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Directly Observed Therapy in HIV Infected Adolescent Focus Groups

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00079729
  Purpose

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
HIV Infections

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Directly Observed Therapy (DOT) in HIV-Infected Adolescents: Part A-Focus Groups

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   30

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.

  Eligibility
Ages Eligible for Study:   16 Years to 21 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Investigators
Study Chair:     Patricia Flynn, MD     St. Jude Children's Research Hospital    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   PACTG P1036A
First Received:   March 11, 2004
Last Updated:   September 8, 2008
ClinicalTrials.gov Identifier:   NCT00079729
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on November 19, 2008




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