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✪ Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya

Authors:

Kenneth K. Mugwanya, Elizabeth Irungu, Elizabeth Bukusi, Nelly R. Mugo, Josephine Odoyo, Elizabeth Wamoni, Kenneth Ngure, Jennifer F. Morton, Kathryn Peebles, Sarah Masyuko, Gena Barnabee, Deborah Donnell, Ruanne Barnabas, Jessica Haberer, Gabrielle O’Malley, and Jared M. Baeten, for the Partners Scale Up Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings.

Methods

The Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods.

Discussion

Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration.

Trial registration

Registered with ClinicalTrials.gov on February 14, 2017:NCT03052010.

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

✪ Confirmatory factor analysis of the Evidence-Based Practice Attitudes Scale with school-based behavioral health consultants

Authors:

Clayton R. Cook, Chayna Davis, Eric C. Brown, Jill Locke, Mark G. Ehrhart, Gregory A. Aarons, Madeline Larson and Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

The Evidence-Based Practice Attitude Scale (EBPAS) is a widely used tool, but it has not been adapted and validated for use in schools, the most common setting where youth access behavioral health services. This study examined the factor structure, psychometric properties, and criterion-related validity of the school-adapted EBPAS in a sample of school-based behavioral health consultants.

Method

A research team comprised of experts in implementation of evidence-based practices in schools along with the original developer adapted the EBPAS for the school setting. The adapted instrument was administered to a representative sample (n = 196) of school-based behavioral health consultants to assess the reliability and structural validity via a series of confirmatory factor analyses.

Results

The original EBPAS factor structure was confirmed, with the final model supporting four first-order factors that load onto a second-order factor capturing general attitudes toward evidence-based practice. Correlations among the subscales indicated both unique and shared variance. Correlations between EBPAS scores and consultant variables demonstrated differential criterion-related validity, with the total score and the Requirements and Openness subscales demonstrating the strongest correlations.

Conclusions

The adapted EBPAS performed well when administered to behavioral health consultants operating in the educator sector, supporting the relevance of assessing attitudes in school settings. Potential directions for future research and applications of the EBPAS in schools and other service sectors are discussed.

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

Making Implementation Science Work for Children and Adolescents Living With HIV

Authors:

Daniella Mark, Elvin Geng, Susan Vorkoper, Shaffiq Essajee, Kim Bloch, Nicola Willis, Bethany Stewart, Sabrina Bakeera-Kitaka, Nandita Sugandhi, Rachel Sturke, Kechi Achebe, B. Jane Ferguson, Marissa Vicari, Chewe Luo, Nande Putta, Grace John-Stewart, Laura Guay, Angela Mushavi, Imran Muhammad, and David A. Ross
University of Washington affiliated authors are displayed in bold.
Published: August 2018

Read the full text in the subscription access Journal of Acquired Immune Deficiency Syndrome

✪ Study protocol: A cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial)

Authors:

Joseph E. Glass, Jennifer F. Bobb, Amy K. Lee, Julie E. Richards, Gwen T. Lapham, Evette Ludman, Carol Achtmeyer, Ryan M. Caldeiro, Rebecca Parrish, Emily C. Williams, Paula Lozano and Katharine A. Bradley

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

Experts recommend that alcohol-related care be integrated into primary care (PC) to improve prevention and treatment of unhealthy alcohol use. However, few healthcare systems offer such integrated care. To address this gap, implementation researchers and clinical leaders at Kaiser Permanente Washington (KPWA) partnered to design a high-quality program of evidence-based care for unhealthy alcohol use: the Sustained Patient-centered Alcohol-related Care (SPARC) program. SPARC implements systems of clinical care designed to increase both prevention and treatment of unhealthy alcohol use. This clinical care for unhealthy alcohol use was implemented using three strategies: electronic health record (EHR) decision support, performance monitoring and feedback, and front-line support from external practice coaches with expertise in alcohol-related care (“SPARC implementation intervention” hereafter).

The purpose of this report is to describe the protocol of the SPARC trial, a pragmatic, cluster-randomized, stepped-wedge implementation trial to evaluate whether the SPARC implementation intervention increased alcohol screening and brief alcohol counseling (so-called brief interventions), and diagnosis and treatment of alcohol use disorders (AUDs) in 22 KPWA PC clinics.

Methods/Design

The SPARC trial sample includes all adult patients who had a visit to any of the 22 primary care sites in the trial during the study period (January 1, 2015–July 31, 2018). The 22 sites were randomized to implement the SPARC program on different dates (in seven waves, approximately every 4 months). Primary outcomes are the proportion of patients with PC visits who (1) screen positive for unhealthy alcohol use and have documented brief interventions and (2) have a newly recognized AUD and subsequently initiate and engage in alcohol-related care. Main analyses compare the rates of these primary outcomes in the pre- and post-implementation periods, following recommended approaches for analyzing stepped-wedge trials. Qualitative analyses assess barriers and facilitators to implementation and required adaptations of implementation strategies.

Discussion

The SPARC trial is the first study to our knowledge to use an experimental design to test whether practice coaches with expertise in alcohol-related care, along with EHR clinical decision support and performance monitoring and feedback to sites, increase both preventive care—alcohol screening and brief intervention—as well as diagnosis and treatment of AUDs.

Trial registration

The trial is registered at ClinicalTrials.Gov: NCT02675777. Registered February 5, 2016, https://clinicaltrials.gov/ct2/show/NCT02675777.

