It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.
This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative.
Study Type
OBSERVATIONAL
Enrollment
2,612
HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA). Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole.
National Hospital for Tropical Diseases
Hanoi, Vietnam
Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative
Time frame: Up to 12 months after recruitment
Proportion of all patients tested for plasma CrAg who have positive results
Time frame: Up to 12 months after recruitment
Percent of patients with HIV-related hospitalizations at 6 and 12 months
Time frame: 12 months after recruitment
Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months
Time frame: 12 months after recruitment
Causes of death
Time frame: 12 months after recruitment
Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative
Time frame: 12 months after recruitment
Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation
Time frame: 12 months after recruitment
% of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment
Time frame: 12 months after recruitment
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