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Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00164385
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centers for Disease Control and Prevention
September 9, 2005
September 14, 2005
December 9, 2005
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Complete list of historical versions of study NCT00164385 on ClinicalTrials.gov Archive Site
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Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS
Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS
The primary objective of Adolescent Impact is to develop and evaluate a developmentally targeted intervention designed to minimize secondary transmission risk behavior and enhance adherence to care and treatment. The intervention is delivered in 12 sessions (five one-to-one, 7 group) over a 3 month period of time. Intervention is delivered in addition to standard of care treatment at the participant's respective clinic. Participants are randomized to either an intervention or control arm; the control group receives standard of care treatment and control group participants are offered the Adolescent Impact intervention following the completion of the nine-month follow up. It is hypothesized that compared to control group participants, intervention group participants will evidence (1) improved or stable virologic and/or immunologic status, mediated by (a) adherence to prescribed antiretroviral medication and/or (b) adherence to HIV care appointments, and (2) reduction/minimization of secondary transmission risk behaviors to include (a) unprotected sex and/or needle sharing, and (b) sexual and drug use behaviors that increase risk for unprotected sex.
The primary objective of Adolescent Impact is to develop and evaluate a developmentally targeted intervention designed to minimize secondary transmission risk behavior and enhance adherence to care and treatment. The intervention is delivered in 12 sessions (five one-to-one, 7 group) over a 3 month period of time. Intervention is delivered in addition to standard of care treatment at the participant's respective clinic. Participants are randomized to either an intervention or control arm; the control group receives standard of care treatment and control group participants are offered the Adolescent Impact intervention following the completion of the nine-month follow up. It is hypothesized that compared to control group participants, intervention group participants will evidence (1) improved or stable virologic and/or immunologic status, mediated by (a) adherence to prescribed antiretroviral medication and/or (b) adherence to HIV care appointments, and (2) reduction/minimization of secondary transmission risk behaviors to include (a) unprotected sex and/or needle sharing, and (b) sexual and drug use behaviors that increase risk for unprotected sex.
Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
Behavioral: Adolescent Impact
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  1. Confirmed HIV infection
  2. Followed at one of the participating clinics for HIV care
  3. Age 13-21 at enrollment (i.e., must be enrolled prior to 22nd birthday)
  4. Aware of HIV status and, for perinatally infected teens, the HIV status of one's biological mother
  5. Able to comprehend English well enough to participate in the study
  6. Able to understand and sign a written informed consent or assent
  7. Parental or legal guardian consent, if under the age of 18 -

Exclusion Criteria:

  1. Less than borderline intellectual functioning, as evidenced by clinician assessment or full scale IQ less than 65
  2. Acute and severe mental illness (including, but not limited to, psychosis, severe depression, or significant suicidal or homicidal ideation) -
Sexes Eligible for Study: All
13 Years to 21 Years   (Child, Adult)
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Contact information is only displayed when the study is recruiting subjects
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NCT00164385
CDC-NCHSTP-3723
U64CCU219448
U64CCU319455
U64CCU319459
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Centers for Disease Control and Prevention
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Study Chair: Linda J Koenig, PhD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP