CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation

NCT07760324 | Suspended DMC

• 1 other identifier: CAIR 5456-2024
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV - Human Immunodeficiency Virus

Keywords

CAIR - CD4 Cell Count at Antiretroviral Therapy Initiation or Re-initiation

Outcome Measures

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead

Study Sites (1)

Chawama

Lusaka, Lusaka Province, 10101, Zambia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: November 28, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

ZA (1)