HIV InfectionNCT00026806
Long-Term Survival With HIV: Psychological and Behavioral Factors Associated With the Transition From Adolescence to Young Adulthood
An observational study of HIV Infection, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jun 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of psychotic symptoms.
- Cognitive impairment or full scale IQ less than or equal to 75.
- Not aware of HIV diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- HIV Infection
- Keywords
- HIV Infection, Mental Health, Risk Behaviors, Post-Traumatic Stress Disorder, Youth, HIV, Long Term Survivor
- Medical subject headings
- HIV Infections, Psychological Well-Being, Risk-Taking, Stress Disorders, Post-Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study startJul 2001
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 55 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026806
- Sponsor's protocol ID
- 010203
- Other IDs
- 01-C-0203
- Status last verified
- Jun 2005
- First submitted
- 14 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bose S, Moss HA, Brouwers P, Pizzo P, Lorion R. Psychologic adjustment of human immunodeficiency virus-infected school-age children. J Dev Behav Pediatr. 1994 Jun;15(3 Suppl):S26-33.
PubMed 8063915Cadman D, Boyle M, Szatmari P, Offord DR. Chronic illness, disability, and mental and social well-being: findings of the Ontario Child Health Study. Pediatrics. 1987 May;79(5):805-13.
PubMed 2952939Chang PN. Psychosocial needs of long-term childhood cancer survivors: a review of literature. Pediatrician. 1991;18(1):20-4.
PubMed 1983856
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Survival With HIV: A Study of the Psychological and Behavioral Factors Associated With the Transition From Adolescence To Young Adulthood
- ClinicalTrials.gov ID
- NCT00026806
- Acronym / sponsor ID
- 010203
- Conditions
- HIV Infection
- Keywords
- HIV Infection, Mental Health, Risk Behaviors, Post-Traumatic Stress Disorder, Youth, HIV, Long Term Survivor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2001
- Study completion
- Jun 2005
- First posted
- 15 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of psychotic symptoms.
- Cognitive impairment or full scale IQ less than or equal to 75.
- Not aware of HIV diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8063915Bose S, Moss HA, Brouwers P, Pizzo P, Lorion R. Psychologic adjustment of human immunodeficiency virus-infected school-age children. J Dev Behav Pediatr. 1994 Jun;15(3 Suppl):S26-33.
- Background: PubMed 2952939Cadman D, Boyle M, Szatmari P, Offord DR. Chronic illness, disability, and mental and social well-being: findings of the Ontario Child Health Study. Pediatrics. 1987 May;79(5):805-13.
- Background: PubMed 1983856Chang PN. Psychosocial needs of long-term childhood cancer survivors: a review of literature. Pediatrician. 1991;18(1):20-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00026806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.