HIV - Human Immunodeficiency VirusCAIRNCT07760324
CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation
An observational study of HIV - Human Immunodeficiency Virus, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV - Human Immunodeficiency Virus
- How many people
- 151 participants
- Where
- 1 siteZambia
- Study dates
- 28 Nov 2024to Mar 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation (CAIR)
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.
Read the detailed description
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.
- Conditions
- HIV - Human Immunodeficiency Virus
- Keywords
- CAIR - CD4 Cell Count at Antiretroviral Therapy Initiation or Re-initiation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start28 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Why it stopped: Suspended because of the current funding restrictions from the NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760324
- Sponsor's protocol ID
- CAIR 5456-2024
- Acronym
- CAIR
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Risk of re-identification - Variables such as age, location, rare diagnoses, dates, and clinical characteristics can sometimes make participants identifiable when combined.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation (CAIR)
- ClinicalTrials.gov ID
- NCT07760324
- Acronym / sponsor ID
- CAIR / CAIR 5456-2024
- Conditions
- HIV - Human Immunodeficiency Virus
- Keywords
- CAIR - CD4 Cell Count at Antiretroviral Therapy Initiation or Re-initiation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Suspended because of the current funding restrictions from the NIH
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided. Risk of re-identification - Variables such as age, location, rare diagnoses, dates, and clinical characteristics can sometimes make participants identifiable when combined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV - Human Immunodeficiency Virus, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.