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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00479141
Enrollment
3199
Registered
2007-05-28
Start date
2006-03-31
Completion date
2008-12-31
Last updated
2009-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Treatment Naive, Treatment Experienced, Complementary Therapies

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.

Interventions

BEHAVIORALHIV skills training

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

BEHAVIORALPopular Opinion Leaders training

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.

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participantsThroughout study

Secondary

MeasureTime frame
Level of stigma among community members, including HIV knowledgeThroughout study

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026