Clinical trial NCT02334670: Vietnam Cryptococcal Retention in Care Study Version 1.0
Official title: Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meningitis, Cryptococcal
Central Nervous System Fungal Infections
Central Nervous System Infections
Meningitis, Fungal
Keywords: cryptococcal meningitis
HIV
AIDS
Fluconazole
Lead sponsor: National Hospital for Tropical Diseases, Hanoi, Vietnam
Sponsor class: OTHER_GOV
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2015-01-08
Enrollment: 2612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly registering and ART-naive patients with advanced HIV infection

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Confirmed HIV infection using National Testing Algorithm
* CD4 ≤100 cells/μL
* Able to provide written informed consent

Exclusion Criteria:

* History of prior CM
* Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
* Currently taking ART or history of ART for more than 4 weeks within the past year
* Known to be currently pregnant or planning to become pregnant during the study period

Primary outcomes:
measure: Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative
timeFrame: Up to 12 months after recruitment
measure: Proportion of all patients tested for plasma CrAg who have positive results
timeFrame: Up to 12 months after recruitment
Secondary outcomes:
measure: Percent of patients with HIV-related hospitalizations at 6 and 12 months
timeFrame: 12 months after recruitment
measure: Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months
timeFrame: 12 months after recruitment
measure: Causes of death
timeFrame: 12 months after recruitment
measure: Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative
timeFrame: 12 months after recruitment
measure: Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation
timeFrame: 12 months after recruitment
measure: % of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment
timeFrame: 12 months after recruitment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Hospital for Tropical Diseases
Study officials:
affiliation: National Hospital for Tropical Diseases
name: Nguyen Van Kinh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: