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HIV Educational Programs for Villagers of Funan County or Yingzhou District, Anhui Province, China

29 mei 2015 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

A Cluster-Randomized Trial to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for HIV-Positive Villagers in Rural China (China CIPRA Project 2)

The purpose of this study is to determine whether two educational programs about HIV will improve the quality of life of HIV infected people living in the rural villages of China. The study will enroll HIV infected adult residents, influential community members, and other community members of selected villages of Funan County or Yingzhou District, Anhui Province, China.

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

A previous study found that HIV-infected villagers in Anhui Province, China describe their quality of life as poor. While poverty, poor health, stigma, and discrimination contribute to this poor quality of life, all these issues are interrelated and deserve further investigation. The quality of life for HIV-infected people may be made better through education, either for HIV-infected people to learn more about HIV, the treatments they are receiving, and how to deal with their disease, or for HIV uninfected people to understand HIV infection and to reduce stigma and discrimination associated with HIV infection. This study will provide skills training to HIV-infected adults and anti-stigma and anti-discrimination training to influential community members. The purpose of this study is to evaluate the changes in quality of life in HIV-infected villagers living in Anhui Province, China that result after these two training programs are administered.

There will be 3 groups in this study. Group 1 participants will be HIV-infected villagers. Group 1 participants will take part in 2-hour skills training sessions every week from study entry to Week 8. Participants will also be asked to bring a family member to each training session. After completing training, participants will be asked to complete a post-training evaluation of the training sessions. Group 1 participants will be asked to complete questionnaires at study entry and 6 and 12 months after completion of training.

Group 2 participants will be villagers considered influential members of their community. In the first 2 months of the study, Group 2 participants will take part in four, 2-hour training sessions focusing on anti-stigma and anti-discrimination messages. Group 2 participants will also attend additional support meetings monthly, from Months 2 to 15. Group 2 participants will be evaluated before and after their training sessions to determine the improvements in knowledge and attitudes about HIV among group participants.

Group 3 participants will be randomly selected community members and will complete a cross-sectional survey at study entry and 6 and 12 months after Group 2's completion of training, to determine changing community attitudes about HIV as a result of Group 2's training. There will be no additional study visits or training for Group 3 participants.

Studietype

Ingrijpend

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
      • Beijing, China, 100050
        • Chinese Center for Disease Control and Prevention

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria for All Participants:

  • Live in one of the fourteen administrative villages in Funan County or Yingzhou District, Anhui Province, China

Inclusion Criteria for Group 1:

  • HIV-infected
  • Willing and able to take part in all study visits
  • Willing and able to provide contact information for locator purposes
  • Willing and able to bring a family member to training sessions

Inclusion Criteria for Group 2:

  • Considered an influential member of their community
  • Willing and able to take part in all training and follow-up support meetings

Inclusion Criteria for Group 3:

  • Willing to complete the cross-sectional survey

Exclusion Criteria for All Study Participants:

  • Spent more than 6 months outside of the community in the year prior to study entry
  • Permanent disability (e.g., deafness, serious mental illness, mental retardation) that would interfere with the study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 1
Participants will be HIV-infected villagers and will will take part in 2-hour skills training sessions every week from study entry to Week 8. Participants will bring a family member to each training session. After training, participants complete a post-training evaluation of the training sessions. Participants will also complete questionnaires at study entry and 6 and 12 months after completion of training.
Gedragsmatig: HIV skills training program and questionnaire
Two-hour weekly skills training sessions followed by evaluation questionnaire
Experimenteel: 2
Participants will be villagers considered influential members of their community. In the first 2 months of the study, Participants will take part in four 2-hour training sessions focusing on anti-stigma and anti-discrimination messages. Participants will also attend additional support meetings monthly, from Months 2 to 15. They will be evaluated before and after their training sessions to determine the improvements in knowledge and attitudes about HIV among group participants.
Gedragsmatig: Community-level stigma reduction program
Two-hour training sessions focusing on anti-stigma and anti-discrimination
Experimenteel: 3
Participants will be randomly selected community members and will complete a cross-sectional survey at study entry and 6 and 12 months after Group 2's completion of training to determine changing community attitudes about HIV as a result of Group 2's training. There will be no additional study visits or training for Group 3 participants.
Gedragsmatig: Cross-sectional survey
Survey evaluation of community attitudes towards HIV

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported
Tijdsspanne: Throughout study
Throughout study
Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores
Tijdsspanne: Throughout study
Throughout study
Self-efficacy score in HIV-infected participants
Tijdsspanne: Throughout study
Throughout study
Knowledge of correct condom use score among HIV-infected participants
Tijdsspanne: Throughout study
Throughout study

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Medewerkers

Comprehensive International Program of Research on AIDS

Onderzoekers

  • Hoofdonderzoeker: Zunyou Wu, MD, PhD, Centers for Disease Control and Prevention, China
  • Hoofdonderzoeker: Jie Xu, MD, MS, Centers for Disease Control and Prevention, China

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

7 december 2022

Primaire voltooiing

7 december 2022

Studie voltooiing

1 juni 2007

Studieregistratiedata

Eerst ingediend

12 september 2003

Eerst ingediend dat voldeed aan de QC-criteria

15 september 2003

Eerst geplaatst (Schatting)

16 september 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

1 juni 2015

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2015

Laatst geverifieerd

1 september 2008

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CIPRA Project 2
  • 1U19AI051915-01 (Subsidie/contract van de Amerikaanse NIH)
  • CIPRA CH 002

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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