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

✪ Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: A study protocol for a randomized controlled trial

Authors:

Laura K. Murray, Emily E. Haroz, S. Benjamin Doty, Namrita S. Singh, Sergey Bogdanov, Judith Bass, Shannon Dorsey and Paul Bolton

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2018

Read the full text in the open access journal Trials

Abstract:

Background

Mental illness is a major public health concern. Despite progress understanding which treatments work, a significant treatment gap remains. An ongoing concern is treatment length. Modular, flexible, transdiagnostic approaches have been offered as one solution to scalability challenges. The Common Elements Treatment Approach (CETA) is one such approach and offers the ability to treat a wide range of common mental health problems. CETA is supported by two randomized trials from low- and middle-income countries showing strong effectiveness and implementation outcomes.

Methods/design

This trial evaluates the effectiveness and implementation of two versions of CETA using a non-inferiority design to test two primary hypotheses: (1) a brief five-session version of CETA (Brief CETA) will provide similar effectiveness for reducing the severity of common mental health problems such as depression, post-traumatic stress, impaired functioning, anxiety, and substance use problems compared with the standard 8–12-session version of CETA (Standard CETA); and (2) both Brief and Standard CETA will have superior impact on the outcomes compared to a wait-list control condition. For both hypotheses, the main effect will be assessed using longitudinal data and mixed-effects regression models over a 6-month period post baseline. A secondary aim includes exploration of implementation factors. Additional planned analyses will include exploration of: moderators of treatment impact by disorder severity and comorbidity; the impact of individual therapeutic components; and trends in symptom change between end of treatment and 6-month assessment for all participants.

Discussion

This trial is the first rigorous study comparing a standard-length (8–12 sessions) modular, flexible, transdiagnostic, cognitive-behavioral approach to a shortened version of the approach (five sessions). Brief CETA entails “front-loading” with elements that research suggests are strong mechanisms of change. The study design will allow us to draw conclusions about the effects of both Brief and Standard CETA as well as which elements are integral to their mechanisms of action, informing future implementation and fidelity efforts. The results from this trial will inform future dissemination, implementation and scale-up of CETA in Ukraine and contribute to our understanding of the effects of modular, flexible, transdiagnostic approaches in similar contexts.

Trial registration

ClinicalTrials.gov, ID: NCT03058302 (U.S. National Library of Medicine). Registered on 20 February 2017.

✪ Pilot to policy: statewide dissemination and implementation of evidence-based treatment for traumatized youth

Authors:

Lisa Amaya-Jackson, Dana Hagele, John Sideris, Donna Potter, Ernestine C. Briggs, Leila Keen, Robert A. Murphy, Shannon Dorsey, Vanessa Patchett, George S. Ake and Rebecca Socolar

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2018

Read the full text in the journal BMC Health Services Research

Abstract:

Background

A model for statewide dissemination of evidence-based treatment (EBT) for traumatized youth was piloted and taken to scale across North Carolina (NC). This article describes the implementation platform developed, piloted, and evaluated by the NC Child Treatment Program to train agency providers in Trauma-Focused Cognitive Behavioral Therapy using the National Center for Child Traumatic Stress Learning Collaborative (LC) Model on Adoption & Implementation of EBTs. This type of LC incorporates adult learning principles to enhance clinical skills development as part of training and many key implementation science strategies while working with agencies and clinicians to implement and sustain the new practice.

Methods

Clinicians (n = 124) from northeastern NC were enrolled in one of two TF-CBT LCs that lasted 12 months each. During the LC clinicians were expected to take at least two clients through TF-CBT treatment with fidelity and outcomes monitoring by trainers who offered consultation by phone and during trainings. Participating clinicians initiated treatment with 281 clients. The relationship of clinician and client characteristics to treatment fidelity and outcomes was examined using hierarchical linear regression.

Results

One hundred eleven clinicians completed general training on trauma assessment batteries and TF-CBT. Sixty-five clinicians met all mastery and fidelity requirements to meet roster criteria. One hundred fifty-six (55%) clients had fidelity-monitored assessment and TF-CBT. Child externalizing, internalizing, and post-traumatic stress symptoms, as well as parent distress levels, decreased significantly with treatment fidelity moderating child PTSD outcomes. Since this pilot, 11 additional cohorts of TF-CBT providers have been trained to these roster criteria.

Conclusion

Scaling up or outcomes-oriented implementation appears best accomplished when training incorporates: 1) practice-based learning, 2) fidelity coaching, 3) clinical assessment and outcomes-oriented treatment, 4) organizational skill-building to address barriers for agencies, and 5) linking clients to trained clinicians via an online provider roster. Demonstrating clinician performance and client outcomes in this pilot and subsequent cohorts led to legislative support for dissemination of a service array of EBTs by the NC Child Treatment Program.

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

HIV-Uninfected Kenyan Adolescent and Young Women Share Perspectives on Using Pre-exposure Prophylaxis During Pregnancy

Authors:

Jillian Pintye, Kristin M. Beima-Sofie, Pamela A. Makabong'O, Anne Njoroge, Susan Brown Trinidad, Renee A. Heffron, Jared M. Baeten, Connie Celum, Daniel Matemo, John Kinuthia, Maureen C. Kelley, and Grace C. John-Stewart

University of Washington affiliated authors are displayed in bold.

Published: July 2018

Read the full text in the subscription access journal AIDS Patient Care and STDs