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ImPlementation REsearCh to DEvelop Interventions for People Living with HIV (the PRECluDE consortium): Combatting chronic disease comorbidities in HIV populations through implementation research

Authors:

Joyonna Carrie Gamble-George, Christopher T. Longenecker, Allison R. Webel, David H. Au, Arleen F. Brown, Hayden Bosworth, Kristina Crothers, William E. Cunningham, Kevin A. Fiscella, Alison B. Hamilton, Christian D. Helfrich, Joseph A. Ladapo, Amneris Luque, Jonathan N. Tobin, Gail E. Wyatt, Implementation Research to Develop Interventions for People Living with HIV (PRECluDE) Consortium

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: March 2020

Read the full text in the subscription access journal Progress in Cardiovascular Diseases

✪ Responding to the challenge of Adolescent Perinatal Depression (RAPiD): Protocol for a cluster randomized hybrid trial of psychosocial intervention in primary maternal care

Authors:

Oye Gureje, Lola Kola, Bibilola D. Oladeji, Jibril Abdulmalik, Olatunde Ayinde, Phyllis Zelkowitz & Ian Bennett

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2020

Read the full text in the open access journal Trials

Abstract:

Background

Adolescent pregnancy is a pressing public health issue globally, and particularly in low and middle-income countries. Depression occurring in the perinatal period is common among women and more so among adolescent mothers. Effective treatments for the condition have been demonstrated in adults but the needs of adolescents are often unique, making such treatments unlikely to meet those needs.

Method/study design

A hybrid effectiveness–implementation research study is described in which a cluster randomized trial design is used to explore the effectiveness as well as the utility in routine practice of an intervention package specifically designed for adolescents with perinatal depression. Consenting pregnant adolescents (aged less than 20 years) who are newly registered for antenatal care are enrolled into the trial if their fetal gestational age is less than 36 weeks and they score 12 or more on the Edinburgh Postnatal Depression Scale (EPDS). The intervention package consists of structured sessions of behavior activation, problem-solving treatment, and parenting skills training, and is delivered by primary maternal health care providers, complemented by support provided by a “neighborhood mother” identified by the adolescent.

Mothers in the control arm receive care as usual. The trial is conducted in clinics where the maternal providers are trained to deliver routine depression care with the use of the WHO Mental Health Gap Action Programme, intervention guide. Assessments are undertaken by trained blinded assessors at baseline, at childbirth, and at 3 and 6 months postpartum. The primary outcome, assessed at 6 months, is the level of maternal depression (measured with the EPDS). The secondary outcome is parenting skills (assessed with the Home Observation Measurement of the Environment, Infant–Toddler version), while tertiary outcomes include measures of disability, quality of life, mother–child bonding, as well as infants’ nutritional and growth indices.

Discussion

This, to the best of our knowledge, will be the first fully-powered trial of an intervention package specifically designed to address the unique needs of adolescents with perinatal depression.

Trial registration

ISRCTN16775958. Registered on 30 April 2019.

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

✪ Study protocol for evaluating Six Building Blocks for opioid management implementation in primary care practices

Authors:

Sarah J. Shoemaker-Hunt, Leigh Evans, Holly Swan, Olivia Bacon, Brooke Ike, Laura-Mae Baldwin, & Michael L. Parchman

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2020

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

Abstract:

Background

The Six Building Blocks for improving opioid management (6BBs) is a program for improving the management of patients in primary care practices who are on long-term opioid therapy for chronic pain. The 6BBs include building leadership and consensus; aligning policies, patient agreements, and workflows; tracking and monitoring patient care; conducting planned, patient-centered visits; tailoring care for complex patients; and measuring success. The Agency for Healthcare Research and Quality funded the development of a 6BBs implementation guide: a step-by-step approach for independently implementing the 6BBs in a practice. This mixed-method study seeks to assess practices’ use of the implementation guide to implement the 6BBs and the effectiveness of 6BBs implementation on opioid management processes of care among practices using the implementation guide.

