Vietnam Cryptococcal Retention in Care Study - Version 2.1

NCT03267407 | Unknown

• 1 other identifier: 5U01GH000758-03
• Study Type: observational
• Target: 1,184
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Proportion of HIV-infected adults who have CD4 count ≤ 100 cells/μL

  The number of HIV-infected adults with CD4 count ≤ 100 cells/μL divided by the total number of HIV-infected patients.

  August 2015 to March 2017

• Prevalence of CrAg-positivity among HIV-infected patients with CD4 ≤100 cells/μL

  The number of CrAg-positivity divided by the number HIV-infected patients with CD4 ≤100 cells/μL

  August 2015 to March 2017

• Clinical outcomes including common causes of mortality for people living with HIV (PLHIV) with CD4 ≤ 100 cells/μL who are enrolled in a programmatic rollout of screening for CrAg

  Clinical outcomes include HIV-related hospitalization, causes of death, new AIDS defining opportunistic infections at 6 and 12 month.

  August 2015 to March 2017

• Twelve (12) month all-causes and cryptococcal meningitis (CM)-related mortality among patients who screen CrAg-positive and CrAg-negative

  The 12-month mortality among two groups of HIV-infected patients with CD4 ≤ 100 cells/μL who are enrolled in care and treatment: * Those who are CrAg-positive and are treated with high-dose fluconazole; * Those who are CrAg-negative.

  August 2015 to March 2017

Secondary Outcomes (8)

• Twelve (12) month retention among patients who screen CrAg-positive and CrAg-negative

  August 2015 to March 2017

• Challenges associated with implementation of routine plasma CrAg screening in clinics providing HIV care

  August 2015 to March 2018

• Lessons learned with participating sites

  August 2015 to March 2018

• Total costs and unit cost per person screened, per CrAg+ treated by site, lab facility type, and cost component.

  August 2015 to March 2017

• Incremental cost-effectiveness ratio (cost per CM death averted and cost per quality adjusted life year (QALY))

  August 2015 to March 2017

Study Arms (3)

CrAg(+) and CM(-)

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

Other: Preemptive high-dose Fluconazole

CrAg(+) and CM(+)

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

Other: Preemptive high-dose Fluconazole

CrAg(-)

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

Other: Preemptive high-dose Fluconazole

Interventions

Preemptive high-dose Fluconazole 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.

Also known as: Preemptive Fluconazole

CrAg(+) and CM(+); CrAg(+) and CM(-); CrAg(-)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced HIV infection (CD4\<100 cells/microliters) who are eligible to inclusion and exclusion criteria are recruited and followed up into the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Hospital for Tropical Diseases, Hanoi, Vietnam: lead
• Centers for Disease Control and Prevention: collaborator
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator

Study Sites (1)

National Hospital for Tropical Diseases

Hanoi, 100000, Vietnam

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Meningitis, Cryptococcal; AIDS-Related Opportunistic Infections; Cryptococcosis; Mycoses; Mycosis Fungoides

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Meningitis, Fungal; Central Nervous System Fungal Infections; Bacterial Infections and Mycoses; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Opportunistic Infections; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kinh V Nguyen, MD

  National Hospital for Tropical Diseases, Hanoi, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Coordinator

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: August 30, 2017
• Study Start: August 14, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

VN (1)