution of responses between the different sites and regression analysis will be used to assess factors associated with high acceptability of the single-dose strategy while controlling for confounding variables.

Discussion:

Our study will describe key barriers and facilitators that affect HPV vaccination from the perspective of multiple stakeholders as well as insights on the perspective of HCPs towards the single-dose strategy to inform the designing of strategies to increase HPV vaccination uptake in Kenya and comparable settings.

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

✪ Learning from national implementation of the Veterans Affairs Clinical Resource Hub (CRH) program for improving access to care: protocol for a six year evaluation

Abstract:

Background

The Veterans Affairs (VA) Clinical Resource Hub (CRH) program aims to improve patient access to care by implementing time-limited, regionally based primary or mental health staffing support to cover local staffing vacancies. VA’s Office of Primary Care (OPC) designed CRH to support more than 1000 geographically disparate VA outpatient sites, many of which are in rural areas, by providing virtual contingency clinical staffing for sites experiencing primary care and mental health staffing deficits. The subsequently funded CRH evaluation, carried out by the VA Primary Care Analytics Team (PCAT), partnered with CRH program leaders and evaluation stakeholders to develop a protocol for a six-year CRH evaluation.
The objectives for developing the CRH evaluation protocol were to prospectively: 1) identify the outcomes CRH aimed to achieve, and the key program elements designed to achieve them; 2) specify evaluation designs and data collection approaches for assessing CRH progress and success; and 3) guide the activities of five geographically dispersed evaluation teams.

Methods

The protocol documents a multi-method CRH program evaluation design with qualitative and quantitative elements. The evaluation’s overall goal is to assess CRH’s return on investment to the VA and Veterans at six years through synthesis of findings on program effectiveness. The evaluation includes both observational and quasi-experimental elements reflecting impacts at the national, regional, outpatient site, and patient levels. The protocol is based on program evaluation theory, implementation science frameworks, literature on contingency staffing, and iterative review and revision by both research and clinical operations partners.

Discussion

Health systems increasingly seek to use data to guide management and decision-making for newly implemented clinical programs and policies. Approaches for planning evaluations to accomplish this goal, however, are not well-established. By publishing the protocol, we aim to increase the validity and usefulness of subsequent evaluation findings. We also aim to provide an example of a program evaluation protocol developed within a learning health systems partnership.

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

Prevention of Opioid Use and Disorder Among Youth Involved in the Legal System: Innovation and Implementation of Four Studies Funded by the NIDA HEAL Initiative

✪ Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services: a protocol for a stepped-wedge cluster randomized trial in Kenya

Abstract:

Background

An important cervical cancer prevention strategy in low- and middle-income countries (LMICs) has been single-visit screen-and-treat (SV-SAT) approach, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. While SV-SAT with VIA and cryotherapy have established efficacy, its population level coverage and impact on reducing cervical cancer burden remains low. In Kenya, the estimated cervical cancer screening uptake among women aged 30–49 is 16% and up to 70% of screen-positive women do not receive treatment. Thermal ablation for treatment of precancerous lesions of the cervix is recommended by the World Health Organization and has the potential to overcome logistical challenges associated with cryotherapy and facilitate implementation of SV-SAT approach and increase treatment rates of screen-positive women. In this 5-year prospective, stepped-wedge randomized trial, we plan to implement and evaluate the SV-SAT approach using VIA and thermal ablation in ten reproductive health clinics in central Kenya.

Methods

The study aims to develop and evaluate implementation strategies to inform the national scale-up of SV-SAT approach with VIA and thermal ablation through three aims: (1) develop locally tailored implementation strategies using multi-level participatory method with key stakeholders (patient, provider, system-level), (2) implement SV-SAT approach with VIA and thermal ablation and evaluate clinical and implementation outcomes, and (3) assess the budget impact of SV-SAT approach with VIA and thermal ablation compared to single-visit, screen-and-treat method using cryotherapy.

Discussion

Our findings will inform national scale-up of the SV-SAT approach with VIA and thermal ablation. We anticipate that this intervention, along with tailored implementation strategies will enhance the adoption and sustainability of cervical cancer screening and treatment compared to the standard of care using cryotherapy.

