Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

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

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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 11096
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guilin, Laibin, Qinzhou, Guangxi, China, 530028
      • Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
  • Henan
    • Zhumadian, Henan, China, 463000
      • Center for Disease Control and Prevention, Henan Province
  • Sichuan
    • Liangshan, Sichuan, China, 615000
      • Center for Disease Control and Prevention, Sichuan Province
  • Xinjiang
    • Urumchi, Ili, Xinjiang, China, 830002
      • Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region
  • Yunnan
    • Kunming, Dehong, Wenshan, Honghe, Yunnan, China, 650022
      • Center for Disease Control and Prevention, Yunnan Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; comprehensive intervention components	Behavioral: comprehensive intervention components; ART promotion, Couple testing and consulting promotion, and Condom use promotion
No Intervention: Usual; According the National HIV Antiretroviral treatment Guideline, provide treatment referrals for those treatment-eligible HIV-positive patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HIV seroconversion rate of HIV negatives among HIV serodiscordant couples	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of HIV positives receiving ART among HIV serodiscordant couples	up to 2 years
The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples	up to 2 years

Collaborators and Investigators

• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Investigators: Principal Investigator: Zuyou Wu, MD, PHD, National Center for AIDS/STD Control and Prevention, China CDC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• National Science and Technology Project

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: HIV; intervention; anti-retroviral therapy; serodiscordant couples HIV sero-conversion
• Other Study ID Numbers: 2012ZX10001007-001