Clinical trial NCT06488846: Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
Official title: Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
Keywords: HIV
Long-acting injectable antiretroviral therapy (LAI-ART)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2024-07-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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
* is not willing or unable to give informed consent.

Primary outcomes:
measure: Feasibility of Home-Based LAI-ART Administration
timeFrame: 12 months
measure: Acceptability of Home-Based LAI-ART Administration
timeFrame: 12 months
measure: HIV viral suppression defined as two suppressed viral load test (HIV-RNA-PCR) results at least three months apart.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Parya Saberi, PharmD
role: PRINCIPAL_INVESTIGATOR
References: