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Implementation Science at UW

Keywords: Fidelity

✪ Using Assisted Partner Services for HIV Testing and the Treatment of Males and Their Female Sexual Partners: Protocol for an Implementation Science Study

Authors:

Edward Kariithi, Monisha Sharma, Emily Kemunto, Harison Lagat, George Otieno, Beatrice M. Wamuti, David A. Katz, Christopher Obong'o, Paul Macharia, Rose Bosire, Sarah Masyuko, Mary Mugambi, Carol E. Levin, Wenjia Liu, Unmesha Roy Paladhi, Bryan J. Weiner, & Carey Farquhar

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2021

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

Background

Despite the effective scale-up of HIV testing and treatment programs, only 75% of people living with HIV (PLWH) globally know their status, and this rate is lower among men. This highlights the importance of implementing HIV testing and linkage interventions with a high uptake in this population. In a cluster randomized controlled trial conducted in Kenya between 2013 and 2015, we found that assisted partner services (APS) for HIV-exposed partners of newly diagnosed PLWH safely reached more HIV-exposed individuals with HIV testing compared with client referral alone. However, more data are needed to evaluate APS implementation in a real-world setting.

Objective

This study aims to evaluate the effectiveness, acceptability, fidelity, and cost of APS when integrated into existing HIV testing services (HTS) in Western Kenya.

Methods

Our study team from the University of Washington and PATH is integrating APS into 31 health facilities in Western Kenya. We are enrolling females newly diagnosed with HIV (index clients) who consent to receiving APS, their male sexual partners, and female sexual partners of male sexual partners who tested HIV positive. Female index clients and sexual partners testing HIV positive will be followed up at 6 weeks, 6 months, and 12 months postenrollment to assess linkage to care, antiretroviral therapy initiation, and HIV viral load suppression. We will evaluate the acceptability, fidelity, and cost of real-world implementation of APS via in-depth interviews conducted with national, county, and subcounty-level policy makers responsible for HTS. Facility health staff providing HTS and APS, in addition to staff working with the study project team, will also be interviewed. We will also conduct direct observations of facility infrastructure and clinical procedures and extract data from the facilities and county and national databases.

Results

As of March 2020, we have recruited 1724 female index clients, 3201 male partners, and 1585 female partners. We have completed study recruitment as well as 6-week (2936/2973, 98.75%), 6-month (1596/1641, 97.25%), and 12-month (725/797, 90.9%) follow-up visits. Preliminary analyses show that facilities scaling up APS identify approximately 12-18 new HIV-positive males for every 100 men contacted and tested. We are currently completing the remaining follow-up interviews and incorporating an HIV self-testing component into the study in response to the COVID-19 pandemic.

Conclusions

The results will help bridge the gap between clinical research findings and real-world practice and provide guidance regarding optimal strategies for APS integration into routine HIV service delivery.

International Registered Report Identifier (IRRID)

DERR1-10.2196/27262

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

✪ Implementation outcomes and strategies for depression interventions in low- and middle-income countries: A systematic review

Authors:

Bradley H. Wagenaar, Wilson H. Hammett, Courtney Jackson, Dana L. Atkins, Jennifer M. Belus, and Christopher G. Kemp

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2020

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

Abstract:

Background

We systematically reviewed implementation research targeting depression interventions in low- and middle-income countries (LMICs) to assess gaps in methodological coverage.

Methods

PubMed, CINAHL, PsycINFO, and EMBASE were searched for evaluations of depression interventions in LMICs reporting at least one implementation outcome published through March 2019.

