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NCT00164385 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00164385
Other study ID # CDC-NCHSTP-3723
Secondary ID U64CCU219448U64C
Status Completed
Phase N/A
First received September 9, 2005
Last updated October 20, 2005

Study information
Verified date September 2005
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 13 Years to 21 Years
Eligibility 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) -

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Adolescent Impact

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention
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