HIV InfectionsPhase 1NCT00068991
HIV Educational Programs for Villagers of Funan County or Yingzhou District, Anhui Province, China
A Phase 1 study testing HIV skills training program and questionnaire, Community-level stigma reduction program and Cross-sectional survey in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV skills training program and questionnaire, Community-level stigma reduction program and Cross-sectional survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- HIV skills training program and questionnaire, Community-level stigma reduction program, Cross-sectional survey
- Keywords
- Behavioral Intervention Study, Randomized Prevention Trial, China, Condom Use, STDs, Sexual Partners, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV skills training program and questionnaireBehavioural
Two-hour weekly skills training sessions followed by evaluation questionnaire
Community-level stigma reduction programBehavioural
Two-hour training sessions focusing on anti-stigma and anti-discrimination
Cross-sectional surveyBehavioural
Survey evaluation of community attitudes towards HIV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Cross-sectional survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants
Measured: Throughout study
Secondary outcomes (4)
Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported
Measured: Throughout study
Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores
Measured: Throughout study
Self-efficacy score in HIV-infected participants
Measured: Throughout study
Knowledge of correct condom use score among HIV-infected participants
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2003 (estimated)
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Comprehensive International Program of Research on AIDS
- Investigators
- Zunyou Wu, MD, PhD, Principal investigator, Centers for Disease Control and Prevention, ChinaJie Xu, MD, MS, Principal investigator, Centers for Disease Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068991
- Sponsor's protocol ID
- CIPRA Project 2
- Other IDs
- 1U19AI051915-01, CIPRA CH 002
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2003
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00068991
- Acronym / sponsor ID
- CIPRA Project 2
- Conditions
- HIV Infections
- Keywords
- Behavioral Intervention Study, Randomized Prevention Trial, China, Condom Use, STDs, Sexual Partners, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Comprehensive International Program of Research on AIDS
- Study completion
- Jun 2007
- First posted
- 16 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: HIV skills training program and questionnaireParticipants 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. |
| 2 | Experimental | Behavioral: Community-level stigma reduction programParticipants 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. |
| 3 | Experimental | Behavioral: Cross-sectional surveyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV skills training program and questionnaireTwo-hour weekly skills training sessions followed by evaluation questionnaire | Behavioural | 1 |
| Community-level stigma reduction programTwo-hour training sessions focusing on anti-stigma and anti-discrimination | Behavioural | 2 |
| Cross-sectional surveySurvey evaluation of community attitudes towards HIV | Behavioural | 3 |
Primary outcome
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants
Time frame: Throughout study
4 secondary outcomes
Level of stigma among community members, as determined by HIV knowledge score and HIV attitudes and stigmatizing behaviors reported
Time frame: Throughout study
Emotional well-being of HIV-infected participants, as determined by perceived support scale and stigma scale scores
Time frame: Throughout study
Self-efficacy score in HIV-infected participants
Time frame: Throughout study
Knowledge of correct condom use score among HIV-infected participants
Time frame: Throughout study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zunyou Wu, MD, PhD principal investigator
Centers for Disease Control and Prevention, China
Jie Xu, MD, MS principal investigator
Centers for Disease Control and Prevention, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIV skills training program and questionnaire, Community-level stigma reduction program and Cross-sectional survey in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in-HIV infected participants (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.