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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||
| Start Date ICMJE | |||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00000780 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | A "Pre-Enrollment" Protocol for HIV-Infected Adolescents | ||||||||||||
| Official Title ICMJE | A "Pre-Enrollment" Protocol for HIV-Infected Adolescents | ||||||||||||
| Brief Summary | PRIMARY: To identify, characterize, and co-enroll HIV-infected adolescents into existing and future ACTG (or other NIH-sponsored) HIV treatment protocols through the systematic and recurrent assessment of eligibility. To assess the ability of adolescents enrolled in ACTG 220 to adhere to ACTG (or other NIH-sponsored) HIV treatment protocols; and to define factors that influence the adolescent's ability to enter or adhere to study protocols. SECONDARY: To describe the nature, stage, and progression of HIV infection in adolescents. Little is known about HIV-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely. |
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| Detailed Description | Little is known about HIV-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely. At entry and at every subsequent visit, participants are systematically evaluated for eligibility and willingness to enter ACTG (or other NIH-sponsored) HIV treatment protocols from a menu developed and updated by the Pediatric Adolescent Working Group of the ACTG. A survey of participant attitudes, behaviors, and beliefs is administered and updated semiannually. Participants attend clinic visits every 3 months and are followed for a minimum of 6 months, until the end of the study. They receive periodic physical exams, STD and gynecologic or genitourinary evaluations, HIV symptom assessment and related diagnoses, TB evaluation, and laboratory tests (hematology and immunology). |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Natural History | ||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||
| Intervention ICMJE | |||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 250 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Participants must meet the following criteria:
Exclusion Criteria Co-existing Condition: Participants with the following condition are excluded:
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| Gender | Both | ||||||||||||
| Ages | 13 Years to 20 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States, Puerto Rico | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00000780 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | ACTG 220 | ||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Verification Date | March 2003 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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