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.
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.
Curriculum to train Treatment Buddies, selected by the people with HIV, to administer LAI-ART at home with supervision of a Study Nurse.
People with HIV who continue to receive LAI-ART in clinic
Oral ART
Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
San Francisco, California, United States
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).
Time frame: 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.
Time frame: 12 months
Acceptability of Home-Based LAI-ART Administration
To assess Acceptability, People With HIV and their chosen Treatment Buddy will complete: 1\. Injection-Treatment Acceptance Questionnaire: Possible scores on the measure range from 0 (very unacceptable) to 120 (very acceptable).
Time frame: 12 months
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Study Type
OBSERVATIONAL
Enrollment
1,000