The impact of HIV infection on bone and muscle development in Zimbabwean childre

Not Applicable

Completed

• Conditions: HIV, musculoskeletal health; Infections and Infestations

• Registration Number: ISRCTN12266984
• Lead Sponsor: Biomedical Research and Training Institute

Brief Summary

2020 Protocol article in http://dx.doi.org/10.1136/bmjopen-2019-031792 (added 30/11/2021) 2022 Results article in https://doi.org/10.1002/jbmr.4752 (added 18/08/2023) 2023 Results article in https://doi.org/10.1097/QAD.0000000000003477 (added 18/08/2023) 2021 Results article in https://doi.org/10.1016/S2352-4642(21)00133-4 (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-22
• Study Completion: 2020-10-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Age 8-16 years (includes pre- and peri-pubertal children)
2. Living in Harare
3. With HIV only if:
3.1 Vertically-acquired HIV and taking ART for at least two years (as adult studies demonstrate ART initiation is followed by an initial decline in BMD which stabilizes after 2 years)
3.2 The child is aware of their HIV status, to avoid inadvertent disclosure as a result of study participation

Exclusion Criteria

1. Acute illness (requiring immediate hospitalisation) and lack of consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Total-body less-head (TBLH) Bone Mineral Content (BMC) for lean mass adjusted-for-height (TBLH-BMCLBM) Z-scores) measured using DXA (dual-energy X-ray absorptiometer) at baseline and one year<br>2. Lumbar spine (LS) Bone Mineral Apparent Density (BMAD) (LS BMAD) Z-score measured using DXA at baseline and one year