HIV InfectionsIMAdARTNCT06159894
Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units".
A study testing DAY HOSPITAL ARM and Specialist-Care arm in people with HIV Infections, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
This is a clinical trial whose main purpose is to evaluate the acceptability of the administration of LA CAB + extended-release RPV as perceived by patients in month 12 in multipurpose day hospital units versus specialized care centers (HIV Units). . 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?
- DAY HOSPITAL ARM and Specialist-Care arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2023to 18 Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. People living with HIV-1 infection; 2. Aged 18 years or older at the time of signing the informed consent. 3. Virologically suppressed (HIV-1 RNA <50 copies/ml) on a stable antiretroviral regimen: i) Documented evidence of plasma HIV-1 RNA measurements <50 copies/mL in the 6 months prior to Screening.
- Documented evidence of plasma HIV-1 RNA measurements <50 copies/mL in one determination > 6 months prior to Screening
- Documented evidence of plasma HIV-1 RNA measurements <50 copies/mL in one determination < 6 months prior to Screening If the last documented evidence of plasma HIV-1 RNA measurements <50 copies/mL is into the 45 days prior to Screening visit, this determination could replace the screening determination. If all the laboratory results from the Screening Visit are available in the 45 days prior to screening visit, Screening visit and Baseline Visit could be done the same day.
- 4. Ability to understand informed consent form and other relevant regulatory documents.
- 5. Prior to starting LA CAB + RPV injections, healthcare professionals should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.
- 6. Investigators may enrol eligible subjects according to their availability and accessibility.
- 7. LA CAB +RPV injection may be preceded by an optional 1-month oral lead-in (OLI) according to the physician's judgement; 8. Participants will be monitored according to usual standard care at their physician's discretion.
- 9. Females of child bearing potential will be required to use a highly effective method of contraception. A female, may be eligible to enter and participate in the study if she: i) Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥50 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.Female participants who have stopped menstruating for ≥12 months and have <50 years of age but do not have documentation of ovarian hormonal failure must have a serum FSH test result at screening that is within the post-menopausal range based on the reference provided in the Central Laboratory Manual ii) Note: FSH test in the prior 12 months within the post-menopausal range iii) Is of child-bearing potential with a negative pregnancy test at both Screening and Visit 1 and agrees to use one of the highly effective methods to avoid pregnancy documented
Who cannot join
- 1. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement ≥50 copies/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 copies/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 copies/mL.
- 2. Present or past evidence of viral resistance to agents of the NNRTI or INSTI class or prior treatment failure with agents of NNRTI or INSTI class
- 3. Any contraindication for LA CAB, LA RPV, oral Cabotegravir or Rilpivirine (see EU SmPC)
- 4. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
- 5. 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/µL are not exclusionary.
- 6. Participants with moderate to severe hepatic impairment
Show all 20Show fewer
- 7. 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
- 8. 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: 8.1. Participants positive for HBsAg are excluded; 8.2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded 8.3. 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.
- 9. 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(Investigators should consult current treatment guidelines when considering choice of therapy for individuals with chronic hepatitis C virus infection. Participants with hepatitis C virus infection should have undergone appropriate work-up, the chronic hepatitis C infection should not be advanced, and not anticipated to require introduction of new HCV therapy (e.g. with oral direct acting antivirals) during the course of the study).
- 10. 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)
- 11. History of liver cirrhosis with or without hepatitis viral co-infection.
- 12. Ongoing or clinically relevant pancreatitis
- 13. 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.
- 14. 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.
- 15. Current platelet count<100,000 x109/Land/or those with a current or anticipated need for chronic or systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding.
- 16. Any evidence of primary resistance based on the presence of any major known Integrase inhibitor (INSTI) or Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation.
- 17. Any verified Grade 4 laboratory abnormality at screening.
- 18. Subjects has estimated creatinine clearance <50mL/minute per 1.73 meter square via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method
- 19. Alanine aminotransferase (ALT) ≥5x ULN, OR ALT ≥3 x ULN and bilirubin ≥1.5 x ULN (with > 35% direct bilirubin).
