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✪ 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

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**

✪ National implementation of HPV vaccination programs in low-resource countries: Lessons, challenges, and future prospects

Authors:

Vivien D. Tsu, D. Scott LaMontagne, Phionah Atuhebwe, Paul N. Bloem, Cathy Ndiaye

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2021

Read the full text open access in the journal Preventive Medicine

Abstract:

More than 90% of cervical cancer deaths occur in low- and middle-income countries (LMICs), which have limited capacity to mount the comprehensive national screening and precancer treatment programs that could prevent most of these deaths. The development of vaccines against the human papillomavirus (HPV) has dramatically altered the landscape of cervical cancer prevention. As of mid-2020, 56 LMICs (41% of all LMICs) have initiated national HPV vaccination programs. This paper reviews the experience of LMICs that have introduced HPV vaccine into their national programs, key lessons learned, HPV vaccination sustainability and scale-up challenges, and future mitigation measures.

As international guidance evolved and countries accumulated experience, strategies for national introduction shifted with regard to target groups, delivery site and timing, preparation and planning, communications and social mobilization, and ultimately monitoring, supervision and evaluation. Despite the successes that LMICs have been able to achieve in reaching large proportions of eligible girls, there are still considerable challenges countries encounter in overcoming rumors, reaching out-of-school girls, completing the vaccine series, estimating target populations, monitoring program performance, and assuring vaccination sustainability. New opportunities, such as the entry of additional vaccine manufacturers and ongoing studies to evaluate one-dose delivery, could help overcome the outstanding barriers to higher coverage and financial sustainability. Effective use of the experience to date and advances on the horizon could enable all LMICs to move towards the coverage levels that are needed to achieve eventual elimination.

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

✪ Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy

Authors:

Aaron R. Lyon, Michael D. Pullmann, Shannon Dorsey, Carol Levin, Larissa M. Gaias, Stephanie K. Brewer, Madeline Larson, Catherine M. Corbin, Chayna Davis, Ian Muse, Mahima Joshi, Rosemary Reyes, Nathaniel J. Jungbluth, Rachel Barrett, David Hong, Michael D. Gomez & Clayton R. Cook

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2021

Read the full text in the open access journal Implementation Science

Abstract:

Background

More than two-thirds of youth experience trauma during childhood, and up to 1 in 5 of these youth develops posttraumatic stress symptoms that significantly impair their functioning. Although trauma-focused cognitive behavior therapy (TF-CBT) has a strong evidence base, it is rarely adopted, delivered with adequate fidelity, or evaluated in the most common setting where youth access mental health services—schools. Given that individual behavior change is ultimately required for successful implementation, even when organizational factors are firmly in place, focusing on individual-level processes represents a potentially parsimonious approach. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a pragmatic, motivationally focused multifaceted strategy that augments training and consultation and is designed to target precise mechanisms of behavior change to produce enhanced implementation and youth clinical outcomes. This study protocol describes a hybrid type 2 effectiveness-implementation trial designed to concurrently evaluate the main effects, mediators, and moderators of both the BASIS implementation strategy on implementation outcomes and TF-CBT on youth mental health outcomes.

Methods

Using a cluster randomized controlled design, this trial will assign school-based mental health (SMH) clinicians and schools to one of three study arms: (a) enhanced treatment-as-usual (TAU), (b) attention control plus TF-CBT, or (c) BASIS+TF-CBT. With a proposed sample of 120 SMH clinicians who will each recruit 4–6 youth with a history of trauma (480 children), this project will gather data across 12 different time points to address two project aims. Aim 1 will evaluate, relative to an enhanced TAU condition, the effects of TF-CBT on identified mechanisms of change, youth mental health outcomes, and intervention costs and cost-effectiveness. Aim 2 will compare the effects of BASIS against an attention control plus TF-CBT condition on theoretical mechanisms of clinician behavior change and implementation outcomes, as well as examine costs and cost-effectiveness.

Discussion

This study will generate critical knowledge about the effectiveness and cost-effectiveness of BASIS—a pragmatic, theory-driven, and generalizable implementation strategy designed to enhance motivation—to increase the yield of evidence-based practice training and consultation, as well as the effectiveness of TF-CBT in a novel service setting.

