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

Overview

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.

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 pill-taking and have the potential to help close critical gaps in HIV care, patients have expressed important barriers to effective implementation and concerns that frequent clinic visits can exacerbate stigma, increase the risk of unwanted disclosure, and lead to frequent disruptions in their daily lives. The need to travel to a clinic for injection visits multiple times throughout the year can also be financially and logistically prohibitive for many patients and can widen existing healthcare disparities. Similarly, clinicians worry that additional visits outside of routine care may lead to missed appointments, decreased engagement in care, and put further strain on limited clinic resources. Administration of LAI-ART by a trained layperson injector (such as family, friend, or partner of the patient) can help mitigate some of these patient- and clinician-identified barriers. This model of care has been used successfully in other contexts, but up to now it has not been evaluated for HIV treatment. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector's confidence, empowerment, convenience, privacy, and self-management skills, and ultimately facilitate LAI-ART uptake and persistence. INVITE-Home (Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home) will support the expansion of LAI-ART in non-clinical settings by developing, implementing, and evaluating a comprehensive, theory-informed training to support the administration of LAI-ART by a trained layperson injector. In Aim 1, the investigators will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings. Investigators will qualitatively evaluate training barriers and needs of PWH, layperson injectors, and clinicians to develop the training. In Aim 2, investigators will enhance understanding of home-based LAI-ART using the training developed in Phase 1, by examining implementation and effectiveness of home-based LAI-ART injections. This study will address a critical need to develop alternative and decentralized LAI-ART delivery methods that can mitigate barriers to uptake and persistence, enhance the real-world LAI-ART effectiveness, reduce systemic and structural inequities, address clinical and policy challenges, and close key gaps in HIV care.

Interventions

• Other INVITE-Home
  Curriculum to train Treatment Buddies, selected by the people with HIV, to administer LAI-ART at home with supervision of a Study Nurse.
• Drug Clinic-Administered LAI-ART
  People with HIV who continue to receive LAI-ART in clinic
• Drug Oral ART
  Oral ART

Primary outcome measures

• Feasibility of Home-Based LAI-ART Administration [Time frame: 12 months]
• HIV viral suppression defined as two suppressed viral load test (HIV-RNA-PCR) results at least three months apart. [Time frame: 12 months]

Secondary outcome measures (1)

• Acceptability of Home-Based LAI-ART Administration [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

United States · 1 center

• Division of Prevention Science, Center for AIDS Prevention Studies (CAPS) — San Francisco

Publications

• Tatlock S, Arbuckle R, Sanchez R, Grant L, Khan I, Manvelian G, Spertus JA. Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection. Value Health. 2017 Mar;20(3):430-440. doi: 10.1016/j.jval.2016.09.2410. Epub 2016 Dec 1. PMID 28292488
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459
• Bourdeau B, Rebchook G, Shade SB, O'Shea J, Buchacz K, Harris O, Johnson MO, Palomares M, Bolton AT, Van Nuys J, Moore E, Saberi P. Innovative administration of long-acting injectables for HIV treatment enhancement at home (INVITE-HOME): implementation science study protocol. BMJ Open. 2025 Aug 5;15(8):e097921. doi: 10.1136/bmjopen-2024-097921. PMID 40764067

Identifiers

NCT: NCT06488846 · 24-42341 · PS005259-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