A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: HIV skills training; Behavioral: Popular Opinion Leaders training

• Registration Number: NCT00479141
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

The HIV epidemic in China has reached a phase of exponential growth; the number of new infections has been steadily increasing over the past decade. The purpose of this study is to evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for HIV-Positive Villagers and decrease HIV related stigma in Rural China.

Detailed Description

Over the past decade, the rates of HIV infection and death due to HIV/AIDS have been steadily increasing in China. The China Comprehensive AIDS Response (China CARES) program was developed in 2003 in order to help poor counties and those with severe epidemic problems increase public awareness and improve knowledge about epidemic diseases such as HIV. Currently, behavioral interventions focusing on individual skills training and self-efficacy building for HIV infected individuals are not included in China CARES. Fuyang, Anhui Province, China has a high rate of HIV infected individuals, many of whom were former plasma donors (FPDs) and would benefit from HIV skills training.

In 2004, CIPRA conducted a study (CIPRA CH 002A), entitled "A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China," which provided insight into HIV infected individuals in Fuyang, Anhui Province, China. According to the results of CIRPA CH 002A, most HIV infected individuals described their QOL as poor. The factors affecting their poor QOL include poverty, poor health, stigma and discrimination. Participants in the CIPRA CH 002A study showed interest in learning more about HIV/AIDS disease and treatment. This study will last 18 months. HIV infected participants and their families will attend eight 2-hour group skills training sessions during Weeks 1 through 8, and booster sessions every two months during Months 3 through 15. Popular Opinion Leaders (POL) participants will attend 4 weeks of 2-hour training sessions about anti-stigma and anti-discrimination, followed by support meetings every 2 months during Months 2 through 13. Some participants will complete cross-sectional surveys evaluating the levels of stigma and discrimination in the community at study entry and at Months 6 and 12 following completion of POL training. All participants will complete follow-up visits at Months 6 and 12.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Primary Completion: 2007-07
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-03-26
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3199

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	HIV skills training	HIV infected participants and their families
2	Popular Opinion Leaders training	Popular Opinion Leaders (POL) participants

Primary Outcome Measures

Name	Time	Method
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants	Throughout study

Secondary Outcome Measures

Name	Time	Method
Level of stigma among community members, including HIV knowledge	Throughout study

Trial Locations

Locations (1)

Fuyang CDC Office; 🇨🇳 Beijing, China