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HIV prevention shots coming to your local pharmacy?

NCT ID NCT07210125

Prevention Sponsor: Kelley-Ross & Associates, Inc. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving a long-acting HIV prevention shot (lenacapavir) in community pharmacies is practical and acceptable. Seventy-five HIV-negative adults will receive the injection either twice a year or every three months, and researchers will track how many stay on the regimen and whether STI rates change. The goal is to see if pharmacies can help more people access this prevention option.

What this could mean

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

Active substance
lenacapavir (long-acting injectable)
What this could lead to
If successful, this could show that community pharmacies are a convenient and effective place to deliver long-acting HIV prevention shots, potentially expanding access and reducing HIV infections.
What could go wrong
This is a small, single-center study with only 75 participants, so results may not apply broadly. It focuses on feasibility and acceptability, not on directly proving the drug prevents HIV.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

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

18 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: * 18 years of age or older at the time of screening * weight greater than or equal to 35kg * HIV-negative status * Willing to provide informed consent and undergo all required study procedures Exclusion Criteria: * Unknown or positive HIV status * Coadministration of drugs that significantly decreases lenacapavir concentrations according to the FDA package insert * Any participant that do not meet criteria for management under the CDTA

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Conditions

The condition(s) this trial relates to.

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

  • Kelley-Ross Pharmacy

    Seattle, Washington, 98122, United States

More trials for these conditions

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