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Clinical Trials

MainTitle

Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

This study has been completed
Sponsor
National Center for AIDS/STD Control and Prevention, China CDC


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: August 24, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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

Condition Intervention
HIV

Behavioral : comprehensive intervention components

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

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 ]
Secondary Outcome Measures:
  • Proportion of HIV positives receiving ART among HIV serodiscordant couples [ Time Frame: up to 2 years ]
  • The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples [ Time Frame: up to 2 years ]

Enrollment: 11096
Study Start Date: January 1, 2012
Study Completion Date: December 31, 2015
Primary Completion Date: December 31, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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

Eligibility

Ages Eligible for Study: 18 Years to 59 Years  
Sexes Eligible for Study: All  
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

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

Locations

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

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

More Information

Additional Information:

National Science and Technology Project

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: August 24, 2017  

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 data on October 20, 2017
This information is provided by ClinicalTrials.gov.