Clinical trial NCT00068991: HIV Educational Programs for Villagers of Funan County or Yingzhou District, Anhui Province, China
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: Behavioral Intervention Study
Randomized Prevention Trial
China
Condom Use
STDs
Sexual Partners
HIV Seronegativity
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Comprehensive International Program of Research on AIDS
First posted: 2003-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants
timeFrame: Throughout study
Secondary outcomes:
measure: Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported
timeFrame: Throughout study
measure: Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores
timeFrame: Throughout study
measure: Self-efficacy score in HIV-infected participants
timeFrame: Throughout study
measure: Knowledge of correct condom use score among HIV-infected participants
timeFrame: Throughout study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Center for Disease Control and Prevention
Study officials:
affiliation: Centers for Disease Control and Prevention, China
name: Zunyou Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention, China
name: Jie Xu, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: