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Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

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ClinicalTrials.gov Identifier: NCT01764282
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC

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

Condition or disease Intervention/treatment Phase
HIV Behavioral: comprehensive intervention components Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11096 participants
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
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. HIV seroconversion rate of HIV negatives among HIV serodiscordant couples [ Time Frame: up to 2 years ]

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


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764282


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

Additional Information:
Publications of Results:
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
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
HIV
serodiscordant couples HIV sero-conversion
anti-retroviral therapy
intervention