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Zambia launches massive study to uncover why some HIV patients still get very sick

NCT ID NCT06904456

Knowledge-focused Sponsor: Boston University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study in Zambia will follow about 11,800 people with advanced HIV who are starting or restarting antiretroviral therapy (ART). Researchers want to learn who these patients are, what challenges they face, and how well they do in the first six months of treatment. The goal is to give Zambia's health officials the information they need to improve care and reduce deaths.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help Zambia's health officials design better programs and guidelines to keep people with advanced HIV healthy and alive during their first months on treatment.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new drug or cure. The findings may not apply to other countries or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 11,800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be adult HIV treatment patients and providers at the study sites who meet inclusion and exclusion criteria for each cohort.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Cohort 1 Inclusion * ≥18 years old * Presenting at a study site clinic for HIV diagnosis or care * Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening) * Screened for AHD by clinic, prior to or within 1 month of ART initiation * Written informed consent to participate Exclusion * Pregnant and/or presenting for antenatal care * Too ill at the time of AHD screening and at the next clinic visit to participate in the study * Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant Cohort 2 Inclusion * ≥18 years old * Living with HIV and screened for AHD at a study site within 12 months of the start of study prospective data collection at that site * All inclusion criteria for the full cohort * Initiated/re-initiated ART within the past 6 months * Returns to the study site for a clinic visit during the study enrollment period * Written informed consent to participate Exclusion * Pregnant and/or presenting for antenatal care as reported in records * All exclusion criteria for the full cohort * Too ill at the time of study enrollment visit to participate in the study * Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant * Been on ART \>6 months Cohort 3 Inclusion * ≥18 years old * Living with HIV * Admitted for inpatient care related to AHD * Initiated or re-initiated ART within the last 6 months * Written informed consent to participate Exclusion * Pregnant and/or presenting for antenatal care * Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff * Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant * Confined to tuberculosis isolation ward; intensive care unit; or other ward specifically for clients with acute infectious disease. Cohort 4 Inclusion * Employed by or at the study site for at least 6 months * Directly interact with clients presenting with AHD * Written informed consent to participate Exclusion * None

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Conditions

The condition(s) this trial relates to.

AIDS

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced HIV disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHAI-Zambia

    RECRUITING

    Lusaka, Zambia

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