Clinical trial NCT00006290: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lipodystrophy
Keywords: Drug Therapy, Combination
Questionnaires
Quality of Life
Patient Compliance
Body Composition
Anti-HIV Agents
Adipose Tissue
Body Image
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Univ of California, San Diego
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Univ of Pennsylvania at Philadelphia
state: Pennsylvania
Study officials:
name: Judith Neidig
role: STUDY_CHAIR
name: William Holmes
role: STUDY_CHAIR
References: