Long-Acting Injectables for HIV Infection
(INVITE-Home Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to simplify access to long-acting injectable antiretroviral therapy for people living with HIV by enabling home administration. The goal is to train friends or family members to give these injections, potentially improving adherence to treatment. The trial compares three groups: those receiving injections at home, those receiving injections at a clinic, and those taking oral medication at a clinic. Eligible participants should already be on HIV treatment without major issues and interested in trying home-based injections with the help of a trained support person.
As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, since the trial involves long-acting injectable antiretroviral therapy, it's best to discuss your current medications with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In earlier studies, researchers have used long-acting injectable antiretroviral therapy (LAI-ART) to treat HIV. Research shows that these treatments are generally well-tolerated. One study examined 233 people using LAI-ART, including a wide range of ages and genders.
The first LAI-ART for HIV received approval in the United States in January 2021, establishing a known safety record. This approval reflects confidence in the treatment's safety based on previous tests and trials.
Overall, while any medical treatment can have side effects, studies suggest that LAI-ART offers a promising option for managing HIV.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative ways to deliver long-acting injectable antiretroviral therapy (LAI-ART) for people living with HIV. Unlike standard treatments that typically require clinic visits for administration, this trial investigates home-based delivery by trained "Treatment Buddies," potentially offering greater convenience and privacy. Additionally, it examines how home-based and clinic-based LAI-ART compare to traditional oral ART, which could lead to more personalized and flexible treatment options. This trial aims to enhance accessibility and adherence, making HIV management more patient-friendly.
What evidence suggests that this trial's treatments could be effective for HIV?
This trial will compare different methods of administering antiretroviral therapy (ART) for people living with HIV. Studies have shown that long-acting injectable antiretroviral therapy (LAI-ART) effectively controls the HIV virus. In a real-world study, over 85% of people using LAI-ART maintained low virus levels after 48 weeks. This treatment offers an alternative to daily pills, which some find challenging to maintain. In this trial, participants may receive LAI-ART either at home from a trained Treatment Buddy or in clinics from healthcare providers. Another group will receive oral ART medication in clinics. Research suggests that many prefer receiving injections at home, potentially making adherence easier. Overall, LAI-ART may improve health and simplify HIV management for many individuals.12467
Who Is on the Research Team?
Parya Saberi, PharmD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Training and Implementation
Development and implementation of a training intervention for layperson injectors to administer LAI-ART at home
Treatment
Participants receive LAI-ART either at home by a trained layperson or in clinics by healthcare providers
Follow-up
Participants are monitored for safety, effectiveness, and viral suppression after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INVITE-Home
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
People living with HIV receiving oral ART medication in clinics from healthcare providers.
People living with HIV receiving LAI-ART in their homes from a trained Treatment Buddy.
People living with HIV receiving LAI-ART in clinics from healthcare providers.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Centers for Disease Control and Prevention
Collaborator
Citations
Innovative administration of long-acting injectables for HIV ...
This study will address a critical need to develop alternative and decentralised LAI-ART delivery methods that can mitigate barriers to ART ...
Acceptability of long acting injectable antiretroviral therapy ...
Long-acting injectable antiretroviral therapy (LAI-ART) has shown to be effective in maintaining virologic suppression as oral treatment. It is ...
Innovative Administration of Long-Acting Injectables for HIV ...
This study will address a critical need to develop alternative and decentralized LAI-ART delivery methods that can mitigate barriers to uptake and persistence, ...
Long‐acting injectable ART to advance health equity
The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38).
Long-Acting Injectable HIV Therapy Outcomes Among ...
In this real-world observational study, over 85% of PWH remained on therapy and virally suppressed 48 weeks after initiating LAI-CAB/RPV. Providers should ...
High Acceptability but Persistent Barriers to Implementation of ...
The first long-acting injectable antiretroviral therapy (LAI ART) for HIV was approved for commercial use in the United States in January 2021.
Bridging the gap: identifying barriers and strategies for ...
The findings of various studies showed that LAI ART can improve adherence, retention, and viral suppression compared to oral ART, and reduce the ...
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