Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Enhanced care package to improve survival in advanced HIV disease

Official title: A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease

Run by Makerere University · NCT05085171 · Data updated 2026-11-12

This study is testing if a better care package can help people with advanced HIV in Uganda live longer compared to the usual care they receive.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment2400 (estimated)
SponsorMakerere University
Academic / other
Locations1 site (Kampala)
StatusRecruiting
StartedMay 4, 2022
Main results expectedMarch 1, 2027
Study endsSeptember 1, 2027
Registry record updatedJuly 12, 2022
Trial IDNCT05085171 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old with advanced HIV disease characterized by a CD4 count of less than 200 cells/µL.

Probably not a fit

Patients who are virologically suppressed or unable to attend regular clinic visits may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III, cluster randomized trial aims to evaluate the survival benefit of an enhanced package of care for patients with advanced HIV disease in Uganda. The study will involve HIV-infected adults with CD4 counts below 200 cells/µL and will compare an enhanced care package, including point-of-care CD4 testing and opportunistic infection prophylaxis, against standard care. Over a duration of 5 years, the trial will assess 24-week survival rates and retention in care among participants. The enhanced package includes innovative screening and treatment options for opportunistic infections.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of care for patients with advanced HIV disease.

How similar studies have gone: Other studies have shown success with enhanced care packages in HIV management, suggesting potential for positive outcomes in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age \>18 years
* CD4\<200 cells/µL
* Ability and willingness to give informed consent for the enhanced package of care arm.

Exclusion Criteria:

* Known virologic suppression (viral load \<1000 copies/mL) within prior 3 months
* Cannot or unlikely to attend regular clinic visits

Where it's running

  • kisugu health center IV
    Kampala, Uganda
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.