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✪ Implementation science in plain language: The use of nonjargon terms to facilitate collaboration

Authors:

Shannon Dorsey, Clara Johnson, Caroline Soi, Rosemary D Meza, Kathryn Whetten & Anne Mbwayo

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2023

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

Interdisciplinary collaboration and stakeholder engagement are key ingredients in implementation science research. However, effective and efficient collaboration can be limited by the complexity of implementation science terms. In this article, we argue that the development and use of plain language implementation science terms is an essential step to facilitate collaboration and engagement.

Methods

We present an example of plain language development to portray the process and the potential benefits plain language can have on implementation science research. Implementation scientists and intervention experts codeveloped plain language implementation terms as a part of an implementation-effectiveness trial in western Kenya and in preparation for a stakeholder collaborative design meeting.

Results

The developed plain language terms facilitated wider stakeholder understanding and integration of implementation science findings that could inform the design of a stakeholder-led implementation coaching program.

Conclusions

We encourage the use of the plain language terms presented in this article, further translation, and additional development of other plain language terms for implementation science constructs.

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

✪ Co-developed implementation guidelines to maximize acceptability, feasibility, and usability of mobile phone supervision in Kenya

Authors:

Noah S. Triplett, Anne Mbwayo, Sharon Kiche, Lucy Liu, Jacinto Silva, Rashed AlRasheed, Clara Johnson, Cyrilla Amanya, Sean Munson, Bryan J. Weiner, Pamela Y. Collins & Shannon Dorsey

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2023

Read the full text in the open access journal Cambridge Prisms: Global Mental Health

Abstract:

Opportunities exist to leverage mobile phones to replace or supplement in-person supervision of lay counselors. However, contextual variables, such as network connectivity and provider preferences, must be considered. Using an iterative and mixed methods approach, we co-developed implementation guidelines to support the implementation of mobile phone supervision with lay counselors and supervisors delivering a culturally adapted trauma-focused cognitive behavioral therapy in Western Kenya. Guidelines were shared and discussed with lay counselors in educational outreach visits led by supervisors. We evaluated the impact of guidelines and outreach on the acceptability, feasibility, and usability of mobile phone supervision. Guidelines were associated with significant improvements in acceptability and usability of mobile phone supervision. There was no evidence of a significant difference in feasibility. Qualitative interviews with lay counselors and supervisors contextualized how guidelines impacted acceptability and feasibility – by setting expectations for mobile phone supervision, emphasizing importance, increasing comfort, and sharing strategies to improve mobile phone supervision. Introducing and discussing co-developed implementation guidelines significantly improved the acceptability and usability of mobile phone supervision. This approach may provide a flexible and scalable model to address challenges with implementing evidence-based practices and implementation strategies in lower-resourced areas.

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

✪ Implementation fidelity to HIV assisted partner services (aPS) during scale-up in western Kenya: a convergent mixed methods study

Authors:

Beatrice Wamuti, Mercy Owuor, Wenjia Liu, David Katz, Harison Lagat, George Otieno, Edward Kariithi, Paul Macharia, Sarah Masyuko, Mary Mugambi, Carey Farquhar & Bryan Weiner

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2023

Read the full text in the open access journal BMC Health Services Research

Abstract:

Background

HIV assisted partner services (aPS) is an intervention to improve HIV status awareness among sex and drug-injecting partners of people newly diagnosed with HIV (index clients). Implementation fidelity—the degree to which an intervention is conducted as intended – is critical to effectiveness, but there are limited data about aPS fidelity when delivered by HIV testing service (HTS) providers. We explored factors affecting implementation fidelity to aPS in two high-HIV prevalence counties in western Kenya.

Methods

We used convergent mixed methods adapting the conceptual framework for implementation fidelity within the aPS scale-up project. This was an implementation study examining scale-up of APS within HTS programs in Kisumu and Homa Bay counties that recruited male sex partners (MSPs) of female index clients. We defined implementation fidelity as the extent to which HTS providers followed the protocol for phone and in-person participant tracing at six expected tracing attempts. Quantitative data were collected from tracing reports in 31 facilities between November 2018 and December 2020, and in-depth interviews (IDIs) were conducted with HTS providers. Descriptive statistics were used to describe tracing attempts. IDIs were analyzed using thematic content analysis.

