NCT Number: NCT00164385
Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS
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.
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Notify MeKey information
Conditions
Age range
13 year–21 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 -
Exclusion criteria
- 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) -
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Centers for Disease Control and Prevention
Fed
Registry information
Important dates
- First posted
- Sep 14, 2005
- Registry last updated
- Oct 21, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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