- 20. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening 21. Use of medications which are associated with Torsade de Pointes.
Trial locations and contacts
1 site in 1 country.
About this study
This is a clinical trial whose main purpose is to evaluate the acceptability of the administration of LA CAB + extended-release RPV as perceived by patients in month 12 in multipurpose day hospital units versus specialized care centers (HIV Units). . Candidates to participate in this study are indicated to receive this medication, so the decision to include the participant in the study will be after the decision to prescribe the drug. These patients will be randomly assigned to one location or another to receive the administration of the medication. Therefore, and after consulting with the AEMPS, it is considered that this is a clinical trial WITHOUT medications. Both the medication and the procedures associated with the follow-up of the participants will follow the usual practice for this type of patient, with the exception of completing the questionnaires aimed at evaluating the primary and secondary objectives of this study.
- Conditions
- HIV Infections
- Being tested
- DAY HOSPITAL ARM, Specialist-Care arm
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAY HOSPITAL ARMOther
Also called acceptability of the administration of CAB LA + RPV LA
The study will evaluate the feasibility and acceptability of the administration of CAB LA + RPV LA as perceived by patients. The focus will be upon both Polyvalent Day Hospital units vs Specialist-Care centers. The evaluations of the two-implementation strategies and their differences will be assessed in essentially descriptive terms.
The study will also explore the fidelity, uptake and costs of LA CAB + RPV administration upon both Polyvalent Day Hospital units vs Specialist-Care Centers. The utility of the implementation strategies devised to support the delivery LA CAB + RPV out of HIV units/Internal medicine services will also be explored.
Finally, the study will assess the safety, tolerability and effectiveness LA CAB + RPV administration in Polyvalent Day Hospital units vs Specialist-Care centers in the total sample, as per clinical practice.
Specialist-Care armOther
Also called acceptability of the administration of CAB LA + RPV LA
The study will evaluate the feasibility and acceptability of the administration of CAB LA + RPV LA as perceived by patients. The focus will be upon both Polyvalent Day Hospital units vs Specialist-Care centers. The evaluations of the two-implementation strategies and their differences will be assessed in essentially descriptive terms.
The study will also explore the fidelity, uptake and costs of LA CAB + RPV administration upon both Polyvalent Day Hospital units vs Specialist-Care Centers. The utility of the implementation strategies devised to support the delivery LA CAB + RPV out of HIV units/Internal medicine services will also be explored.
Finally, the study will assess the safety, tolerability and effectiveness LA CAB + RPV administration in Polyvalent Day Hospital units vs Specialist-Care centers in the total sample, as per clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with LA CAB + RPV and follow-up at Specialist-Care centers (Specialist-Care arm). | Active comparator | Treatment with LA CAB + RPV and follow-up at Specialist-Care centers (Specialist-Care arm). Receives: Other: Specialist-Care arm |
| Treatment with LA CAB + RPV and follow-up in Polyvalent Day Hospital units (Day Hospital arm). | Experimental | Treatment with LA CAB + RPV and follow-up in Polyvalent Day Hospital units (Day Hospital arm). Receives: Other: DAY HOSPITAL ARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM) at M12
Number and 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) at M12
Measured: 12 months
Secondary outcomes (26)
Feasibility of Implementation Measure (FIM) at M12
Number and 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) at M12
Measured: 12 months
FIM and AIM at M3 and M7
- Number and proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of FIM and AIM at M3 and M7
Measured: month 3 and month 7
FIM and AIM at 3, 7 and 12 months
- Differences among the proportions of participants receiving injections with an average composite score greater than or equal to 4 across the questions of FIM and AIM at 3, 7 and 12 months
Measured: 3, 7 and 12 months
FIM and AIM at M3, M7 and M12 answered by patients
Average composite score across the questions on FIM and AIM at M3, M7 and M12 answered by patients
Measured: 3, 7 and 12 months
FIM and AIM answered by HCPs and nonclinical staff at M3, M7 and M12.
