HIV InfectionsNCT00479141
A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China
A study testing HIV skills training and Popular Opinion Leaders training in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in China.
Trial summary
The HIV epidemic in China has reached a phase of exponential growth; the number of new infections has been steadily increasing over the past decade. The purpose of this study is to evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV skills training and Popular Opinion Leaders training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,199 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to Dec 2008
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Willing to provide location information
- Inclusion Criteria for Family members of HIV Infected Individuals:
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Family member of HIV infected participant
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- Identified as an influential member of the community
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Willing to attend training and follow-up meetings Note: Both HIV infected and non HIV infected individuals may participate as POLs
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Randomly selected and invited to participate in study
Who cannot join
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Has not made contact with study staff after three attempts
- Exclusion Criteria for Family Members of HIV Infected Individuals:
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Spent more than 6 months outside the community within the year prior to study entry
Show all 10Show fewer
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Has not made contact with study staff after three attempts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster-Randomized Trail to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life (QOL) For HIV-Positive Villagers in Rural China
The HIV epidemic in China has reached a phase of exponential growth; the number of new infections has been steadily increasing over the past decade. The purpose of this study is to evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for HIV-Positive Villagers and decrease HIV related stigma in Rural China.
Read the detailed description
Over the past decade, the rates of HIV infection and death due to HIV/AIDS have been steadily increasing in China. The China Comprehensive AIDS Response (China CARES) program was developed in 2003 in order to help poor counties and those with severe epidemic problems increase public awareness and improve knowledge about epidemic diseases such as HIV. Currently, behavioral interventions focusing on individual skills training and self-efficacy building for HIV infected individuals are not included in China CARES. Fuyang, Anhui Province, China has a high rate of HIV infected individuals, many of whom were former plasma donors (FPDs) and would benefit from HIV skills training.
In 2004, CIPRA conducted a study (CIPRA CH 002A), entitled "A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China," which provided insight into HIV infected individuals in Fuyang, Anhui Province, China. According to the results of CIRPA CH 002A, most HIV infected individuals described their QOL as poor. The factors affecting their poor QOL include poverty, poor health, stigma and discrimination. Participants in the CIPRA CH 002A study showed interest in learning more about HIV/AIDS disease and treatment. This study will last 18 months. HIV infected participants and their families will attend eight 2-hour group skills training sessions during Weeks 1 through 8, and booster sessions every two months during Months 3 through 15. Popular Opinion Leaders (POL) participants will attend 4 weeks of 2-hour training sessions about anti-stigma and anti-discrimination, followed by support meetings every 2 months during Months 2 through 13. Some participants will complete cross-sectional surveys evaluating the levels of stigma and discrimination in the community at study entry and at Months 6 and 12 following completion of POL training. All participants will complete follow-up visits at Months 6 and 12.
- Conditions
- HIV Infections
- Being tested
- HIV skills training, Popular Opinion Leaders training
- Keywords
- Treatment Naive, Treatment Experienced, Complementary Therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV skills trainingBehavioural
Eight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15
Popular Opinion Leaders trainingBehavioural
Two-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HIV infected participants and their families Receives: Behavioral: HIV skills training |
| 2 | Experimental | Popular Opinion Leaders (POL) participants Receives: Behavioral: Popular Opinion Leaders training |
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 (1)
Level of stigma among community members, including HIV knowledge
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 posted28 May 2007 (estimated)
- Study startMar 2006
- Primary completionJul 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,199 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Zunyou Wu, MD, PhD, Study chair, Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and PreventionJie Xu, MD, MS, MPH, Study chair, Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479141
- Sponsor's protocol ID
- CIPRA CH 002B
- Status last verified
- Jan 2009
- First submitted
- 25 May 2007
- Last updated
- 27 Mar 2009
- Results posted
- No
Publications
Wu Z, Sullivan SG, Wang Y, Rotheram-Borus MJ, Detels R. Evolution of China's response to HIV/AIDS. Lancet. 2007 Feb 24;369(9562):679-90. doi: 10.1016/S0140-6736(07)60315-8.
