HIVALADDINNCT06468995
Antiviral Long Acting Drugs Landing in People Living With HIV
A study testing Surveys completion, Home administration of CAB+RPV and Hospital administration of CAB+RPV in people with HIV and Antiviral Agents, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Antiviral Agents
- What is being tested?
- Surveys completion, Home administration of CAB+RPV and Hospital administration of CAB+RPV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2024to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV;
- Aged 18 years or older at the time of signing the informed consent.
- People willing to switch to long-acting therapy
- on a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA <50 copies/ml):
- Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6 months prior to Screening.
- Plasma HIV-1 RNA <50 c/mL at Screening.
- Ability to understand informed consent form and other relevant regulatory documents.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
- Present or past evidence of viral resistance to agents of the NNRTI or INI class or prior treatment failure with agents of NNRTI or INSTI class
- Unwillingness or any condition that might prevent the completion of all surveys over study follow-up.
- Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC):
- Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
Show all 26Show fewer
- Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/mL are not exclusionary
- Participants with moderate to severe hepatic impairment
- Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
- Participants positive for HBsAg are excluded;
- Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded
- Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
- Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Clinicians must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded
- Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis (eg. ascites, encephalopathy, or variceal bleeding)), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
- History of liver cirrhosis with or without hepatitis viral co-infection.
- Ongoing or clinically relevant pancreatitis
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical and anal intraepithelial neoplasia.
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
- Current platelet count<100,000 x109/L.
- Any evidence of primary resistance based on the presence of any major known Integrase inhibitor (INI) or Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation, except for K103N by any historical resistance test result.
- Any verified Grade 4 laboratory abnormality at screening.
- Subjects has estimated creatinine clearance <50mL/minute per 1.73-meter square via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method
- Alanine aminotransferase (ALT) >=3 × Upper limit of normal (ULN)
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Use of medications which are associated with Torsade de Pointes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients.
Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.
Read the detailed description
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study. This means that the study will focus both on implementation and effectiveness by examination of two different settings of treatment administration (hospital-based and home-based) to identify what facilitators or barriers may improve feasibility (i.e. factors that can either help or hinder the successful implementation), appropriateness and acceptability of each strategy delivery mode in order to address the needs of PLWH followed in a large clinical center in Milan, Italy.
The study will use an implementation science approach to address the question of 'what works, where and why' by identifying factors and processes that negatively and positively affect implementation outcomes from both the patients and providers perspective.
Real-world efforts to delivering the treatment to HIV-1-infected, virologically suppressed adults in two different settings (home or hospital) will be sustained.
Two healthcare delivery pathways will be explored in this study:
- Hospital-based setting: HIV clinic nurse will administer injections at the clinic;
- Home-patient setting: HIV clinic nurse will administer injections at patient home.
San Raffaele Hospital has participated in the phase III trials of CAB LA + RPV LA and has already developed a large experience in treating patients with LA regimes. LA administration in out-of-hospital sites could be a safe and viable option to satisfy patient needs in terms of time to move to the hospital.
Enrolled participants will be randomized, in a ratio 1:1, to the following arms:
- drug treatment and follow-up in hospital (hospital arm);
- drug treatment and follow-up at home (home arm).
HCPs will also be study participants. Their insight regarding feasibility, acceptability, and appropriateness of CAB LA + RPV LA administration overall and in a home-based or a hospital-based setting will be evaluated during the study period.
Cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) is a licensed new drug, already used in clinical practice, for the treatment of HIV infection.
At the discretion of the person with HIV and the physician, there are two ways to begin the long acting therapy regimen:
- By taking the two drugs cabotegravir and rilpivirine orally for about a month (one tablet each), taken together 1 time a day and on a full stomach, and then switching to injectable (LA) formulations (optional according to clinical practice).
- Directly with injectable formulation.
In this study IM CAB + RPV will be delivered in the hospital-based or the home-based setting. Injections will be delivered by HCPs in the two study settings.
Study participants living with HIV receiving IM CAB + RPV, HCPs will provide their insight on the implementation of LA IM CAB+RPV by means of questionnaires and scales over the study period.
Study participants living with HIV receiving IM CAB + RPV will be asked to complete the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), a Likert scale, the EQ-5D-5L questionnaire, the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire and the HIV Treatment Satisfaction Questionnaire (HIVTSQ).
