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Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764282
First Posted: January 9, 2013
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC
December 26, 2012
January 9, 2013
August 25, 2017
January 1, 2012
December 31, 2015   (Final data collection date for primary outcome measure)
HIV seroconversion rate of HIV negatives among HIV serodiscordant couples [ Time Frame: up to 2 years ]
Proportion of HIV positives receiving ART among HIV serodiscordant couples [ Time Frame: up to 3 years ]
Complete list of historical versions of study NCT01764282 on ClinicalTrials.gov Archive Site
  • 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 ]
  • HIV seroconvertion rate of HIV negatives among HIV serodiscordant couples [ Time Frame: up to 3 years ]
  • The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples [ Time Frame: up to 3 years ]
Not Provided
Not Provided
 
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV
Behavioral: comprehensive intervention components
ART promotion, Couple testing and consulting promotion, and Condom use promotion
  • Experimental: Intervention
    comprehensive intervention components
    Intervention: Behavioral: comprehensive intervention components
  • No Intervention: Usual
    According the National HIV Antiretroviral treatment Guideline, provide treatment referrals for those treatment-eligible HIV-positive patients.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11096
December 31, 2015
December 31, 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01764282
2012ZX10001007-001
Yes
Not Provided
Not Provided
National Center for AIDS/STD Control and Prevention, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
Not Provided
Principal Investigator: Zuyou Wu, MD, PHD National Center for AIDS/STD Control and Prevention, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP