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Tracking Information | |||||||||
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First Received Date † | September 21, 2000 | ||||||||
Last Updated Date | September 24, 2008 | ||||||||
Start Date † | |||||||||
Current Primary Outcome Measures † | |||||||||
Original Primary Outcome Measures † | |||||||||
Change History | Complete list of historical versions of study NCT00006290 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs | ||||||||
Official Title † | Perceived Changes in Body Habitus and Body Image Among HIV+ Persons Currently Receiving or Recently Discontinuing Combination Antiretroviral Therapy | ||||||||
Brief Summary | The purpose of this study is to learn how changes in body build affect the lives of people taking anti-HIV medications. By learning this, a set of questions can be created to help understand how changes in body build and image affect people living with HIV infection. A set of questions used to measure body image might be useful in future HIV studies. It may help doctors understand patient concerns about their body image and why some patients stop taking their anti-HIV medications. |
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Detailed Description | A valid measure of body image would be useful for AACTG studies. Such a measure might permit investigators to examine dissatisfaction with body image as a predictor variable in analyses of premature study drug discontinuation, loss to follow-up, and study drug non-adherence, and as a secondary outcome in antiretroviral and fat redistribution treatment trials. Six focus group interviews, each lasting approximately 2 hours, are conducted at 4 AACTG sites. Separate groups are run for men and women, and male groups are segmented by sexual orientation. A moderator leads discussions about patients' perceived changes in body habitus and body image. Group interviews are audio-taped and transcribed verbatim. Qualitative interview data are sent electronically to the Data Management Center, where they are thematically analyzed using qualitative data analysis (content analysis) techniques. Salient focus group findings are used to construct questionnaire items. |
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Study Phase | |||||||||
Study Type † | Observational | ||||||||
Study Design † | |||||||||
Condition † |
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Intervention † | |||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Completed | ||||||||
Enrollment † | 60 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria Patients may be eligible for this study if they:
Exclusion Criteria Patients will not be eligible for this study if they:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00006290 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | AACTG A5089 | ||||||||
Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Verification Date | June 2003 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |