Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs

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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.
    

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.
    


Study Type

Observational




Condition

HIV Infections



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60




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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Judith Neidig, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00006290

Organization ID

ACTG A5089

Secondary IDs

AACTG A5089


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

Judith Neidig, Study Chair, 


Verification Date

June 2003