HIV InfectionsNCT00094354
HIV Assessment in Fuyang, Anhui Province, China
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
The purpose of this study was to examine the needs, concerns, stigmas, and social networks of HIV infected former plasma donors (FPDs) and their relatives in Fuyang, Anhui Province, 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
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Apr 2006
- Phase
- Observational
- 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
Study population: HIV-infected former plasma donors (FPDs) , family members of HIV-infected FPDs, local healthcare workers and villagers not related to an HIV-infected individual in Fuyang, Anhui Province, China
Who may be able to join
- HIV infected
- Between 20 and 59 years of age
- Living in Funan County or Yingzhou District, Fuyang, Anhui Province, China
- Married
- Former plasma donor
- Inclusion Criteria for Family Members of HIV Infected Villagers:
Show all 17Show fewer
- HIV uninfected
- Living in Funan County or Yingzhou District, Fuyang, Anhui Province, China
- Parent, spouse, brother, sister, or child of HIV infected participant of the study
- Aware of participating family member's HIV-positive status
- Doctor, nurse, or other village health worker in Funan County or Yingzhou District, Fuyang, Anhui Province, China
- Working at county or township hospital or clinic in study villages in either Funan County or Yingzhou District, Fuyang, Anhui Province, China
- Inclusion Criteria for Villagers Who Are Not From Households with an HIV Infected Participant:
- HIV uninfected OR unknown HIV status
- Between 18 and 59 years of age
- Living in Funan County or Yingzhou District, Fuyang, Anhui Province, China
- Not a family member of someone who is HIV infected
Who cannot join
- Traveled outside of Funan County and Yingzhou District, Fuyang, Anhui Province, China for more than 6 months in the year prior to study entry
- Permanent disability such as deafness, serious mental illness, or mental retardation that may interfere with participation in the study
About this study
Official title: A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China
The purpose of this study was to examine the needs, concerns, stigmas, and social networks of HIV infected former plasma donors (FPDs) and their relatives in Fuyang, Anhui Province, China. Interviews and focus groups were used to collect data in preparation for a future, larger behavioral study for HIV infected individuals in China.
Read the detailed description
The HIV epidemic in China has reached a phase of exponential growth. Among the infected are former commercial plasma donors (FPDs) in rural communities, who became infected through contaminated blood collection equipment. This study examined the needs, concerns, stigmas, social networks, and discrimination among HIV infected FPDs and their families. The study was designed to provide preliminary information and help prepare for the implementation of a second study, which evaluated community based intervention on quality of life of HIV infection villagers and HIV-related stigma.
Four groups of people were enrolled in this study: HIV infected FPDs; family members of HIV infected FPDs; local healthcare workers; and other villagers not related to an HIV infected individual. Participants were recruited based on sampling framework which stratified potential participants by gender, age, and place of residence. Selected study participants from all four groups had in-depth, one-on-one interviews approximately 2 to 3 hours in length. The interviews were taped and transcribed, and the transcriptions were coded with respect to responses. In addition, there were 2 separate focus groups; one for local healthcare workers and a second for other villagers not related to an HIV infected individual.
Information was collected from 111 participants through face-to-face, in-depth interviews (FFI) and focus group discussions (FGD). FFIs were held with 20 HIV+ FPDs, 20 family members, 20 villagers from HIV-negative households and 20 local health workers. A further 31 participants participated in four FGDs; two each with villagers from HIV-negative households and local health workers, respectively.
Main findings
- HIV testing and disclosure: Most of the interviewed HIV+ FPDs were tested when the local CDC went to their villages and offered testing. Most of their spouses were also tested. Villagers usually knew who is HIV+ in their village because there have been confidentiality issues in the notification process and because they see who is seeking AIDS-related healthcare or getting assistance from the government's HIV/AIDS care and support programs.
- Discrimination and stigma: There have been no acts of physical violence as a result of discrimination or stigma. Acts of discrimination included being deliberately ignored, both by other villagers and their families. Stigma associated with HIV/AIDS includes imminent death, loss of labor and family economy, and bad reputation. The severity of stigma/discrimination is inversely related to the prevalence of HIV in a village.
