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:
National Center for AIDS/STD Control and Prevention, China CDC
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 7, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to increase coverage of ART and reduce HIV transmission and AIDS-related diseases among serodiscordant couples.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV ART |
Behavioral: Comprehensive intervention group |
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:
- Proportion of HIV positives receiving ART among HIV serodiscordant couples [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 8000 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
HIV serodiscordant couples in intervention arm can receive the following intervention services: 1. Intensified consultation and follow-up：1 per month for the first 6 months, 1 per two months after 6 months； 2. Patient-level pay-for-performance incentives for enrolling in ART; 3. Certification for ART physicians; 4. Checklist of SOP for heath workers for promoting ART
|
Behavioral: Comprehensive intervention group
Intensified consultation and follow-up：1 per month for the first 6 months, 1 per two months after 6 months； Patient-level pay-for-performance incentives for enrolling in ART; Certification for ART physicians; Checklist of SOP for heath workers for promoting ART.
|
|
No Intervention: Usual
According the National HIV Antiretroviral treatment Guideline, provide treatment referrals for those treatment-eligible HIV-positive patients.
|
Detailed Description:
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:
- Increase coverage of ART among HIV serodiscordant couples by at least 50%, comparing with the control group by 2015 .
- Reduce HIV transmission among serodiscordant couples by at least 50%, comparing with the control group by 2015 .
- Reduce AIDS-related diseases among serodiscordant couples by at least 50%, comparing with the control group by 2015.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| 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 or equal to 18 years old.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764282
Contacts
| Contact: Zunyou Wu, MD, PHD | 86-10-58900900 | wuzunyou@chinaaids.cn |
| Contact: Yurong Mao, MD, PHD | 86-10-58900985 | zoemao@gmail.com |
Locations
| China, Guangxi | |
| Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region | Recruiting |
| Nanning, Guilin, Laibin, Qinzhou, Guangxi, China, 530028 | |
| Contact: Zhiyong Shen, MD 0771-2518838 shenzhiyong99999@sina.com | |
| Contact: Jinhui Zhu, MD 0771-2518838 gxzhujinhui@qq.com | |
| Principal Investigator: Zhiyong Shen, MD | |
| China, Henan | |
| Center for Disease Control and Prevention, Henan Province | Recruiting |
| Zhumadian, Henan, China, 463000 | |
| Contact: Zhe Wang, MD 0371-68089112 wangzhe@hncdc.com.cn | |
| Principal Investigator: Zhe Wang, MD | |
| China, Sichuan | |
| Center for Disease Control and Prevention, Sichuan Province | Recruiting |
| Liangshan, Sichuan, China, 615000 | |
| Contact: Linglin Zhang, MD 028-85589207 weirzhang@vip.163.com | |
| Principal Investigator: Linglin Zhang, MD | |
| China, Xinjiang | |
| Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region | Recruiting |
| Urumchi, Ili, Xinjiang, China, 830002 | |
| Contact: Mingjian Ni, MD 86-991-2621390 xjnmj@126.com | |
| Principal Investigator: Mingjian Ni, MD | |
| China, Yunnan | |
| Center for Disease Control and Prevention, Yunnan Province | Recruiting |
| Kunming, Dehong, Wenshan, Honghe, Yunnan, China, 650022 | |
| Contact: Manhong Jia, MD 0871-3626304 jmanhong@yahoo.com.cn | |
| Contact: Yong Zhang, MD 0871-3630775 | |
| Principal Investigator: Manhong Jia, MD | |
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: | January 7, 2013 |
| Health Authority: | China: Ministry of Health |
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 May 19, 2013