Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: comprehensive intervention components

• Registration Number: NCT01764282
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2012-12-26
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11096

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	comprehensive intervention components	comprehensive intervention components

Primary Outcome Measures

Name	Time	Method
HIV seroconversion rate of HIV negatives among HIV serodiscordant couples	up to 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guilin, Laibin, Qinzhou, Guangxi, China

Center for Disease Control and Prevention, Henan Province; 🇨🇳 Zhumadian, Henan, China

Center for Disease Control and Prevention, Yunnan Province; 🇨🇳 Kunming, Dehong, Wenshan, Honghe, Yunnan, China

Center for Disease Control and Prevention, Sichuan Province; 🇨🇳 Liangshan, Sichuan, China

Center for Disease Control and Prevention, Xinjiang Uygur Autonomous Region; 🇨🇳 Urumchi, Ili, Xinjiang, China