Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
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.
Conditions:
🦠 HIV Infections
🗓️ Study Start (Actual) 31 May 2024
🗓️ Primary Completion (Estimated) 29 September 2024
✅ Study Completion (Estimated) 29 September 2027
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • PWH:
    • * Age ≥18 years, patient receiving care at one of the 3 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 one of 3 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 June 2024
  • First Submitted that Met QC Criteria 28 June 2024
  • First Posted 5 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 July 2024
  • Last Update Posted 9 July 2024
  • Last Verified July 2024