Status:
NOT_YET_RECRUITING
Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
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 t...
Detailed Description
There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with (PWH), with many conveniences for uptake and persistence. While LAI-ART eliminate the need for daily...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 29 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06488846
Start Date
January 15 2026
End Date
September 29 2027
Last Update
September 8 2025
Active Locations (1)
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1
Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
San Francisco, California, United States, 94143