NCT06159894

Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units".

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). . 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

Interventions

Type	Name	Description
OTHER	DAY HOSPITAL ARM	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.
OTHER	Specialist-Care arm	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.

Timeline

• Start date: 2023-12-18
• Primary completion: 2025-04-21
• Completion: 2026-02-18
• First posted: 2023-12-07
• Last updated: 2026-02-20

Locations

1 site across 1 country: Spain