Pharmacy Delivery to Expand the Reach of PrEP in Kenya

Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Pilot Study

3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Other: pharmacy-based PrEP delivery

Detailed Description

Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to a public health infrastructure which is sometimes burdened by overcrowding and drug stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting times, costs of staffing and healthcare providers' unfamiliarity with delivering prevention interventions. In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important gap in the health care system providing first stop access to treatment, monitoring and preventive care of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over facility-delivered PrEP for reasons including increased convenience, increased privacy and greater engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer free, subsidized or affordable healthcare services. The core components of PrEP - including HIV testing, adherence and risk reduction counselling, assessment of side effects and provision of refills - are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. Prior formative qualitative research and a stakeholder meeting led to development of a care pathway for pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation meeting that included a wide spectrum of regulatory, professional, government, and community stakeholders in Kenya. We will conduct 3 separate, consecutive studies.

During Study 1a (13 months), we will pilot this care pathway in 2 retail pharmacies evenly split between 2 different geographies in Kenya: Kisumu and Thika. Activities will include data collection aimed at potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.

During Study 1b (12 months, happening concurrently with Study 1a), we will additionally offer pharmacy-based PrEP refills only to clients who initiated PrEP at select public health clinics, to assess how many clients opt to refill PrEP at a study pharmacy (for a fee) as opposed to at the clinic (for free).

During Study 2 (6 months, happening right after Study 1a), we will modify the delivery model (e.g., add new implementation strategies) to address the weak points identified during Study 1a, and we will expand PrEP delivery to six additional retail pharmacies (for a total of 12 pharmacies), evenly split between Kisumu and Thika.

• Study Type: Interventional
• Enrollment (Actual): 1216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute
  • Thika, Kenya
    • Kenya Medical Research Institute (Center for Clinical Research - PHRD Thika-Project)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• >=18 years
• Interested in initiating PrEP at a pilot pharmacy (Study 1a and Study 2), interested in refilling PrEP at a pilot pharmacy (Study 1b), or interested in initiating PEP and/or STI testing at a pilot pharmacy (select pharmacies in Study 2 only)
• Initiated PrEP at a project-affiliated clinic (Study 1b only)
• Meets all criteria (e.g., tests HIV-negative) on checklist for initiating and/or refilling PrEP (all phases), PEP (Study 2 only), and/or STI testing (Study 2 only)
• Able & willing to provide written informed consent

Exclusion Criteria:

• Currently pregnant or breastfeeding (Study 1a & 1b only)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study 1a: Pharmacy-based PrEP delivery Pilot (13 months); Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya.	Other: pharmacy-based PrEP delivery; The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.
Experimental: Study 1b: Pharmacy-based PrEP delivery Refill (12 months); Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies in Kenya after having initiated PrEP at one of 2 public clinics.	Other: pharmacy-based PrEP delivery; The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.
Experimental: Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months); Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing.	Other: pharmacy-based PrEP delivery; The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Initiation	Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services.	Over 13-month duration of Study 1a and 6-month duration of Study 2
PrEP Retention	For Study 1a and 2: Percentage of participants who refilled PrEP at a pilot pharmacy, among those who initiated PrEP at a pilot pharmacy. Study 1b: Percentage of participants who refilled PrEP either at a pilot pharmacy or at a pilot clinic, among those who initiated PrEP at a pilot clinic.	Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEP Initiation	Study 2: Number of participants who initiated PEP at a pilot pharmacy.	Over 6-month duration of Study 2
Selection of Pharmacy-based PrEP Refills	Study 1b: Percentage of participants who initiated PrEP at a clinic and subsequently opted to refill their PrEP prescription at a pilot pharmacy.	During the 12-month duration of Study 1b
PrEP Adherence	Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence	Over 12-month duration of Study 1a and the 6-month duration of Study 2
STI Testing Uptake	Study 2: Number of participants who opt to undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies	Over 6-month duration of Study 2
Transition From PEP to PrEP	Study 2: Percentage of participants who completed the full PEP regimen and subsequently initiated PrEP at a pilot pharmacy, among those who initiated PEP at a pilot pharmacy,	Over 6-month duration of Study 2
PrEP Initiation Among STI Testing Clients	Study 2: Number of participants who come to a study pharmacy for STI testing, undergo STI testing, and initiate PrEP at the pilot pharmacy during the same study visit or a subsequent study visit	Over 6-month duration of Study 2
Selection of Option to Self-administer HIV Risk Assessment Screening Tool	Study 2: Number of participants who opt to self-administer the HIV Risk Assessment Screening Tool (as opposed to having the pharmacy provider administer it)	Over 6-month duration of Study 2

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Mental Health (NIMH); Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Katrina Ortblad, MPH, ScD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Kenya; care pathway; HIV self-testing; pre-exposure prophylaxis; pharmacy; pilot
• Other Study ID Numbers: STUDY00009587; R34MH120106 (U.S. NIH Grant/Contract); P30AI027757 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No