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Directly Observed Therapy in HIV Infected Adolescent Focus Groups

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00079729
Recruitment Status : Completed
First Posted : March 12, 2004
Last Update Posted : October 29, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to help researchers use information from HIV infected adolescents to design a directly observed therapy (DOT) program that will help adolescents take their anti-HIV medications correctly.

Condition or disease
HIV Infections

Detailed Description:

The rate of HIV infection among adolescents is increasing at an alarming rate. Adherence to antiretroviral therapy has been a major challenge in achieving and maintaining adequate control of the disease in this population. DOT has been shown effective in individuals with tuberculosis (TB), but DOT in HIV infected populations has not been thoroughly examined. This study will collect information from HIV infected adolescents in order to establish a DOT program that will increase successful adherence to HIV treatment and will benefit the public by preventing development of viral resistance and reducing the risk of transmission.

Adolescent participants in this study will be assigned to one of three 2-hour focus group sessions, each at a different site. The participants will complete a questionnaire and will give input about designing a DOT intervention model that will be accepted by adolescents. The model will then be used in a pilot study to determine the feasibility of implementing DOT programs in the community to help HIV infected adolescents.


Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Directly Observed Therapy (DOT) in HIV-Infected Adolescents: Part A-Focus Groups
Study Start Date : April 2004
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected due to high-risk behavior
  • Regular attendee of local adolescent HIV support group
  • Current use of antiretrovirals or history of antiretroviral therapy
  • Permission of parent or legal guardian if participant is less than the legal age of consent. Assent of the minor participant should be obtained where required.

Exclusion Criteria:

  • Perinatal HIV infection
  • Visibly distraught or emotionally unstable
  • Pregnancy or breast-feeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079729


Locations
United States, California
Los Angeles County Medical Center/USC
Los Angeles, California, United States, 90033
United States, Florida
University of Miami (Pediatric)
Miami, Florida, United States, 33136
United States, Tennessee
St. Jude Childrens Research Hospital, Memphis
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: Patricia Flynn, MD St. Jude Children's Research Hospital
More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00079729     History of Changes
Other Study ID Numbers: PACTG P1036A
10193 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: March 12, 2004    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases