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

NCT ID: NCT00164385

Last Updated: 2005-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Adolescent Impact

Intervention Type BEHAVIORAL

Eligibility Criteria

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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) -
Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Linda J Koenig, PhD

Role: STUDY_CHAIR

Centers for Disease Control and Prevention

Other Identifiers

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U64CCU219448

Identifier Type: -

Identifier Source: secondary_id

U64CCU319455

Identifier Type: -

Identifier Source: secondary_id

U64CCU319459

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-3723

Identifier Type: -

Identifier Source: org_study_id