Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs
Perceived Changes in Body Habitus and Body Image Among HIV+ Persons Currently Receiving or Recently Discontinuing Combination Antiretroviral Therapy
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.
研究概览
详细说明
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.
研究类型
注册
联系人和位置
学习地点
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California
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San Diego、California、美国、92103
- Univ of California, San Diego
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Hosp
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Ohio
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Columbus、Ohio、美国、432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Univ of Pennsylvania at Philadelphia
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
Patients may be eligible for this study if they:
- Are 18 years or older.
- Are HIV-positive.
- Are experiencing at least 1 of the following symptoms associated with fat changes due to HIV: 1) increase in belt or waist size; 2) increase in size of back of neck; 3) increase in bra, shirt, or blouse size to fit increasing breast size; 4) fat increase in other areas of the body; 5) loss of facial fat; 6) loss of fat in arms or legs; 7) loss of fat in buttocks.
- Agree to protect the confidentiality of other focus group participants.
- Are able to speak and read English.
- Have taken 2 or more anti-HIV medications for a total of at least 6 months at any time before entering this study. Patients must have taken some anti-HIV treatment during the 6-month period before study entry. Patients who have stopped taking these medications in the 6 months before study entry may still be eligible.
- Are willing to talk about personal topics in a taped group interview.
- Are male and either gay or bisexual (if enrolling in the Ohio State University or University of California focus groups).
- Are either female or heterosexual male (if enrolling in the University of Pennsylvania or Johns Hopkins University focus groups).
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a mental disability that, in the opinion of the researcher, could interfere with study participation.
- Have already taken part in an A5089 focus group interview.
- Have diabetes or Cushing's disease or have had surgery that might otherwise explain changes in body fat.
- Have changes in diet or physical activity that might explain changes in body fat.
- Have been on glucocorticoid therapy for a long time.
- Are pregnant.
学习计划
研究是如何设计的?
合作者和调查者
调查人员
- 学习椅:Judith Neidig
- 学习椅:William Holmes
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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