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New program aims to make HIV injections easier for women facing homelessness or food insecurity

NCT ID NCT06411223

Disease control Sponsor: Yale University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a pharmacist-led program to help women with HIV who also face social challenges like housing or food insecurity. The program supports switching from daily pills to a long-acting injectable medication (cabotegravir/rilpivirine) given every two months. The goal is to see if this approach is practical and acceptable for these women.

What this could mean

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

Active substance
Cabotegravir/Rilpivirine (long-acting injectable HIV medication)
What this could lead to
If successful, this could show that a pharmacist-led support program helps women with social challenges stick with long-acting HIV treatment, improving their health.
What could go wrong
This is a small early-phase study (50 people) focused on feasibility, not on proving the treatment works. Results may not apply to all women or settings.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Mar 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: * Living with diagnosed HIV * Receiving HIV care-related services from Yale New Haven Health (YNHH) * Currently on oral ART and virally suppressed for at least 6 months (from electronic health review). * Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 3 years (from self-report at screening). * Able to converse comfortably in English or Spanish Exclusion Criteria: * Unable or unwilling to complete informed consent (e.g., have a conservator of person) * Have initiated CAB/RPV oral lead-in prior to enrollment. * Have a contraindication to CAB/RPV LA per label. * Have known or suspected resistance to CAB/RPV * Pregnant or breast-feeding

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease Psychological Well-Being

As listed by the trial registrant

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

HIV

Contacts and locations

Locations

  • Yale Clinical and Community Research

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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