Results

Overall, 3017 MSPs were mentioned of whom 98% (2969/3017) were traced, with most tracing attempts being successful (2831/2969, 95%). Fourteen HTS providers participated in the IDIs—mostly females (10/14, 71%) with a median age of 35 years (range 25–52), who all had post-secondary education (14/14, 100%). The proportion of tracing attempts occurring by phone ranged from 47 to 66%, with the highest proportion occurring on the first attempt and lowest on the sixth attempt. Contextual factors either enhanced or impeded implementation fidelity to aPS. Positive provider attitudes towards aPS and conducive work environment factors promoted implementation fidelity, while negative MSP responses and challenging tracing conditions impeded it.

Conclusion

Interactions at the individual (provider), interpersonal (client—provider), and health systems (facility) levels affected implementation fidelity to aPS. As policymakers prioritize strategies to reduce new HIV infections, our findings highlight the importance of conducting fidelity assessments to better anticipate and mitigate the impact of contextual factors during the scale-up of interventions.

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

✪ Real-world impact of integrating HIV assisted partner services into 31 facilities in Kenya: a single-arm, hybrid type 2 implementation-effectiveness study

Authors:

Monisha Sharma, Brienna Naughton, Harison Lagat, George Otieno, David A Katz, Beatrice M Wamuti, Sarah Masyuko, Rose Bosire, Mary Mugambi, Unmesha Roy Paladhi, Bryan J Weiner, Edward Kariithi & Carey Farquhar

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2023

Read the full text in the open access journal The Lancet Global Health

Abstract:

Background

Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of individuals diagnosed with HIV (index clients), have been shown to be safe and effective in clinical trials. We assessed the real-world effectiveness of APS when integrated into HIV clinics in western Kenya.

Methods

In this single-arm, hybrid type 2 implementation science study, we facilitated APS implementation in 31 health facilities in Kenya by training existing health-care staff. We focused on male partner outcomes to assess the impact of APS in reaching male individuals in sub-Saharan Africa, who have lower rates of HIV testing than female individuals. Female individuals (aged ≥18 years or emancipated minor) who tested positive for HIV at participating facilities in Kenya were offered APS; consenting female participants provided contact information for all male sexual partners in the past 3 years. Male partners were notified of their potential HIV exposure and offered a choice of community-based or facility-based HIV testing services (HTS). Female index clients and male partners with HIV were followed up at 6 weeks, 6 months, and 12 months after enrolment, to assess linkage to antiretroviral treatment. Viral load was assessed at 12 months.

Findings

Between May 1, 2018, and March 31, 2020, 32 722 female individuals received HTS; 1910 (6%) tested positive for HIV, of whom 1724 (90%) received APS. Female index clients named 5137 male partners (median 3 per index [IQR 2–4]), of whom 4422 (86%) were reached with exposure notification and HTS. 524 (12%) of the male partners tested were newly diagnosed with HIV and 1292 (29%) reported a previous HIV diagnosis. At 12 months follow-up, 1512 (88%) female index clients and 1621 (89%) male partners with HIV were taking ART, with few adverse events: 25 (2%) female index clients and seven (<1%) male partners reported intimate partner violence, and 60 (3%) female index clients and ten (<1%) male partners reported relationship dissolution.

Interpretation

Evidence from this real-world APS scale-up project shows that APS is a safe, acceptable, and effective strategy to identify males with HIV and retain them in care.

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

✪ Time Utilization Among Immunization Clinics Using an Electronic Immunization Registry (Part 2): Time and Motion Study of Modified User Workflows

Authors:

Samantha B Dolan, Rachel Wittenauer, Anne Njoroge, Penina Onyango, George Owiso, Jessica C Shearer, William B Lober, Shan Liu, Nancy Puttkammer & Peter Rabinowitz

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

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

Abstract:

Background

Digital health interventions have the potential to improve the provision of health care services through digitized data collection and management. Low- and middle-income countries are beginning to introduce electronic immunization registries (EIRs) into their routine immunization services to better capture and store childhood vaccination information. Especially in Africa, where 25% of children remain unimmunized or underimmunized, technologies that can help identify children due for a vaccination are particularly important for improving vaccination coverage. However, an improved understanding of the effectiveness of these systems is needed to develop and deploy sustainable EIRs in low- and middle-income countries.

Objective

We conducted an interventional pretest-posttest design study that sought to improve time efficiency through workflow modifications in Kenyan immunization clinics. Our aim was to describe how activity times differed after introducing workflow modifications that could potentially reduce the time needed to perform routine data entry activities. Our intent was to demonstrate changes in efficiency when moving from the existing dual–data entry workflow to a future paperless workflow by health facility size and experience length of health care workers (HCWs).