Average composite score on FIM and AIM answered by HCPs and nonclinical staff at M3, M7 and M12.
Measured: 3, 7 and 12 months
Number and proportion of patients willing to enroll in the study out of total screened collected at M7 and M12.
Number and proportion of patients willing to enroll in the study out of total screened collected at M7 and M12.
Measured: Month 7 and Month12.
Number and proportion of patients enrolled in the study out of total eligible collected at M7 and M12.
Number and proportion of patients enrolled in the study out of total eligible collected at M7 and M12.
Measured: Month 7 and Month12.
Number and proportion of patients voluntary asking to stop LA CAB+RPV administration out of those enrolled in the Polyvalent Day Hospital units or Specialist-Care centers collected at M7 and M12.
Number and proportion of patients voluntary asking to stop LA CAB+RPV administration out of those enrolled in the Polyvalent Day Hospital units or Specialist-Care centers collected at M7 and M12.
Measured: Month 7 and Month12.
Number and proportion of patients voluntary asking to stop LA CAB+RPV LA administration out of total enrolled in the study collected at M7 and M12.
Number and proportion of patients voluntary asking to stop LA CAB+RPV LA administration out of total enrolled in the study collected at M7 and M12.
Measured: Month 7 and Month12.
Number and proportion of injections occurring within the target window from target date (+/- 7 days of target date) collected at M7 and M12.
Number and proportion of injections occurring within the target window from target date (+/- 7 days of target date) collected at M7 and M12.
Measured: Month 7 and Month12.
WHOQOL-HIV-Bref Questionnaire
Average change vs baseline on the seven domains scores derived from WHOQOL-HIV-Bref Questionnaire
Measured: Month12
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Average change vs baseline on the nine domains scores derived from the HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Measured: Month12
HIV stigma scale (HSS)
Average change vs baseline on the four domains scores derived from 12-item short version of the HIV stigma scale (HSS)
Measured: Month 12
Average change vs baseline on Preference of CAB+RPV LA injected vs. oral ART
Average change vs baseline on Preference of CAB+RPV LA injected vs. oral ART
Measured: Month 12
Perception of pain and ISRs Questionnaire (PIN)
Average change vs baseline on the acceptability domain scores derived from the Perception of pain and ISRs Questionnaire (PIN)
Measured: Month12
WHOQOL-HIV-Bref questionnaire
Changes in domain scores derived from WHOQOL-HIV-Bref questionnaire
Measured: Month12
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Changes in domain scores derived from HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Measured: Month12
HIV stigma scale (HSS)
Changes in domain scores derived from the short version of the the HIV stigma scale (HSS)
Measured: Month12
ART preference oral vs LA-injectable and and other aspects related to ART change (FAD questionniare)
Changes in utility value derived from ART preference of LA-injected vs oral.
Measured: Month12
Perception of pain and ISRs Questionnaire (PIN)
Changes in the acceptability domain scores derived form value derived from Perception of pain and ISRs Questionnaire (PIN)
Measured: Month12
Likert scale
Average score of satisfaction on a Likert scale for each implementation strategy used answered by patients, HCPs and nonclinical staff at M7 and M12
Measured: Month 7 and Month12.
Average patient direct resource consumption for the LA CAB + RPV administration in a Polyvalent Day Hospital units and Specialist-Care centers at M3, M7 and M12.
Average patient direct resource consumption for the LA CAB + RPV administration in a Polyvalent Day Hospital units and Specialist-Care centers at M3, M7 and M12.
Measured: Month 7 and Month12.
Number and proportion of people with confirmed HIV-RNA >50 copies/mL
Number and proportion of people with confirmed HIV-RNA >50 copies/mL
Measured: Month12.
Time to LA CAB + RPV discontinuation
Time to LA CAB + RPV discontinuation
Measured: Month12
Frequencies of Adverse Events and Serious AEs
Frequencies of Adverse Events and Serious AEs
Measured: Month12
Design an implementation pathway that can be used as a guide or plan in future sites.