Methods

Data collection is guided by the Consolidated Framework for Implementation Research, Proctor’s taxonomy of implementation outcomes, and the Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain. A diverse group of health care organizations with primary care clinics across the USA will participate in the study over 15 months. Qualitative data collection will include semi-structured interviews with stakeholders at each organization at two time points, notes from routine check-in calls, and document review. These data will be used to understand practices’ motivation for participation, history with opioid management efforts, barriers and facilitators to implementation, and implementation progress. Quantitative data collection will consist of a provider and staff survey, an implementation milestones assessment, and quarterly opioid prescribing quality measures. These data will supplement our understanding of implementation progress and will allow us to assess changes over time in providers’ opioid prescribing practices, prescribing self-efficacy, challenges to providing guideline-driven care, and practices’ opioid prescribing quality measures. Qualitative data will be coded and analyzed for emergent themes. Quantitative data will be analyzed using descriptive statistics and clustered multivariate regression.

Discussion

This study contributes to the knowledge of the implementation and effectiveness of a team-based approach to opioid management in primary care practices. Information gleaned from this study can be used to inform efforts to curtail opioid prescribing and assist primary care practices considering implementing the 6BBs.

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

Validation of a counseling guide for adherence to antiretroviral therapy using implementation science

Authors:

Flor Yesenia Musayón-Oblitas, Cesar Paul Cárcamo, Sarah Gimbel, Juan Ignacio Echevarria Zarate, and Ana Beatriz Graña Espinoza

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2020

Read the full text in the open access journal Revista Latino-Americana de Enfermagem

Abstract:

Objective:

To determine the contents that must be included in the usual counseling to improve the adherence to antiretroviral therapy (ART) of HIV patients, according to their different levels of alcohol consumption, and to determine the validity of the Counseling Guide in improving the adherence to ART in patients who consume alcohol using Implementation Science.

Method:

This is an observational study with formative and validation phases. The formative phase defined the content, approach and structure of the counseling. Validation included focus groups with patients and nurses, trial process by an expert and a pilot test. The criteria evaluated based on Implementation Science were: intervention source, evidence strength and quality, relative advantage, and complexity. The following criteria were also evaluated: usefulness, practicality, acceptability, sustainability, effectiveness; content consistency and congruence; procedural compliance and difficulties, and time spent in counseling.

Results:

The strength of evidence of the counseling is High-IIA, with strong level of recommendation and presenting usefulness, practicality, acceptability, sustainability and effectiveness. Eight in 11 experts argued that the Guide is clear, consistent and congruent. Initial counseling takes around 24 minutes; and follow-up counseling, 21. The instruments of the Guide present reliability levels between good and high (0.65 ≥ alpha ≤ 0.92).

Conclusion:

The Counseling Guide is valid to improve the adherence to antiretroviral therapy in patients who consume alcohol.

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

✪ Longitudinal Remote Coaching for Implementation of Perinatal Collaborative Care: A Mixed-Methods Analysis

Authors:

Amritha Bhat, Ian M. Bennett, Amy M. Bauer, Rinad S. Beidas, Whitney Eriksen, Frances K. Barg, Rachel Gold, Jürgen Unützer

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2020

Read the full text in the open access journal Psychiatric Services

Abstract:

The collaborative care model (CoCM) is a multicomponent, team-based integrated behavioral health framework. Its effectiveness in the treatment of perinatal depression is established, but implementation has been limited. The authors used longitudinal remote coaching (LRC) as a novel implementation strategy to support systematic case review in a multistate cluster-randomized trial of CoCM for perinatal depression. They describe LRC for perinatal CoCM in three clinics and use of a mixed-methods analysis of data from LRC feedback forms and interviews with participants. LRC is a scalable implementation strategy with potential to support complex models of integrated behavioral health, such as perinatal CoCM.