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

✪ Team-focused implementation strategies to improve implementation of mental health screening and referral in rural Children’s Advocacy Centers: study protocol for a pilot cluster randomized hybrid type 2 trial

Abstract:

Background

Children’s Advocacy Centers (CACs) use multidisciplinary teams to investigate and respond to maltreatment allegations. CACs play a critical role in connecting children with mental health needs to evidence-based mental health treatment, especially in low-resourced rural areas. Standardized mental health screening and referral protocols can improve CACs’ capacity to identify children with mental health needs and encourage treatment engagement. In the team-based context of CACs, teamwork quality is likely to influence implementation processes and outcomes. Implementation strategies that target teams and apply the science of team effectiveness may enhance implementation outcomes in team-based settings.

Methods

We will use Implementation Mapping to develop team-focused implementation strategies to support the implementation of the Care Process Model for Pediatric Traumatic Stress (CPM-PTS), a standardized screening and referral protocol. Team-focused strategies will integrate activities from effective team development interventions. We will pilot team-focused implementation in a cluster-randomized hybrid type 2 effectiveness-implementation trial. Four rural CACs will implement the CPM-PTS after being randomized to either team-focused implementation (n = 2 CACs) or standard implementation (n = 2 CACs). We will assess the feasibility of team-focused implementation and explore between-group differences in hypothesized team-level mechanisms of change and implementation outcomes (implementation aim). We will use a within-group pre-post design to test the effectiveness of the CPM-PTS in increasing caregivers’ understanding of their child’s mental health needs and caregivers’ intentions to initiate mental health services (effectiveness aim).

Conclusions

Targeting multidisciplinary teams is an innovative approach to improving implementation outcomes. This study will be one of the first to test team-focused implementation strategies that integrate effective team development interventions. Results will inform efforts to implement evidence-based practices in team-based service settings.

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

Bridging HCI and Implementation Science for Innovation Adoption and Public Health Impact

✪ A policy implementation study of earmarked taxes for mental health services: study protocol

Abstract:

Background

Insufficient funding is frequently identified as a critical barrier to the implementation and sustainment of evidence-based practices (EBPs). Thus, increasing access to funding is recognized as an implementation strategy. Policies that create earmarked taxes—defined as taxes for which revenue can only be spent on specific activities—are an increasingly common mental health financing strategy that could improve the reach of EBPs. This project’s specific aims are to (1) identify all jurisdictions in the USA that have implemented earmarked taxes for mental health and catalogue information about tax design; (2) characterize experiences implementing earmarked taxes among local (e.g., county, city) mental health agency leaders and other government and community organization officials and assess their perceptions of the acceptability and feasibility of different types of policy implementation strategies; and (3) develop a framework to guide effect earmarked tax designs, inform the selection of implementation strategies, and disseminate the framework to policy audiences.

Methods

The project uses the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to inform data collection about the determinants and processes of tax implementation and Leeman’s typology of implementation strategies to examine the acceptability and feasibility strategies which could support earmarked tax policy implementation. A legal mapping will be conducted to achieve aim 1. To achieve aim 2, a survey will be conducted of 300 local mental health agency leaders and other government and community organization officials involved with the implementation of earmarked taxes for mental health. The survey will be followed by approximately 50 interviews with these officials. To achieve aim 3, quantitative and qualitative data will be integrated through a systematic framework development and dissemination process.

Discussion

This exploratory policy implementation process study will build the evidence base for outer-context implementation determinants and strategies by focusing on policies that earmarked taxes for mental health services.

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

✪ A sequential, multiple assignment randomized trial comparing web-based education to mobile video interpreter access for improving provider interpreter use in primary care clinics: the mVOCAL hybrid type 3 study protocol

Abstract:

Background

Individuals who use a language other than English for medical care are at risk for disparities related to healthcare safety, patient-centered care, and quality. Professional interpreter use decreases these disparities but remains underutilized, despite widespread access and legal mandates. In this study, we compare two discrete implementation strategies for improving interpreter use: (1) enhanced education targeting intrapersonal barriers to use delivered in a scalable format (interactive web-based educational modules) and (2) a strategy targeting system barriers to use in which mobile video interpreting is enabled on providers’ own mobile devices.

