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

26 mars 2009 uppdaterad av: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

3199

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
      • Beijing, Kina, 100050
        • Fuyang CDC Office

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
HIV infected participants and their families
Beteende: HIV 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
Experimentell: 2
Popular Opinion Leaders (POL) participants
Beteende: Popular 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants
Tidsram: Throughout study
Throughout study

Sekundära resultatmått

Resultatmått
Tidsram
Level of stigma among community members, including HIV knowledge
Tidsram: Throughout study
Throughout study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Utredare

  • 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 och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2006

Primärt slutförande (Faktisk)

1 juli 2007

Avslutad studie (Faktisk)

1 december 2008

Studieregistreringsdatum

Först inskickad

25 maj 2007

Först inskickad som uppfyllde QC-kriterierna

25 maj 2007

Första postat (Uppskatta)

28 maj 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 mars 2009

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 mars 2009

Senast verifierad

1 januari 2009

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • CIPRA CH 002B

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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