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

December 26, 2012
January 9, 2014
January 2012
August 2014   (final data collection date for primary outcome measure)
HIV seroconversion rate of HIV negatives among HIV serodiscordant couples [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Proportion of HIV positives receiving ART among HIV serodiscordant couples [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
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 ] [ 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 ]
  • HIV seroconvertion rate of HIV negatives among HIV serodiscordant couples [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
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 increase coverage of ART and reduce HIV transmission and AIDS-related diseases among serodiscordant couples.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • ART
Behavioral: Comprehensive intervention group
ART promotion, Couple testing and consulting promotion, and Condom use promotion
  • 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
    Intervention: Behavioral: Comprehensive intervention group
  • 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.
 
Recruiting
8000
December 2015
August 2014   (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.
Both
18 Years to 59 Years
No
Contact: Zunyou Wu, MD, PHD 86-10-58900900 wuzunyou@chinaaids.cn
Contact: Yurong Mao, MD, PHD 86-10-58900985 maoyr@chinaaids.cn
China
 
NCT01764282
2012ZX10001007-001
Yes
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
January 2013

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