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

Who is this study for? Patients with advanced HIV disease
What treatments are being studied? Enhanced care package
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• CD4\<200 cells/µL

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

Locations
Other Locations
Uganda
kisugu health center IV
RECRUITING
Kampala
Contact Information
Primary
Radha Rajasingham, MD
radha@umn.edu
612 626-8171
Backup
Elizabeth Nalintya, MBChB,MPH
nalintyaelizabeth@gmail.com
0414307000
Time Frame
Start Date: 2022-05-04
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 2400
Treatments
Experimental: intervention(Enhanced package of care) Arm
The patients with advanced HIV disease that receive HIV care at the intervention clinics will receive the enhanced intervention package which will include: point of care CD4 testing with visitect, screening for TB and cryptococcal meningitis using Fujifilm LAM and semiquantitative crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for one month. Those with a high crAg titers will receive treatment for CNS cryptococcal disease.
No_intervention: Standard of care Arm
The patients with advanced HIV disease that receive HIV care at the standard of care clinics will receive the usual routine HIV care as per the Uganda national guidelines. That is CD4 testing with flowcytometry or other CD4 testing modalities available, screening for TB and cryptococcal meningitis using Alere LAM and crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for 3-6 month. Treatment of all asymptomatic crAG positives with fluconazole as per guidelines.
Related Therapeutic Areas
Sponsors
Leads: Makerere University
Collaborators: University of Minnesota

This content was sourced from clinicaltrials.gov