A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
- Conditions
- HIV Infections
- Registration Number
- NCT00000780
- 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, 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 Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Westchester Hosp
🇺🇸Valhalla, New York, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
🇺🇸Buffalo, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
🇺🇸Worcester, Massachusetts, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Univ Texas Health Science Ctr / Univ Texas Med School
🇺🇸Houston, Texas, United States
West Central Ohio Hemophilia Ctr / Children's Med Ctr
🇺🇸Dayton, Ohio, United States
Saint Christopher's Hosp for Children
🇺🇸Philadelphia, Pennsylvania, United States
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
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Children's Hosp of Los Angeles
🇺🇸Los Angeles, California, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
George Washington Univ / Hershey Med Ctr
🇺🇸Washington, District of Columbia, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
King's County Hosp Ctr / Pediatrics
🇺🇸Brooklyn, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Cincinnati Children's Hosp / Univ Hosp
🇺🇸Cincinnati, Ohio, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Great Lakes Hemophilia Foundation
🇺🇸Wauwatosa, Wisconsin, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
🇺🇸Knoxville, Tennessee, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Tulane Med Ctr Hosp
🇺🇸New Orleans, Louisiana, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States