PubMed 17321313
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-Randomized Trail to Evaluate the Efficacy of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life (QOL) For HIV-Positive Villagers in Rural China
- ClinicalTrials.gov ID
- NCT00479141
- Acronym / sponsor ID
- CIPRA CH 002B
- Conditions
- HIV Infections
- Keywords
- Treatment Naive, Treatment Experienced, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,199 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 May 2007 (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 HIV epidemic in China has reached a phase of exponential growth; the number of new infections has been steadily increasing over the past decade. The purpose of this study is to evaluate the effectiveness of a Combined Individual- and Community-Based Behavioral Intervention to Improve Quality of Life for HIV-Positive Villagers and decrease HIV related stigma in Rural China.
Detailed description
Over the past decade, the rates of HIV infection and death due to HIV/AIDS have been steadily increasing in China. The China Comprehensive AIDS Response (China CARES) program was developed in 2003 in order to help poor counties and those with severe epidemic problems increase public awareness and improve knowledge about epidemic diseases such as HIV. Currently, behavioral interventions focusing on individual skills training and self-efficacy building for HIV infected individuals are not included in China CARES. Fuyang, Anhui Province, China has a high rate of HIV infected individuals, many of whom were former plasma donors (FPDs) and would benefit from HIV skills training.
In 2004, CIPRA conducted a study (CIPRA CH 002A), entitled "A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China," which provided insight into HIV infected individuals in Fuyang, Anhui Province, China. According to the results of CIRPA CH 002A, most HIV infected individuals described their QOL as poor. The factors affecting their poor QOL include poverty, poor health, stigma and discrimination. Participants in the CIPRA CH 002A study showed interest in learning more about HIV/AIDS disease and treatment. This study will last 18 months. HIV infected participants and their families will attend eight 2-hour group skills training sessions during Weeks 1 through 8, and booster sessions every two months during Months 3 through 15. Popular Opinion Leaders (POL) participants will attend 4 weeks of 2-hour training sessions about anti-stigma and anti-discrimination, followed by support meetings every 2 months during Months 2 through 13. Some participants will complete cross-sectional surveys evaluating the levels of stigma and discrimination in the community at study entry and at Months 6 and 12 following completion of POL training. All participants will complete follow-up visits at Months 6 and 12.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: HIV skills trainingHIV infected participants and their families |
| 2 | Experimental | Behavioral: Popular Opinion Leaders trainingPopular Opinion Leaders (POL) participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV infected
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Willing to provide location information
- Resident of Funan County or Yingzhou District, Anhui Province, China
- Family member of HIV infected participant
Key exclusion criteria (10 listed)
- Spent more than 6 months outside the community within the year prior to study entry
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Has not made contact with study staff after three attempts
- Permanent disability (e.g., deafness, serious mental illness, mental retardation)
- Spent more than 6 months outside the community within the year prior to study entry
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 trainingEight 2-hour group skills training sessions will occur during Weeks 1 through 8 and booster sessions will occur every two months during Months 3 through 15 | Behavioural | 1 |
| Popular Opinion Leaders trainingTwo-hour training sessions about anti-stigma and anti-discrimination will occur for 4 weeks, followed by support meetings every 2 months during Months 2 through 13. | Behavioural | 2 |
Primary outcome
Medical Outcomes Study HIV Health Survey (MOS-HIV) score in HIV infected participants
Time frame: Throughout study
1 secondary outcome
Level of stigma among community members, including HIV knowledge
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2009.
- Background: PubMed 17321313Wu Z, Sullivan SG, Wang Y, Rotheram-Borus MJ, Detels R. Evolution of China's response to HIV/AIDS. Lancet. 2007 Feb 24;369(9562):679-90. doi: 10.1016/S0140-6736(07)60315-8.
- Click here for more information about CIPRA CH 002A: HIV Assessment in Fuyang, Anhui Province, ChinaLink provided by the sponsor.
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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 study chair
Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
Jie Xu, MD, MS, MPH study chair
Division of Health Education and Behavioral Intervention, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV skills training and Popular Opinion Leaders training 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 27 Mar 2009. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00479141, which also lists 1 linked publication.
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 27 Mar 2009.