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✪ 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**

✪ Acceptability and Feasibility of Pharmacy-Based Delivery of Pre-Exposure Prophylaxis in Kenya: A Qualitative Study of Client and Provider Perspectives

Authors:

Stephanie D. Roche, Njeri Wairimu, Peter Mogere, Kevin Kamolloh, Josephine Odoyo, Zachary A. Kwena, Elizabeth A. Bukusi, Kenneth Ngure, Jared M. Baeten, & Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2021

Read the full text in the open access journal AIDS and Behavior

Abstract:

As countries scale up pre-exposure prophylaxis (PrEP) for HIV prevention, diverse PrEP delivery models are needed to expand access to populations at HIV risk that are unwilling or unable to access clinic-based PrEP care. To identify factors that may influence implementation of retail pharmacy-based PrEP delivery in Kenya, we conducted in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from two provinces. Most participants expressed strong support for expanding PrEP to retail pharmacies, though conditioned their acceptance on assurances that care would be private, respectful, safe, and affordable. Participant-reported determinants of feasibility centered primarily on ensuring that the intervention is compatible with retail pharmacy operations (e.g., staffing levels, documentation requirements). Future research is needed to develop and test tailored packages of implementation strategies that are most effective at integrating PrEP delivery into routine pharmacy practice in Kenya and other high HIV prevalence settings.

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

✪ Design of a care pathway for pharmacy-based PrEP delivery in Kenya: Results from a collaborative stakeholder consultation

Authors:

Katrina F. Ortblad, Peter Mogere, Stephanie Roche, Kevin Kamolloh, Josephine Odoyo, Elizabeth Irungu, Nelly R. Mugo, Jillian Pintye, Jared M. Baeten, Elizabeth Bukusi, Kenneth Ngure & on Behalf of Stakeholders for Pharmacy-based PrEP Delivery in Kenya Consultation

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2020

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

Abstract:

Introduction

In Kenya, pre-exposure prophylaxis (PrEP) for HIV prevention is almost exclusively delivered at HIV clinics. Developing novel PrEP delivery models is important for increasing the reach of PrEP. Delivery of PrEP through pharmacies is one approach utilized in the US to improve accessibility. Retail pharmacies are commonly used as a first-line access point for medical care in Kenya, but have not been utilized for PrEP delivery. We conducted a collaborative consultative meeting of stakeholders to develop a care pathway for pharmacy-based PrEP delivery in Kenya.

Methods

In January 2020, we held a one-day meeting in Nairobi with 36 stakeholders from PrEP regulatory, professional, healthcare service delivery, civil society, and research organizations. Attendees reviewed a theory of change model, results from formative qualitative research with pharmacy providers and clients, and anticipated core components of pharmacy-based PrEP delivery: counseling, HIV testing, prescribing, and dispensing. Stakeholders participated in small and large group discussions to identify potential challenges and solutions. We synthesized the key findings from these discussions.

Results

Stakeholders were enthusiastic about a model for pharmacy-based PrEP delivery. Potential challenges identified included insufficient pharmacy provider knowledge and skills, regulatory hurdles to providing affordable HIV testing at pharmacies, and undefined pathways for PrEP procurement. Potential solutions identified included having pharmacy providers complete the Kenya Ministry of Health-approved PrEP training, use of a PrEP prescribing checklist with remote clinician oversight and provider-assisted HIV self-testing, and having the government provide PrEP and HIV self-testing kits to pharmacies during a pilot test. A care pathway was developed over the course of the meeting.

Conclusions

PrEP delivery stakeholders in Kenya were strongly supportive of developing and testing a model for pharmacy-based PrEP delivery to increase PrEP access. We collaboratively developed a care pathway for pilot testing that has the potential to expand PrEP delivery options in Kenya and other similar settings.

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

✪ Unintended uses, meanings, and consequences: HIV self-testing among female sex workers in urban Uganda

Authors:

Shannon A. McMahon, Daniel Kibuuka Musoke, Jonas Wachinger, Aidah Nakitende, Jocelyn Amongin, Esther Nanyiri, Anne-Marie Turcotte-Tremblay, Catherine E. Oldenburg, Till Barnighausen, & Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2020

Read the full text in the (partially) open access journal AIDS Care

Abstract:

Female sex workers (FSWs) are at increased risk of HIV and face significant barriers to clinic-based HIV testing, including provider stigma and privacy constraints. HIV self-testing (HIVST) has been proven to significantly increase HIV testing among FSWs. Less is known, however, about how FSWs make meaning of oral-fluid HIV self-tests, and the unintended ways they use and understand this novel technology. From October 2016 to March 2017, we conducted 61 in-depth interviews with FSWs (n = 31) in Kampala, Uganda. Eligible participants were: female, ≥18 years, exchanged sex for money or goods, and had not recently tested for HIV. We used inductive coding to identify emerging themes and re-arranged these into an adapted framework. Unintended desirable ways FSWs described self-testing included as a means to test others, to bolster their reputation as a health-conscious sex worker, and to avoid bearing witness to suffering at health facilities. Unintended undesirable meanings ascribed to self-testing included misunderstandings about how HIV is transmitted (via saliva versus blood) and whether self-tests also test for other infections. HIVST can increase FSWs’ knowledge of their own HIV status and that of their sexual partners, but messaging and intervention design must address misunderstandings and misuses of self-testing.

Trial registration:

ClinicalTrials.gov identifier: NCT02846402

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

✪ Pharmacy delivery to expand the reach of PrEP in Africa

Authors:

Katrina F. Ortblad, Peter Mogere, Elizabeth Bukusi, Kenneth Ngure, & Jared M. Baeten

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2020

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

Excerpt:

Several African countries have recently integrated pre‐exposure prophylaxis (PrEP) into their national HIV prevention programmes and are in the process of scaling‐up healthcare facility‐based PrEP delivery. To maximize the public health benefit of PrEP, there is need to prioritize access, minimize the costs of delivery and reach HIV at‐risk populations. Major barriers to facility‐based PrEP delivery exist, including facility‐associated HIV stigma, long waiting times, the costs of staffing and providers’ unfamiliarity with delivering prevention interventions. In Africa, PrEP is also being added to public health infrastructures that are sometimes burdened by overcrowding and drug stock outs. Thus, the ability of African health systems to maximize PrEP access necessitates finding novel models of PrEP delivery.

In low‐resource settings, including a number of African settings, private pharmacies fill an important gap in the medical system and individuals often rely on and prefer the use of pharmacies over healthcare facilities to address their medical needs. Pharmacies can address care needs that are both urgent (e.g. evaluation and medication for sexually transmitted infections) and preventive (e.g. contraception) and have advantages over healthcare facilities, including increased convenience and provider engagement. Compared to providers at healthcare facilities, providers at pharmacies can often spend more time with clients because they do not have to focus on treating sick patients and build better rapport with clients because they are for‐profit businesses that rely on repeat services. In low‐resource settings, it is common for individuals to first go to a pharmacy to address a medical issue (e.g. symptoms of malaria), then only go to a healthcare facility later if the issue is not resolved.

Delivery of PrEP through pharmacies is one approach being utilized in the US to improve PrEP accessibility. In Seattle, the... [READ MORE]

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