NCT06488846Enrolling by invitation
Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- 16 Feb 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT06488846
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 16 Feb 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \<18 years of age, not receiving care at partnering clinic sites,
- has not received at least the loading dose of CAB/RPV,
- is not interested in receiving home-based injections,
Other illness
- has a history of treatment failure,
Age
- \<18 years of age,
Other
- PWH:
- cannot identify a support person injector,
- had serious adverse events with CAB/RPV with the loading dose,
- is not virologically suppressed,
- has a known or suspected resistance to either RPV or CAB,
- 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:
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Prevention Science, Center for AIDS Prevention Studies (CAPS) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.