HCPs will be asked to complete the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM) and a Likert scale.
Study participants receiving drug treatment will be treated in the home-based or hospital-based study setting for 12 [1 month for screening + 11 of hospital or home treatment administration, in accordance to the clinical practice. People receiving optional OLI according to clinical practice will receive oral antiretrovirals in the month before baseline. HCPs are responsible for the administration of LA IM CAB + RPV in the two study settings.
People receiving LA IM CAB + RPV in the hospital setting will receive injections as per medical practice in dedicated spaces within the Infectious Diseases Unit of San Raffaele Hospital.
People receiving LA IM CAB + RPV in the home-based setting will receive injections at their home within the Metropolitan Area of Milan. HCPs will directly reach the study participant's home. Administration of CAB + RPV, completion of study surveys, blood collection for laboratory exams according to clinical practice and all study procedures will be performed by the HCPs at the study participant home.
- Conditions
- HIV, Antiviral Agents
- Being tested
- Surveys completion, Home administration of CAB+RPV, Hospital administration of CAB+RPV
- Keywords
- Rilpivirine, Cabotegravir, HIV, Long acting, Antiretroviral, PLWH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveys completionOther
Completion of surveys: the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), a Likert scale, the EQ-5D-5L questionnaire, the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire and the HIV Treatment Satisfaction Questionnaire (HIVTSQ).
Home administration of CAB+RPVDrug
Drug treatment and follow-up at home (home arm).
Hospital administration of CAB+RPVDrug
Drug treatment and follow-up in hospital (hospital arm)
| Study group | Role | What they receive |
|---|---|---|
| Hospital arm | Active comparator | CAB 600mg +RPV 900mg q2M IM administration and follow-up in hospital Receives: Other: Surveys completion; Drug: Hospital administration of CAB+RPV |
| Home arm | Experimental | CAB 600mg +RPV 900mg q2M IM administration and follow-up at home Receives: Other: Surveys completion; Drug: Home administration of CAB+RPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Implementation Measure (FIM) scale
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Feasibility of Implementation Measure (FIM) and average composite score.
Measured: Months 1 and 7 and 11
Acceptability of Intervention Measure (AIM) scale
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Acceptability of Intervention Measure (AIM) and average composite score.
Measured: Months 1 and 7 and 11
Intervention Appropriateness Measure (IAM) scale
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Intervention Appropriateness Measure (IAM) and average composite score.
Measured: Months 1 and 7 and 11
Qualitative insights
Qualitative insights regarding feasibility, acceptability, and appropriateness of CAB+RPV IM q2M.
Measured: Months 1 and 7 and 11
Secondary outcomes (10)
Proportion of patients willing to enroll in the study
Proportion of patients willing to enroll in the study out of total screened to assess the uptake, and fidelity of CAB LA + RPV LA administration overall and in a home-based or hospital-based setting.
Measured: Months 7 and 11
Proportion of patients voluntary asking to stop CAB+RPV LA administration
Proportion of patients voluntary asking to stop CAB+RPV LA administration out of total enrolled in the study to assess the uptake, and fidelity of CAB LA + RPV LA administration overall and in a home-based or hospital-based settingy
Measured: Months 7 and 11
Proportion of CAB+RPV LA injections occurring within the target window
Proportion of CAB+RPV IM injections occurring within the target window from target date (+/- 7 days of target date) to assess the uptake, and fidelity of CAB LA + RPV LA administration overall and in a home-based or hospital-based setting
Measured: Months 7 and 11
Average score of satisfaction on a Likert scale
Average score of satisfaction on a Likert scale for each implementation strategy used and qualitative insights into the relative value of the strategies and any adaptations informed by Consolidated Framework for Implementation Research Constructs (CFIR) to assess the satisfaction with the implementation strategies adopted, including unanticipated adaptations, facilitators and barriers to the uptake and process of CAB LA + RPV LA from the perspectives of patients, overall and in a home-based or hospital-based setting
Measured: Months 7 and 11
Proportion of PWH with HIV-RNA >50 copies/mL
Proportion of people with confirmed HIV-RNA >50 copies/mL to monitor safety and effectiveness of CAB LA + RPV LA administration overall and in a home-based and hospital-based setting, as per clinical practice.
