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Clinical Trials/ISRCTN12266984
ISRCTN12266984
Completed
未知

The IMpact of Vertical HIV infection on child and Adolescent Skeletal development in Harare (IMVASK) study

Biomedical Research and Training Institute0 sites600 target enrollmentJuly 22, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Biomedical Research and Training Institute
Enrollment
600
Status
Completed
Last Updated
2 years ago

Overview

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)

Registry
who.int
Start Date
July 22, 2019
End Date
October 31, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Biomedical Research and Training Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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