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Can better testing and TB prevention keep advanced HIV patients alive?

NCT ID NCT05510973

Disease control Sponsor: Elizabeth Glaser Pediatric AIDS Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are studying whether an enhanced package of care helps people with advanced HIV in Malawi stay in treatment and keep the virus suppressed. The package adds CD4 and TB-LAM tests and starts patients on TB preventive therapy, delivered through a hub-and-spoke system of clinics with continuous quality improvement. The study follows about 700 patients of all ages and also looks at whether the approach is acceptable, feasible, and affordable.

What this could mean

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

Active substance
an enhanced package of advanced HIV care including CD4 testing, TB-LAM testing, and TB preventive therapy
What this could lead to
If the enhanced package works, clinics in Malawi and similar settings could adopt it to keep more people with advanced HIV alive, in care, and virally suppressed.
What could go wrong
This is a non-randomized implementation study, so differences between clinics may reflect other factors rather than the care package itself. Results from Malawi may not transfer to other health systems.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

700 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2024

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Inclusion Criteria: HIV-infected clients (all ages) meeting the WHO definition for AHD: * CD4 count of \<200c/mm3 * or WHO clinical stage 3 or 4 * or children under the age of 5 on treatment for less than 12 months or unstable on treatment after 12 months Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

AIDS AIDS-related disorder AIDS-related Kaposi sarcoma AIDS-Related Opportunistic Infections cryptococcosis Infections Kaposi's sarcoma

As listed by the trial registrant

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

AIDS and infections AIDS with tuberculosis AIDS-related Kaposi sarcoma Cryptococcal infections Opportunistic infections, HIV-related

Contacts and locations

Locations

  • Chiradzulu District Hospital

    Chiradzulu, Chiradzulu, Malawi

  • Dedza district hospital

    Dedza, Dedza, Malawi

  • Domasi Rural Hospital

    Domasi, Zomba, Malawi

  • Kapiri Mission Hospital

    Kapiri, Mchinji, Malawi

  • Lobi rural hospital

    Lobi, Dedza, Malawi

  • Malamulo Mission Hospital

    Thyolo, Thyolo, Malawi

  • Mchinji District Hopsital

    Mchinji, Malawi

  • Mlambe Mission Hospital

    Mlambe, Blantyre, Malawi

  • Mua Mission Hospital

    Mtakataka, Dedza, Malawi

  • Ntcheu District Hospital

    Ntcheu, Malawi

  • Saint Luke's Mission Hospital

    Zomba, Zomba, Malawi

  • Sister Theresa Community Hospital

    Ntcheu, Malawi

  • St Michael's Guilleme Community Hospital

    Mchinji, Mchinji, Malawi

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