Measured: Months 7 and 11
Time (months) to LA discontinuation
Time (months) to CAB+RPV LA discontinuation from enrollment to monitor safety and effectiveness of CAB LA + RPV LA administration overall and in a home-based and hospital-based setting, as per clinical practice
Measured: Months 7 and 11
Adverse Events and Serious AEs
Proportion of people with Adverse Events and Serious AEs to monitor safety and effectiveness of CAB LA + RPV LA administration overall and in a home-based and hospital-based setting, as per clinical practice
Measured: Months 7 and 11
EQ-5D-5L questionnaire
Average change vs baseline on the utility value derived from EQ-5D-5L questionnaire
Measured: Months 1 and 7 and 11
HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire
Average change vs baseline on the utility value derived from the nine domains scores derived from the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire
Measured: Months 1 and 7 and 11
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Average change vs baseline on the utility value derived from the nine domains scores derived from the HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Measured: Months 1 and 7 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start2 Dec 2024
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Castagna Antonella, IRCCS San Raffaele
- Investigators
- Silvia Nozza, MD, Principal investigator, Università Vita-Salute San RaffaeleAntonella Castagna, Prof, Study chair, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468995
- Sponsor's protocol ID
- CET 166-2024
- Acronym
- ALADDIN
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study
- ClinicalTrials.gov ID
- NCT06468995
- Acronym / sponsor ID
- ALADDIN / CET 166-2024
- Conditions
- HIV, Antiviral Agents
- Keywords
- Rilpivirine, Cabotegravir, HIV, Long acting, Antiretroviral, PLWH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 21 Jun 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 is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients.
Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.
Detailed description
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study. This means that the study will focus both on implementation and effectiveness by examination of two different settings of treatment administration (hospital-based and home-based) to identify what facilitators or barriers may improve feasibility (i.e. factors that can either help or hinder the successful implementation), appropriateness and acceptability of each strategy delivery mode in order to address the needs of PLWH followed in a large clinical center in Milan, Italy.
The study will use an implementation science approach to address the question of 'what works, where and why' by identifying factors and processes that negatively and positively affect implementation outcomes from both the patients and providers perspective.
Real-world efforts to delivering the treatment to HIV-1-infected, virologically suppressed adults in two different settings (home or hospital) will be sustained.
Two healthcare delivery pathways will be explored in this study:
- Hospital-based setting: HIV clinic nurse will administer injections at the clinic;
- Home-patient setting: HIV clinic nurse will administer injections at patient home.
San Raffaele Hospital has participated in the phase III trials of CAB LA + RPV LA and has already developed a large experience in treating patients with LA regimes. LA administration in out-of-hospital sites could be a safe and viable option to satisfy patient needs in terms of time to move to the hospital.
Enrolled participants will be randomized, in a ratio 1:1, to the following arms:
- drug treatment and follow-up in hospital (hospital arm);
- drug treatment and follow-up at home (home arm).
HCPs will also be study participants. Their insight regarding feasibility, acceptability, and appropriateness of CAB LA + RPV LA administration overall and in a home-based or a hospital-based setting will be evaluated during the study period.
Cabotegravir long-acting + rilpivirine long-acting (CAB LA + RPV LA) is a licensed new drug, already used in clinical practice, for the treatment of HIV infection.
At the discretion of the person with HIV and the physician, there are two ways to begin the long acting therapy regimen:
- By taking the two drugs cabotegravir and rilpivirine orally for about a month (one tablet each), taken together 1 time a day and on a full stomach, and then switching to injectable (LA) formulations (optional according to clinical practice).
- Directly with injectable formulation.
In this study IM CAB + RPV will be delivered in the hospital-based or the home-based setting. Injections will be delivered by HCPs in the two study settings.
Study participants living with HIV receiving IM CAB + RPV, HCPs will provide their insight on the implementation of LA IM CAB+RPV by means of questionnaires and scales over the study period.
Study participants living with HIV receiving IM CAB + RPV will be asked to complete the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), a Likert scale, the EQ-5D-5L questionnaire, the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire and the HIV Treatment Satisfaction Questionnaire (HIVTSQ).