Methods

We tested how 3 workflow modifications would affect time utilization among HCWs using the EIR at the point of care compared with baseline immunization clinic workflows. Our outcome of interest was the time taken to complete individual activities and a patient’s total time in the clinic where we compared the time spent during the baseline workflow with that during the modified workflow. We used a standardized tool to observe and document the immunization clinic workflow. To estimate differences in time utilization, we used bivariate analyses and fit multivariate linear mixed-effects models.

Results

Our study found that for HCWs using an EIR, the introduction of modified workflows decreased the amount of time needed to provide services to children seen in the immunization clinic. With a baseline mean time of 10 minutes spent per child, this decreased by about 3 minutes when the preparation modification was introduced and almost 5 minutes for the paperless and combined modifications. Results pertaining to the EIR’s performance and ability to connect to the internet were particularly insightful about potential causes of delays.

Conclusions

We were able to conduct a concise clinical simulation exercise by introducing modified workflows and estimating their impact on time utilization in immunization clinics using an EIR. We found that the paperless workflow provided the largest time savings when delivering services, although this was threatened by poor EIR performance and internet connectivity. This study demonstrated that not only should digital health interventions be built and adapted for particular use cases but existing user workflows also need to adapt to new technology.

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

✪ Integration of a Digital Health Intervention Into Immunization Clinic Workflows in Kenya: Qualitative, Realist Evaluation of Technology Usability

Authors:

Samantha B Dolan, Rachel Wittenauer, Jessica C Shearer, Anne Njoroge, Penina Onyango, George Owisom, William B Lober, Shan Liu, Nancy Puttkammer, & Peter Rabinowitz

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

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

Abstract:

Background

In an effort to increase vaccination coverage in low-resource settings, digital tools have been introduced to better track immunization records, improve data management practices, and provide improved access to vaccination coverage data for decision-making. Despite the potential of these electronic systems to improve the provision of health services, few digital health interventions have been institutionalized at scale in low- and middle-income countries.

Objective

In this paper, we aimed to describe how health care workers in Kenya had integrated an electronic immunization registry into their immunization clinic workflows and to use these findings to inform the development of a refined program theory on the registry’s usability.

Methods

Informed by realist methodology, we developed a program theory to explain usability of the electronic immunization registry. We designed a qualitative study based on our theory to describe the barriers and facilitators influencing data entry and use. Qualitative data were collected through semistructured interviews with users and workflow observations of immunization clinic sessions. Our findings were summarized by context-mechanism-outcome relationships formed after analyzing our key themes across interviews and workflow observations. Using these relationships, we were able to identify common rules for future implementers.

Results

Across the 12 facilities included in our study, 19 health care workers were interviewed, and 58 workflow sessions were observed. The common rules developed from our qualitative findings are as follows: rule 1—ensure that the users complete training to build familiarity with the system, understand the value of the system and data, and know where to find support; rule 2—confirm that the system captures all data needed for users to provide routine health care services and is easy to navigate; rule 3—identify work-arounds for poor network, system performance, and too few staff or resources; and rule 4—make users aware of expected changes to their workflow, and how these changes might differ over time and by facility size or number of patients. Upon study completion, we revised the program theory to reflect the importance of the goals and workflows of electronic immunization registries aligning with reality.

Conclusions

We created a deeper understanding of the underlying mechanisms for usability of the registry. We found that the electronic immunization registry had high acceptability among users; however, there were numerous barriers to using the system, even under ideal conditions, causing a misalignment between the system and the reality of the users’ workflows and their environment. Human-centered design and human-factors methods can assist during pilot stages to better align systems with users’ needs and again after scale-up to ensure that interventions are suitable for all user settings."

