Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

This study is ongoing, but not recruiting participants.
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: October 22, 2014
Last verified: October 2014

December 26, 2012
October 22, 2014
January 2012
December 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 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
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
8000
December 2015
December 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 information is only displayed when the study is recruiting subjects
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
October 2014

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