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Home HIV shots by loved ones could revolutionize care

NCT ID NCT06488846

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a trained friend, family member, or partner can safely give long-acting HIV injections at home. It involves 1,000 people with HIV who are already on the injectable treatment and have the virus under control. The goal is to make it easier for people to stick with their HIV medication and close gaps in care.

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.

Participants

About 1,000 people

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

Started

Feb 2026

Expected to finish

Sep 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.

Who is studied

PWH who have been prescribed injectable cabotegravir/rilpivirine (CAB/RPV) as part of their routine care who have clinician approval to participate in the home-based program.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: PWH: * Age ≥18 years, patient receiving care at partnering clinical sites; * can identify a support person injector (i.e., family, friend, or partner) who is willing and able to provide injections; * has received at least the loading dose of cabotegravir/rilpivirine CAB/RPV (i.e., 600mg/900mg IM) without serious adverse events; * is virologically suppressed (HIV RNA \<50 copies/mL); * has no history of treatment failure; * has no known or suspected resistance to either RPV or CAB; * is interested in receiving home-based injections; is approved by their clinical team as a candidate for home-based injections; * has the intention to use CAB/RPV for at least 12 months; * and is willing and able to give informed consent. Treatment Buddy: * Age ≥18 years, * identified by the PWH, * is willing and able to provide monthly or bimonthly LAI-ART injections at the PWH's place of residence, and * is willing and able to give informed consent. Exclusion Criteria: PWH: * \<18 years of age, not receiving care at partnering clinic sites, * cannot identify a support person injector, * has not received at least the loading dose of CAB/RPV, * had serious adverse events with CAB/RPV with the loading dose, * is not virologically suppressed, * has a history of treatment failure, * has a known or suspected resistance to either RPV or CAB, * is not interested in receiving home-based injections, * is not approved but their clinical team as a candidate for home-based injections; * does not have the intention to use CAB/RPV for at least 12 months; * and is not willing or unable to give informed consent. Treatment Buddy: * \<18 years of age, * is not willing or unable to provide monthly or bimonthly LAI-ART injections at the PWH's place of residence, and * is not willing or unable to give informed consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)

    San Francisco, California, 94143, United States

More trials for these conditions

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