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

✪ Barriers and Facilitators to Father’s Engagement in a Depression and Alcohol Use Intervention in Kenya: Father, Family, and Community Factors

Authors:

Ali Giusto, Florence Jaguga, Victor Pereira-Sanchez, Wilter Rono, Noah Triplett, Hani Rukh-E-Qamar, Mattea Parker & Milton L. Wainberg

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal International Journal of Environmental Health

Abstract:

In Kenya, there is a treatment gap for depression and alcohol use that is especially large for fathers, which has consequences for families. While treatments exist, there are challenges to implementation. This study aimed to understand barriers and facilitators to implementing a treatment for fathers’ depression and alcohol use in Eldoret, Kenya. Guided by the Consolidated Framework for Implementation Research and the Integrated Sustainability Framework, we conducted 18 key informant interviews and 7 focus group discussions (31 total participants) with stakeholders in Eldoret (hospital leaders, policy makers, mental health providers, community leaders, fathers, lay providers, and patients previously engaged in treatment). Interviews were analyzed using the framework method; themes were matrixed by framework domains. Participants identified barriers and facilitators, and opportunities for implementation, in the following domains: innovation, outer setting, inner setting, individual, sustainability, and characteristics of systems. Barriers included a lack of resources, stigma, masculine norms, cost of services, and alcohol dependence. Facilitators included community buy-in, family support, providers with lived experience, government support, and relevant treatment content. Findings will inform implementation strategy development for an intervention for fathers with depression and alcohol use, and family problems with local relevance and scalable potential.

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

✪ Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study

Authors:

Catherine Kiptinness, Paulami Naik, Nicholas Thuo, Rachel C. Malen, Julia C. Dettinger, Jillian Pintye, Maeve Rafferty, Edwin Jomo, Nicky Nyamasyo, Tony Wood, Paul Isabelli, Sarah Morris, David Hattery, Andy Stergachis, Daniel Were, Monisha Sharma, Kenneth Ngure, Melissa Latigo Mugambi, and Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

Read the full text in the open access journal Frontiers in Public Health

Abstract:

Background

Online pharmacies in Kenya provide sexual and reproductive health products (e.g., HIV self-testing, contraception) and could be leveraged to increase the reach of HIV pre-exposure and post-exposure prophylaxis (PrEP/PEP) to populations who do not frequently attend health facilities. To date, evidence is limited for operationalizing online PrEP/PEP delivery and the type of populations reached with this differential service delivery model.

Methods

The ePrEP Kenya Pilot will deliver daily oral PrEP and PEP via MYDAWA, a private online pharmacy retailer, to clients in Nairobi for 18 months. Potential clients will obtain information about PrEP/PEP on MYDAWA's sexual wellness page and self-screen for HIV risk. Individuals ≥18 years, identified as at HIV risk, and willing to pay for a blood-based HIV self-test and PrEP/PEP delivery will be eligible for enrollment. To continue with online PrEP/PEP initiation, eligible clients will purchase a blood-based HIV self-test for 250 KES (~USD 2) [delivered to their setting of choice for 99 KES (~USD 1)], upload an image of their self-test result, and attend a telemedicine visit with a MYDAWA provider. During the telemedicine visit, providers will screen clients for PrEP/PEP eligibility, including clinical concerns (e.g., kidney disease), discuss self-test results, and complete counseling on PrEP/PEP use and safety. Providers will refer clients who self-test HIV positive or report any existing medical conditions to the appropriate services at healthcare facilities that meet their preferences. Eligible clients will be prescribed PrEP (30-day PrEP supply at initiation; 90-day PrEP supply at follow-up visits) or PEP (28-day supply) for free and have it delivered for 99 KES (~USD 1). We will measure PrEP and PEP initiation among eligible clients, PEP-to-PrEP transition, PrEP continuation, and implementation outcomes (e.g., feasibility, acceptability, and costs).

Discussion

Establishing pathways to increase PrEP and PEP access is crucial to help curb new HIV infections in settings with high HIV prevalence. The findings from this study will provide evidence on the implementation of online pharmacy PrEP and PEP service delivery that can help inform guidelines in Kenya and similar settings.

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

✪ Barriers to and strategies for early implementation of pharmacy-delivered HIV PrEP services in Kenya: An analysis of routine data

Authors:

Hilma N. Nakambale, Stephanie D. Roche, Peter Mogere, Victor Omollo, Alexandra P. Kuo, Andy Stergachis, Jared M. Baeten, Elizabeth Bukusi, Kenneth Ngure, Melissa Latigo Mugambi & Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

Read the full text in the open access journal Frontiers in Reproductive Health

Abstract:

Background

For individuals who face challenges accessing clinic-based HIV pre-exposure prophylaxis (PrEP), differentiated service delivery models are needed to expand access and reach. During a pilot study testing a novel pharmacy-delivered oral PrEP model in Kenya, we used routine programmatic data to identify early implementation barriers and actions that providers and study staff took in response to the barriers.