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

✪ Lay Counselor Perspectives of Providing a Child-Focused Mental Health Intervention for Children: Task-Shifting in the Education and Health Sectors in Kenya

Authors:

Shannon Dorsey, Rosemary D. Meza, Prerna Martin, Christine L. Gray, Noah S. Triplett, Caroline Soi, Grace S. Woodard, Leah Lucid, Cyrilla Amanya, Augustine Wasonga and Kathryn Whetten

University of Washington affiliated authors are displayed in bold.

Published: December 2019

Read the full text in the open access journal Frontiers in Psychiatry

Abstract:

The global mental health treatment gap has increasingly been addressed using task-shifting; however, very little research has focused on lay counselors’ perspectives on the acceptability, feasibility, and appropriateness of mental health interventions in specific government-supported sectors that might scale up and sustain mental health care for children and adolescents. In western Kenya, these sectors include Education and Health.

Data come from a large hybrid effectiveness-implementation study examining implementation practices and policies in either or both sectors that support successful implementation of a child-focused intervention, Trauma-focused Cognitive Behavioral Therapy (TF-CBT), for children and adolescents who had experienced parental death. We examined lay counselors’ self-report of acceptability, feasibility, and appropriateness of TF-CBT. Lay counselors were teachers (n = 30) from the Education sector and Community Health Volunteers (CHVs; n = 30) from the Health sector, who were part of Sequence 1 of a large stepped-wedge, cluster randomized trial.

Lay counselor self-report surveys included reflective and formative measurement of acceptability, feasibility, and appropriateness administered after lay counselors in both sectors had experience delivering the locally-adapted, group-based TF-CBT intervention. Descriptive statistics (means, standard deviations) were used to understand counselors’ perspectives stratified by sector.

Both teachers and CHVs endorsed high acceptability, feasibility, and appropriateness of TF-CBT, with lay counselors’ responses on items from the formative measures providing some insight into specific aspects of acceptability, feasibility, and appropriateness that may be important to consider when planning for implementation support.

These early findings suggest that both sectors may hold promise for task-shifting of mental health care for children and adolescents but also underline the importance of considering the multiple facets of these three implementation outcomes as well as lay counselor context (Education vs. Health).

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

Feasibility and acceptability of an iris biometric system for unique patient identification in routine HIV services in Kenya

Authors:

Anne Njoroge, Matthew D. Dunbar, Felix Abuna, Peter Simpson, Paul Macharia, Bourke Betz, Peter Cherutich, David Bukusi, Carey Farquhar

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: November 2019

Read the full text in the subscription access International Journal of Medical Informatics

✪ The power of peers: an effectiveness evaluation of a cluster-controlled trial of group antenatal care in rural Nepal

Authors:

Poshan Thapa, Alex Harsha Bangura, Isha Nirola, David Citrin, Bishal Belbase, Bhawana Bogati, B. K. Nirmala, Sonu Khadka, Lal Kunwar, Scott Halliday, Nandini Choudhury, Al Ozonoff, Jasmine Tenpa, Ryan Schwarz, Mukesh Adhikari, S. P. Kalaunee, Sharon Rising, Duncan Maru & Sheela Maru

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2019

Read the full text in the open access journal Reproductive Health

Abstract:

Background

Reducing the maternal mortality ratio to less than 70 per 100,000 live births globally is one of the Sustainable Development Goals. Approximately 830 women die from pregnancy- or childbirth-related complications every day. Almost 99% of these deaths occur in developing countries. Increasing antenatal care quality and completion, and institutional delivery are key strategies to reduce maternal mortality, however there are many implementation challenges in rural and resource-limited settings. In Nepal, 43% of deliveries do not take place in an institution and 31% of women have insufficient antenatal care. Context-specific and evidence-based strategies are needed to improve antenatal care completion and institutional birth. We present an assessment of effectiveness outcomes for an adaptation of a group antenatal care model delivered by community health workers and midwives in close collaboration with government staff in rural Nepal.

