NCT00164385

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

October 21, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

October 20, 2005

Conditions

HIV Infections

Keywords

HIV/AIDS

Interventions

Adolescent ImpactBEHAVIORAL

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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) -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Linda J Koenig, PhD

    Centers for Disease Control and Prevention

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Last Updated

October 21, 2005

Record last verified: 2005-09