Clinical trial NCT01764282: Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission
Official title: A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
serodiscordant couples HIV sero-conversion
anti-retroviral therapy
intervention
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
First posted: 2013-01-09
Enrollment: 11096
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of reducing HIV transmission among sero-discordant couples by applying comprehensive intervention components.

Detailed description: A cluster-randomized controlled trial was carried out in forty counties from 16 cities. The strategy of Social Marketing was applied to influence sero-discordant couples' behavioral changes including safer sexual intercourses, regular HIV testing for the negative partners, antiretroviral therapy initiation.

Eligibility criteria: Inclusion Criteria:

* Couples are required to have a stable relationship and live together in the last 3 months;
* Older than 18 years and younger than 60 years; without regard to CD4 count;
* Open cohort(any newly diagnosed serodiscordant couples who are eligible for treatment will be included during the study period).

Exclusion Criteria:

* Couples are not have a stable relationship or do not live together in the last 3 months;
* Younger than 18 years old.

Primary outcomes:
measure: HIV seroconversion rate of HIV negatives among HIV serodiscordant couples
timeFrame: up to 2 years
Secondary outcomes:
measure: Proportion of HIV positives receiving ART among HIV serodiscordant couples
timeFrame: up to 2 years
measure: The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Nanning, Guilin, Laibin, Qinzhou
country: China
facility: Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
state: Guangxi
city: Zhumadian
country: China
facility: Center for Disease Control and Prevention, Henan Province
state: Henan
city: Liangshan
country: China
facility: Center for Disease Control and Prevention, Sichuan Province
state: Sichuan
city: Urumchi, Ili
country: China
facility: Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Kunming, Dehong, Wenshan, Honghe
country: China
facility: Center for Disease Control and Prevention, Yunnan Province
state: Yunnan
Study officials:
affiliation: National Center for AIDS/STD Control and Prevention, China CDC
name: Zuyou Wu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang F, Dou Z, Ma Y, Zhang Y, Zhao Y, Zhao D, Zhou S, Bulterys M, Zhu H, Chen RY. Effect of earlier initiation of antiretroviral treatment and increased treatment coverage on HIV-related mortality in China: a national observational cohort study. Lancet Infect Dis. 2011 Jul;11(7):516-24. doi: 10.1016/S1473-3099(11)70097-4.
citation: Cohen MS, Gay CL. Treatment to prevent transmission of HIV-1. Clin Infect Dis. 2010 May 15;50 Suppl 3(0 3):S85-95. doi: 10.1086/651478.
citation: Stephenson R, Barker J, Cramer R, Hall MA, Karita E, Chomba E, Vwalika C, Allen S. The demographic profile of sero-discordant couples enrolled in clinical research in Rwanda and Zambia. AIDS Care. 2008 Mar;20(3):395-405. doi: 10.1080/09540120701593497.
citation: He N, Duan S, Ding Y, Rou K, McGoogan JM, Jia M, Yang Y, Wang J, Montaner JS, Wu Z; China National HIV Prevention Study Group. Antiretroviral therapy reduces HIV transmission in discordant couples in rural Yunnan, China. PLoS One. 2013 Nov 13;8(11):e77981. doi: 10.1371/journal.pone.0077981. eCollection 2013.