Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00094354
Other study ID # CIPRA CH 002A
Secondary ID CIPRAProject 2
Status Completed
Phase N/A
First received October 16, 2004
Last updated March 26, 2009
Start date October 2004
Est. completion date April 2006

Study information

Verified date January 2009
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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. Interviews and focus groups were used to collect data in preparation for a future, larger behavioral study for HIV infected individuals in China.


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

1. 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.

2. 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.

3. Psychological status: The ART program has improved people's outlook on life, however many remain pessimistic about their health, economic situation and future.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date April 2006
Est. primary completion date March 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria for HIV Infected Villagers:

- 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:

- 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

Inclusion Criteria for Local Health Workers:

- 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

Exclusion Criteria:

- 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

References & Publications (5)

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. — View Citation

Chen 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. — View Citation

Feng 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. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2