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NCT06488846

Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home

Enrolling by Invitation
Not specifiedAges 18+Observational
University of California, San Francisco
~1,000 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:INVITE-HomeClinic-Administered LAI-ARTOral ART

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Home-Based LAI-ART Administration
Measured over 12 months
+1 more outcome measured

Conditions

HIV Infections

Explore related trials

HIV InfectionHIV Infection

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Parya Saberi, PharmD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

\<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.
\<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.

What this trial measures

  • Feasibility of Home-Based LAI-ART Administration12 months

    To assess Feasibility, HIV clinicians will complete the Feasibility of Intervention Measure. Possible scores on the Feasibility of Intervention Measure range from 4 (less feasible) to 20 (very feasible).

  • HIV viral suppression defined as two suppressed viral load test (HIV-RNA-PCR) results at least three months apart.12 months

    The investigators will assess viral suppression with two suppressed viral load test results at least three months apart within a 12-month period. A suppressed result is considered less than 200 copies/mL.