Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

NCT ID: NCT01764282

Last Updated: 2017-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11096 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

comprehensive intervention components

Group Type EXPERIMENTAL

comprehensive intervention components

Intervention Type BEHAVIORAL

ART promotion, Couple testing and consulting promotion, and Condom use promotion

Usual

According the National HIV Antiretroviral treatment Guideline, provide treatment referrals for those treatment-eligible HIV-positive patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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comprehensive intervention components

ART promotion, Couple testing and consulting promotion, and Condom use promotion

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for AIDS/STD Control and Prevention, China CDC

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zuyou Wu, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

National Center for AIDS/STD Control and Prevention, China CDC

Locations

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Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region

Nanning, Guilin, Laibin, Qinzhou, Guangxi, China

Site Status

Center for Disease Control and Prevention, Henan Province

Zhumadian, Henan, China

Site Status

Center for Disease Control and Prevention, Sichuan Province

Liangshan, Sichuan, China

Site Status

Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region

Urumchi, Ili, Xinjiang, China

Site Status

Center for Disease Control and Prevention, Yunnan Province

Kunming, Dehong, Wenshan, Honghe, Yunnan, China

Site Status

Countries

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China

References

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Zhang F, Dou Z, Ma Y, Zhang Y, Zhao Y, Zhao D, Zhou S, Bulterys M, Zhu H, Chen RY. Effect of earlier initiation of antiretroviral treatment and increased treatment coverage on HIV-related mortality in China: a national observational cohort study. Lancet Infect Dis. 2011 Jul;11(7):516-24. doi: 10.1016/S1473-3099(11)70097-4.

Reference Type RESULT
PMID: 21600849 (View on PubMed)

Cohen MS, Gay CL. Treatment to prevent transmission of HIV-1. Clin Infect Dis. 2010 May 15;50 Suppl 3(0 3):S85-95. doi: 10.1086/651478.

Reference Type RESULT
PMID: 20397961 (View on PubMed)

Stephenson R, Barker J, Cramer R, Hall MA, Karita E, Chomba E, Vwalika C, Allen S. The demographic profile of sero-discordant couples enrolled in clinical research in Rwanda and Zambia. AIDS Care. 2008 Mar;20(3):395-405. doi: 10.1080/09540120701593497.

Reference Type RESULT
PMID: 18351489 (View on PubMed)

He N, Duan S, Ding Y, Rou K, McGoogan JM, Jia M, Yang Y, Wang J, Montaner JS, Wu Z; China National HIV Prevention Study Group. Antiretroviral therapy reduces HIV transmission in discordant couples in rural Yunnan, China. PLoS One. 2013 Nov 13;8(11):e77981. doi: 10.1371/journal.pone.0077981. eCollection 2013.

Reference Type RESULT
PMID: 24236010 (View on PubMed)

Other Identifiers

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2012ZX10001007-001

Identifier Type: -

Identifier Source: org_study_id

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