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Kenya pharmacy PrEP trial: a new way to fight HIV?

NCT ID NCT05842122

Prevention Sponsor: Fred Hutchinson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether providing HIV prevention pills (PrEP and PEP) at local pharmacies in Kenya helps more people start and continue taking them, compared to the usual clinic referral. Over 5,800 participants from 60 pharmacies were involved. The goal was to see if pharmacy-based delivery, with a small fee, improves access and adherence to these life-saving medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PrEP (pre-exposure prophylaxis) and PEP (post-exposure prophylaxis) medications
What this could lead to
If successful, this model could make HIV prevention pills more accessible and convenient, potentially reducing new HIV infections in Kenya and similar settings.
What could go wrong
This is a completed trial, but results may not apply to other countries or populations. The intervention relies on pharmacy staff training and client willingness to pay a small fee, which could limit uptake.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5,808 people

The number who actually took part.

Started

Jun 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * Must be willing to use a study-specific module within a digital platform (Maisha Meds) to record pharmacy PrEP/PEP dispensing * Owner must agree to allow a trained research assistant to come to the pharmacy on select days to collect data from a random subset of participants * Owner must agree to allow providers to participate in a monitored WhatsApp group, optional surveys, and optional in-depth interview * Owner must agree to allow providers to routinely engage with a technical assistant Pharmacists/HTS counselors * ≥ 18 years old * Licensed pharmacist, licensed pharmaceutical technologist, or NASCOP-certified HTS counselor * Willing to provide PrEP and PEP services, including HIV testing and associated counseling services * Completed training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing * Able and willing to provide informed consent * Complete study training * Willing to use a study-specific module within a digital platform (Maisha Meds) to document PrEP/PEP services rendered Clients * ≥ 16 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 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

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

Contacts and locations

Locations

  • Kenya Medical Research Institute

    Kisumu, Kenya

  • Partners in Health & Research Development

    Thika, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.