NCT01764282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,096

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

December 26, 2012

Last Update Submit

August 24, 2017

Conditions

HIV

Keywords

HIVserodiscordant couples HIV sero-conversionanti-retroviral therapyintervention

Outcome Measures

Primary Outcomes (1)

  • HIV seroconversion rate of HIV negatives among HIV serodiscordant couples

    up to 2 years

Secondary Outcomes (2)

  • Proportion of HIV positives receiving ART among HIV serodiscordant couples

    up to 2 years

  • The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples

    up to 2 years

Study Arms (2)

Intervention

EXPERIMENTAL

comprehensive intervention components

Behavioral: comprehensive intervention components

Usual

NO INTERVENTION

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

Interventions

comprehensive intervention componentsBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Couples are not have a stable relationship or do not live together in the last 3 months;
  • Younger than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region

Nanning, Guilin, Laibin, Qinzhou, Guangxi, 530028, China

Location

Center for Disease Control and Prevention, Henan Province

Zhumadian, Henan, 463000, China

Location

Center for Disease Control and Prevention, Sichuan Province

Liangshan, Sichuan, 615000, China

Location

Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region

Urumchi, Ili, Xinjiang, 830002, China

Location

Center for Disease Control and Prevention, Yunnan Province

Kunming, Dehong, Wenshan, Honghe, Yunnan, 650022, China

Location

Related Publications (4)

  • 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.

    PMID: 21600849RESULT

  • 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.

    PMID: 20397961RESULT

  • 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.

    PMID: 18351489RESULT

  • 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.

    PMID: 24236010RESULT

Study Officials

  • Zuyou Wu, MD, PHD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2012

First Posted

January 9, 2013

Study Start

January 1, 2012

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

CN(5)