About this trial
This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes.
Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV
Secondary outcomes
• Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV-1 patients, aged 18 years and above, having received at least 1 dose of LAI CAB/RPV between September 1, 2021, and March 31, 2024.
Disqualifiers
None
Trial population
Participants will be recruited at one of the participating HIV reference centers (HRCs). These centers are part of the 12 official HIV treatment centers in Belgium and work in concert as members of the Belgian Research on AIDS \& HIV Consortium (BREACH).
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV
Participants will be asked to complete a 32-item paper questionnaire relating to their HIV treatment of LAI CAB/RPV. Questions will focus on how their daily life and quality of life has been affected by switching to LAI CAB/RPV. The questionnaire that will be used is not a standardized questionnaire but rather a questionnaire that was developped by the study team.
Secondary outcomes
Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV
Proportion of participants that experience loss of virologic suppression by month 11
Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression
If a participant experiences loss of virologic suppression, then if an HIV resistance test was performed at that time, the resistance-associated mutations observed will be reported.
Proportion of participants with a viral blip at months 5 and 11
Sponsors and contacts
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