Pharmacy Delivery to Expand the Reach of PrEP in Kenya

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558554
• Other study ID #: STUDY00009587
• Secondary ID: R34MH120106P30AI
• Status: Completed
• Phase: N/A
• Start date: November 26, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1216
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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.

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu
Kenya	Kenya Medical Research Institute (Center for Clinical Research - PHRD Thika-Project)	Thika

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Bill and Melinda Gates Foundation, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PEP Initiation	Study 2: Number of participants who initiated PEP at a pilot pharmacy.	Over 6-month duration of Study 2
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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