If the acceptability of receiving treatment in specialty sites does not differ from receiving it in HIV units or standard hospital settings, the implementation trajectory will include that option in its design or recommendation.
Measured: Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start18 Dec 2023
- Primary completion21 Apr 2025
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159894
- Sponsor's protocol ID
- IMAdART
- Acronym
- IMAdART
- Status last verified
- Jun 2025
- First submitted
- 14 Nov 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units".
- ClinicalTrials.gov ID
- NCT06159894
- Acronym / sponsor ID
- IMAdART / IMAdART
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 7 Dec 2023 (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 clinical trial whose main purpose is to evaluate the acceptability of the administration of LA CAB + extended-release RPV as perceived by patients in month 12 in multipurpose day hospital units versus specialized care centers (HIV Units). . Candidates to participate in this study are indicated to receive this medication, so the decision to include the participant in the study will be after the decision to prescribe the drug. These patients will be randomly assigned to one location or another to receive the administration of the medication. Therefore, and after consulting with the AEMPS, it is considered that this is a clinical trial WITHOUT medications. Both the medication and the procedures associated with the follow-up of the participants will follow the usual practice for this type of patient, with the exception of completing the questionnaires aimed at evaluating the primary and secondary objectives of this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with LA CAB + RPV and follow-up at Specialist-Care centers (Specialist-Care arm). | Active comparator | Other: Specialist-Care armTreatment with LA CAB + RPV and follow-up at Specialist-Care centers (Specialist-Care arm). |
| Treatment with LA CAB + RPV and follow-up in Polyvalent Day Hospital units (Day Hospital arm). | Experimental | Other: DAY HOSPITAL ARMTreatment with LA CAB + RPV and follow-up in Polyvalent Day Hospital units (Day Hospital arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. People living with HIV-1 infection; 2. Aged 18 years or older at the time of signing the informed consent. 3. Virologically suppressed (HIV-1 RNA <50 copies/ml) on a stable antiretroviral regimen: i) Documented evidence of plasma HIV-1 RNA measurements <50 copies/mL in the 6 months prior to Screening.
- 4. Ability to understand informed consent form and other relevant regulatory documents.
- 5. Prior to starting LA CAB + RPV injections, healthcare professionals should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.
- 6. Investigators may enrol eligible subjects according to their availability and accessibility.
- 7. LA CAB +RPV injection may be preceded by an optional 1-month oral lead-in (OLI) according to the physician's judgement; 8. Participants will be monitored according to usual standard care at their physician's discretion.
Key exclusion criteria (20 listed)
- 1. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement ≥50 copies/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 copies/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 copies/mL.
- 2. Present or past evidence of viral resistance to agents of the NNRTI or INSTI class or prior treatment failure with agents of NNRTI or INSTI class
- 3. Any contraindication for LA CAB, LA RPV, oral Cabotegravir or Rilpivirine (see EU SmPC)
- 4. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
- 5. 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/µL are not exclusionary.
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 |
|---|---|---|
| DAY HOSPITAL ARMAlso: acceptability of the administration of CAB LA + RPV LAThe study will evaluate the feasibility and acceptability of the administration of CAB LA + RPV LA as perceived by patients. The focus will be upon both Polyvalent Day Hospital units vs Specialist-Care centers. The evaluations of the two-implementation strategies and their differences will be assessed in essentially descriptive terms. The study will also explore the fidelity, uptake and costs of LA CAB + RPV administration upon both Polyvalent Day Hospital units vs Specialist-Care Centers. The utility of the implementation strategies devised to support the delivery LA CAB + RPV out of HIV units/Internal medicine services will also be explored. Finally, the study will assess the safety, tolerability and effectiveness LA CAB + RPV administration in Polyvalent Day Hospital units vs Specialist-Care centers in the total sample, as per clinical practice. | Other | Treatment with LA CAB + RPV and follow-up in Polyvalent Day Hospital units (Day Hospital arm). |
| Specialist-Care armAlso: acceptability of the administration of CAB LA + RPV LAThe study will evaluate the feasibility and acceptability of the administration of CAB LA + RPV LA as perceived by patients. The focus will be upon both Polyvalent Day Hospital units vs Specialist-Care centers. The evaluations of the two-implementation strategies and their differences will be assessed in essentially descriptive terms. The study will also explore the fidelity, uptake and costs of LA CAB + RPV administration upon both Polyvalent Day Hospital units vs Specialist-Care Centers. The utility of the implementation strategies devised to support the delivery LA CAB + RPV out of HIV units/Internal medicine services will also be explored. Finally, the study will assess the safety, tolerability and effectiveness LA CAB + RPV administration in Polyvalent Day Hospital units vs Specialist-Care centers in the total sample, as per clinical practice. | Other | Treatment with LA CAB + RPV and follow-up at Specialist-Care centers (Specialist-Care arm). |
Primary outcome
Acceptability of Intervention Measure (AIM) at M12
Time frame: 12 months
Number and 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) at M12
26 secondary outcomes
Feasibility of Implementation Measure (FIM) at M12
Time frame: 12 months
FIM and AIM at M3 and M7
Time frame: month 3 and month 7
FIM and AIM at 3, 7 and 12 months
Time frame: 3, 7 and 12 months
FIM and AIM at M3, M7 and M12 answered by patients
Time frame: 3, 7 and 12 months
FIM and AIM answered by HCPs and nonclinical staff at M3, M7 and M12.
Time frame: 3, 7 and 12 months
Number and proportion of patients willing to enroll in the study out of total screened collected at M7 and M12.
Time frame: Month 7 and Month12.
Number and proportion of patients enrolled in the study out of total eligible collected at M7 and M12.
Time frame: Month 7 and Month12.
Number and proportion of patients voluntary asking to stop LA CAB+RPV administration out of those enrolled in the Polyvalent Day Hospital units or Specialist-Care centers collected at M7 and M12.
Time frame: Month 7 and Month12.
Number and proportion of patients voluntary asking to stop LA CAB+RPV LA administration out of total enrolled in the study collected at M7 and M12.
Time frame: Month 7 and Month12.
Number and proportion of injections occurring within the target window from target date (+/- 7 days of target date) collected at M7 and M12.
Time frame: Month 7 and Month12.
WHOQOL-HIV-Bref Questionnaire
Time frame: Month12
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Time frame: Month12
HIV stigma scale (HSS)
Time frame: Month 12
Average change vs baseline on Preference of CAB+RPV LA injected vs. oral ART
Time frame: Month 12
Perception of pain and ISRs Questionnaire (PIN)
Time frame: Month12
WHOQOL-HIV-Bref questionnaire
Time frame: Month12
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Time frame: Month12
HIV stigma scale (HSS)
Time frame: Month12
ART preference oral vs LA-injectable and and other aspects related to ART change (FAD questionniare)
Time frame: Month12
Perception of pain and ISRs Questionnaire (PIN)
Time frame: Month12
Likert scale
Time frame: Month 7 and Month12.
Average patient direct resource consumption for the LA CAB + RPV administration in a Polyvalent Day Hospital units and Specialist-Care centers at M3, M7 and M12.
Time frame: Month 7 and Month12.
Number and proportion of people with confirmed HIV-RNA >50 copies/mL
Time frame: Month12.
Time to LA CAB + RPV discontinuation
Time frame: Month12
Frequencies of Adverse Events and Serious AEs
Time frame: Month12
Design an implementation pathway that can be used as a guide or plan in future sites.
Time frame: Month12
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 20 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAY HOSPITAL ARM and Specialist-Care arm in people with HIV Infections, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 8 inclusion and 20 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 20 Feb 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 Spain. 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?
Acceptability of Intervention Measure (AIM) at M12 (time frame: 12 months). 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 20 Feb 2026.