Trial registration

ClinicalTrials.gov registration number NCT04451161. Registered on June 30, 2020.

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

Use of the Consolidated Framework for Implementation Research (CFIR) to Characterize Healthcare Workers’ Perspectives on Financial Incentives to Increase Pediatric HIV Testing

Authors:

Dana Atkins, Anjuli D. Wagner, Junyi Zhang, Irene N. Njuguna, Jillian Neary, Vincent O. Omondi, Verlinda A. Otieno, Kenneth Ondeng'e, Dalton C. Wamalwa, Grace John-Stewart, Jennifer A. Slyker, and Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: May 2020

Read the full text in the subscription access journal JAIDS

✪ Situational analysis of breast health care systems: Why context matters

Authors:

Catherine Duggan, Allison Dvaladze, John R. Scheel, Lisa M. Stevens, & Benjamin O. Anderson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2020

Read the full text in the open access journal Cancer

Abstract:

Background

Implementation of evidence‐based, resource‐appropriate guidelines for breast cancer control should be preceded by a baseline assessment or situational analysis to assess breast health infrastructure, workforce capacity, patient pathways, existing practices, accessibility, and costs.

Methods

To support the assessment of breast health care systems within the broader context in which they exist, the Breast Health Global Initiative (BHGI) developed, tested, and refined a set of situational analysis tools with which to guide the assessment of breast health care capacity, identify the relative strengths and weaknesses of the health system, and support stakeholders in prioritizing actionable items to advance breast cancer care using evidence‐based strategies tailored to their setting. The tools address 6 domains of breast health care delivery: 1) breast cancer early detection practices; 2) breast cancer awareness programs; 3) the availability of breast cancer surgery; 4) the availability of pathology; 5) the availability of radiotherapy, and 6) the availability of systemic therapy services. The current study also describes the more comprehensive International Atomic Energy Agency Programme of Action for Cancer Therapy (PACT) integrated missions for PACT (imPACT) review.

Results

As of 2020, 5 formal BHGI situational analyses have been performed in India, Brazil, Panama, Tanzania, and Uganda. As of August 2019, a total of 100 imPACT reviews have been conducted in 91 countries. These assessments can contribute to more informed policymaking.

Conclusions

Situational analyses are a prerequisite for the development of resource‐appropriate strategies with which to advance breast cancer control in any setting and should assess services across the entire breast health care continuum as well as the broader structural, sociocultural, personal, and financial contexts within which they operate.

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

✪ The Breast Health Global Initiative 2018 Global Summit on Improving Breast Healthcare Through Resource‐Stratified Phased Implementation: Methods and overview

Authors:

Catherine Duggan, Allison Dvaladze, Anne F. Rositch, Ophira Ginsburg, Cheng‐Har Yip, Susan Horton, Rolando Camacho Rodriguez, Alexandru Eniu, Miriam Mutebi, Jean‐Marc Bourque, Shahla Masood, Karla Unger‐Saldaña, Anna Cabanes, Robert W. Carlson, Julie R. Gralow, and Benjamin O. Anderson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2020

Read the full text in the open access journal Cancer

Abstract:

Background

The Breast Health Global Initiative (BHGI) established a series of resource‐stratified, evidence‐based guidelines to address breast cancer control in the context of available resources. Here, the authors describe methodologies and health system prerequisites to support the translation and implementation of these guidelines into practice.

Methods

In October 2018, the BHGI convened the Sixth Global Summit on Improving Breast Healthcare Through Resource‐Stratified Phased Implementation. The purpose of the summit was to define a stepwise methodology (phased implementation ) for guiding the translation of resource‐appropriate breast cancer control guidelines into real‐world practice. Three expert consensus panels developed stepwise, resource‐appropriate recommendations for implementing these guidelines in low‐income and middle‐income countries as well as underserved communities in high‐income countries. Each panel focused on 1 of 3 specific aspects of breast cancer care: 1) early detection, 2) treatment, and 3) health system strengthening.

Results

Key findings from the summit and subsequent article preparation included the identification of phased‐implementation prerequisites that were explored during consensus debates. These core issues and concepts are key components for implementing breast health care that consider real‐world resource constraints. Communication and engagement across all levels of care is vital to any effectively operating health care system, including effective communication with ministries of health and of finance, to demonstrate needs, outcomes, and cost benefits.

