Testing and Linkage to HIV Care in China

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

August 31, 2014

Study Completion Date

January 31, 2016

Conditions
HIV
Interventions
BEHAVIORAL

One4All

Participants with HIV-positive screening results on EIA will immediately have their blood drawn for CD4 and VL tests. Participants will receive post-screening test counseling. Two venous blood samples will be collected-one for immediate numeration of CD4 T-lymphocytes in the same hospital lave using PIMA POC CD4 analyzer and the other for later VL testing at the province CDC which takes 10-15 days. Participant will be notified in person of their CD4 results on the same day and provided post-CD4 test counseling. Counseling in the One4all intervention has been modified from the national SOC guidelines due to the different order of tests and the shortened time period between screening and CD4 testing. The participant will be provided with a tentative assessment of ART eligibility based on CD4 results and other factors. Those who are eligible for ART are encouraged to seek HIV care at the study hospitals via China's National Free ART program.

BEHAVIORAL

Standard of Care

"The control condition is the current standard of care (SOC) utilized within the county hospitals in Guangxi China. This SOC has some variability between counties but in general follows the national policies. After the initial positive screening on EIA and subsequent repeat screening, participants will receive post-screening test counseling. Participants will then be tested by WB either at the same visit or a subsequent visit. The WB is sent offsite.~After WB test results are reported to the hospital, the health care provider will contact the participant by phone. The participant will be asked to return to the hospital for results and post-WB test counseling. At this visit, a blood sample will be collected for CD4 testing, and an initial epidemiological investigation will be carried out.~Once CD4 test results are available, participants must be located again to inform them of their results and ART eligibility and to provide post-CD4 test counseling."

Trial Locations (12)

Unknown

Fusui County People's Hospital, Chongzuo

Ningming County People's Hospital, Chongzuo

Daxin County People's Hospital, Chongzu

Lingui County People's Hospital, Guilin

Lipu County People's Hospital, Guilin

Duan County People's Hospital, Hechi

Xiangzhou County People's Hospital, Laibin

Rongan County People's Hospital, Liuzhou

Longan County People's Hospital, Nanning

Lingshan County People's Hospital, Qingzhoucun

Cenxi County People's Hospital, Wuzhou

Bobai County People's Hospital, Yulin

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of California, Los Angeles

OTHER

NCT02084316 - Testing and Linkage to HIV Care in China | Biotech Hunter | Biotech Hunter