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Evaluation of advanced HIV disease differentiated care model in malawi: a mixed methods non-randomized cluster study

NCT ID NCT05510973

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026

Summary

This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis \[TPT and CPT\], on retention in care and viral suppression ((\<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment. The study will also assess the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project, evaluate the acceptability and feasibility of the AHD package of care among patients and HCWs providing related health services, and conduct a cost analysis of implementing the enhanced AHD package of care in a hub-and-spoke implementation of care model.

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 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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