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A "Pre-Enrollment" Protocol for HIV-Infected Adolescents

Completed
Conditions
HIV Infections
Registration Number
NCT00000780
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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.

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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
250
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (51)

Univ of Alabama at Birmingham Schl of Med / Pediatrics

🇺🇸

Birmingham, Alabama, United States

Long Beach Memorial (Pediatric)

🇺🇸

Long Beach, California, United States

Children's Hosp of Los Angeles/UCLA Med Ctr

🇺🇸

Los Angeles, California, United States

Children's Hosp of Los Angeles

🇺🇸

Los Angeles, California, United States

Los Angeles County - USC Med Ctr

🇺🇸

Los Angeles, California, United States

UCLA Med Ctr / Pediatric

🇺🇸

Los Angeles, California, United States

Children's Hosp of Oakland

🇺🇸

Oakland, California, United States

UCSF / Moffitt Hosp - Pediatric

🇺🇸

San Francisco, California, United States

Children's Hosp of Denver

🇺🇸

Denver, Colorado, United States

Georgetown Univ Med Ctr

🇺🇸

Washington, District of Columbia, United States

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Univ of Alabama at Birmingham Schl of Med / Pediatrics
🇺🇸Birmingham, Alabama, United States

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