Clinical Trial: Vietnam Cryptococcal Retention in Care Study

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients

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 Summary: 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.
Sponsor: National Hospital for Tropical Diseases, Hanoi, Vietnam

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: National Hospital for Tropical Diseases, Hanoi, Vietnam

Dates:
Date Received: January 5, 2015
Date Started: May 2015
Date Completion: May 2017
Last Updated: January 6, 2015
Last Verified: January 2015