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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
90
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.
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.
Fundación Jimenez Díaz
Madrid, Spain
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
Time frame: 12 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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.
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.
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.
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.
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.
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
Average change vs baseline on the seven domains scores derived from WHOQOL-HIV-Bref Questionnaire
Time frame: Month12
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Average change vs baseline on the nine domains scores derived from the HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Month12
WHOQOL-HIV-Bref questionnaire
Changes in domain scores derived from WHOQOL-HIV-Bref questionnaire
Time frame: Month12
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Changes in domain scores derived from HIV Treatment Satisfaction Questionnaire (HIVTSQ)
Time frame: Month12
HIV stigma scale (HSS)
Changes in domain scores derived from the short version of the the HIV stigma scale (HSS)
Time frame: 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.
Time frame: 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)
Time frame: 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
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.
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
Number and proportion of people with confirmed HIV-RNA \>50 copies/mL
Time frame: Month12.
Time to LA CAB + RPV discontinuation
Time to LA CAB + RPV discontinuation
Time frame: Month12
Frequencies of Adverse Events and Serious AEs
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.
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.
Time frame: Month12
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