- Psychological status: The ART program has improved people's outlook on life, however many remain pessimistic about their health, economic situation and future.
- HIV knowledge: Almost all the interviewees had heard of HIV/AIDS and knew the three main transmission routes (i.e. blood, sex, mother-to-child), however there were some misconceptions about transmission and prevention.
- Sexual behavior: Most of the HIV+ FPDs reduced their frequency of sex, and some even stopped having sex, after they learned their sero-status. Extra-marital sex was rare. HIV+ FPDs rarely used condoms before they knew they were positive. While they reported that they now use condoms every time they have sex, some of them do not use condoms correctly.
- Healthcare seeking behavior: After the introduction of the Four Free and One Care program, HIV+ FPDs tended to seek health services in HIV-designated hospitals/clinics because they provide financial support for medications. Despite the subsidies, many still found healthcare unaffordable. A minority forgot to take or could not adhere to their regimen at first, however this situation was very much improved by regular home visits by local health workers.
- Social network and support: Social networks among HIV+ FPDs have been formed as a result of daily life, work and medical treatment. However the networks vary. In Funan, a stable network has been formed among HIV+ people who know each other quite well because they live close to each other and were together when selling blood, seeking medical care after being informed of their HIV+ status and participating in AIDS-related programs. In Yingzhou, PLWHAs have less contact with each other, partly because they do not have a fixed treatment place. They do, however, have some opportunities to meet and chat with each other.
- Perceived needs: Participants were keen to learn more about HIV in general and in particular about treatment. They also desire more opportunity for communication to help them deal with the stress and pressure they experience. Family member recognized the need for some kind of intervention to help their HIV+ relatives.
- Economic situation: HIV+ individuals are the main income earners for their household, however most are not fit enough for jobs in the cities and rely on crops as their main source of income. People in Yingzhou are generally better off than people in Funan. A large proportion of the family income is spent on healthcare for the HIV+ family member.
- Modality of intervention: Participants' opinions on AIDS-related programs varied widely. HIV+ participants indicated their willingness to participate in any kind of AIDS-related programs. Group activities seemed to be acceptable. It was suggested that groups be divided by gender; that activities be held in a nearby or convenient location; that the intervention be scheduled during the off-season for farming; and that village leaders or doctors act as the contact persons for AIDS-related programs.
- Conditions
- HIV Infections
- Keywords
- HIV infected former Plasma Donors, Needs assessment, HIV-related stigma and discrimination, In-depth interview, Focus Groups
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV-infected FPDs | |
| 2 | Family members of HIV-infected FPDs | |
| 3 | Local healthcare workers | |
| 4 | Villagers not related to an HIV-infected individual |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2004 (estimated)
- Study startOct 2004
- Primary completionMar 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Time perspective
- Prospective
- Enrolment
- 111 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 PreventionMary Jane Rotheram-Borus, PhD, Study chair, Division of Social and Community Psychiatry, Neuropsychiatric Institute, University of California, Los AngelesJie 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
- NCT00094354
- Sponsor's protocol ID
- CIPRA CH 002A
- Other IDs
- CIPRA, Project 2
- Status last verified
- Jan 2009
- First submitted
- 16 Oct 2004
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cao X, Sullivan SG, Xu J, Wu Z; China CIPRA Project 2 Team. Understanding HIV-related stigma and discrimination in a "blameless" population. AIDS Educ Prev. 2006 Dec;18(6):518-28. doi: 10.1521/aeap.2006.18.6.518.
PubMed 17166078Chen J, Choe MK, Chen S, Zhang S. Community environment and HIV/AIDS-related stigma in China. AIDS Educ Prev. 2005 Feb;17(1):1-11. doi: 10.1521/aeap.17.1.1.58689.