Methods

The study was conducted in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized, cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allowed for iterative improvement in design by making changes to improve the quality of the intervention. We evaluated effectiveness through a difference in difference analysis of institutional birth rates between groups prior to implementation of the intervention and 1 year after implementation. Additionally, we assessed the change in knowledge of key danger signs and the acceptability of the group model compared with individual visits in a nested cohort of women receiving home visit care and home visit care plus group antenatal care. Using a directed content and thematic approach, we analyzed qualitative interviews to identify major themes related to implementation.

Results

At baseline, there were 457 recently-delivered women in the six village clusters receiving home visit care and 214 in the seven village clusters receiving home visit care plus group antenatal care. At endline, there were 336 and 201, respectively. The difference in difference analysis did not show a significant change in institutional birth rates nor antenatal care visit completion rates between the groups. There was, however, a significant increase in both institutional birth and antenatal care completion in each group from baseline to endline. We enrolled a nested cohort of 52 participants receiving home visit care and 62 participants receiving home visit care plus group antenatal care. There was high acceptability of the group antenatal care intervention and home visit care, with no significant differences between groups. A significantly higher percentage of women who participated in group antenatal care found their visits to be ‘very enjoyable’ (83.9% vs 59.6%, p = 0.0056). In the nested cohort, knowledge of key danger signs during pregnancy significantly improved from baseline to endline in the intervention clusters only (2 to 31%, p < 0.001), while knowledge of key danger signs related to labor and childbirth, the postpartum period, and the newborn did not in either intervention or control groups. Qualitative analysis revealed that women found that the groups provided an opportunity for learning and discussion, and the groups were a source of social support and empowerment. They also reported an improvement in services available at their village clinic. Providers noted the importance of the community health workers in identifying pregnant women in the community and linking them to the village clinics. Challenges in birth planning were brought up by both participants and providers.

Conclusion

While there was no significant change in institutional birth and antenatal care completion at the population level between groups, there was an increase of these outcomes in both groups. This may be secondary to the primary importance of community health worker involvement in both of these groups. Knowledge of key pregnancy danger signs was significantly improved in the home visit plus group antenatal care cohort compared with the home visit care only group. This initial study of Nyaya Health Nepal’s adapted group care model demonstrates the potential for impacting women’s antenatal care experience and should be studied over a longer period as an intervention embedded within a community health worker program.

Trial registration

ClinicalTrials.gov Identifier: NCT02330887, registered 01/05/2015, retroactively registered.

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

✪ Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability


Authors:

Aaron R Lyon, Sean A Munson, Brenna N Renn, David C Atkins, Michael D Pullmann, Emily Friedman, & Patricia A Areán

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2019

Read the full text in the open access journal JMIR Research Protocols

Abstract:

Background

This paper presents the protocol for the National Institute of Mental Health (NIMH)–funded University of Washington’s ALACRITY (Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness) Center (UWAC), which uses human-centered design (HCD) methods to improve the implementation of evidence-based psychosocial interventions (EBPIs). We propose that usability—the degree to which interventions and implementation strategies can be used with ease, efficiency, effectiveness, and satisfaction—is a fundamental, yet poorly understood determinant of implementation.

Objective

We present a novel Discover, Design/Build, and Test (DDBT) framework to study usability as an implementation determinant. DDBT will be applied across Center projects to develop scalable and efficient implementation strategies (eg, training tools), modify existing EBPIs to enhance usability, and create usable and nonburdensome decision support tools for quality delivery of EBPIs.

Methods

Stakeholder participants will be implementation practitioners/intermediaries, mental health clinicians, and patients with mental illness in nonspecialty mental health settings in underresourced communities. Three preplanned projects and 12 pilot studies will employ the DDBT model to (1) identify usability challenges in implementing EBPIs in underresourced settings; (2) iteratively design solutions to overcome these challenges; and (3) compare the solution to the original version of the EPBI or implementation strategy on usability, quality of care, and patient-reported outcomes. The final products from the center will be a streamlined modification and redesign model that will improve the usability of EBPIs and implementation strategies (eg, tools to support EBPI education and decision making); a matrix of modification targets (ie, usability issues) that are both common and unique to EBPIs, strategies, settings, and patient populations; and a compilation of redesign strategies and the relative effectiveness of the redesigned solution compared to the original EBPI or strategy.

