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Implementation Science at UW

Keywords: cRCT

✪ Assessing the sustainability of the Systems Analysis and Improvement Approach to increase HIV testing in family planning clinics in Mombasa, Kenya: results of a cluster randomized trial

Authors:

Jessica E. Long, McKenna C. Eastment, George Wanje, Barbra A. Richardson, Emily Mwaringa, Mwanakarama Athman Mohamed, Kenneth Sherr, Ruanne V. Barnabas, Kishorchandra Mandaliya, Walter Jaoko, and R. Scott McClelland

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2022

Read the full text in the open access journal Implementation Science
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Abstract:

Background

In Kenya, HIV incidence is highest among reproductive-age women. A key HIV mitigation strategy is the integration of HIV testing and counseling (HTC) into family planning services, but successful integration remains problematic. We conducted a cluster-randomized trial using the Systems Analysis and Improvement Approach (SAIA) to identify and address bottlenecks in HTC integration in family planning clinics in Mombasa County, Kenya. This trial (1) assessed the efficacy of this approach and (2) examined if SAIA could be sustainably incorporated into the Department of Health Services (DOHS) programmatic activities. In Stage 1, SAIA was effective at increasing HTC uptake. Here, we present Stage 2, which assessed if SAIA delivery would be sustained when implemented by the Mombasa County DOHS and if high HTC performance would continue to be observed.

Methods

Twenty-four family planning clinics in Mombasa County were randomized to either the SAIA implementation strategy or standard care. In Stage 1, the study staff conducted all study activities. In Stage 2, we transitioned SAIA implementation to DOHS staff and compared HTC in the intervention versus control clinics 1-year post-transition. Study staff provided training and minimal support to DOHS implementers and collected quarterly HTC outcome data. Interviews were conducted with family planning clinic staff to assess barriers and facilitators to sustaining HTC delivery.

Results

Only 39% (56/144) of planned SAIA visits were completed, largely due to the COVID-19 pandemic and a prolonged healthcare worker strike. In the final study quarter, 81.6% (160/196) of new clients at intervention facilities received HIV counseling, compared to 22.4% (55/245) in control facilities (prevalence rate ratio [PRR]=3.64, 95% confidence interval [CI]=2.68–4.94). HIV testing was conducted with 60.5% (118/195) of new family planning clients in intervention clinics, compared to 18.8% (45/240) in control clinics (PRR=3.23, 95% CI=2.29–4.55). Interviews with family planning clinic staff suggested institutionalization contributed to sustained HTC delivery, facilitated by low implementation strategy complexity and continued oversight.

Conclusions

Intervention clinics demonstrated sustained improvement in HTC after SAIA was transitioned to DOHS leadership despite wide-scale healthcare disruptions and incomplete delivery of the implementation strategy. These findings suggest that system interventions may be sustained when integrated into DOHS programmatic activities.

Trial registration

ClinicalTrials.gov (NCT02994355) registered on 16 December 2016.

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

✪ A pragmatic approach to identifying implementation barriers and facilitators for a novel pre-exposure prophylaxis (PrEP) delivery model at public facilities in urban Uganda

Authors:

Dorothy Thomas, Andrew Mujugira, Katrina Ortblad, Sylvia Namanda, Joseph Kibuuka, Mai Nakitende, Florence Nambi, Lylianne Nakabugo, Caitlin Scoville, Timothy Muwonge, Renee Heffron

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2022

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

Background

Scalable HIV pre-exposure prophylaxis (PrEP) delivery models for resource-limited settings are critical for improving PrEP coverage and interrupting HIV transmission. This research uses technical assistance (TA) reports to evaluate implementation barriers and facilitators for a novel delivery model integrating PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples in public health facilities in Kampala, Uganda.

Methods

We used data from the Partners PrEP Program (PPP)—a stepped-wedge cluster randomized trial that is launching PrEP delivery through an integrated model of oral PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples at public health facilities in Kampala and Wakiso, Uganda (NCT03586128). Technical assistance teams, comprised of PPP program staff, conducted monthly TA visits to implementing facilities where they identified and addressed implementation challenges in collaboration with health facility staff. Findings were recorded in TA reports, a standardized form structured using the Consolidated Framework for Implementation Research (CFIR). We used a conceptual content analysis approach to evaluate TA reports completed from January to December 2019 and identify implementation barriers and facilitators.

