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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: HIV skills training
* Behavioral: Popular Opinion Leaders training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HIV infected participants and their families | Behavioral: HIV skills training<br>* Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15<br>|
| Experimental: 2<br>Popular Opinion Leaders (POL) participants | Behavioral: Popular Opinion Leaders training<br>* Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of stigma among community members, including HIV knowledge |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Naive, Treatment Experienced, Complementary Therapies