Protocol No: ECCT/20/02/01 Date of Protocol: 19-09-2019

Study Title:

Pilot evaluation of pharmacy-based pre-exposure prophylaxis (PrEP) delivery

Study Objectives:

The primary objectives of this evaluation are to:

1. To determine acceptability of pharmacy-based PrEP delivery among AGYW by situating a PrEP-prescribing at up to 4 commercial pharmacies in Kisumu, Kenya who will offer PrEP per national guidelines to all AGYW (age 15-24 years) seeking contraception (e.g., emergency contraception, oral contraceptive pills [OCP], injectables, condoms) over a 3-month period. a. Secondary objectives: i. To describe reasons for declining PrEP among AGYW with behavioral risk factors for HIV. ii. To compare frequency of PrEP acceptability by specific behavioral risk factors for HIV per national guidelines for PrEP screening (e.g., partner HIV status, transactional sex, intimate partner violence)

2. To evaluate utilization and describe user experiences among AGYW who accepted PrEP using a mixed methods approach by:

1) administering questionnaires at a one-time follow-up visit among all AGYW who accepted PrEP (n=200) to quantify the proportion of AGYW who initiated PrEP use since acceptance and

2) conducting qualitative IDIs among a subset (n=40) of AGYW who did an did not initiate PrEP use to describe user experiences.

a. Secondary objectives:

i. To determine utilization of HIV self-test kits for at-home male partner and/or couples testing after accepting kits in commercial pharmacies.

ii. To compare potential barriers and facilitators of pharmacy PrEP described by AGYW who did and not initiate PrEP use.

Laymans Summary:

PrEP is a new medication to prevent HIV. It works when you take it as prescribed by a healthcare provider. To take full advantage of the public health benefits of PrEP for HIV prevention, there is need to increase access and reduce costs for people who may be at risk of HIV, such as adolescent girls and young women. In Africa, PrEP is being added to busy public health clinics and health systems will need to finding novel strategies to improve access. Additionally, there are major barriers to PrEP which include stigma, long waiting times, costs of staffing, and healthcare providers’ unfamiliarity with PrEP. In Kenya, retail pharmacies fill an important gap in the health care system by providing first stop access to treatment and preventive care of health conditions. Adolescent girls and young women frequently obtain contraception at pharmacies without attending a health facility. Potential PrEP users may prefer obtaining PrEP at a retail pharmacy due to its convenience and privacy. The core components of PrEP – including HIV testing, counselling, assessment of side effects, and refills – can easily be delivered within pharmacies. We will offer PrEP to adolescent girls and young women at two retail pharmacies in Kisumu, Kenya to assess whether pharmacies are acceptable as a new PrEP access point.

Abstract of Study:

Over two million persons become newly infected with HIV each year with the majority in Africa. In Kenya, more than 1.4 million people are living with HIV[1] making it the country with the fourth largest epidemic globally. The past five years has witnessed major strides in the development of highly-effective HIV prevention interventions, particularly using pre-exposure prophylaxis (PrEP) to prevent acquisition. Kenya is a leader for PrEP delivery in Africa and efforts are ongoing to increase PrEP accessibility; however, most approaches include expanding access within health facility-based settings. Novel strategies to successfully and efficiently deliver PrEP are needed to achieve maximum prevention impact and reach HIV prevention priority populations who do not frequently attend health facilities. For example, many adolescent girls and young women (AGYW) at risk for HIV in Kenya access contraception at commercial pharmacies without interfacing with public sector health facilities and would be missed by current PrEP delivery platforms. Pharmacy-based PrEP delivery has never been explored in an African setting. Adding pharmacies to the range of locations that deliver PrEP would increase the available options for reaching individuals at risk of HIV infection, including AGYW who frequently obtain contraception at pharmacies outside of health facilities. Development of collaborative practice agreements with pharmacies for fully self-contained PrEP delivery is ongoing in Kenya, but has not yet been tested. Collecting data on acceptability, utilization, user experiences of pharmacy-based PrEP delivery among individuals at HIV risk could inform future implementation of pharmacy-based PrEP delivery in this setting. We propose that situating a PrEP-prescribing nurse within pharmacies could expedite evidence gathering for aspects of delivery (e.g., acceptability and utilization of PrEP among AGYW in this setting). We will conduct a pilot evaluation by offering PrEP to AGYW within commercial pharmacies according to current national guidelines (i.e., a nurse stationed in the pharmacy with remote physician oversight) in Kisumu, Kenya to collect information on whether or not AGYW accept and utilize PrEP when offered in pharmacies. We will also gather qualitative perspectives from in-depth interviews on user experiences