Phase III Trial of Point-of-Care CD4 Testing and Enhanced Infection Screening to Improve Survival in Advanced HIV Disease

What this Trial Is About

Researchers are evaluating a community-based Phase III cluster randomized trial in Uganda involving adults with advanced HIV disease, defined by a CD4 count below 200 cellsL. The study aims to assess 24-week survival with retention in care by comparing an enhanced package of care to the standard of care. This trial focuses on improving prompt screening and treatment of opportunistic infections, which are a major cause of death in this population, while ensuring timely initiation of antiretroviral therapy ART. The intervention group receives an enhanced care package consisting of point-of-care CD4 testing using the Visitect lateral flow assay, screening for tuberculosis with FujiFilm SILVAMP TB LAM, and cryptococcal antigen testing using a semi-quantitative CrAg LFA. They also receive a one-month preemptive therapy with isoniazid and rifapentine for latent tuberculosis and treatment for disseminated CNS cryptococcal infection when indicated. The standard care group undergoes CD4 testing by flow cytometry, WHO-recommended opportunistic infection screening including urine TB LAM and CrAg LFA, and receives longer isoniazid prophylaxis and fluconazole treatment for cryptococcal antigen positivity as per national guidelines. Participants will be monitored over 24 weeks to assess survival while retained in care. Researchers will evaluate the sensitivity and specificity of the tuberculosis point-of-care tests, the incidence of opportunistic infections and related hospitalizations or deaths, and adherence and tolerability to the prophylactic regimens. The study includes regular clinic visits for testing, treatment, and follow-up, with safety and adherence monitoring throughout the trial period. Total participation spans at least 24 weeks from enrollment.

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