Results

Among 39 reports from the 8 implementing facilities (~ 5 per facility), we identified 11 CFIR constructs. Key implementation facilitators included sensitizing and educating facility staff about PrEP (knowledge and beliefs about the innovation); establishing formal and informal feedback and accountability mechanisms (reflecting and evaluating); and empowering facility staff to address implementation challenges (self-efficacy). Key implementation barriers were related to ineffective recruitment and referral of sero-different couples to and from nearby facilities (cosmopolitanism) as well as stockouts of laboratory resources and testing supplies (available resources).

Conclusions

This analysis featured a robust implementation science framework to assess the relationship between early implementation determinants and outcomes of this innovative PrEP delivery model. Further, we have provided important descriptions of early implementation barriers and facilitators that will inform scale-up efforts for PrEP delivery within and beyond Uganda. Future work will refine the analysis of pragmatic program data, qualitatively investigate the identified key themes, and explore strategies for addressing implementation barriers.

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

✪ Structural readiness to implement community-wide mass drug administration programs for soil-transmitted helminth elimination: results from a three-country hybrid study

Authors:

Arianna Rubin Means, Elizabeth Orlan, Marie-Claire Gwayi-Chore, Angelin Titus, Saravanakumar Puthupalayam Kaliappan, Comlanvi Innocent Togbevi, Félicien Chabi, Katherine E. Halliday, Providence Nindi, Euripide Avokpaho, Khumbo Kalua, Moudachirou Ibikounlé, Sitara S. R. Ajjampur, Bryan J. Weiner, Judd L. Walson, & Kumudha Aruldas

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2021

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

Background

Current soil-transmitted helminth (STH) control programs target pre-school and school-age children with mass drug administration (MDA) of deworming medications, reducing morbidity without interrupting ongoing transmission. However, evidence suggests that STH elimination may be possible if MDA is delivered to all community members. Such a change to the STH standard-of-care would require substantial systems redesign. We measured baseline structural readiness to launch community-wide MDA for STH in Benin, India, and Malawi.

Methods

After field piloting and adaptation, the structural readiness survey included two constructs: Organizational Readiness for Implementing Change and Organizational Capacity for Change. Sub-constructs of organizational readiness include change commitment and change efficacy. Sub-constructs of organizational capacity include flexibility, organizational structure, and demonstrated capacity. Survey items were also separately organized into seven implementation domains. Surveys were administered to policymakers, mid-level managers, and implementers in each country using a five-point Likert scale. Item, sub-construct, construct, and domain-level medians and interquartile ranges were calculated for each stakeholder level within each country.

Results

Median organizational readiness for change scores were highest in Malawi (5.0 for all stakeholder groups). In India, scores were 5.0, 4.0, and 5.0 while in Benin, scores were 4.0, 3.0, and 4.0 for policymakers, mid-level managers, and implementers, respectively. Median change commitment was equal to or higher than median change efficacy across all countries and stakeholder groups.

Median organizational capacity for change was highest in India, with a median of 4.5 for policymakers and mid-level managers and 5.0 for implementers. In Malawi, the median capacity was 4.0 for policymakers and implementers, and 3.5 for mid-level managers. In Benin, the median capacity was 4.0 for policymakers and 3.0 for mid-level managers and implementers. Median sub-construct scores varied by stakeholder and country.

Across countries, items reflective of the implementation domain ‘policy environment’ were highest while items reflective of the ‘human resource’ domain were consistently lower.

Conclusion

Across all countries, stakeholders valued community-wide MDA for STH but had less confidence in their collective ability to effectively implement it. Perceived capacity varied by stakeholder group, highlighting the importance of accounting for multi-level stakeholder perspectives when determining organizational preparedness to launch new public health initiatives.

Trial registration

NCT03014167

**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**

✪ 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**

✪ 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**