Pharmacy Delivery to Expand the Reach of PrEP in Kenya

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT04558554

Collaborator

National Institute of Mental Health (NIMH) (NIH), National Institute of Allergy and Infectious Diseases (NIAID) (NIH), Bill and Melinda Gates Foundation (Other)

1,600

Enrollment

Locations

Arm

20.1

Anticipated Duration (Months)

800

Patients Per Site

39.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A pilot study to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.

Condition or Disease	Intervention/Treatment	Phase
HIV Prevention	Other: pharmacy-based PrEP delivery	N/A

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. This study will occur in two phases. During Phase One, we will pilot this care pathway in six retail pharmacies in two 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 Phase Two, we will modify the delivery model (e.g., add new implementation strategies) to address the weak points identified during Phase One, and we will expand PrEP delivery to six additional retail pharmacies (for a total of 12 pharmacies), evenly split between Kisumu and Thika.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

During Phases One and Two, all individuals meeting study and PrEP eligibility criteria will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) for HIV prevention at study pharmacies. During Phase Two, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Phase Two, a subset of four study pharmacies (two per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.During Phases One and Two, all individuals meeting study and PrEP eligibility criteria will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) for HIV prevention at study pharmacies. During Phase Two, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Phase Two, a subset of four study pharmacies (two per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 26, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmacy-based PrEP delivery Participants in this experimental arm (which includes all participants) will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at community pharmacies in Kenya. During Phase Two of the study, participants will also have the option to initiate post-exposure prophylaxis (PEP) at the 12 study pharmacies, and in a subset of four study 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.

Arm

Intervention/Treatment

Experimental: Pharmacy-based PrEP delivery

Participants in this experimental arm (which includes all participants) will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at community pharmacies in Kenya. During Phase Two of the study, participants will also have the option to initiate post-exposure prophylaxis (PEP) at the 12 study pharmacies, and in a subset of four study 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.

Outcome Measures

Primary Outcome Measures

PrEP initiation [Over 7-month duration of Phase One and the 6-month duration of Phase Two]
Number of participants who initiate PrEP at pilot pharmacies
PrEP retention [Over 7-month duration of Phase One and the 6-month duration of Phase Two]
Percentage of participants who returned to the pilot pharmacies (or clinic) for PrEP refills
PrEP adherence [Over 7-month duration of Phase One and the 6-month duration of Phase Two]
Percentage of DBS samples with drug concentrations indicating PrEP adherence
Selection of pharmacy-based PrEP [Month 0 of Phase One]
Percentage of participants who initiated PrEP at a clinic and subsequently selected pharmacy-based PrEP refills
PEP initiation [Over 6-month duration of Phase Two]
Number of participants who initiate PEP at pilot pharmacies
STI testing uptake [Over 6-month duration of Phase Two]
Number of participants who undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies

Secondary Outcome Measures

Transition from PEP to PrEP [Over 6-month duration of Phase Two]
Number of participants who initiate PEP at a pilot pharmacy, complete the full PEP regimen, and subsequently initiate PrEP at a pilot pharmacy
PrEP initiation among STI testing clients [Over 6-month duration of Phase Two]
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
Selection of option to self-administer HIV Risk Assessment Screening Tool [Over 6-month duration of Phase Two]
Number of participants seeking PrEP who opt to self-administer the HIV Risk Assessment Screening Tool (as opposed to having the pharmacy provider administer it)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

=18 years
Interested in initiating PrEP at a pilot pharmacy (Phase One/Aim 1a and Phase Two/Aim 1c) or interested in initiating PEP and/or STI testing at a pilot pharmacy (Phase Two/Aim 1c only)
Initiated PrEP at a project-affiliated CCC (Phase One/Aim 2 only)
Meets all criteria (e.g., tests HIV-negative) on checklist for initiating PrEP (Phase One/Aim 1a and Phase Two/Aim 1c), PEP (Phase Two/Aim 1c only), and/or STI testing (Phase Two/Aim 1c only)
Able & willing to provide written informed consent