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A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
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Purpose
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 |
|---|
| HIV Infections |
| Study Type: | Observational |
| Official Title: | A "Pre-Enrollment" Protocol for HIV-Infected Adolescents |
| Estimated Enrollment: | 250 |
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).
Eligibility| Ages Eligible for Study: | 13 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Participants must meet the following criteria:
- HIV infection.
- NOT currently enrolled in an ACTG treatment protocol.
Exclusion Criteria
Co-existing Condition:
Participants with the following condition are excluded:
- No legal provision for consent to participate in clinical research can be determined.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00000780
Show 51 Study Locations
| Study Chair: | D'Angelo LJ | |
| Study Chair: | Futterman D | |
| Study Chair: | Abdalian S |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00000780 History of Changes |
| Other Study ID Numbers: |
ACTG 220 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex Adolescent Behavior |
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 |
ClinicalTrials.gov processed this record on September 19, 2017