- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00479141
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Beijing, Kina, 100050
- Fuyang CDC Office
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
HIV infected participants and their families
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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
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Eksperimentel: 2
Popular Opinion Leaders (POL) participants
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants
Tidsramme: Throughout study
|
Throughout study
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Level of stigma among community members, including HIV knowledge
Tidsramme: Throughout study
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Throughout study
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Zunyou Wu, MD, PhD, Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
- Studiestol: Jie Xu, MD, MS, MPH, Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
Publikationer og nyttige links
Generelle publikationer
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CIPRA CH 002B
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