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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006290 |
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.
Condition |
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HIV Infections Lipodystrophy |
Study Type: | Observational |
Official Title: | Perceived Changes in Body Habitus and Body Image Among HIV+ Persons Currently Receiving or Recently Discontinuing Combination Antiretroviral Therapy |
Estimated Enrollment: | 60 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Univ of California, San Diego | |
San Diego, California, United States, 92103 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Ohio | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
United States, Pennsylvania | |
Univ of Pennsylvania at Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Judith Neidig | |
Study Chair: | William Holmes |
Study ID Numbers: | ACTG A5089, AACTG A5089 |
Study First Received: | September 21, 2000 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00006290 History of Changes |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Questionnaires Quality of Life Patient Compliance |
Body Composition Anti-HIV Agents Adipose Tissue Body Image |
Sexually Transmitted Diseases, Viral Anti-HIV Agents Metabolic Diseases Skin Diseases Acquired Immunodeficiency Syndrome Quality of Life Immunologic Deficiency Syndromes |
Virus Diseases HIV Infections Lipodystrophy Sexually Transmitted Diseases Retroviridae Infections Metabolic Disorder Lipid Metabolism Disorders |
RNA Virus Infections Sexually Transmitted Diseases, Viral Metabolic Diseases Slow Virus Diseases Skin Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases Skin Diseases, Metabolic HIV Infections Lipodystrophy Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Lipid Metabolism Disorders |