A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
|ClinicalTrials.gov Identifier: NCT00000780|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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.
|Condition or disease|
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).
|Study Type :||Observational|
|Enrollment :||250 participants|
|Official Title:||A "Pre-Enrollment" Protocol for HIV-Infected Adolescents|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000780
Show 51 Study Locations
|Study Chair:||D'Angelo LJ|
|Study Chair:||Futterman D|
|Study Chair:||Abdalian S|