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

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ClinicalTrials.gov Identifier: NCT00164385
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 21, 2005
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Adolescent Impact

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164385


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

ClinicalTrials.gov Identifier: NCT00164385     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3723
U64CCU219448
U64CCU319455
U64CCU319459
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 21, 2005
Last Verified: September 2005

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

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