TelePharm PrEP/PEP

Leveraging Telehealth to Optimize PrEP and PEP Delivery at Pharmacies in Kenya

In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between pharmacy visits increases PrEP/PEP initiations and continuation compared to standard PrEP/PEP delivery by pharmacy providers. The investigators hypothesize that pharmacy PrEP/PEP services delivered with telehealth support will result in better service utilization and implementation outcomes compared to standard delivery and be cost-effective to implement.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV
• Intervention / Treatment: Other: Telehealth delivery of pharmacy PrEP/PEP; Other: Standard pharmacy PrEP/PEP delivery

Detailed Description

Participating study pharmacies will be 1:1 randomized 24 pharmacies (n=1,580 clients ≥15 years) to either: 1) telehealth support, where a remote nurse screens, counsels, and guides clients through HIV self-testing (HIVST) and, between visits, communicates with interested clients via 2-way SMS, or 2) standard delivery, where the pharmacy provider performs all delivery tasks and clients are not given additional support. The primary outcomes are PrEP/PEP initiation and continuation, assessed 180 days following clients' first pharmacy PrEP/PEP visit.

• Study Type: Interventional
• Enrollment (Estimated): 1580
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrina F Ortblad; Phone Number: 206-667-7267; Email: kortblad@fredhutch.org

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute
    • Contact: Elizabeth A Bukusi; Phone Number: +254-572021036; Email: ebukusi@rctp.or.ke
    • Principal Investigator: Elizabeth A Bukusi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Pharmacies

• Registered with the Pharmacy and Poisons Board (PPB)
• Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff
• Must have a private room where HIV testing and PrEP/PEP counseling can occur
• >3 km from other study pharmacies
• Willing to participate in research activities, including 2-day training for pharmacy providers
• Willing to share pharmacy records with us
• Sells HIVST kits that are WHO certified.

Pharmacists/remote nurses

• ≥ 18 years old
• Licensed pharmacist, pharmaceutical technologist, or nurse
• Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
• Willing to complete training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
• Able and willing to provide informed consent

Clients

• ≥ 15 years old
• Interested in being screened for PrEP or PEP
• Meets all criteria to be eligible for pharmacy-delivered PrEP or PEP on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP/PEP safety
• Able and willing to provide informed consent

Exclusion Criteria:

