Trial record 14 of 32 for:    " December 19, 2012":" January 18, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014