NCT00079729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2004

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2004

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

First QC Date

March 11, 2004

Last Update Submit

October 26, 2012

Conditions

Keywords

Treatment Experienced

Eligibility Criteria

Age16 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Perinatal HIV infection
  • Visibly distraught or emotionally unstable
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Los Angeles County Medical Center/USC

Los Angeles, California, 90033, United States

Location

University of Miami (Pediatric)

Miami, Florida, 33136, United States

Location

St. Jude Childrens Research Hospital, Memphis

Memphis, Tennessee, 38105-2794, United States

Location

Related Publications (5)

  • 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.

    PMID: 11177463BACKGROUND
  • 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.

    PMID: 10889588BACKGROUND
  • 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.

    PMID: 11103053BACKGROUND
  • 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.

    PMID: 10527179BACKGROUND
  • 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.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Patricia Flynn, MD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2004

First Posted

March 12, 2004

Study Start

April 1, 2004

Study Completion

July 1, 2004

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations