Vietnam Cryptococcal Retention in Care Study - Version 2.1

NCT ID: NCT03267407

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-14
• Study Completion Date: 2018-03-31

Brief Summary

This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam.

Detailed Description

The project will be implemented in 2 phases; Phase 1: From August 2015 to March 2017 [projected], HIV-infected patients who present for HIV care and undergo CD4 testing will be reviewed to determine the proportion of newly presenting patients with advanced disease (CD4 ≤100 cells/μL). Reflex CrAg screening will be performed using Lateral Flow Assay (LFA) for those with CD4≤100 cells/μL, per Vietnam national guidelines.

Patients with CD4≤100 cells/μL who present for antiretroviral treatment (ART) at a study OPCs-CRICS Sites- will be recruited into the longitudinal study and followed up with assessments and the collection of routine and supplemental data for 12 months or through September 2017 (whichever comes sooner). 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. Data from those tested at participating labs but not eligible for enrollment in the longitudinal study will contribute to the estimation of the prevalence of CrAg.

Phase 2: From April 2017 to September 2017, a cost and cost-effectiveness analysis of CrAg screening will be conducted, a routine screening will be continued at existing sites and expanded to additional sites (preferentially to hospitals affiliated with Phase 1 OPCs and to other OPCs whose CD4 testing is conducted at laboratories already conducting CrAg screening as part of Phase 1). CrAg tests will also be made available to screen all patients with CD4≤100 cells/μL including those who are treatment-experienced. The test will also be made available for use among symptomatic patients for diagnostic purposes, including cerebral spinal fluid (CSF) and blood testing. Investigators will monitor prevalence at each testing site, but screened patients will not be enrolled in longitudinal follow-up. Phase 2 will last for at least 6 months based on the availability of funding and fluconazole for those who screen CrAg positive and the availability/stability of CD4 testing.

[Note that follow up of patients enrolled in Phase 1 will continue during this time period, but is considered to be part of Phase 1 rather than Phase 2. Also, sites included in Phase 2 may change over time as a result of the instability of CD4 testing (e.g., if participating laboratories stop conducting CD4 testing, those sites might no longer be included; if participating laboratories begin CD4 testing for other sites, those sites might be included).]

Conditions

HIV/AIDS; Cryptococcal Meningitis; Opportunistic Infections, HIV Related; Cryptococcosis; Mycosis; Opportunistic; Mycosis Fungoides

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CrAg(+) and CM(-)

(1) Patients with CrAg positive without meningitis results will receive preemptive high-dose fluconazole to prevent developing meningitis.

Preemptive high-dose Fluconazole

Intervention Type: OTHER

Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.

CrAg(+) and CM(+)

(2) Patients with CrAg positive and meningitis results will receive standard treatment for cryptococcal meningitis, following national guidelines.

Preemptive high-dose Fluconazole

Intervention Type: OTHER

Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.

CrAg(-)

(3) Patients with CrAg negative results will be managed as other HIV infected patients with the standard of care, following national guidelines.

Preemptive high-dose Fluconazole

Intervention Type: OTHER

Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.

Interventions

Preemptive high-dose Fluconazole

Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.

Intervention Type: OTHER

Other Intervention Names

Preemptive Fluconazole

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 18 years (having passed 18th birthday using Western calendar)
• Confirmed HIV infection using National Testing Algorithm
• CD4 ≤100 cells/μL
• Able to provide written informed consent
• Enrolled at and plan to receive ongoing outpatient care at one of the selected study OPCs

Exclusion Criteria

• History of prior CM
• Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
• Receipt of ART for more than 4 consecutive weeks within the past year
• For CrAg-positive patients only: Known to be currently pregnant or planning to become pregnant during the study period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

OTHER

Sponsor Role: collaborator

National Hospital for Tropical Diseases, Hanoi, Vietnam

OTHER_GOV

Sponsor Role: lead

Responsible Party

Vu Quoc Dat

Lead Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kinh V Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

National Hospital for Tropical Diseases, Hanoi, Vietnam

Locations

National Hospital for Tropical Diseases

Hanoi, , Vietnam

Countries

Vietnam

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5U01GH000758-03

Identifier Type: NIH

Identifier Source: org_study_id

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