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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adolescent Impact
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV/AIDS

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All Sexes

Inclusion Criteria: Confirmed HIV infection Followed at one of the participating clinics for HIV care Age 13-21 at enrollment (i.e., must be enrolled prior to 22nd birthday) Aware of HIV status and, for perinatally infected teens, the HIV status of one's biological mother Able to comprehend English well enough to participate in the study Able to understand and sign a written informed consent or assent Parental or legal guardian consent, if under the age of 18 - Exclusion Criteria: Less than borderline intellectual functioning, as evidenced by clinician assessment or full scale IQ less than 65 Acute and severe mental illness (including, but not limited to, psychosis, severe depression, or significant suicidal or homicidal ideation) -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    October 20, 2005
    Sponsor
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00164385
    Brief Title
    Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS
    Official Title
    Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    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
    Centers for Disease Control and Prevention

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    HIV/AIDS

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Adolescent Impact

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    21 Years
    Eligibility Criteria
    Inclusion Criteria: Confirmed HIV infection Followed at one of the participating clinics for HIV care Age 13-21 at enrollment (i.e., must be enrolled prior to 22nd birthday) Aware of HIV status and, for perinatally infected teens, the HIV status of one's biological mother Able to comprehend English well enough to participate in the study Able to understand and sign a written informed consent or assent Parental or legal guardian consent, if under the age of 18 - Exclusion Criteria: Less than borderline intellectual functioning, as evidenced by clinician assessment or full scale IQ less than 65 Acute and severe mental illness (including, but not limited to, psychosis, severe depression, or significant suicidal or homicidal ideation) -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Linda J Koenig, PhD
    Organizational Affiliation
    Centers for Disease Control and Prevention
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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