NCT00259389

Brief Summary

Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a strategy in which patients are observed while taking their medications, has been proven useful in increasing patient adherence. The purpose of this study is to determine the effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in the past.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

6 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

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

First QC Date

November 28, 2005

Last Update Submit

September 17, 2012

Conditions

HIV Infections

Keywords

Treatment ExperiencedAdherenceComplianceDirectly Observed TherapyDOTTreatment Naive

Outcome Measures

Primary Outcomes (2)

  • Proportion of completed directly observed therapy (DOT) facilitator-participant interactions, among all scheduled interactions, for each participant during the second 4-week period on study

  • number and proportion of participants who were able to complete the recommended duration of DOT

Secondary Outcomes (16)

  • Subject satisfaction with DOT, assessed by the Exit Survey Instrument

  • cost of implementing DOT per participant

  • effective ratio of DOT facilitators to participants, determined by the calculation of actual time spent by each DOT facilitator

  • reproducibility of DOT implementation across sites and participants' adherence to DOT interactions and ability to complete the prescribed duration of DOT, compared across sites

  • adherence for each participant in the 4-week period prior to a study visit, determined at Weeks 8 and 12 by participant self-report and adherence to DOT interactions and by pill count and participant 4-week recall at Week 24

  • +11 more secondary outcomes

Interventions

Directly observed therapy (DOT)BEHAVIORAL

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Infected with HIV after age 12
  • Initiating, continuing, changing, or reinitiating a daily or twice-daily HAART regimen AND have demonstrated adherence problems (less than 85% of prescribed doses taken, as clinically disclosed, on 2 consecutive occasions at least 1 month apart). More information on this criterion can be found in the protocol.
  • Able and willing to swallow medication
  • Have access to HAART
  • Parent or guardian willing to provide informed consent, if applicable
  • Willing to use acceptable forms of contraception

You may not qualify if:

  • Clinically significant diseases other than HIV infection or clinically significant findings during screening or physical examination that, in the opinion of the investigator, would require much closer follow-up and frequent monitoring than would be generally done for other HIV infected patients of comparable age
  • HAART regimens that include medications taken more often than twice-daily
  • Investigational agents (HAART or other medications) administered as part of other clinical trials
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Los Angeles County Medical Center/USC

Los Angeles, California, 90033, United States

Location

UCSD Mother, Child & Adolescent HIV Program

San Diego, California, 92103, United States

Location

Childrens Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642-0001, United States

Location

St. Jude Childrens Research Hospital, Memphis

Memphis, Tennessee, 38105-2794, United States

Location

Related Publications (5)

  • Martinez J, Bell D, Camacho R, Henry-Reid LM, Bell M, Watson C, Rodriguez F. Adherence to antiviral drug regimens in HIV-infected adolescent patients engaged in care in a comprehensive adolescent and young adult clinic. J Natl Med Assoc. 2000 Feb;92(2):55-61.

    PMID: 10800292BACKGROUND

  • Mitty JA, Stone VE, Sands M, Macalino G, Flanigan T. Directly observed therapy for the treatment of people with human immunodeficiency virus infection: a work in progress. Clin Infect Dis. 2002 Apr 1;34(7):984-90. doi: 10.1086/339447. Epub 2002 Feb 27.

    PMID: 11880965BACKGROUND

  • Murphy DA, Sarr M, Durako SJ, Moscicki AB, Wilson CM, Muenz LR; Adolescent Medicine HIV/AIDS Research Network. Barriers to HAART adherence among human immunodeficiency virus-infected adolescents. Arch Pediatr Adolesc Med. 2003 Mar;157(3):249-55. doi: 10.1001/archpedi.157.3.249.

    PMID: 12622674BACKGROUND

  • Wohl AR, Garland WH, Squires K, Witt M, Larsen R, Kovacs A, Hader S, Weidle PJ. The feasibility of a community-based directly administered antiretroviral therapy program. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S388-92. doi: 10.1086/421401.

    PMID: 15156427BACKGROUND

  • Garvie PA, Flynn PM, Belzer M, Britto P, Hu C, Graham B, Neely M, McSherry GD, Spector SA, Gaur AH; Pediatric AIDS Clinical Trials Group (PACTG) P1036B Team. Psychological factors, beliefs about medication, and adherence of youth with human immunodeficiency virus in a multisite directly observed therapy pilot study. J Adolesc Health. 2011 Jun;48(6):637-40. doi: 10.1016/j.jadohealth.2010.09.014. Epub 2010 Dec 18.

    PMID: 21575827RESULT

MeSH Terms

Conditions

HIV InfectionsPatient ComplianceDirectly Observed Therapy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorMedication Adherence

Study Officials

  • Aditya Gaur, MD

    Department of Infectious Disease, St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

April 1, 2006

Study Completion

September 1, 2007

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

US(6)