HIV Assessment in Fuyang, Anhui Province, China
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| ClinicalTrials.gov Identifier: NCT00094354 |
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Recruitment Status
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Completed
First Posted
: October 18, 2004
Last Update Posted
: March 27, 2009
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
| Tracking Information | ||||||||||
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| First Submitted Date | October 16, 2004 | |||||||||
| First Posted Date | October 18, 2004 | |||||||||
| Last Update Posted Date | March 27, 2009 | |||||||||
| Study Start Date | October 2004 | |||||||||
| Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures | Not Provided | |||||||||
| Original Primary Outcome Measures | Not Provided | |||||||||
| Change History | Complete list of historical versions of study NCT00094354 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Outcome Measures | Not Provided | |||||||||
| Original Other Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | HIV Assessment in Fuyang, Anhui Province, China | |||||||||
| Official Title | A Qualitative Study for the Development of an Intervention Among HIV-Positive Former Plasma Donors (FPDs) in Fuyang, Anhui Province, China | |||||||||
| Brief 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. | |||||||||
| 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
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| Study Type | Observational | |||||||||
| Study Design | Time Perspective: Prospective | |||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| 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 | |||||||||
| Condition | HIV Infections | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
111 | |||||||||
| Original Enrollment |
80 | |||||||||
| Actual Study Completion Date | April 2006 | |||||||||
| Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria for HIV Infected Villagers:
Inclusion Criteria for Family Members of HIV Infected Villagers:
Inclusion Criteria for Local Health Workers:
Inclusion Criteria for Villagers Who Are Not From Households with an HIV Infected Participant:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Not Provided | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT00094354 | |||||||||
| Other Study ID Numbers | CIPRA CH 002A CIPRA Project 2 |
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| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Rona Siskind, DAIDS | |||||||||
| Study Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
| Verification Date | January 2009 | |||||||||