HIV/AIDSNCT03100331
Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus
A study testing Neuropsychological testing in people with HIV/AIDS, run by Corewell Health West.
Trial summary
Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and neglect. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Neuropsychological testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2017to Jun 2021
- Phase
- Interventional
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Perinatally infected with HIV, internationally adopted
Who cannot join
- Prior neuropsychological testing
About this study
Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and neglect. While cognitive and psychiatric issues have been described in HIV-infected children, and even more so in HIV-positive adults, there have been no reports on neuropsychiatric interventions that can improve cognitive and psychiatric states in this highly vulnerable population. Without these needed data, Pediatric HIV providers have not been able to advocate for optimal neuropsychiatric care in perinatally HIV-infected children, let alone those who has suffered the additional risk of being internationally adopted. In the proposed study, the investigators will report on the neuropsychological profiles and outcomes in a cohort of internationally-adopted, perinatally HIV-infected children between ages 6 to 16 years who have not previously undergone neuropsychological testing or treatment. Data obtained from this study will provide important contributions to the literature by building understanding of the complex needs of this population as well as guiding future intervention efforts. The investigators predict that intervention efforts aimed at helping educators understand the learning and cognitive challenges for many of our patients will guide targeted academic supports in the school setting and lead to gains in academic skills. The detailed information obtained during the comprehensive neuropsychological assessment and follow-up care will be shared with the child's key educators at school so that individualized educational strategies can be developed, while maintaining confidentiality regarding the child's HIV status.
- Conditions
- HIV/AIDS
- Being tested
- Neuropsychological testing
- Keywords
- neuropsychological outcomes, HIV/AIDS, international adoption, perinatal infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingOther
Comprehensive neuropsychological assessment and implementation of appropriate support and resources.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm; all receive neuropsychological testing & follow-up | Experimental | Not described Receives: Other: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rating scales of behavioral and social/emotional functioning
Parental reporting
Measured: 24-36 months
Change in Score of Wechsler Intelligence Scale for Children - Fifth Edition
Measured: 24-36 months
Change in Score of Wechsler Individual Achievement Test - Third Edition
Measured: 24-36 months
Change in Score of Gordon Diagnostic System
Measured: 24-36 months
Change in Score of Grooved Pegboard
Measured: 24-36 months
Change in Score of Token Test for Children - Second Edition
Measured: 24-36 months
Change in Score of Wide Range Assessment of Memory and Learning - Second Edition
Measured: 24-36 months
Change in Score of Delis Kaplan Executive Function System: Selected Subtests
Measured: 24-36 months
Change in Score of Rey-Osterrieth Complex Figure Test
Measured: 24-36 months
Change in Score of Beery-Buktenica Developmental Test of Visual Motor Integration - Sixth Edition
Measured: 24-36 months
Change in Score of Peabody Picture Vocabulary Test - Fourth Edition
Measured: 24-36 months
Change in Score of Behavior Assessment System for Children - Second Edition: Self, Parent, and Teacher Reports
Measured: 24-36 months
Change in Score of Pediatric Sleep Questionnaire
Measured: 24-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start13 Jan 2017
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100331
- Sponsor's protocol ID
- 2016-299
- Status last verified
- May 2023
- First submitted
- 20 Mar 2017
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We may share the data with future co-investigators at the NIH Peds HIV observational cohort study
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT03100331
- Acronym / sponsor ID
- 2016-299
- Conditions
- HIV/AIDS
- Keywords
- neuropsychological outcomes, HIV/AIDS, international adoption, perinatal infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and neglect. While cognitive and psychiatric issues have been described in HIV-infected children, and even more so in HIV-positive adults, there have been no reports on neuropsychiatric interventions that can improve cognitive and psychiatric states in this highly vulnerable population. Without these needed data, Pediatric HIV providers have not been able to advocate for optimal neuropsychiatric care in perinatally HIV-infected children, let alone those who has suffered the additional risk of being internationally adopted. In the proposed study, the investigators will report on the neuropsychological profiles and outcomes in a cohort of internationally-adopted, perinatally HIV-infected children between ages 6 to 16 years who have not previously undergone neuropsychological testing or treatment. Data obtained from this study will provide important contributions to the literature by building understanding of the complex needs of this population as well as guiding future intervention efforts. The investigators predict that intervention efforts aimed at helping educators understand the learning and cognitive challenges for many of our patients will guide targeted academic supports in the school setting and lead to gains in academic skills. The detailed information obtained during the comprehensive neuropsychological assessment and follow-up care will be shared with the child's key educators at school so that individualized educational strategies can be developed, while maintaining confidentiality regarding the child's HIV status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm; all receive neuropsychological testing & follow-up | Experimental | Other: Neuropsychological testing |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Perinatally infected with HIV, internationally adopted
Key exclusion criteria (1 listed)
- Prior neuropsychological testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingComprehensive neuropsychological assessment and implementation of appropriate support and resources. | Other | Single Arm; all receive neuropsychological testing & follow-up |
Primary outcome
Change in Rating scales of behavioral and social/emotional functioning
Time frame: 24-36 months
Parental reporting
Change in Score of Wechsler Intelligence Scale for Children - Fifth Edition
Time frame: 24-36 months
Change in Score of Wechsler Individual Achievement Test - Third Edition
Time frame: 24-36 months
Change in Score of Gordon Diagnostic System
Time frame: 24-36 months
Change in Score of Grooved Pegboard
Time frame: 24-36 months
Change in Score of Token Test for Children - Second Edition
Time frame: 24-36 months
Change in Score of Wide Range Assessment of Memory and Learning - Second Edition
Time frame: 24-36 months
Change in Score of Delis Kaplan Executive Function System: Selected Subtests
Time frame: 24-36 months
Change in Score of Rey-Osterrieth Complex Figure Test
Time frame: 24-36 months
Change in Score of Beery-Buktenica Developmental Test of Visual Motor Integration - Sixth Edition
Time frame: 24-36 months
Change in Score of Peabody Picture Vocabulary Test - Fourth Edition
Time frame: 24-36 months
Change in Score of Behavior Assessment System for Children - Second Edition: Self, Parent, and Teacher Reports
Time frame: 24-36 months
Change in Score of Pediatric Sleep Questionnaire
Time frame: 24-36 months
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 2 Jun 2023.
- Individual participant dataSharing planned: Yes. We may share the data with future co-investigators at the NIH Peds HIV observational cohort study
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological testing in people with HIV/AIDS, run by Corewell Health West.
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 1 inclusion and 1 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Change in Rating scales of behavioral and social/emotional functioning (time frame: 24-36 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2023.