Directly Observed Therapy in HIV Infected Adolescent Focus Groups - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

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

Additional Information:

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

Publications:

Garvie PA, Lawford J, Flynn PM, Gaur AH, Belzer M, McSherry GD, Hu C; Pediatric AIDS Clinical Trials Group 1036A Study Team. Development of a directly observed therapy adherence intervention for adolescents with human immunodeficiency virus-1: application of focus group methodology to inform design, feasibility, and acceptability. J Adolesc Health. 2009 Feb;44(2):124-32. Epub 2008 Oct 18.

Murphy DA, Wilson CM, Durako SJ, Muenz LR, Belzer M; Adolescent Medicine HIV/AIDS Research Network. Antiretroviral medication adherence among the REACH HIV-infected adolescent cohort in the USA. AIDS Care. 2001 Feb;13(1):27-40.

Babudieri S, Aceti A, D'Offizi GP, Carbonara S, Starnini G. Directly observed therapy to treat HIV infection in prisoners. JAMA. 2000 Jul 12;284(2):179-80. No abstract available.

Lanzafame M, Trevenzoli M, Cattelan AM, Rovere P, Parrinello A. Directly observed therapy in HIV therapy: A realistic perspective? J Acquir Immune Defic Syndr. 2000 Oct 1;25(2):200-1. No abstract available.

Mitty JA, McKenzie M, Stenzel M, Flanigan T, Carpenter CC. Modified directly observed therapy for treatment of human immunodeficiency virus. JAMA. 1999 Oct 13;282(14):1334. No abstract available.

Study ID Numbers:	PACTG P1036A
Study First Received:	March 11, 2004
Last Updated:	November 3, 2009
ClinicalTrials.gov Identifier:	NCT00079729 History of Changes
Health Authority:	United States: Federal Government

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

Treatment Experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 05, 2009