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Implementation Science at UW

Keywords: Andy Stergachis

✪ Combining legal epidemiology and implementation science to improve global access to medicines: challenges and opportunities

Authors:

Jeff Lane & Andy Stergachis

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

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

Abstract:

Laws and policies affecting access to medicines have been in the global health spotlight for decades, yet our understanding of their effects remains substantially underdeveloped. The emerging field of legal epidemiology combined with the methods of implementation science presents an opportunity to help address this gap. Legal epidemiology refers to the scientific study and deployment of law as a factor in the cause, distribution, and prevention of disease and injury in a population. Legal epidemiology studies consist of a systematic collection and coding of laws and policies relating to a particular topic. Quasi-experimental or observational research methods can then be applied to take advantage of natural experiments resulting from heterogenous adoption and/or implementation of laws and policies.

Often legal epidemiology studies fail to account for heterogenous law implementation processes, presenting a need and opportunity to integrate implementation science methods. Researchers may face challenges in integrating these methods for access to medicines studies, including data access issues and a complex legal and implementation environment. Yet, the opportunities presented by increasingly transparent legal environments, improved monitoring of medicine availability, universal health coverage expansion, and electronic health and insurance records integration may facilitate overcoming these challenges. Improved collaboration and communication between researchers, health authorities, manufacturers, and health providers from public and private sectors will be critical. In spite of the challenges, combining the fields of legal epidemiology and implementation science may present an important strategy toward creating a legal and policy environment that supports global and equitable access to medicines.

**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**