Health TrialsbyHealthPanel

An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease

ConditionThe Study Will Focus on Assessing the Survival Benefit on an Enhanced Package of Care for Patients With Advanced HIV Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMakerere University

About this trial

A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

CD4<200 cells/µL

Ability and willingness to give informed consent for the enhanced package of care arm.

Disqualifiers

Known virologic suppression (viral load <1000 copies/mL) within prior 3 months

Cannot or unlikely to attend regular clinic visits

Trial design

Design model

Factorial

Treatments tested in this trial

  • Enhanced care package

    Other intervention

    The intervention is an improved package of care for patients with advanced HIV disease with point of care CD4 testing, more sensitive screening tests for opportunistic infections and more intensive pre-emptive treatment for opportunistic infections

Treatment groups

2,400 Participants
are divided into 2 treatment groups
Group A: intervention(Enhanced package of care) ArmExperimental treatment 1 intervention
Group B: Standard of care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

24-week survival with retention in care

Comparison will be made between study arms of those who receive POC CD4 testing vs. those who receive standard flow cytometry, and those who receive the enhanced package of OI screening and prophylaxis, vs. those who receive the current WHO standard.

Time frame
24 weeks

Secondary outcomes

1

Evaluate sensitivity and specificity of the different TB point of care tests.

After a positive FujiFilm TB LAM test, incidence of Xpert-positive or culture positive TB, and clinical outcomes to distinguish between false positive vs. true positive urine tests

Time frame
24 weeks
2

Incidence of OIs and associated hospitalization and mortality

Incidence of active TB within 6 months, Incidence of cryptococcal meningitis and associated mortality.

Time frame
Six months
3

Tolerability and adherence to prophylaxis regimen and associated grade 3 to 5 adverse events

percentage completion of regimen and proportions that get grade 3 and above AEs.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Makerere University

Lead sponsor

University of Minnesota

Collaborator

Source ClinicalTrials.gov
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