PubMed 15843106Feng G, Pang L, Wu Z. Impact of being willing to disclose HIV sero-status on voluntary counseling and testing, Chinese J AIDS/STD, 2005, 11: 237-238 (Chinese)
Wang X, Wu Z. Factors associated with adherence to ARV among AIDS patients and related intervention, Chinese J AIDS/STD, 2005, 11, 225-227 (Chinese)
Xu J, Sullivan SG, Dou Z, Wu Z; China CIPRA Project 2 Team. Economic stress and HIV-associated health care utilization in a rural region of China: a qualitative study. AIDS Patient Care STDS. 2007 Nov;21(11):787-98. doi: 10.1089/apc.2007.0005.
PubMed 17944555
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 Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China
- ClinicalTrials.gov ID
- NCT00094354
- Acronym / sponsor ID
- CIPRA CH 002A
- Conditions
- HIV Infections
- Keywords
- HIV infected former Plasma Donors, Needs assessment, HIV-related stigma and discrimination, In-depth interview, Focus Groups
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 18 Oct 2004 (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 was to examine the needs, concerns, stigmas, and social networks of HIV infected former plasma donors (FPDs) and their relatives in Fuyang, Anhui Province, China. Interviews and focus groups were used to collect data in preparation for a future, larger behavioral study for HIV infected individuals in China.
Detailed description
The HIV epidemic in China has reached a phase of exponential growth. Among the infected are former commercial plasma donors (FPDs) in rural communities, who became infected through contaminated blood collection equipment. This study examined the needs, concerns, stigmas, social networks, and discrimination among HIV infected FPDs and their families. The study was designed to provide preliminary information and help prepare for the implementation of a second study, which evaluated community based intervention on quality of life of HIV infection villagers and HIV-related stigma.
Four groups of people were enrolled in this study: HIV infected FPDs; family members of HIV infected FPDs; local healthcare workers; and other villagers not related to an HIV infected individual. Participants were recruited based on sampling framework which stratified potential participants by gender, age, and place of residence. Selected study participants from all four groups had in-depth, one-on-one interviews approximately 2 to 3 hours in length. The interviews were taped and transcribed, and the transcriptions were coded with respect to responses. In addition, there were 2 separate focus groups; one for local healthcare workers and a second for other villagers not related to an HIV infected individual.
Information was collected from 111 participants through face-to-face, in-depth interviews (FFI) and focus group discussions (FGD). FFIs were held with 20 HIV+ FPDs, 20 family members, 20 villagers from HIV-negative households and 20 local health workers. A further 31 participants participated in four FGDs; two each with villagers from HIV-negative households and local health workers, respectively.
Main findings
- HIV testing and disclosure: Most of the interviewed HIV+ FPDs were tested when the local CDC went to their villages and offered testing. Most of their spouses were also tested. Villagers usually knew who is HIV+ in their village because there have been confidentiality issues in the notification process and because they see who is seeking AIDS-related healthcare or getting assistance from the government's HIV/AIDS care and support programs.
- Discrimination and stigma: There have been no acts of physical violence as a result of discrimination or stigma. Acts of discrimination included being deliberately ignored, both by other villagers and their families. Stigma associated with HIV/AIDS includes imminent death, loss of labor and family economy, and bad reputation. The severity of stigma/discrimination is inversely related to the prevalence of HIV in a village.
- Psychological status: The ART program has improved people's outlook on life, however many remain pessimistic about their health, economic situation and future.
- HIV knowledge: Almost all the interviewees had heard of HIV/AIDS and knew the three main transmission routes (i.e. blood, sex, mother-to-child), however there were some misconceptions about transmission and prevention.
- Sexual behavior: Most of the HIV+ FPDs reduced their frequency of sex, and some even stopped having sex, after they learned their sero-status. Extra-marital sex was rare. HIV+ FPDs rarely used condoms before they knew they were positive. While they reported that they now use condoms every time they have sex, some of them do not use condoms correctly.