Clients

• Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
• Currently enrolled in any other HIV vaccine or prevention trial
• Have a condition that would preclude provision of informed consent, make study participation unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving study objectives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth support; Pharmacy provider-led PrEP/PEP delivery, with telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing and optional 2-way SMS with remote nurses).	Other: Telehealth delivery of pharmacy PrEP/PEP; Remote nurses screen, counsel, and guide HIV self-testing for pharmacy clients; pharmacy providers dispense PrEP or PEP. SMS support from remote nurses available between pharmacy visits.
Active Comparator: Standard delivery; Pharmacy provider-led PrEP/PEP delivery, without telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing).	Other: Standard pharmacy PrEP/PEP delivery; Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP. SMS support not available between pharmacy visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP/PEP initiation	Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP or PEP over the implementation period	18 months post implementation
PrEP/PEP continuation	Pharmacy-level; count outcome: # of unique clients that refilled PrEP, transitioned from PEP-to-PrEP, or were dispensed PEP or on-demand PrEP 1+ times over the implementation period	18 months post implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation	Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP over the implementation period	18 months post implementation
PEP initiation	Pharmacy-level; count outcome: # unique clients dispensed any form of PEP over the implementation period	18 months post implementation
PrEP/PEP use	Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP or PEP during the implementation period	1.5 and 6 months from initiation
PrEP use	Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP during the implementation period	1.5 and 6 months from initiation
PEP use	Pharmacy-level; count outcome: # of unique clients who swallowed any PEP during the implementation period	1.5 and 6 months from initiation
PrEP refill	Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP	18 months post implementation
Repeat PEP	Pharmacy-level; count outcome: # unique clients who were dispensed PEP or PEP-in-pocket after initiating PEP	18 months post implementation
PEP-to-PrEP	Pharmacy-level; count outcome: # unique clients who were dispensed PrEP after initiating PEP (any form) over the implementation period	18 months post implementation
Engaged with 1+ product	Pharmacy-level; count outcome: # of unique clients that were dispensed more than one HIV prevention product (oral PrEP, injectable PrEP, PEP, etc) over the implementation period	18 months post implementation
On-demand PrEP use	Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any on-demand PrEP over the implementation period	6 months from initiation
PEP-in-Pocket use	Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any PEP-in-Pocket over the implementation period	6 months from initiation
Product choice	Individual-level; binary outcome: % of total PrEP/PEP clients that were dispensed each type of product (e.g., oral PrEP, on- demand PrEP, PEP, DVR, etc).	18 months post implementation
PrEP adherence	Individual-level; binary outcome: % PrEP initiators (excluding on-demand) with optimal TFV-DP concentration in DBS	1.5 months from initiation
Reach	Individual-level; binary outcome: % of PrEP/PEP clients in different populations of interest (e.g., men; youth <25 years); with separate evaluations by product type	18 months post implementation
Efficiency	Pharmacy-level; continuous outcome: Avg. duration (per visit & annually) of pharmacy providers' encounter per PrEP/PEP client, and clients' PrEP/PEP visit duration	18 months post implementation
Fidelity	Individual-level; binary outcome: % of clients that received PrEP/PEP services as intended (e.g., correct quantity of drugs)	1.5 months post initiation
Sustainment	Pharmacy-level; count outcome: Volume of unique PrEP/PEP clients served in the past 6 months, assessed at 24 months	24 months post implementation
Acceptability	Individual-level; cont, binary outcome: # of unique client who find the study components acceptable; % of providers, including remote nurses, indicating acceptability; Also assessed in Aim 2 (described below)	24 months post implementation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to use (for on-demand PrEP) at 1.5 months	Pharmacy-level; continuous outcome: Avg. duration (in days) from on-demand PrEP dispensing to use, among on-demand clients	1.5 months
Time to use (for on-demand PrEP) at 6 months	Pharmacy-level; continuous outcome: Avg. duration (in days) from on-demand PrEP dispensing to use, among on-demand clients	6 months
STI diagnosis	Individual-level; binary outcome: % of PrEP/PEP clients with a syndromic STI diagnosis (at any pharmacy PrEP/PEP visit)	18 months post implementation
Other drugs dispensed	Pharmacy-level; binary outcome: % of PrEP/PEP clients dispensed other drugs (e.g., hypertension, contraception) at their visit	18 months post implementation
HIV incidence	Pharmacy-level; binary outcome: % of PrEP/PEP clients who tested positive	18 months
HIV risk	Inidiviudal-level; binary outcome: % of PrEP/PEP clients reporting specific behaviors (i.e., multiple sex partners)	18 months post implementation

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute of Mental Health (NIMH); Kenya Medical Research Institute; ClickMedix LLC
• Investigators: Study Chair: Kendall V Harkey, Fred Hutch Cancer Center; Study Chair: Rachel C Malen, Fred Hutch Cancer Center; Principal Investigator: Katrina F Ortblad, Fred Hutch Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Kenya; pre-exposure prophylaxis (PrEP); Pharmacy; post-exposure prophylaxis (PEP)
• Other Study ID Numbers: RG1125680; R01MH140465 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant-level pharmacy record and research data will be shared through deposition of the data in an open-access public repository (Dryad). In addition to sharing the study data publicly, data dictionaries and other tools supporting use of the data will be shared.
• IPD Sharing Time Frame: De-identified pharmacy record and research data from this study will be deposited in the Dryad data repository within 12 months of publication.

IPD Sharing Access Criteria

The study data will be accessible through the Dryad data repository. For all publications, a dataset will be created that is assigned a digital object identifier (DOI), which will be referenced in the publication so the research community can easily find and access the data, if interested. The Dryad repository can also be searched by topic, institution, and investigator name, which should make it easy for other interested parties to find and access the study data.

Any study data that cannot be shared via Dryad, will be made available through a formal request to the PIs. We will share data and supporting documentation upon request to outside investigators, after scientific review, IRB approval, and obtaining relevant Data Use Agreements.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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