Long-Term Survival With HIV: Psychological and Behavioral Factors Associated With the Transition From Adolescence to Young Adulthood
|First Received Date ICMJE||November 14, 2001|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||July 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00026806 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Long-Term Survival With HIV: Psychological and Behavioral Factors Associated With the Transition From Adolescence to Young Adulthood|
|Official Title ICMJE||Long-Term Survival With HIV: A Study of the Psychological and Behavioral Factors Associated With the Transition From Adolescence To Young Adulthood|
This study will examine the emotional and behavioral aspects of long-term survival of HIV/AIDS among adolescents and young adults with HIV infection.
HIV-infected individuals between 13 and 23 years of age may be eligible for this study. They must be aware of their HIV diagnosis, have been infected for at least 13 years and have been on an active NIH protocol during the past 5 years.
In addition to the usual stresses of growing up, children with HIV infection may have spent much of their time in hospitals and may have lost parents, friends and other loved ones. This study will explore psychological aspects of growing up with HIV, including self esteem, possible risk behaviors, how disclosure to others changes over time, the commonness of anxiety and depression, and the impact that losses have had on the adolescents' emotional health. To gather this information, participants will be interviewed and asked to fill out a set of forms. Caregivers will also fill out forms.
Patients who are not currently on an active NIH protocol will have the option of having a physical examination and routine blood work. The results will be sent to their home care provider.
Children and adolescents with HIV/AIDS are living well beyond the life expectancy that was projected for them in the past. As the number of survivors of vertically or transfusion associated pediatric HIV disease increases, attention to the psychosocial adjustment of these adolescents and young adults becomes increasingly important. Studies in the late 1990s described child and adolescent survivors as generally well adjusted, though difficulties become more apparent as the child approached the age of 18. Nothing is known about these HIV positive youngsters as they enter late adolescence and young adulthood. This study will examine psychosocial factors associated with long-term survival of HIV/AIDS, including the prevalence of psychiatric diagnoses, risk behaviors, evaluation of self competence, and the impact that multiple losses has on the adolescents' emotional well-being. In addition, data will be collected from the primary caregivers on the prevalence of parenting stress compared to national norms. Subjects will include children who have been infected (either perinatally or through transfusion) for at least eight years and who are aware of their diagnosis.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||HIV Infection|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
HIV-infected adolescents 13-24 years of age with documented HIV infection for greater than or equal to 13 years.
On active protocol at NIH during the past 5 years.
Willingness to sign informed consent.
Ability to understand and read English.
Presence of psychotic symptoms.
Cognitive impairment or full scale IQ less than or equal to 75.
Not aware of HIV diagnosis.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00026806|
|Other Study ID Numbers ICMJE||010203, 01-C-0203|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP