Clinical Trials


Directly Observed Therapy in HIV Infected Adolescent Focus Groups

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: March 11, 2004
Last updated: October 26, 2012
Last Verified: October 2012
History of Changes


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.

HIV Infections

Study Type: Observational
Study Design: Time Perspective: 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):

Enrollment: 30
Study Start Date: April 2004
Study Completion Date: July 2004

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.



Ages Eligible for Study: 16 Years to 21 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00079729


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)


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

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00079729   History of Changes  
Other Study ID Numbers: PACTG P1036A  
Study First Received: March 11, 2004  
Last Updated: October 26, 2012  

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

Treatment Experienced

Additional relevant MeSH terms:
HIV Infections processed this data on March 27, 2020
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