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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 |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00259389 |
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 | Intervention |
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HIV Infections |
Behavioral: Directly observed therapy (DOT) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Directly Observed Therapy (DOT) in HIV-1 Infected Adolescents |
Estimated Enrollment: | 24 |
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:
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:
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.
Ages Eligible for Study: | 16 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD Mother, Child & Adolescent HIV Program | |
San Diego, California, United States, 92103 | |
Los Angeles County Medical Center/USC | |
Los Angeles, California, United States, 90033 | |
Childrens Hospital Los Angeles | |
Los Angeles, California, United States, 90027 | |
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 |
Study Chair: | Aditya Gaur, MD | Department of Infectious Disease, St. Jude Children's Research Hospital |
Study ID Numbers: | PACTG P1036B |
Study First Received: | November 28, 2005 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00259389 |
Health Authority: | United States: Federal Government |
Treatment Experienced Adherence Compliance |
Directly Observed Therapy DOT Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |