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Home-Based LAI-ART Administration for HIV Suppression (INVITE-Home Trial)

N/A
Recruiting
Led By Parya Saberi, PharmD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • HIV Suppression
  • Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of Home-Based LAI-ART Administration
Feasibility of Home-Based LAI-ART Administration
HIV viral suppression defined as two suppressed viral load test (HIV-RNA-PCR) results at least three months apart.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Oral ART AdministrationExperimental Treatment1 Intervention
People living with HIV receiving oral ART medication in clinics from healthcare providers.
Group II: Home-Based LAI-ART AdministrationExperimental Treatment1 Intervention
People living with HIV receiving LAI-ART in their homes from a trained Treatment Buddy.
Group III: Clinic-Based LAI-ART AdministrationExperimental Treatment1 Intervention
People living with HIV receiving LAI-ART in clinics from healthcare providers.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,584 Previous Clinical Trials
15,083,076 Total Patients Enrolled
Centers for Disease Control and PreventionFED
887 Previous Clinical Trials
21,992,457 Total Patients Enrolled
Parya Saberi, PharmDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
78 Total Patients Enrolled
~667 spots leftby Nov 2025