Background:
The ongoing More Options for Children and Adolescents Study (MOCHA; IMPAACT 2017; Clinicaltrials.gov NCT03497676) is the first to examine use of long-acting injectable (LAI) cabotegravir (CAB) plus rilpivirine (RPV) in virologically suppressed adolescents, 12 to <18 years of age, with HIV-1. Little is known about the acceptability of this treatment approach for adolescents, including whether it changes over time.
Methods:
Participants switched from pre-study antiretrovirals to adolescent/adult dosing of CAB-LAI plus RPV-LAI after oral lead-in MOCHA Cohort 2. They were queried about their preferred choice of treatment (every 8-week LAI versus daily oral) and the reasons for this preference at 8- (n=142), 24- (n=141), and 48-weeks (n=115). Reasons for the preferred regimen were recorded verbatim and coded thematically by the study team. In-depth interviews (IDIs) were conducted by phone with 8 U.S.-based adolescents and separately with 4 parents after at least 24 weeks on study to provide insight into participants’ experiences. Interview transcripts were coded and analyzed using the Consolidated Framework for Implementation Research.
Results:
Overall, 144 adolescents enrolled in Cohort 2 at 18 sites in 5 countries. All but 4/142 (3%) participants at week 8 and 2/141 (1%) at week 24 stated that they preferred injectable LA medicines over daily orals. The primary themes for preferring LAI were: convenience and burden reduction. The most prominent components of burden reduction were the decrease in adherence-related stress and increased privacy. IDI participants expanded on these themes. All interviewees (adolescents and parents) favored LAI and reported convenience as a driving factor for them/their child to continue the LAI regimen. Having their medical team’s support and monitoring for adherence to each LAI dose was repeatedly raised as a key reducer of perceived treatment burden, as was freedom from the daily reminder of HIV diagnosis seen as inherent to oral treatment. A surprising element of the IDI data was feedback that several adolescents had not understood vital elements of the LAI process such as the location of the injections needing to be in the buttocks, despite having completed informed consent/assent counseling.
Conclusions:
Feedback from adolescents receiving LAI antiretrovirals for up to 48 weeks in the MOCHA study has been favorable thus far. IDIs data suggest that structured and developmentally tailored counseling may be essential to LAI implementation for adolescents.