A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission

National Center for AIDS/STD Control and Prevention, China CDC5 sites in 1 country11,096 target enrollmentJanuary 1, 2012

ConditionsHIV

Overview

Phase: N/A
Intervention: Not specified
Conditions: HIV
Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Enrollment: 11096
Locations: 5
Primary Endpoint: HIV seroconversion rate of HIV negatives among HIV serodiscordant couples
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2012

End Date

December 31, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

HIV seroconversion rate of HIV negatives among HIV serodiscordant couples

Time Frame: up to 2 years

Secondary Outcomes

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)