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Directly Observed Therapy for HIV Infected Adolescents

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ClinicalTrials.gov Identifier: NCT00259389
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : September 18, 2012
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Directly observed therapy (DOT)

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Directly Observed Therapy (DOT) in HIV-1 Infected Adolescents
Study Start Date : April 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  1. 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
  2. number and proportion of participants who were able to complete the recommended duration of DOT

Secondary Outcome Measures :
  1. Subject satisfaction with DOT, assessed by the Exit Survey Instrument
  2. cost of implementing DOT per participant
  3. effective ratio of DOT facilitators to participants, determined by the calculation of actual time spent by each DOT facilitator
  4. reproducibility of DOT implementation across sites and participants' adherence to DOT interactions and ability to complete the prescribed duration of DOT, compared across sites
  5. 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
  6. virologic outcomes, determined by the suppression of HIV-1 viral load at Weeks 8, 12, and 24
  7. immunologic outcome, defined by a change in absolute CD4 count from baseline to Week 24
  8. self-efficacy (confidence), assessed by Patient Assessment Tool - Part I and Beliefs About Medicine Scale
  9. beliefs about highly active antiretroviral therapy (HAART), assessed by Beliefs About Medicine Scale
  10. severity of depression experienced by each participant, assessed by Beck Depression Inventory (BDI)-II
  11. hopelessness, assessed by Beck Hopelessness Scale (BHS)
  12. emotional and behavioral problems, assessed by Youth Self Report (YSR)/Adult Self Report (ASR)
  13. coping of each participant, assessed by Coping Responses Inventory (CRI)-Youth and CRI-Adult
  14. perceived barriers to adherence, assessed at baseline and Weeks 12 and 24 by Patient Assessment Tool - Part I and Beliefs About Medication Scale
  15. substance abuse, assessed at baseline and Weeks 12 and 24 by Patient Assessment Tool - Part II
  16. sustainability of DOT benefits, assessed as the proportion of participants adherent at Week 24 among those who successfully complete the first 8 weeks of DOT and are taken off DOT at 12 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259389

United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Los Angeles County Medical Center/USC
Los Angeles, California, United States, 90033
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, United States, 92103
United States, Michigan
Childrens Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
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)
Pediatric AIDS Clinical Trials Group
Study Chair: Aditya Gaur, MD Department of Infectious Disease, St. Jude Children's Research Hospital

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00259389     History of Changes
Other Study ID Numbers: PACTG P1036B
10044 ( Registry Identifier: DAIDS-ES )
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Directly Observed Therapy
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases