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

Primary Purpose

HIV Infections

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Adolescent Behavior

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham Schl of Med / Pediatrics
  • Long Beach Memorial (Pediatric)
  • Children's Hosp of Los Angeles/UCLA Med Ctr
  • Children's Hosp of Los Angeles
  • Los Angeles County - USC Med Ctr
  • UCLA Med Ctr / Pediatric
  • Children's Hosp of Oakland
  • UCSF / Moffitt Hosp - Pediatric
  • Children's Hosp of Denver
  • Georgetown Univ Med Ctr
  • Children's Hosp of Washington DC
  • George Washington Univ / Hershey Med Ctr
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami (Pediatric)
  • Emory Univ Hosp / Pediatrics
  • Chicago Children's Memorial Hosp
  • Univ of Chicago Children's Hosp
  • Tulane Univ / Charity Hosp of New Orleans
  • Tulane Med Ctr Hosp
  • Univ of Maryland at Baltimore / Univ Med Ctr
  • Children's Hosp of Boston
  • Boston City Hosp / Pediatrics
  • Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
  • Univ of Nebraska Med Ctr
  • Bronx Lebanon Hosp Ctr
  • Montefiore Med Ctr Adolescent AIDS Program
  • King's County Hosp Ctr / Pediatrics
  • SUNY / Erie County Med Ctr at Buffalo
  • Children's Hosp Pact Prog / Children's Hosp of Buffalo
  • Schneider Children's Hosp
  • Bellevue Hosp / New York Univ Med Ctr
  • Mount Sinai Med Ctr / Pediatrics
  • Mount Sinai Med Ctr
  • Harlem Hosp Ctr
  • Westchester Hosp
  • Duke Univ Med Ctr
  • Cincinnati Children's Hosp / Univ Hosp
  • Univ of Cincinnati
  • Columbus Children's Hosp
  • West Central Ohio Hemophilia Ctr / Children's Med Ctr
  • Milton S Hershey Med Ctr
  • Children's Hosp of Philadelphia
  • Saint Christopher's Hosp for Children
  • Med Univ of South Carolina
  • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
  • Saint Jude Children's Research Hosp of Memphis
  • Univ Texas Health Science Ctr / Univ Texas Med School
  • Great Lakes Hemophilia Foundation
  • Ramon Ruiz Arnau Univ Hosp / Pediatrics
  • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000780
Brief Title
A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
Official Title
A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
Study Type
Observational

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Adolescent Behavior

7. Study Design

Enrollment
250 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D'Angelo LJ
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Futterman D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abdalian S
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham Schl of Med / Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Long Beach Memorial (Pediatric)
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Children's Hosp of Los Angeles/UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276016
Country
United States
Facility Name
Children's Hosp of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Children's Hosp of Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
946091809
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Children's Hosp of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
802181088
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's Hosp of Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102916
Country
United States
Facility Name
George Washington Univ / Hershey Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ Hosp / Pediatrics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Tulane Med Ctr Hosp
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ of Maryland at Baltimore / Univ Med Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Boston City Hosp / Pediatrics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Univ of Nebraska Med Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985130
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
King's County Hosp Ctr / Pediatrics
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Children's Hosp Pact Prog / Children's Hosp of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Schneider Children's Hosp
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Westchester Hosp
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Cincinnati Children's Hosp / Univ Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452292899
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
West Central Ohio Hemophilia Ctr / Children's Med Ctr
City
Dayton
State/Province
Ohio
ZIP/Postal Code
454041815
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Saint Christopher's Hosp for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191341095
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
Country
United States
Facility Name
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Univ Texas Health Science Ctr / Univ Texas Med School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Great Lakes Hemophilia Foundation
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
532130127
Country
United States
Facility Name
Ramon Ruiz Arnau Univ Hosp / Pediatrics
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Univ of Puerto Rico / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
7814276
Citation
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.
Results Reference
background
PubMed Identifier
11362042
Citation
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. doi: 10.1089/apc.1998.12.853.
Results Reference
background
PubMed Identifier
21037891
Citation
Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
Results Reference
background

Learn more about this trial

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

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