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

Enrolling By InvitationN/A

Sponsor: University of California, San Francisco

Conditions: HIV Infections

Interventions: INVITE-Home, Clinic-Administered LAI-ART, Oral ART

Countries: United States

This study will support the expansion of long-acting injectable antiretroviral therapy (LAI-ART) in non-clinical settings by developing, implementing, and evaluating a comprehensive, theory-informed training intervention to support the administration of LAI-ART by a trained layperson injector (e.g., friend, family, partner identified by a person living with HIV). This study will address barriers to LAI-ART uptake and persistence, enhance real-world effectiveness, and help close critical HIV care gaps.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

San Francisco, California, United States