HCPs will be asked to complete the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM) and a Likert scale.
Study participants receiving drug treatment will be treated in the home-based or hospital-based study setting for 12 [1 month for screening + 11 of hospital or home treatment administration, in accordance to the clinical practice. People receiving optional OLI according to clinical practice will receive oral antiretrovirals in the month before baseline. HCPs are responsible for the administration of LA IM CAB + RPV in the two study settings.
People receiving LA IM CAB + RPV in the hospital setting will receive injections as per medical practice in dedicated spaces within the Infectious Diseases Unit of San Raffaele Hospital.
People receiving LA IM CAB + RPV in the home-based setting will receive injections at their home within the Metropolitan Area of Milan. HCPs will directly reach the study participant's home. Administration of CAB + RPV, completion of study surveys, blood collection for laboratory exams according to clinical practice and all study procedures will be performed by the HCPs at the study participant home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital arm | Active comparator | Other: Surveys completion, Drug: Hospital administration of CAB+RPVCAB 600mg +RPV 900mg q2M IM administration and follow-up in hospital |
| Home arm | Experimental | Other: Surveys completion, Drug: Home administration of CAB+RPVCAB 600mg +RPV 900mg q2M IM administration and follow-up at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV;
- Aged 18 years or older at the time of signing the informed consent.
- People willing to switch to long-acting therapy
- on a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA <50 copies/ml):
- Ability to understand informed consent form and other relevant regulatory documents.
Key exclusion criteria (26 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
- Present or past evidence of viral resistance to agents of the NNRTI or INI class or prior treatment failure with agents of NNRTI or INSTI class
- Unwillingness or any condition that might prevent the completion of all surveys over study follow-up.
- Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC):
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 |
|---|---|---|
| Surveys completionCompletion of surveys: the Feasibility of Implementation Measure (FIM), the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), a Likert scale, the EQ-5D-5L questionnaire, the HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire and the HIV Treatment Satisfaction Questionnaire (HIVTSQ). | Other | Home arm, Hospital arm |
| Home administration of CAB+RPVDrug treatment and follow-up at home (home arm). | Drug | Home arm |
| Hospital administration of CAB+RPVDrug treatment and follow-up in hospital (hospital arm) | Drug | Hospital arm |
Primary outcome
Feasibility of Implementation Measure (FIM) scale
Time frame: Months 1 and 7 and 11
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Feasibility of Implementation Measure (FIM) and average composite score.
Acceptability of Intervention Measure (AIM) scale
Time frame: Months 1 and 7 and 11
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Acceptability of Intervention Measure (AIM) and average composite score.
Intervention Appropriateness Measure (IAM) scale
Time frame: Months 1 and 7 and 11
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Intervention Appropriateness Measure (IAM) and average composite score.
Qualitative insights
Time frame: Months 1 and 7 and 11
Qualitative insights regarding feasibility, acceptability, and appropriateness of CAB+RPV IM q2M.
10 secondary outcomes
Proportion of patients willing to enroll in the study
Time frame: Months 7 and 11
Proportion of patients voluntary asking to stop CAB+RPV LA administration
Time frame: Months 7 and 11
Proportion of CAB+RPV LA injections occurring within the target window
Time frame: Months 7 and 11
Average score of satisfaction on a Likert scale
Time frame: Months 7 and 11
Proportion of PWH with HIV-RNA >50 copies/mL
Time frame: Months 7 and 11
Time (months) to LA discontinuation
Time frame: Months 7 and 11
Adverse Events and Serious AEs
Time frame: Months 7 and 11
EQ-5D-5L questionnaire
Time frame: Months 1 and 7 and 11
HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire
Time frame: Months 1 and 7 and 11
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Time frame: Months 1 and 7 and 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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. This study is not recruiting at the moment.
Silvia Nozza, MD principal investigator
Università Vita-Salute San Raffaele
Antonella Castagna, Prof study chair
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys completion, Home administration of CAB+RPV and Hospital administration of CAB+RPV in people with HIV and Antiviral Agents, run by IRCCS San Raffaele at 1 site in Italy.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 19 Oct 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Implementation Measure (FIM) scale (time frame: Months 1 and 7 and 11). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.