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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

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

MedlinePlus related topics:  AIDS

Study Type: Observational
Study Design: Natural History

Further Study Details: 

Expected Total 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   -   20 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Participants must meet the following criteria:

Exclusion Criteria

Co-existing Condition: Participants with the following condition are excluded:


Location Information


Alabama
      Univ of Alabama at Birmingham Schl of Med / Pediatrics, Birmingham,  Alabama,  35294,  United States

California
      UCSF / Moffitt Hosp - Pediatric, San Francisco,  California,  941430105,  United States

      Children's Hosp of Oakland, Oakland,  California,  946091809,  United States

      UCLA Med Ctr / Pediatric, Los Angeles,  California,  900951752,  United States

      Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles,  California,  900276016,  United States

      Long Beach Memorial (Pediatric), Long Beach,  California,  90801,  United States

      Children's Hosp of Los Angeles, Los Angeles,  California,  90027,  United States

      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States

Colorado
      Children's Hosp of Denver, Denver,  Colorado,  802181088,  United States

District of Columbia
      Children's Hosp of Washington DC, Washington,  District of Columbia,  200102916,  United States

      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States

      George Washington Univ / Hershey Med Ctr, Washington,  District of Columbia,  20037,  United States

Florida
      Univ of Miami (Pediatric), Miami,  Florida,  33161,  United States

      Univ of Florida Health Science Ctr / Pediatrics, Jacksonville,  Florida,  32209,  United States

Georgia
      Emory Univ Hosp / Pediatrics, Atlanta,  Georgia,  30306,  United States

Illinois
      Chicago Children's Memorial Hosp, Chicago,  Illinois,  606143394,  United States

      Univ of Chicago Children's Hosp, Chicago,  Illinois,  606371470,  United States

Louisiana
      Tulane Med Ctr Hosp, New Orleans,  Louisiana,  70112,  United States

      Tulane Univ / Charity Hosp of New Orleans, New Orleans,  Louisiana,  701122699,  United States

Maryland
      Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore,  Maryland,  21201,  United States

Massachusetts
      Children's Hosp of Boston, Boston,  Massachusetts,  021155724,  United States

      Boston City Hosp / Pediatrics, Boston,  Massachusetts,  02118,  United States

      Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial, Worcester,  Massachusetts,  01605,  United States

Nebraska
      Univ of Nebraska Med Ctr, Omaha,  Nebraska,  681985130,  United States

New York
      King's County Hosp Ctr / Pediatrics, Brooklyn,  New York,  11203,  United States

      Harlem Hosp Ctr, New York,  New York,  10037,  United States

      Westchester Hosp, Valhalla,  New York,  10595,  United States

      Schneider Children's Hosp, New Hyde Park,  New York,  11040,  United States

      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States

      Mount Sinai Med Ctr, New York,  New York,  10029,  United States

      Mount Sinai Med Ctr / Pediatrics, New York,  New York,  10029,  United States

      SUNY / Erie County Med Ctr at Buffalo, Buffalo,  New York,  14215,  United States

      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10457,  United States

      Montefiore Med Ctr Adolescent AIDS Program, Bronx,  New York,  10467,  United States

      Children's Hosp Pact Prog / Children's Hosp of Buffalo, Buffalo,  New York,  14222,  United States

North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  277103499,  United States

Ohio
      Univ of Cincinnati, Cincinnati,  Ohio,  452670405,  United States

      Cincinnati Children's Hosp / Univ Hosp, Cincinnati,  Ohio,  452292899,  United States

      Columbus Children's Hosp, Columbus,  Ohio,  432052696,  United States

      West Central Ohio Hemophilia Ctr / Children's Med Ctr, Dayton,  Ohio,  454041815,  United States

Pennsylvania
      Children's Hosp of Philadelphia, Philadelphia,  Pennsylvania,  191044318,  United States

      Milton S Hershey Med Ctr, Hershey,  Pennsylvania,  170330850,  United States

      Saint Christopher's Hosp for Children, Philadelphia,  Pennsylvania,  191341095,  United States

South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  294253312,  United States

Tennessee
      Saint Jude Children's Research Hosp of Memphis, Memphis,  Tennessee,  381052794,  United States

      Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr, Knoxville,  Tennessee,  37920,  United States

Texas
      Univ Texas Health Science Ctr / Univ Texas Med School, Houston,  Texas,  77030,  United States

Wisconsin
      Great Lakes Hemophilia Foundation, Wauwatosa,  Wisconsin,  532130127,  United States

Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico

      Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan,  009365067,  Puerto Rico

      Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon,  00956,  Puerto Rico

Study chairs or principal investigators

D'Angelo LJ,  Study Chair
Futterman D,  Study Chair
Abdalian S,  Study Chair

More Information

Publications

Fry LJ, Fernandez RA. HIV prevention: factors that predict compliance with testing and counseling procedures. J Am Osteopath Assoc. 1994 Oct;94(10):825-30.

D'Angelo LJ, Lindsey J, Zimmer B, Culnane M, Futtermann D. Attempting to enhance the enrollment of adolescents into AIDS clinical trials: the design of ACTG Protocol 220. AIDS Patient Care STDS. 1998 Nov;12(11):853-9.

Dankner WM, Lindsey JC, Levin MJ. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8.

Study ID Numbers:  ACTG 220
Record last reviewed:  March 2003
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000780
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-29
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