Clinical trial NCT00479141: A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China
Official title: A Cluster-Randomized Trail to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life (QOL) For HIV-Positive Villagers in Rural China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Treatment Naive
Treatment Experienced
Complementary Therapies
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2007-05-28
Enrollment: 3199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: Inclusion Criteria for HIV Infected Individuals:

* HIV infected
* Resident of Funan County or Yingzhou District, Anhui Province, China
* Willing to provide location information

Inclusion Criteria for Family members of HIV Infected Individuals:

* Resident of Funan County or Yingzhou District, Anhui Province, China
* Family member of HIV infected participant

Inclusion Criteria for POLs:

* Identified as an influential member of the community
* Resident of Funan County or Yingzhou District, Anhui Province, China
* Willing to attend training and follow-up meetings Note: Both HIV infected and non HIV infected individuals may participate as POLs

Inclusion Criteria for Cross-Sectional Survey Participants:

* Resident of Funan County or Yingzhou District, Anhui Province, China
* Randomly selected and invited to participate in study

Exclusion Criteria for HIV Infected Individuals:

* Spent more than 6 months outside the community within the year prior to study entry
* Permanent disability (e.g., deafness, serious mental illness, mental retardation)
* Has not made contact with study staff after three attempts

Exclusion Criteria for Family Members of HIV Infected Individuals:

* Permanent disability (e.g., deafness, serious mental illness, mental retardation)

Exclusion Criteria for POLs:

* Spent more than 6 months outside the community within the year prior to study entry
* Permanent disability (e.g., deafness, serious mental illness, mental retardation)

Exclusion Criteria for Cross-Sectional Survey Participants:

* Spent more than 6 months outside the community within the year prior to study entry
* Permanent disability (e.g., deafness, serious mental illness, mental retardation)
* Has not made contact with study staff after three attempts

Primary outcomes:
measure: Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants
timeFrame: Throughout study
Secondary outcomes:
measure: Level of stigma among community members, including HIV knowledge
timeFrame: Throughout study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuyang CDC Office
Study officials:
affiliation: Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
name: Zunyou Wu, MD, PhD
role: STUDY_CHAIR
affiliation: Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
name: Jie Xu, MD, MS, MPH
role: STUDY_CHAIR
References:
citation: Wu Z, Sullivan SG, Wang Y, Rotheram-Borus MJ, Detels R. Evolution of China's response to HIV/AIDS. Lancet. 2007 Feb 24;369(9562):679-90. doi: 10.1016/S0140-6736(07)60315-8.