TelePharm PrEP/PEP
Leveraging Telehealth to Optimize PrEP and PEP Delivery at Pharmacies in Kenya
2 other identifiers
interventional
1,580
1 country
1
Brief Summary
In this study, we 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. We 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
Study Completion
Last participant's last visit for all outcomes
September 30, 2028
May 1, 2026
April 1, 2026
1.5 years
April 24, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PrEP/PEP initiations
\# of unique clients dispensed any form of PrEP or PEP over the implementation period
18 months post implementation
PrEP/PEP continuation
\# of unique clients that refilled PrEP, transitioned from PEP-to-PrEP, or were dispensed PEP or on-demand PrEP again after initiating PrEP/PEP over the implementation period
18 months post implementation
Secondary Outcomes (13)
PrEP initiation
18 months post implementation
PEP initiation
18 months post implementation
PrEP/PEP use
1.5 and 6 months from initiation
PrEP use
1.5 and 6 months from initiation
PEP use
1.5 and 6 months from initiation
- +8 more secondary outcomes
Study Arms (2)
Telehealth support
EXPERIMENTALPharmacy 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).
Standard delivery
ACTIVE COMPARATORPharmacy 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).
Interventions
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.
Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP. SMS support not available between pharmacy visits.
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Mental Health (NIMH)collaborator
- Fred Hutchinson Cancer Centerlead
- ClickMedix LLCcollaborator
- Kenya Medical Research Institutecollaborator
Study Sites (1)
Kenya Medical Research Institute
Kisumu, Kenya
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 24, 2026
First Posted
May 1, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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.