HIV InfectionsINVITE-HomeNCT06488846
Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
An observational study of HIV Infections, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- INVITE-Home, Clinic-Administered LAI-ART and Oral ART
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 29 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- INVITE-Home, Clinic-Administered LAI-ART, Oral ART
- Keywords
- HIV, Long-acting injectable antiretroviral therapy (LAI-ART)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVITE-HomeOther
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-ARTDrug
People with HIV who continue to receive LAI-ART in clinic
Oral ARTDrug
Oral ART
| Study group | Role | What they receive |
|---|---|---|
| Home-Based LAI-ART Administration | People living with HIV receiving LAI-ART in their homes from a trained Treatment Buddy. Receives: Other: INVITE-Home | |
| Clinic-Based LAI-ART Administration | People living with HIV receiving LAI-ART in clinics from healthcare providers. Receives: Drug: Clinic-Administered LAI-ART | |
| Oral ART Administration | People living with HIV receiving oral ART medication in clinics from healthcare providers. Receives: Drug: Oral ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 months
Secondary outcomes (1)
Acceptability of Home-Based LAI-ART Administration
To assess Acceptability, People With HIV and their chosen Treatment Buddy will complete:
- Injection-Treatment Acceptance Questionnaire: Possible scores on the measure range from 0 (very unacceptable) to 120 (very acceptable).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start16 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Parya Saberi, PharmD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488846
- Sponsor's protocol ID
- 24-42341
- Other IDs
- PS005259-02
- Acronym
- INVITE-Home
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tatlock S, Arbuckle R, Sanchez R, Grant L, Khan I, Manvelian G, Spertus JA. Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection. Value Health. 2017 Mar;20(3):430-440. doi: 10.1016/j.jval.2016.09.2410. Epub 2016 Dec 1.
PubMed 28292488Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Bourdeau B, Rebchook G, Shade SB, O'Shea J, Buchacz K, Harris O, Johnson MO, Palomares M, Bolton AT, Van Nuys J, Moore E, Saberi P. Innovative administration of long-acting injectables for HIV treatment enhancement at home (INVITE-HOME): implementation science study protocol. BMJ Open. 2025 Aug 5;15(8):e097921. doi: 10.1136/bmjopen-2024-097921.
PubMed 40764067
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Administration of Long-Acting Injectables for HIV Treatment Enhancement at Home
- ClinicalTrials.gov ID
- NCT06488846
- Acronym / sponsor ID
- INVITE-Home / 24-42341
- Conditions
- HIV Infections
- Keywords
- HIV, Long-acting injectable antiretroviral therapy (LAI-ART)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-Based LAI-ART Administration | – | Other: INVITE-HomePeople living with HIV receiving LAI-ART in their homes from a trained Treatment Buddy. |
| Clinic-Based LAI-ART Administration | – | Drug: Clinic-Administered LAI-ARTPeople living with HIV receiving LAI-ART in clinics from healthcare providers. |
| Oral ART Administration | – | Drug: Oral ARTPeople living with HIV receiving oral ART medication in clinics from healthcare providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (16 listed)
- <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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INVITE-HomeCurriculum to train Treatment Buddies, selected by the people with HIV, to administer LAI-ART at home with supervision of a Study Nurse. | Other | Home-Based LAI-ART Administration |
| Clinic-Administered LAI-ARTPeople with HIV who continue to receive LAI-ART in clinic | Drug | Clinic-Based LAI-ART Administration |
| Oral ARTOral ART | Drug | Oral ART Administration |
Primary outcome
Feasibility of Home-Based LAI-ART Administration
Time frame: 12 months
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).
HIV viral suppression defined as two suppressed viral load test (HIV-RNA-PCR) results at least three months apart.
Time frame: 12 months
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.
1 secondary outcome
Acceptability of Home-Based LAI-ART Administration
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 28292488Tatlock S, Arbuckle R, Sanchez R, Grant L, Khan I, Manvelian G, Spertus JA. Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection. Value Health. 2017 Mar;20(3):430-440. doi: 10.1016/j.jval.2016.09.2410. Epub 2016 Dec 1.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Derived from this study: PubMed 40764067Bourdeau B, Rebchook G, Shade SB, O'Shea J, Buchacz K, Harris O, Johnson MO, Palomares M, Bolton AT, Van Nuys J, Moore E, Saberi P. Innovative administration of long-acting injectables for HIV treatment enhancement at home (INVITE-HOME): implementation science study protocol. BMJ Open. 2025 Aug 5;15(8):e097921. doi: 10.1136/bmjopen-2024-097921.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Parya Saberi, PharmD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Home-Based LAI-ART Administration (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06488846, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.