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

NCT06488846 | Enrolling By Invitation FDA Drug

• 2 other identifiers: 24-42341PS005259-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 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

Keywords

HIV; Long-acting injectable antiretroviral therapy (LAI-ART)

Outcome Measures

Primary Outcomes (2)

• Feasibility of Home-Based LAI-ART Administration

  To assess Feasibility, HIV clinicians will complete the Feasibility of Intervention Measure. Possible scores on the Feasibility of Intervention Measure range from 4 (less feasible) to 20 (very feasible).

  12 months

• HIV viral suppression defined as two suppressed viral load test (HIV-RNA-PCR) results at least three months apart.

  The investigators will assess viral suppression with two suppressed viral load test results at least three months apart within a 12-month period. A suppressed result is considered less than 200 copies/mL.

  12 months

Secondary Outcomes (1)

• Acceptability of Home-Based LAI-ART Administration

  12 months

Study Arms (3)

Home-Based LAI-ART Administration

People living with HIV receiving LAI-ART in their homes from a trained Treatment Buddy.

Other: INVITE-Home

Clinic-Based LAI-ART Administration

People living with HIV receiving LAI-ART in clinics from healthcare providers.

Drug: Clinic-Administered LAI-ART

Oral ART Administration

People living with HIV receiving oral ART medication in clinics from healthcare providers.

Drug: Oral ART

Interventions

INVITE-Home OTHER

Curriculum to train Treatment Buddies, selected by the people with HIV, to administer LAI-ART at home with supervision of a Study Nurse.

Home-Based LAI-ART Administration

Clinic-Administered LAI-ART DRUG

People with HIV who continue to receive LAI-ART in clinic

Clinic-Based LAI-ART Administration

Oral ART DRUG

Oral ART

Oral ART Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PWH who have been prescribed injectable cabotegravir/rilpivirine (CAB/RPV) as part of their routine care who have clinician approval to participate in the home-based program.

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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: collaborator
• University of California, San Francisco: lead

Study Sites (1)

Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)

San Francisco, California, 94143, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Parya Saberi, PharmD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 5, 2024
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 29, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)