Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
Enrolling by invitation
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT06488846
- Run by
- University of California, San Francisco
- People needed
- 1000
- Starts
- 2026-02-16
- Expected to finish
- 2027-09-29
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Division of Prevention Science, Center for AIDS Prevention Studies (CAPS) — San Francisco, California, United States
Full record on ClinicalTrials.gov
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