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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)

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00068991
Enrollment
0
Registered
2003-09-16
Start date
Unknown
Completion date
2007-06-30
Last updated
2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Behavioral Intervention Study, Randomized Prevention Trial, China, Condom Use, STDs, Sexual Partners, HIV Seronegativity

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALHIV skills training program and questionnaire

Two-hour weekly skills training sessions followed by evaluation questionnaire

BEHAVIORALCommunity-level stigma reduction program

Two-hour training sessions focusing on anti-stigma and anti-discrimination

Survey evaluation of community attitudes towards HIV

Sponsors

Comprehensive International Program of Research on AIDS
CollaboratorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participantsThroughout study

Secondary

MeasureTime frame
Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reportedThroughout study
Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scoresThroughout study
Self-efficacy score in HIV-infected participantsThroughout study
Knowledge of correct condom use score among HIV-infected participantsThroughout study

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026