Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1,Two to Less Than 12 Years of Age.


This study will use a mixed-methods approach to gather participant experience data that includes brief staff-collected questionnaires for parents/caregivers of all participants and for participants who meet age eligibility requirements specified in Section 6.15 as well as semi-structured in-depth interviews (IDIs) with a subset of enrolled parents/caregivers to expand upon the themes explored in the questionnaires. For Cohort 2, qualitative IDIs will also include an exploration of how and why the decision to join Cohort 2a or Cohort 2b was made. Qualitative work is important in populations where experience is limited and there is reason to believe that interests and behaviors could be different than previously studied populations (i.e., adult/adolescents vs. children). In this case, there is a lack of qualitative data on the topic of a long-acting injectable, repeat dose medicine in young children. The caregiver will have tremendous influence on the healthcare of the child, so understanding their interests and the driving force behind their behaviors is key. Such data will also provide nuance to the validity and relevance of the questions asked in the quantitative questionnaires. In addition, by incorporating both quantitative and qualitative components in a single study, we can integrate (mix) findings to address inherent limitations in each of the methodologies when used in isolation.


  • Prof Lee Fairlie, Principal Investigator
  • Dr Muneerah Khan
  • Dr Faeezah Patel
  • Dr Elizea Horne
  • Dr Mrinmayee Dhar
  • Dr Robert Kieser
  • Dr Pemphero Chesela
  • Dr Jeanne Coetzee

Latest Update

May 2023

For more about IMPAACT 2036 CRAYON Study please email

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