2.1. Study Population
HIV infection, active lung infection, tuberculosis, Chronic Lung Disease, CLD
HIV INFECTION, TUBERCULOSIS, CHRONIC LUNG DISEASE, SECONDARY, CLD
This study was a secondary data analysis of prospectively collected anthropometry data, at one or two time points for each participant, from two studies, one cohort and one randomised controlled trial (RCT). Children living with HIV (CWH) and HIV-negative individuals were recruited into the cohort study (IMVASK) [The IMpact of Vertical HIV infection on child and Adolescent SKeletal development (IMVASK) cohort study, conducted in Zimbabwe between August 2018 and January 2021, enrolled 8–16-year-olds, using quota-based sampling, stratified by age group (8–10, 11–13, and 14–16 years), sex, and HIV status, aiming to recruit 50 in each stratum [The Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children (BREATHE) randomised controlled trial was an individually randomised, multi-site, placebo-controlled, double-blind trial of azithromycin versus placebo, with a 1:1 allocation ratio stratified by site, and was conducted between June 2016 and August 2019 [Trial eligibility criteria were perinatal HIV transmission, established on ART (minimum 6 months), intention to remain in the area, knowledge of HIV status (for those over 11 years), and meeting criteria for CLD. Exclusion criteria included pregnancy, creatinine clearance < 30 mls/minute, alanine aminotransferase (ALT) >2 times the upper limit of normal, evidence of prolonged QTc interval, and active lung infection (acute respiratory exacerbation or tuberculosis for which all participants were screened actively at baseline). Participants, health care providers, and outcome assessors were blinded to trial allocation. The trial intervention had no effect on anthropometry over 48 weeks [