SuspendedNot Applicable

CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation

Stopped: Suspended because of the current funding restrictions from the NIH

Zambia151 participantsStarted 2024-11-28

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cross-sectional

Trial details

NCT IDNCT07760324

SponsorCentre for Infectious Disease Research in Zambia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

View on ClinicalTrials.gov More HIV - Human Immunodeficiency Virus trials