Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

HIV Clinical Trial

Official title:

A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764282
• Other study ID #: 2012ZX10001007-001
• Status: Completed
• Phase: N/A
• First received: December 26, 2012
• Last updated: August 24, 2017
• Start date: January 1, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: August 2017
• Source: National Center for AIDS/STD Control and Prevention, China CDC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11096
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• comprehensive intervention components
ART promotion, Couple testing and consulting promotion, and Condom use promotion

Locations

Country	Name	City	State
China	Center for Disease Control and Prevention, Yunnan Province	Kunming, Dehong, Wenshan, Honghe	Yunnan
China	Center for Disease Control and Prevention, Sichuan Province	Liangshan	Sichuan
China	Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region	Nanning, Guilin, Laibin, Qinzhou	Guangxi
China	Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region	Urumchi, Ili	Xinjiang
China	Center for Disease Control and Prevention, Henan Province	Zhumadian	Henan

Sponsors (1)

Lead Sponsor	Collaborator
National Center for AIDS/STD Control and Prevention, China CDC

Country where clinical trial is conducted

China, 

References & Publications (4)

Cohen MS, Gay CL. Treatment to prevent transmission of HIV-1. Clin Infect Dis. 2010 May 15;50 Suppl 3:S85-95. doi: 10.1086/651478. Review. — View 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 — View 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. — View 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 I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV seroconversion rate of HIV negatives among HIV serodiscordant couples		up to 2 years
Secondary	Proportion of HIV positives receiving ART among HIV serodiscordant couples		up to 2 years
Secondary	The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples		up to 2 years

External Links

•   National Science and Technology Project