People living with HIV on injectable antiretroviral treatment (CAB+RPV) Infections and Infestations
Conditions
Interventions
Current interventions:
This is a 2-year study (with a 12-month recruitment and a 12-month follow-up period for each participant), two-arm, multi-centre, mixed methods study examining the real-world
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand the participant information and the study requirements and has the capacity to consent 2. Willing to comply with study procedures 3. Age 16 years or above 4. Is a member of one of the following groups: 4.1. LA group - PLWH who have been recently switched (within the prior 6 months) or are prospectively switched to LA CAB+RPV during the enrolment period. This includes those who have received LA CAB+RPV outside of BHIVA criteria or on compassionate grounds. 4.2. Oral ART group - PLWH who are demographically similar but not eligible for LA CAB+RPV according to BHIVA eligibility criteria and who continue oral ART within the study period (e.g. those who are HBVcoreAb+ or who have an underlying drug resistance mutation that precludes use of LA CAB+RPV). The intervention group to the oral group will be matched 3:1 by calendar period and other key variables where possible. (added 08/04/2025) CORAL-Light sub-cohort: Anyone >16 years old who has received one or more doses of LA CAB+RPV who is not in the main CORAL study cohort or exiting the main CORAL cohort
Exclusion criteria
Exclusion criteria: 1. In the opinion of the investigator is unable or unwilling to comply with the study requirements 2. Aged < 16 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adoption of LA CAB+RPV measured using data collected from patient medical records at the end of the study (2 years from site opening) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of LA CAB+RPV will be assessed based on: 1.1. Findings from in-depth qualitative interviews and focus groups with patient participants and healthcare workers (HCWs) 1.2. Comparison of patient-reported outcomes, measured using the patient-reported outcome measure for adults living with HIV (HIV PROM) and the treatment satisfaction and treatment preference questionnaire, at months 0, 6 and 12 post-switch to LA CAB+RPV 2. The feasibility of LA CAB+RPV will be assessed based on: 2.1. Findings from in-depth qualitative interviews and focus groups with patient participants and HCWs 2.2. Patient and HCW questionnaires, measured using the treatment satisfaction and treatment preference questionnaire at months 0, 6 and 12 post-switch to LA CAB+RPV (patient) and the HCW survey collected during the participant recruitment period (HCWs) 3. Fidelity will be assessed based on the below and measured using data collected from participant medical records: 3.1. The proportion of injections delivered within the visit window 3.2. Number of oral bridging courses per patient per year 3.3. Fidelity to 2-monthly HIV viral load monitoring (+/- 2 weeks of target date) 4. Effectiveness assessed based on: 4.1. The proportion of those who begin LA CAB+RPV who remain virologically suppressed at 12 months (by FDA snapshot algorithm and intention to treat approach), and the proportion of those on oral ART who remain virologically suppressed at 12 months after the baseline date measured using data collected from participant medical records 4.2. The proportion of each group who have experienced virological failure at 12 months measured using data collected from participant medical records 4.3 The number of HIV-related medical events at 12 months measured using data collected from participant medical records | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactKate Alford
Outcome results
None listed