Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

This study is currently recruiting participants.
Verified January 2013 by National Center for AIDS/STD Control and Prevention, China CDC
Sponsor:
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:
NCT01764282
First received: December 26, 2012
Last updated: January 9, 2014
Last verified: January 2013
  Purpose

The purpose of this study is to increase coverage of ART and reduce HIV transmission and AIDS-related diseases among serodiscordant couples.


Condition Intervention Phase
HIV
ART
Behavioral: Comprehensive intervention group
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

Resource links provided by NLM:


Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:

Primary Outcome Measures:
  • HIV seroconversion rate of HIV negatives among HIV serodiscordant couples [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of HIV positives receiving ART among HIV serodiscordant couples [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
HIV serodiscordant couples in intervention arm can receive the following intervention services: ART promotion, Couple testing and consulting promotion, and Condom use promotion
Behavioral: Comprehensive intervention group
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.

Detailed Description:

Early initiation of antiretroviral therapy (ART) could reduce HIV sexually transmission in sero-discordant couples by 96% (HPTN 052) and 67% (Chinese National S&T Major Project). And the proportion of received HIV ART among HIV serodiscordant couples is still low in China (53.3% by Sep 30, 2011).

The purposes of this study are:

  1. Increase coverage of ART among HIV serodiscordant couples by at least 50%, comparing with the control group by 2015 .
  2. Reduce HIV transmission among serodiscordant couples by at least 50%, comparing with the control group by 2015 .
  3. Reduce AIDS-related diseases among serodiscordant couples by at least 50%, comparing with the control group by 2015.
  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764282

Contacts
Contact: Zunyou Wu, MD, PHD 86-10-58900900 wuzunyou@chinaaids.cn
Contact: Yurong Mao, MD, PHD 86-10-58900985 maoyr@chinaaids.cn

Locations
China, Guangxi
Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guilin, Laibin, Qinzhou, Guangxi, China, 530028
Contact: Qiuying Zhu, MD    0771-2518960    zhuqiuying2003@126.com   
Contact: He Jiang, MD    0771-2518339    21472948@qq.com   
Principal Investigator: Qiuying Zhu, MD         
China, Henan
Center for Disease Control and Prevention, Henan Province Recruiting
Zhumadian, Henan, China, 463000
Contact: Zhe Wang, MD    0371-68089112    wangzhe@hncdc.com.cn   
Principal Investigator: Zhe Wang, MD         
China, Sichuan
Center for Disease Control and Prevention, Sichuan Province Recruiting
Liangshan, Sichuan, China, 615000
Contact: Linglin Zhang, MD    028-85589207    weirzhang@vip.163.com   
Principal Investigator: Linglin Zhang, MD         
China, Xinjiang
Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region Recruiting
Urumchi, Ili, Xinjiang, China, 830002
Contact: Mingjian Ni, MD    86-991-2621390    xjnmj@126.com   
Principal Investigator: Mingjian Ni, MD         
China, Yunnan
Center for Disease Control and Prevention, Yunnan Province Recruiting
Kunming, Dehong, Wenshan, Honghe, Yunnan, China, 650022
Contact: Manhong Jia, MD    0871-3626304    jmanhong@yahoo.com.cn   
Contact: Yong Zhang, MD    0871-3630775      
Principal Investigator: Manhong Jia, MD         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier: NCT01764282     History of Changes
Other Study ID Numbers: 2012ZX10001007-001
Study First Received: December 26, 2012
Last Updated: January 9, 2014
Health Authority: China: National Health and Family Planning Commission

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
HIV
serodiscordant couples HIV sero-conversion
anti-retroviral therapy
intervention

ClinicalTrials.gov processed this record on April 20, 2014