Conclusions

Underserved communities at all economic levels require effective strategies to deploy scarce resources to ensure access to timely, effective, and affordable health care. Systematically strategic approaches translating guidelines into practice are needed to build health system capacity to meet the current and anticipated global breast cancer burden.

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

✪ Breast cancer early detection: A phased approach to implementation

Authors:

Ophira Ginsburg, Cheng‐Har Yip, Ari Brooks, Anna Cabanes, Maira Caleffi, Jorge Antonio, Dunstan Yataco, Bishal Gyawali, Valerie McCormack, Myrna McLaughlin de Anderson, Ravi Mehrotra, Alejandro Mohar, Raul Murillo, Lydia E. Pace, Electra D. Paskett, Anya Romanoff, Anne F. Rositch, John R. Scheel, Miriam Schneidman, Karla Unger‐Saldaña, Verna Vanderpuye, Tsu‐Yin Wu, Safina Yuma, Allison Dvaladze, Catherine Duggan, and Benjamin O. Anderson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2020

Read the full text in the open access journal Cancer

Abstract:

When breast cancer is detected and treated early, the chances of survival are very high. However, women in many settings face complex barriers to early detection, including social, economic, geographic, and other interrelated factors, which can limit their access to timely, affordable, and effective breast health care services. Previously, the Breast Health Global Initiative (BHGI) developed resource‐stratified guidelines for the early detection and diagnosis of breast cancer.

In this consensus article from the sixth BHGI Global Summit held in October 2018, the authors describe phases of early detection program development, beginning with management strategies required for the diagnosis of clinically detectable disease based on awareness education and technical training, history and physical examination, and accurate tissue diagnosis. The core issues address include finance and governance, which pertain to successful planning, implementation, and the iterative process of program improvement and are needed for a breast cancer early detection program to succeed in any resource setting.

Examples are presented of implementation, process, and clinical outcome metrics that assist in program implementation monitoring. Country case examples are presented to highlight the challenges and opportunities of implementing successful breast cancer early detection programs, and the complex interplay of barriers and facilitators to achieving early detection for breast cancer in real‐world settings are considered.

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

✪ A targeted systematic review of cost analyses for implementation of simulation-based education in healthcare

Authors:

Daniel S Hippe, Rachel A Umoren, Alex McGee, Sherri L Bucher, Brian W Bresnahan

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2020

Read the full text in the open access journal SAGE Open Medicine

Abstract:

Over the past two decades, there has been an increase in the use of simulation-based education for training healthcare providers in technical and non-technical skills. Simulation education and research programs have mostly focused on the impact on clinical knowledge and improvement of technical skills rather than on cost. To study and characterize existing evidence to inform multi-stakeholder investment decisions, we performed a systematic review of the literature on costs in simulation-based education in medicine in general and in neonatal resuscitation as a particular focus.

We conducted a systematic literature search of the PubMed database using two targeted queries. The first searched for cost analyses of healthcare simulation-based education more broadly, and the second was more narrowly focused on cost analyses of neonatal resuscitation training. The more general query identified 47 qualified articles. The most common specialties for education interventions were surgery (51%); obstetrics, gynecology, or pediatrics (11%); medicine, nursing, or medical school (11%); and urology (9%), accounting for over 80% of articles. The neonatal resuscitation query identified five qualified articles. The two queries identified seven large-scale training implementation studies, one in the United States and six in low-income countries. There were two articles each from Tanzania and India and one article each from Zambia and Ghana. Methods, definitions, and reported estimates varied across articles, implying interpretation, comparison, and generalization of program effects are challenging.

More work is needed to understand the costs, processes, and outcomes likely to make simulation-based education programs cost-effective and scalable. To optimize return on investments in training, assessing resource requirements, associated costs, and subsequent outcomes can inform stakeholders about the potential sustainability of SBE programs. Healthcare stakeholders and decision makers will benefit from more transparent, consistent, rigorous, and explicit assessments of simulation-based education program development and implementation costs in low- and high-income countries.

**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**