An observational study in HIV - Human Immunodeficiency Virus, sponsored by Centre for Infectious Disease Research in Zambia. Suspended at 1 site in Zambia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Centre for Infectious Disease Research in Zambia · Observational
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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.
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 the region, the aim is to enrol 500 participants aged 18 years and older and to 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, extraction of 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.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 151 is below the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Centre for Infectious Disease Research in Zambia is the lead sponsor of 41 studies on the registry; 5 are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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 the 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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cross-sectional
The investigators 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
Plan to share: Undecided — Risk of re-identification - Variables such as age, location, rare diagnoses, dates, and clinical characteristics can sometimes make participants identifiable when combined.
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Dec 2027, 37 months after the start.
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This study is suspended, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Centre for Infectious Disease Research in Zambia