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)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Beijing, Kina, 100050
- Chinese Center for Disease Control and Prevention
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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 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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.
|
Two-hour training sessions focusing on anti-stigma and anti-discrimination
|
|
Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants
Tidsramme: Throughout study
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Throughout study
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported
Tidsramme: 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
Tidsramme: Throughout study
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Throughout study
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Self-efficacy score in HIV-infected participants
Tidsramme: Throughout study
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Throughout study
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Knowledge of correct condom use score among HIV-infected participants
Tidsramme: Throughout study
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Throughout study
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Zunyou Wu, MD, PhD, Centers for Disease Control and Prevention, China
- Ledende efterforsker: Jie Xu, MD, MS, Centers for Disease Control and Prevention, China
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse
Studieafslutning
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIPRA Project 2
- 1U19AI051915-01 (U.S. NIH-bevilling/kontrakt)
- CIPRA CH 002
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