From: The physical sequelae of perinatally acquired HIV in adolescents: a research proposal
 | Phase one | Phase two | Phase three |
---|---|---|---|
Study design | Semi-structured interviews | A cohort study with a comparison group of age-matched participants | Consensus for a model of care using NGT |
Source of participants | CHANGES at RMMCH (for phase three medical professionals will be sourced from the site) | ||
Sample size | Eight participants per group; 2 groups (early and middle phase adolescence: ages 10–14 and 15–17 years, respectively) | 308 (154 HIV+ and 154 HIV− [matched]) participants | Five to nine participants per group; 2 groups (representatives of PHIVA and of clinical experts) |
Inclusion criteria | PHIVA in CHANGES, aged 10–17 years | Adolescents aged 10–17 years (HIV+ and −) | PHIVA in CHANGES, aged 10–17 years Interdisciplinary team member in field of HIV and adolescence |
Exclusion criteria | Physical/cognitive impairments preventing their participation Physical/cognitive impairment not due to HIV | ||
Procedure and instrumentation | Individual, semi-structured interviews | HIV related fatigue scale Six minute walk test MABC-2 Brief peripheral neuropathy screen WHODAS-child Standing broad jump PedsQL 4.0 Body mass index | Nominal group technique for consensus on a model of care [37] |
Data analysis | Identify substantive statements Inductive approach Manifest analysis Separate coding done to identify themes, subthemes and categories | Descriptive statistics Appropriate tests of association Logistic regression analysis | Qualitative data: inductive analysis as per phase one Quantitative data: descriptive statistics of averages and means |