HIV Educational Programs for Villagers of Funan County or Yingzhou District, Anhui Province, China
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)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Beijing, China, 100050
- Chinese Center for Disease Control and Prevention
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
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Two-hour weekly skills training sessions followed by evaluation questionnaire
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Experimental: 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.
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Two-hour training sessions focusing on anti-stigma and anti-discrimination
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Experimental: 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.
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Survey evaluation of community attitudes towards HIV
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants
Zeitfenster: Throughout study
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Throughout study
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported
Zeitfenster: Throughout study
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Throughout study
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Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores
Zeitfenster: Throughout study
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Throughout study
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Self-efficacy score in HIV-infected participants
Zeitfenster: Throughout study
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Throughout study
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Knowledge of correct condom use score among HIV-infected participants
Zeitfenster: Throughout study
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Throughout study
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Zunyou Wu, MD, PhD, Centers for Disease Control and Prevention, China
- Hauptermittler: Jie Xu, MD, MS, Centers for Disease Control and Prevention, China
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- CIPRA Project 2
- 1U19AI051915-01 (US NIH Stipendium/Vertrag)
- CIPRA CH 002
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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