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Directly Observed Therapy in HIV Infected Adolescent Focus Groups

NCT ID: NCT00079729

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-07-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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Treatment Experienced

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Flynn, MD

Role: STUDY_CHAIR

St. Jude Children's Research Hospital

Locations

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Los Angeles County Medical Center/USC

Los Angeles, California, United States

Site Status

University of Miami (Pediatric)

Miami, Florida, United States

Site Status

St. Jude Childrens Research Hospital, Memphis

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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. doi: 10.1080/09540120020018161.

Reference Type BACKGROUND
PMID: 11177463 (View on PubMed)

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. doi: 10.1001/jama.284.2.179. No abstract available.

Reference Type BACKGROUND
PMID: 10889588 (View on PubMed)

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. doi: 10.1097/00042560-200010010-00018. No abstract available.

Reference Type BACKGROUND
PMID: 11103053 (View on PubMed)

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. doi: 10.1001/jama.282.14.1334. No abstract available.

Reference Type BACKGROUND
PMID: 10527179 (View on PubMed)

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):124-132. doi: 10.1016/j.jadohealth.2008.05.006. Epub 2008 Oct 18.

Reference Type RESULT
PMID: 19167660 (View on PubMed)

Other Identifiers

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10193

Identifier Type: REGISTRY

Identifier Source: secondary_id

PACTG P1036A

Identifier Type: -

Identifier Source: org_study_id