Clinical trial NCT02084316: Testing and Linkage to HIV Care in China
Official title: Testing and Linkage to HIV Care in China: A Clustered Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV
Keywords: China CDC
One4All testing algorithm
Guangxi Autonomous Region
Testing and Linkage to HIV Care in China
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-03-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Detailed description: The study consists of a cluster randomized trial (CRT) at county hospitals in Guangxi, China to assess the effectiveness of a structural intervention: a new testing algorithm, consisting of rapid point-of-care (POC) HIV and CD4 testing, with viral load (VL) testing in parallel, designed to ensure completeness of diagnostic assessment and accelerate time to ART initiation for patients deemed ART eligible (hereafter called the One4all Test Intervention).

This CRT will be conducted in 12 county general hospitals with an estimated average of 30 participants per hospital, totaling an estimated 360 participants. The unit of randomization is the hospital. Hospitals will be randomized to 1) theOne4all Test Intervention, or 2) the control condition, consisting of the current standard of care (SOC). The efficacy of the intervention will be evaluated at 1, 3, and 12 month follow-up assessments, and the differential efficacy for drug users (DUs) and non-drug users will be examined.

The study population will consist of adult participants who screen positive on an initial HIV enzyme immunoassay (EIA) in the 12 study hospitals. Since the study will be conducted in China, the vast majority of participants will be of Chinese or Asian descent. Women will be included and are expected to represent approximately 26% of the study population.

Eligibility Criteria:

Site Eligibility Criteria: The location of our study is Guangxi Zhuang Autonomous Region (Guangxi). We will select county-level general hospitals in order to ensure sufficient caseload at each hospital and homogeneity across hospitals. Guangxi counties usually have one general hospital (a limited number of counties have two or more general hospitals); this hospital has been designated as the only setting for delivering ART services in the respective county.

Study hospitals (n=12) will be selected based on the number of reported HIV positive screenings in the first 6 months of the previous year (2012) and on homogeneity in testing procedures between hospitals. Selected hospitals will have reported at least 30 patients who screened positive during the period of January to June 2012. Should more than 12 hospitals be identified the lowest screen positive hospital will not be considered for participation.

Participant Eligibility Criteria: Inclusion criteria will be 1) age 18 or older, 2) seeking care in study hospitals, 3) local residency or intent to live in study area for at least 90 days, and 4) received HIV positive results on the initial screening test. Any patient who does not meet these inclusion criteria will be excluded from the study. Additionally, patients who are pregnant or who have previously received confirmation of HIV infection in other care settings (e.g. CDC clinic, infectious disease hospital, sub-county-level hospital) are not eligible to participate. Any patient who is a prisoner or detainee at the time of initial screening will be excluded from the study. In the event that a participant is enrolled at a study hospital and subsequently incarcerated, data will be collected.

Eligibility criteria: Inclusion Criteria:

Participating individuals must:

1. Be at least 18 years old
2. Be an inpatient or outpatient seeking care in study hospitals
3. Test positive on an initial EIA HIV screen
4. Have local residency or intent to live in study area for at least 90 days

Exclusion Criteria:

Individuals will be excluded from study participation if they:

1. Do not meet any one or more of the above inclusion criteria
2. Test result negative on initial EIA HIV screen
3. 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)
4. Are prisoners or detainees at the time of initial screening
5. Are pregnant women (pregnant women are subject to mandatory testing)

Primary outcomes:
measure: Receipt of post-test results and counseling following testing completeness
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of treatment-eligible participants with CD4 < 350
timeFrame: 90 days
Other outcomes:
measure: Proportion of participants who have viral suppression based on the 12-month viral load test.
timeFrame: 12 months
Locations:
city: Chongzuo
country: China
facility: Fusui County People's Hospital
state: Guangxi
city: Chongzuo
country: China
facility: Ningming County People's Hospital
state: Guangxi
city: Chongzu
country: China
facility: Daxin County People's Hospital
state: Guangxi
city: Guilin
country: China
facility: Lingui County People's Hospital
state: Guangxi
city: Guilin
country: China
facility: Lipu County People's Hospital
state: Guangxi
city: Hechi
country: China
facility: Duan County People's Hospital
state: Guangxi
city: Laibin
country: China
facility: Xiangzhou County People's Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Rongan County People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Longan County People's Hospital
state: Guangxi
city: Qingzhou
country: China
facility: Lingshan County People's Hospital
state: Guangxi
city: Wuzhou
country: China
facility: Cenxi County People's Hospital
state: Guangxi
city: Yulin
country: China
facility: Bobai County People's Hospital
state: Guangxi
Study officials:
affiliation: National Center for AIDS/STD Control and Prevention
name: Zunyou Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Walter Ling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Roger Detels, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.