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Suspended

NCT Number: NCT07760324

CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation

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.

Why the study stopped: Suspended because of the current funding restrictions from the NIH
Suspended

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adults aged ≥18 years who are willing and able to provide consent and are: newly enrolling in HIV care and starting ART at study sites OR
  • re-enrolling after a known ≥24-month ART gap confirmed by clinic records or patient recall at eligibility screening.

Exclusion criteria

  • Patients known to be on ART for more than 7 days at the time of assessment for enrollment into study.
  • Patients with a gap in ART that is <24 months.
  • Patients with a gap in ART of unknown duration

Treatment and study plan

Primary outcomes

  1. Cross-sectional

    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

Sponsors and collaborators

Lead sponsor

Centre for Infectious Disease Research in Zambia

Other

Registry information

Official study title

CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation (CAIR)

Acronym: CAIR

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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