Directly Observed Therapy in HIV Infected Adolescent Focus Groups

Completed

• Conditions: HIV Infections

• Registration Number: NCT00079729
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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 Timeline

• Study First Submitted: 2004-03-11
• Study First Submitted QC: 2004-03-11
• Study First Posted: 2004-03-12
• Study Start: 2004-04
• Study Completion: 2004-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-26
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

St. Jude Childrens Research Hospital, Memphis; 🇺🇸 Memphis, Tennessee, United States

Los Angeles County Medical Center/USC; 🇺🇸 Los Angeles, California, United States

University of Miami (Pediatric); 🇺🇸 Miami, Florida, United States