Methods

We trained pharmacy providers at five private pharmacies in Kisumu and Kiambu Counties to initiate and continue clients at risk of HIV acquisition on PrEP for a fee of 300 KES per visit (∼$3 USD) using a prescribing checklist with remote clinician oversight. Research assistants stationed at the pharmacies completed weekly observation reports of pharmacy-delivered PrEP services using a structured template. We analyzed reports from the first 6 month of implementation using content analysis and identified multi-level early implementation barriers and actions taken to address these. We then organized the identified barriers and actions according to the Consolidated Framework for Implementation Research (CFIR).

Results

From November 2020 to May 2021, research assistants completed 74 observation reports (∼18/pharmacy). During this period, pharmacy providers screened 496 potential PrEP clients, identified 425 as eligible for pharmacy-delivered PrEP services, and initiated 230 (54%) on PrEP; 125 of 197 (63%) clients eligible for PrEP continuation refilled PrEP. We identified the following early implementation barriers to pharmacy-delivered PrEP services (by CFIR domain): high costs to clients (intervention characteristics), client discomfort discussing sexual behaviors and HIV testing with providers (outer setting), provider frustrations that PrEP delivery was time-consuming and disruptive to their workflow (inner setting), and provider hesitancy to deliver PrEP due to concerns about encouraging sexual promiscuity (characteristics of individuals). To help address these, pharmacy providers implemented a self-screening option for behavioral HIV risk assessment for prospective PrEP clients, allowed flexible appointment scheduling, and conducted pharmacy PrEP trainings for newly hired staff.

Conclusion

Our study provides insight into early barriers to implementing pharmacy-delivered PrEP services in Kenya and potential actions to mitigate these barriers. It also demonstrates how routine programmatic data can be used to understand the early implementation process.

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

✪ Risk-based versus universal PrEP delivery during pregnancy: a cluster randomized trial in Western Kenya from 2018 to 2019

Authors:

John Kinuthia, Julia C. Dettinger, Joshua Stern, Nancy Ngumbau, Ben Ochieng, Laurén Gómez, Felix Abuna, Salphine Watoyi, Mary Marwa, Daniel Odinga, Anjuli D. Wagner, Barbra A. Richardson, Jillian Pintye, Jared M. Baeten & Grace John-Stewart

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

Read the full text in the open access journal Journal of the International AIDS Society

Abstract:

Introduction

Integrating pre-exposure prophylaxis (PrEP) delivery for pregnant and postpartum women within maternal and child health (MCH) clinics is feasible and acceptable. It is unknown whether a risk-guided model would facilitate appropriate PrEP use among MCH attendees better than universally offering PrEP.

Methods

The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study was a cluster randomized trial to assess two models for PrEP delivery among pregnant women seeking routine MCH care at 20 public clinics in Kenya between January 2018 and July 2019 (NCT03070600). In the Universal arm, all participants received PrEP counselling and self-selected whether to initiate PrEP. In the Targeted arm, participants underwent an HIV risk assessment, including an objective risk-scoring tool and an offer of HIV self-tests for at-home partner testing; those determined to be at high risk received a PrEP offer. Participants were followed through 9 months postpartum. Primary outcomes included incident HIV and appropriate PrEP use (defined as PrEP uptake among those at high risk and no PrEP uptake for those not at risk). Outcomes were compared using intention-to-treat analyses, adjusting for baseline HIV risk and marital status.

Results

Among 4447 women enrolled, the median age was 24.0 years (interquartile range [IQR]: 20.9, 28.3), and most were married (84.8%). The median gestational age at enrolment was 24 weeks (IQR: 20, 30). Women in the Targeted arm were more likely to be at high risk for HIV acquisition at baseline (51.6% vs. 33.3%). During 4638 person-years (p-yr) of follow-up, there were 16 maternal HIV infections with no difference in maternal HIV incidence between arms: 0.31/100 p-yr (95% CI: 0.15, 0.65) Targeted and 0.38/100p-yr (95% CI: 0.20, 0.73) Universal (adjusted relative risk [aRR]: 0.85 [CI: 0.28, 2.55]). There was no significant difference in the frequency of appropriate PrEP use between the arms (68.2% vs. 59.1% in Targeted vs. Universal, respectively) (aRR: 1.03 [CI: 0.96, 1.10]).

Conclusions

Given comparable maternal HIV incidence and PrEP uptake in Universal and Targeted approaches, and the simplicity that universal PrEP offers, our findings suggest that universal PrEP counselling is optimal for integrating PrEP in MCH systems.

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