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

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• Clinic-Administered LAI-ART — DRUG
  People with HIV who continue to receive LAI-ART in clinic
• Oral ART — DRUG
  Oral ART

Study Details

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.

Key Dates

Start date

Feb 16, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Sep 29, 2027

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Home-Based LAI-ART Administration
  People living with HIV receiving LAI-ART in their homes from a trained Treatment Buddy.
• Arm: Clinic-Based LAI-ART Administration
  People living with HIV receiving LAI-ART in clinics from healthcare providers.
• Arm: Oral ART Administration
  People living with HIV receiving oral ART medication in clinics from healthcare providers.

Primary Outcome Measure

Feasibility of Home-Based LAI-ART Administration [ Time Frame: 12 months ]

Locations (1)

Find similar trials in San Francisco, CA

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