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

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164385
First received: September 9, 2005
Last updated: October 20, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Adolescent Impact

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Criteria

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) -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164385

Sponsors and Collaborators
Investigators
Study Chair: Linda J Koenig, PhD Centers for Disease Control and Prevention
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164385     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3723, U64CCU219448, U64CCU319455, U64CCU319459
Study First Received: September 9, 2005
Last Updated: October 20, 2005
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
HIV/AIDS

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2014