NCT02084316

Brief Summary

This study will evaluate the effects of a comprehensive approach (One4All) to increase the percentage of patients that receive their HIV testing results and counseling. Primary Hypothesis: The One4All approach will increase the proportion of individuals who have completed all tests to confirm HIV diagnosis and received counseling within 30 days of screening HIV+, given they have screened HIV+ on the initial test, from 40% to 60%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 18, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

March 7, 2014

Last Update Submit

August 16, 2016

Conditions

HIV

Keywords

China CDCOne4All testing algorithmGuangxi Autonomous RegionTesting and Linkage to HIV Care in China

Outcome Measures

Primary Outcomes (1)

  • Receipt of post-test results and counseling following testing completeness

    The numerator is the number of HIV-positive participants who have received post-test results and counseling within 30 days of initial screening blood draw. The denominator is the number of participants who screened positive on the initial HIV EIA in the study arm (control or intervention).

    30 days

Secondary Outcomes (1)

  • Proportion of treatment-eligible participants with CD4 < 350

    90 days

Other Outcomes (1)

  • Proportion of participants who have viral suppression based on the 12-month viral load test.

    12 months

Study Arms (2)

One4All

EXPERIMENTAL

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: One4All

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care

Interventions

One4AllBEHAVIORAL

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.

One4All
Standard of CareBEHAVIORAL

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.

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participating individuals must:
  • Be at least 18 years old
  • Be an inpatient or outpatient seeking care in study hospitals
  • Test positive on an initial EIA HIV screen
  • Have local residency or intent to live in study area for at least 90 days

You may not qualify if:

  • Individuals will be excluded from study participation if they:
  • Test result negative on initial EIA HIV screen
  • Have previously received confirmation on HIV infection in the study hospital or in any other setting (e.g., CDC clinic, infectious disease hospital, sub-county-level hospital)
  • Are prisoners or detainees at the time of initial screening
  • Are pregnant women (pregnant women are subject to mandatory testing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Fusui County People's Hospital

Chongzuo, Guangxi, China

Location

Ningming County People's Hospital

Chongzuo, Guangxi, China

Location

Daxin County People's Hospital

Chongzu, Guangxi, China

Location

Lingui County People's Hospital

Guilin, Guangxi, China

Location

Lipu County People's Hospital

Guilin, Guangxi, China

Location

Duan County People's Hospital

Hechi, Guangxi, China

Location

Xiangzhou County People's Hospital

Laibin, Guangxi, China

Location

Rongan County People's Hospital

Liuchow, Guangxi, China

Location

Longan County People's Hospital

Nanning, Guangxi, China

Location

Lingshan County People's Hospital

Qingzhoucun, Guangxi, China

Location

Cenxi County People's Hospital

Wuzhou, Guangxi, China

Location

Bobai County People's Hospital

Yulin, Guangxi, China

Location

Related Publications (2)

  • Wu Z, Tang Z, Mao Y, Van Veldhuisen P, Ling W, Liu D, Shen Z, Detels R, Lan G, Erinoff L, Lindblad R, Gu D, Tang H, Hu L, Zhu Q, Lu L, Oden N, Hasson AL, Zhao Y, McGoogan JM, Ge X, Zhang N, Rou K, Zhu J, Wei H, Shi CX, Jin X, Li J, Montaner JSG. Testing and linkage to HIV care in China: a cluster-randomised trial. Lancet HIV. 2017 Dec;4(12):e555-e565. doi: 10.1016/S2352-3018(17)30131-5. Epub 2017 Aug 31.

    PMID: 28867267DERIVED

  • Mao Y, Wu Z, McGoogan JM, Liu D, Gu D, Erinoff L, Ling W, VanVeldhuisen P, Detels R, Hasson AL, Lindblad R, Montaner JSG, Tang Z, Zhao Y. Care cascade structural intervention versus standard of care in the diagnosis and treatment of HIV in China: a cluster-randomized controlled trial protocol. BMC Health Serv Res. 2017 Jun 12;17(1):397. doi: 10.1186/s12913-017-2323-z.

    PMID: 28606085DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Zunyou Wu, MD, PhD

    National Center for AIDS/STD Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Walter Ling, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Roger Detels, MD, MS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Founding Director Integrated Substance Abuse Programs

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

January 1, 2016

Last Updated

August 18, 2016

Record last verified: 2016-01

Locations

CN(12)