Results

A total of 8714 studies were screened, 759 were assessed for eligibility, and 79 studies met inclusion criteria. Common implementation outcomes reported were acceptability (n = 50; 63.3%), feasibility (n = 28; 35.4%), and fidelity (n = 18; 22.8%). Only four studies (5.1%) reported adoption or penetration, and three (3.8%) reported sustainability. The Sub-Saharan Africa region (n = 29; 36.7%) had the most studies. The majority of studies (n = 59; 74.7%) reported outcomes for a depression intervention implemented in pilot researcher-controlled settings. Studies commonly focused on Hybrid Type-1 effectiveness-implementation designs (n = 53; 67.1), followed by Hybrid Type-3 (n = 16; 20.3%). Only 21 studies (26.6%) tested an implementation strategy, with the most common being revising professional roles (n = 10; 47.6%). The most common intervention modality was individual psychotherapy (n = 30; 38.0%). Common study designs were mixed methods (n = 27; 34.2%), quasi-experimental uncontrolled pre-post (n = 17; 21.5%), and individual randomized trials (n = 16; 20.3).

Conclusions

Existing research has focused on early-stage implementation outcomes. Most studies have utilized Hybrid Type-1 designs, with the primary aim to test intervention effectiveness delivered in researcher-controlled settings. Future research should focus on testing and optimizing implementation strategies to promote scale-up of evidence-based depression interventions in routine care. These studies should use high-quality pragmatic designs and focus on later-stage implementation outcomes such as cost, penetration, and sustainability.

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

✪ 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**

✪ Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal

Authors:

Alex Harsha Bangura, Isha Nirola, Poshan Thapa, David Citrin, Bishal Belbase, Bhawana Bogati, Nirmala B.K., Sonu Khadka, Lal Kunwar, Scott Halliday, Nandini Choudhury, 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: January 2020

Read the full text in the open access journal Reproductive Health

Abstract:

Background

Access to high-quality antenatal care services has been shown to be beneficial for maternal and child health. In 2016, the WHO published evidence-based recommendations for antenatal care that aim to improve utilization, quality of care, and the patient experience. Prior research in Nepal has shown that a lack of social support, birth planning, and resources are barriers to accessing services in rural communities. The success of CenteringPregnancy and participatory action women’s groups suggests that group care models may both improve access to care and the quality of care delivered through women’s empowerment and the creation of social networks. We present a group antenatal care model in rural Nepal, designed and implemented by the healthcare delivery organization Nyaya Health Nepal, as well as an assessment of implementation outcomes.

Methods

The study was conducted at Bayalata Hospital 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 allows for iterative improvement in design, making changes to improve the quality of the intervention. Assessments of implementation process and model fidelity were undertaken using a mobile checklist completed by nurse supervisors, and observation forms completed by program leadership. We evaluated data quarterly using descriptive statistics to identify trends. Qualitative interviews and team communications were analyzed through immersion crystallization to identify major themes that evolved during the implementation process.

Results

A total of 141 group antenatal sessions were run during the study period. This paper reports on implementation results, whereas we analyze and present patient-level effectiveness outcomes in a complementary paper in this journal. There was high process fidelity to the model, with 85.7% (95% CI 77.1–91.5%) of visits completing all process elements, and high content fidelity, with all village clusters meeting the minimum target frequency for 80% of topics. The annual per capita cost for group antenatal care was 0.50 USD. Qualitative analysis revealed the compromise of stable gestation-matched composition of the group members in order to make the intervention feasible. Major adaptations were made in training, documentation, feedback and logistics.

Conclusion

Group antenatal care provided in collaboration with local government clinics has the potential to provide accessible and high quality antenatal care to women in rural Nepal. The intervention is a feasible and affordable alternative to individual antenatal care. Our experience has shown that adaptation from prior models was important for the program to be successful in the local context within the national healthcare system.

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**

✪ Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): Protocol for a stepped wedge cluster randomized trial

Authors:

Shannon Dorsey, Christine L. Gray, Augustine I. Wasonga, Cyrilla Amanya, Bryan J. Weiner, C. Micha Belden, Prerna Martin, Rosemary D. Meza, Andrew K. Weinhold, Caroline Soi, Laura K. Murray, Leah Lucid, Elizabeth L. Turner, Robyn Mildon & Kathryn Whetten

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2020

Read the full text in the open access journal BMC Psychiatry

Abstract:

Background

The mental health treatment gap—the difference between those with mental health need and those who receive treatment—is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery.

Methods

BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites’ counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences’ sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors.

Discussion

The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts.

Trial registration

ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017

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

✪ 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
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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**