- Healthcare seeking behavior: After the introduction of the Four Free and One Care program, HIV+ FPDs tended to seek health services in HIV-designated hospitals/clinics because they provide financial support for medications. Despite the subsidies, many still found healthcare unaffordable. A minority forgot to take or could not adhere to their regimen at first, however this situation was very much improved by regular home visits by local health workers.
- Social network and support: Social networks among HIV+ FPDs have been formed as a result of daily life, work and medical treatment. However the networks vary. In Funan, a stable network has been formed among HIV+ people who know each other quite well because they live close to each other and were together when selling blood, seeking medical care after being informed of their HIV+ status and participating in AIDS-related programs. In Yingzhou, PLWHAs have less contact with each other, partly because they do not have a fixed treatment place. They do, however, have some opportunities to meet and chat with each other.
- Perceived needs: Participants were keen to learn more about HIV in general and in particular about treatment. They also desire more opportunity for communication to help them deal with the stress and pressure they experience. Family member recognized the need for some kind of intervention to help their HIV+ relatives.
- Economic situation: HIV+ individuals are the main income earners for their household, however most are not fit enough for jobs in the cities and rely on crops as their main source of income. People in Yingzhou are generally better off than people in Funan. A large proportion of the family income is spent on healthcare for the HIV+ family member.
- Modality of intervention: Participants' opinions on AIDS-related programs varied widely. HIV+ participants indicated their willingness to participate in any kind of AIDS-related programs. Group activities seemed to be acceptable. It was suggested that groups be divided by gender; that activities be held in a nearby or convenient location; that the intervention be scheduled during the off-season for farming; and that village leaders or doctors act as the contact persons for AIDS-related programs.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HIV-infected FPDs |
| 2 | – | –Family members of HIV-infected FPDs |
| 3 | – | –Local healthcare workers |
| 4 | – | –Villagers not related to an HIV-infected individual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected former plasma donors (FPDs) , family members of HIV-infected FPDs, local healthcare workers and villagers not related to an HIV-infected individual in Fuyang, Anhui Province, China
Key inclusion criteria (17 listed)
- HIV infected
- Between 20 and 59 years of age
- Living in Funan County or Yingzhou District, Fuyang, Anhui Province, China
- Married
- Former plasma donor
Key exclusion criteria (2 listed)
- Traveled outside of Funan County and Yingzhou District, Fuyang, Anhui Province, China for more than 6 months in the year prior to study entry
- Permanent disability such as deafness, serious mental illness, or mental retardation that may interfere with participation in 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.
Primary outcome
Not reported in the source record.
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 17166078Cao X, Sullivan SG, Xu J, Wu Z; China CIPRA Project 2 Team. Understanding HIV-related stigma and discrimination in a "blameless" population. AIDS Educ Prev. 2006 Dec;18(6):518-28. doi: 10.1521/aeap.2006.18.6.518.
- Background: PubMed 15843106Chen J, Choe MK, Chen S, Zhang S. Community environment and HIV/AIDS-related stigma in China. AIDS Educ Prev. 2005 Feb;17(1):1-11. doi: 10.1521/aeap.17.1.1.58689.
- BackgroundFeng G, Pang L, Wu Z. Impact of being willing to disclose HIV sero-status on voluntary counseling and testing, Chinese J AIDS/STD, 2005, 11: 237-238 (Chinese)
- BackgroundWang X, Wu Z. Factors associated with adherence to ARV among AIDS patients and related intervention, Chinese J AIDS/STD, 2005, 11, 225-227 (Chinese)
- Background: PubMed 17944555Xu J, Sullivan SG, Dou Z, Wu Z; China CIPRA Project 2 Team. Economic stress and HIV-associated health care utilization in a rural region of China: a qualitative study. AIDS Patient Care STDS. 2007 Nov;21(11):787-98. doi: 10.1089/apc.2007.0005.
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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
Mary Jane Rotheram-Borus, PhD study chair
Division of Social and Community Psychiatry, Neuropsychiatric Institute, University of California, Los Angeles
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
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 17 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: 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094354, which also lists 5 linked publications.
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.