Directly Observed Therapy for HIV Infected Adolescents

NCT ID: NCT00259389

Last Updated: 2012-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-09-30

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.

Detailed Description

For HIV infected people, control of HIV infection is best achieved by adhering to the highly active antiretroviral therapy (HAART) regimen prescribed by their doctors. Poor adherence to a HAART regimen leads to clinical failure and the development of resistance. Many HIV infected adolescents have difficulty adhering to their prescribed anti-HIV regimens or OI prophylaxis; often, they cite forgetting to take their medications as the reason for poor adherence. This is a pilot study of using DOT and assessing adherence during DOT in HIV infected adolescents who have had difficulty adhering to HAART regimens in the past. The purpose of this study is to evaluate the efficacy in increasing patient adherence and the feasibility of using DOT among HIV infected adolescents.

This study will last 24 weeks. For the first 2 weeks of the study, DOT will be provided 7 days a week at the study site; participants will visit the study site daily and will be observed taking their medication. For the next 6 weeks, the frequency of DOT will be reduced from 7 days a week to 5 days a week. Based on adherence from Weeks 4 to 8, each participant will be recommended to continue with a DOT strategy as follows:

• Adherence Level 1 (greater than 93%) - DOT 3 days a week
• Adherence Level 2 (86% to 93%) - DOT 5 days a week
• Adherence Level 3 (less than 86%) - DOT 7 days a week

Participants will decide whether to accept their DOT assignment and to continue in the study. At Week 12 and every 4 weeks thereafter, adherence will be assessed and DOT may be adjusted as follows:

• Adherence Level 1 - Reduce frequency of DOT. Those already receiving DOT 3 days a week stop DOT and start self-administered therapy.
• Adherence Level 2 - Keep same frequency of DOT as the past 4 weeks.
• Adherence Level 3 - Increase frequency of DOT by one level, as described in previous list.

HAART will not be provided by this study, so participants must have access to their HAART medications coordinated separately through the study site. Participants who are taking medication requiring twice-daily dosing will self-administer their second doses.

There will be 7 study visits; they will occur at study entry and every 4 weeks thereafter. Medical history will occur at study entry. At every visit, participants' adherence to their regimens will be assessed, and they will also be interviewed by a social worker about their use of support services. Participants will undergo several assessments at study entry and Weeks 12 and 24 to determine participant confidence, beliefs about medicine, severity of depression, feelings of hopelessness, coping responses, and emotional and behavioral problems. Blood collection will occur at study entry and Weeks 8, 12, and 24. When participants successfully complete their prescribed courses of DOT or elect to discontinue DOT, they will again be interviewed by study staff.

Conditions

HIV Infections

Keywords

Treatment Experienced; Adherence; Compliance; Directly Observed Therapy; DOT; Treatment Naive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Directly observed therapy (DOT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Pediatric AIDS Clinical Trials Group

NETWORK

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aditya Gaur, MD

Role: STUDY_CHAIR

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

Locations

Childrens Hospital Los Angeles

Los Angeles, California, United States

Los Angeles County Medical Center/USC

Los Angeles, California, United States

UCSD Mother, Child & Adolescent HIV Program

San Diego, California, United States

Childrens Hospital of Michigan

Detroit, Michigan, United States

University of Rochester Medical Center

Rochester, New York, United States

St. Jude Childrens Research Hospital, Memphis

Memphis, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10800292 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11880965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12622674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15156427 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21575827 (View on PubMed)

Other Identifiers

10044

Identifier Type: REGISTRY

Identifier Source: secondary_id

PACTG P1036B

Identifier Type: -

Identifier Source: org_study_id