Chawama
Lusaka, Lusaka Province, 10101, Zambia
NCT Number: NCT07760324
The primary purpose of this study is to assess the burden of advanced HIV disease (CD4 cell count <200 or <350 cells/μL) among new patients and those returning to care after a gap in treatment, and the extent to which low coverage of CD4 cell count measurement among these patients may prevent adequate management of those with advanced HIV disease.
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Notify Me18 year–99 year
All sexes
Observational
Lusaka, Lusaka Province, 10101, Zambia
This study is part of a multi-regional IeDEA study across four African regions to assess the burden of advanced HIV disease among PLWH at ART initiation and re-initiation. Among adults and adolescents. The WHO defines advanced HIV disease as having a CD4 cell count <200 cells/uL or having WHO stage 3 or 4 disease. In our region we aim to enrol 500 participants aged 18 years and older and we will conduct a cross-sectional evaluation that will include assessments of WHO clinical stage, CD4 cell count, and ART exposure status at enrolment/re-enrolment into care, as well as barriers to HIV testing and care.
In addition, we will extract routinely collected clinical data on all study participants from within the cohort dataset, including prospective data on participant treatment outcomes, and CD4 and HIV VL measurements performed as part of routine patient care. These data will be harmonized using the IeDEA-DES, which is a common data model for sharing observational HIV data designed and maintained by the Data Harmonization Working Group (DHWG) of IeDEA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We will conduct a cross-sectional evaluation that will include assessments of WHO clinical stage, CD4 cell count, and ART exposure status at enrolment/re-enrolment into care, as well as barriers to HIV testing and care
Centre for Infectious Disease Research in Zambia
Other
CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation (CAIR)
Acronym: CAIR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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