Results

The UWAC received institutional review board approval for the three separate studies in March 2018 and was funded in May 2018.

Conclusions

The outcomes from this center will inform the implementation of EBPIs by identifying cross-cutting features of EBPIs and implementation strategies that influence the use and acceptability of these interventions, actively involving stakeholder clinicians and implementation practitioners in the design of the EBPI modification or implementation strategy solution and identifying the impact of HCD-informed modifications and solutions on intervention effectiveness and quality.

Trial Registration

ClinicalTrials.gov NCT03515226 (https://clinicaltrials.gov/ct2/show/NCT03515226), NCT03514394 (https://clinicaltrials.gov/ct2/show/NCT03514394), and NCT03516513 (https://clinicaltrials.gov/ct2/show/NCT03516513).

International Registered Report Identifier (IRRID)

DERR1-10.2196/14990

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

✪ Development and Implementation of a Mobile Phone–Based Prevention of Mother-To-Child Transmission of HIV Cascade Analysis Tool: Usability and Feasibility Testing in Kenya and Mozambique

Authors:

Nami Kawakyu, Ruth Nduati, Khátia Munguambe, Joana Coutinho, Nancy Mburu, Georgina DeCastro, Celso Inguane, Andrew Zunt, Neil Abburi, Kenneth Sherr, & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

Published: March 2019

Read the full text in the open access journal JMIR mHealth and uHealth

Abstract:

Background

Prevention of mother-to-child HIV transmission (PMTCT) care cascade failures drive pediatric HIV infections in sub-Saharan Africa. As nurses’ clinical and management role in PMTCT expand, decision-support tools for nurses are needed to facilitate identification of cascade inefficiencies and solutions. The mobile phone–based PMTCT cascade analysis tool (mPCAT) provides health facility staff a quick summary of the number of patients and percentage drop-off at each step of the PMCTC care cascade, as well as how many women-infant pairs would be retained if a step was optimized.

Objective

The objective of this study was to understand and improve the mPCAT’s core usability factors and assess the health workers’ experience with using the mPCAT.

Methods

Overall, 2 rounds of usability testing were conducted with health workers from 4 clinics and leading experts in maternal and child health in Kenya and Mozambique using videotaped think aloud assessment techniques. Semistructured group interviews gauged the understanding of mPCAT’s core usability factors, based on the Nielsen Usability Framework, followed by development of cognitive demand tables describing the needed mPCAT updates. Post adaptation, feasibility was assessed in 3 high volume clinics over 12 weeks. Participants completed a 5-point Likert questionnaire designed to measure ease of use, convenience of integration into work, and future intention to use the mPCAT. Focus group discussions with nurse participants at each facility and in-depth interviews with nurse managers were also conducted to assess the acceptability, use, and recommendations for adaptations of the mPCAT.

Results

Usability testing with software engineers enabled real-time feedback to build a tool following empathic design principles. The revised mPCAT had improved navigation and simplified data entry interface, with only 1 data entry field per page. Improvements to the results page included a data visualization feature and the ability to share results through WhatsApp. Coding was simplified to enable future revisions by nontechnical staff—critical for context-specific adaptations for scale-up. Health care workers and facility managers found the tool easy to use (mean=4.3), used the tool very often (mean=4.1), and definitely intended to continue to use the tool (mean=4.8). Ease of use was the most common theme identified, with emphasis on how the tool readily informed system improvement decision making.

Conclusions

The mPCAT was well accepted by frontline health workers and facility managers. The collaborative process between software developer and user led to the development of a more user-friendly, context-specific tool that could be easily integrated into routine clinical practice and workflow. The mPCAT gave frontline health workers and facility managers an immediate, direct, and tangible way to use their clinical documentation and routinely reported data for decision making for their own clinical practice and facility-level improvements.

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