Vietnam Cryptococcal Retention in Care Study - Version 2.1

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03267407
• Date of registration: 27/08/2017
• Prospective Registration: No
• Primary sponsor: National Hospital for Tropical Diseases, Hanoi, Vietnam
• Public title: Vietnam Cryptococcal Retention in Care Study - Version 2.1
• Scientific title: Vietnam Cryptococcal Retention in Care Study (CRICS) - Version 2.1
• Date of first enrolment: August 14, 2015
• Target sample size: 1184
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03267407
• Study type: Observational
• Phase: N/A

Countries of recruitment

Vietnam

Contacts

• Name: Kinh V Nguyen, MD
• Affiliation: National Hospital for Tropical Diseases, Hanoi, Vietnam

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cryptococcal Meningitis

Cryptococcosis

Mycosis Fungoides

HIV/AIDS

Mycosis; Opportunistic

Opportunistic Infections, HIV Related

Intervention(s)

Other: Preemptive high-dose Fluconazole

Primary Outcome(s)

Prevalence of CrAg-positivity among HIV-infected patients with CD4 =100 cells/µL [Time Frame: August 2015 to March 2017]

Proportion of HIV-infected adults who have CD4 count = 100 cells/µL [Time Frame: 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 [Time Frame: 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 [Time Frame: August 2015 to March 2017]

Secondary Outcome(s)

Lessons learned with participating sites [Time Frame: August 2015 to March 2018]

Six (6) and twelve (12) month all-causes and Talaromyces marneffei-related mortality among patients who screen TmAg-positive and TmAg-negative [Time Frame: August 2015 to March 2017]

Proportion of stored samples that test positive for TmAg [Time Frame: August 2015 to March 2017]

Total costs and unit cost per person screened, per CrAg+ treated by site, lab facility type, and cost component. [Time Frame: August 2015 to March 2017]

Twelve (12) month retention among patients who screen CrAg-positive and CrAg-negative [Time Frame: August 2015 to March 2017]

Incremental cost-effectiveness ratio (cost per CM death averted and cost per quality adjusted life year (QALY)) [Time Frame: August 2015 to March 2017]

Total cost savings and amount of financial resources required to implement CrAg screening [Time Frame: August 2015 to March 2017]

Challenges associated with implementation of routine plasma CrAg screening in clinics providing HIV care [Time Frame: August 2015 to March 2018]

Secondary ID(s)

5U01GH000758-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Centers for Disease Control and Prevention