Overview

This trial is active, not recruiting.

Condition hiv
Treatment comprehensive intervention components
Phase phase 1
Sponsor National Center for AIDS/STD Control and Prevention, China CDC
Start date January 2012
End date December 2015
Trial size 8000 participants
Trial identifier NCT01764282, 2012ZX10001007-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
comprehensive intervention components
comprehensive intervention components
ART promotion, Couple testing and consulting promotion, and Condom use promotion
(No Intervention)
According the National HIV Antiretroviral treatment Guideline, provide treatment referrals for those treatment-eligible HIV-positive patients.

Primary Outcomes

Measure
HIV seroconversion rate of HIV negatives among HIV serodiscordant couples
time frame: up to 2 years

Secondary Outcomes

Measure
Proportion of HIV positives receiving ART among HIV serodiscordant couples
time frame: up to 2 years
The incidence rate of AIDS-related diseases of HIV positives among serodiscordant couples
time frame: up to 2 years

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

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.

Additional Information

Official title A Cluster-randomized Controlled Trial of Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission
Principal investigator Zuyou Wu, MD, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by National Center for AIDS/STD Control and Prevention, China CDC.