Methods

We will conduct a type 3 hybrid implementation-effectiveness study in 3–5 primary care organizations, using a sequential multiple assignment randomized trial (SMART) design. Our primary implementation outcome is interpreter use, calculated by matching clinic visits to interpreter invoices. Our secondary effectiveness outcome is patient comprehension, determined by comparing patient-reported to provider-documented visit diagnosis. Enrolled providers (n = 55) will be randomized to mobile video interpreting or educational modules, plus standard interpreter access. After 9 months, providers with high interpreter use will continue as assigned; those with lower use will be randomized to continue as before or add the alternative strategy. After another 9 months, both strategies will be available to enrolled providers for 9 more months. Providers will complete 2 surveys (beginning and end) and 3 in-depth interviews (beginning, middle, and end) to understand barriers to interpreter use, based on the Theoretical Domains Framework. Patients who use a language other than English will be surveyed (n = 648) and interviewed (n = 75) following visits with enrolled providers to understand their experiences with communication. Visits will be video recorded (n = 100) to assess fidelity to assigned strategies. We will explore strategy mechanism activation to refine causal pathway models using a quantitative plus qualitative approach. We will also determine the incremental cost-effectiveness of each implementation strategy from a healthcare organization perspective, using administrative and provider survey data.

Discussion

Determining how these two scalable strategies, alone and in sequence, perform for improving interpreter use, the mechanisms by which they do so, and at what cost, will provide critical insights for addressing a persistent cause of healthcare disparities.

Trial registration

NCT05591586

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

✪ Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study

Authors:

Catherine Kiptinness, Paulami Naik, Nicholas Thuo, Rachel C. Malen, Julia C. Dettinger, Jillian Pintye, Maeve Rafferty, Edwin Jomo, Nicky Nyamasyo, Tony Wood, Paul Isabelli, Sarah Morris, David Hattery, Andy Stergachis, Daniel Were, Monisha Sharma, Kenneth Ngure, Melissa Latigo Mugambi, and Katrina F. Ortblad

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

✪ Open Access

Published: February 2023

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

Abstract:

Background

Online pharmacies in Kenya provide sexual and reproductive health products (e.g., HIV self-testing, contraception) and could be leveraged to increase the reach of HIV pre-exposure and post-exposure prophylaxis (PrEP/PEP) to populations who do not frequently attend health facilities. To date, evidence is limited for operationalizing online PrEP/PEP delivery and the type of populations reached with this differential service delivery model.

Methods

The ePrEP Kenya Pilot will deliver daily oral PrEP and PEP via MYDAWA, a private online pharmacy retailer, to clients in Nairobi for 18 months. Potential clients will obtain information about PrEP/PEP on MYDAWA's sexual wellness page and self-screen for HIV risk. Individuals ≥18 years, identified as at HIV risk, and willing to pay for a blood-based HIV self-test and PrEP/PEP delivery will be eligible for enrollment. To continue with online PrEP/PEP initiation, eligible clients will purchase a blood-based HIV self-test for 250 KES (~USD 2) [delivered to their setting of choice for 99 KES (~USD 1)], upload an image of their self-test result, and attend a telemedicine visit with a MYDAWA provider. During the telemedicine visit, providers will screen clients for PrEP/PEP eligibility, including clinical concerns (e.g., kidney disease), discuss self-test results, and complete counseling on PrEP/PEP use and safety. Providers will refer clients who self-test HIV positive or report any existing medical conditions to the appropriate services at healthcare facilities that meet their preferences. Eligible clients will be prescribed PrEP (30-day PrEP supply at initiation; 90-day PrEP supply at follow-up visits) or PEP (28-day supply) for free and have it delivered for 99 KES (~USD 1). We will measure PrEP and PEP initiation among eligible clients, PEP-to-PrEP transition, PrEP continuation, and implementation outcomes (e.g., feasibility, acceptability, and costs).

Discussion

Establishing pathways to increase PrEP and PEP access is crucial to help curb new HIV infections in settings with high HIV prevalence. The findings from this study will provide evidence on the implementation of online pharmacy PrEP and PEP service delivery that can help inform guidelines in Kenya and similar settings.

^{**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 JMIR Research Protocols

Abstract:

Background

Objective

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal Frontiers in Health Services

Abstract:

Background:

Methods:

Discussion:

Authors:

✪ Open Access

Read the full text in the open access journal BMC Health Services Research

Abstract:

Background

Methods

Discussion

Authors:

Subscription Required for Full Text Access

Read the full text in the subscription access journal Prevention Science

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Conclusions

Authors:

Subscription Required for Full Text Access

Read the full text in the subscription access journal Extended Abstracts on Human Factors Computing Systems. CHI Conference

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

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Discussion