The ongoing More Options for Children and Adolescents Study (MOCHA; Clinicaltrials.gov NCT03497676) is the first to examine use of long-acting injectable (LA) antiretrovirals (ARV) (cabotegravir [CAB-LA] and rilpivirine [RPV-LA]) in adolescents, 12 to <18 years old, living with HIV-1. While LA may improve adherence and viral suppression, little is known about the acceptability of this treatment approach for adolescents.
To assess LA acceptability issues of importance to adolescents, participants completed questionnaires about reasons for choosing the LA regimen, perceptions of injections, and health-related quality of life (PedsQLTM) at study entry and after receipt of 3 injectable doses (CAB-LA or RPV-LA). In-depth interviews (IDIs) were conducted by phone sequentially with adolescent participants and separately with parents/caregivers (‘parents’) of participants who were English-speaking and agreed to IDIs. Interview transcripts were coded and analyzed thematically using the consolidated framework for advancing implementation research.
To date, as part of Cohort 1 of MOCHA, 21 virologically suppressed adolescents received 3 IM injections of CAB-LA or RPV-LA 4 weeks apart (in addition to their stable oral combination ARVs) for an initial pharmacokinetic evaluation and completed the noted questionnaires. For 16 adolescents (76.2%), the primary reason for enrolling was the desire to avoid having to take daily pills or finding it difficult to take daily pills. Of 21 adolescents who received 3 study injections, 90.5% (19/21) reported wanting to receive injectable medicines even when not in the study. PedsQLTM scores indicated overall good quality of life at both study entry and following the 3 injections. 11 adolescents and 11 parents underwent IDIs. In the IDIs, themes related to not having to remember to take pills/avoiding the stress of monitoring adolescents’ daily medication-taking and not having to worry about hiding pills from peers dominated discussions of the relative advantage of LA versus pills. Concerns regarding long-term use of LA ARVs included questions about ability to maintain a routine injection schedule when busy with school, extracurricular activities, and work, particularly for those planning to move to college.
Feedback from adolescents receiving CAB-LA or RPV-LA to date was overall favorable. Issues and concerns identified will help inform future studies and implementation planning when LAs become commercially available for this age group.