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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
  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 Phase
HIV
Behavioral: comprehensive intervention components
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 8000
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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
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, 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
  More Information

Additional Information:
Publications:
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: October 22, 2014
Health Authority: China: National Health and Family Planning Commission

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 record on November 24, 2014