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

NCT00068991 | Withdrawn Phase 1

• 3 other identifiers: CIPRA Project 21U19AI051915-01CIPRA CH 002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants

  Throughout study

Secondary Outcomes (4)

• Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported

  Throughout study

• Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores

  Throughout study

• Self-efficacy score in HIV-infected participants

  Throughout study

• Knowledge of correct condom use score among HIV-infected participants

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

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.

Behavioral: HIV skills training program and questionnaire

2

EXPERIMENTAL

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.

Behavioral: Community-level stigma reduction program

3

EXPERIMENTAL

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.

Behavioral: Cross-sectional survey

Interventions

HIV skills training program and questionnaire BEHAVIORAL

Two-hour weekly skills training sessions followed by evaluation questionnaire

1

Community-level stigma reduction program BEHAVIORAL

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

2

Cross-sectional survey BEHAVIORAL

Survey evaluation of community attitudes towards HIV

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live in one of the fourteen administrative villages in Funan County or Yingzhou District, Anhui Province, China
• 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
• Considered an influential member of their community
• Willing and able to take part in all training and follow-up support meetings
• Willing to complete the cross-sectional survey

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Comprehensive International Program of Research on AIDS: collaborator

Study Sites (1)

Chinese Center for Disease Control and Prevention

Beijing, 100050, China

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Interventions

Surveys and Questionnaires; Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Epidemiologic Studies; Epidemiologic Study Characteristics

Study Officials

• Zunyou Wu, MD, PhD

  Centers for Disease Control and Prevention, China

  PRINCIPAL INVESTIGATOR

• Jie Xu, MD, MS

  Centers for Disease Control and Prevention, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 12, 2003
• First Posted: September 16, 2003
• Study Completion: June 1, 2007
• Last Updated: June 1, 2015

Record last verified: 2008-09

Locations

CN (1)