Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus

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 Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Other: Neuropsychological testing

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Perinatally infected with HIV, internationally adopted

Exclusion Criteria:

• Prior neuropsychological testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; all receive neuropsychological testing & follow-up	Other: Neuropsychological testing; Comprehensive neuropsychological assessment and implementation of appropriate support and resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rating scales of behavioral and social/emotional functioning	Parental reporting	24-36 months
Change in Score of Wechsler Intelligence Scale for Children - Fifth Edition		24-36 months
Change in Score of Wechsler Individual Achievement Test - Third Edition		24-36 months
Change in Score of Gordon Diagnostic System		24-36 months
Change in Score of Grooved Pegboard		24-36 months
Change in Score of Token Test for Children - Second Edition		24-36 months
Change in Score of Wide Range Assessment of Memory and Learning - Second Edition		24-36 months
Change in Score of Delis Kaplan Executive Function System: Selected Subtests		24-36 months
Change in Score of Rey-Osterrieth Complex Figure Test		24-36 months
Change in Score of Beery-Buktenica Developmental Test of Visual Motor Integration - Sixth Edition		24-36 months
Change in Score of Peabody Picture Vocabulary Test - Fourth Edition		24-36 months
Change in Score of Behavior Assessment System for Children - Second Edition: Self, Parent, and Teacher Reports		24-36 months
Change in Score of Pediatric Sleep Questionnaire		24-36 months

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2017
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HIV/AIDS; neuropsychological outcomes; international adoption; perinatal infection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2016-299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We may share the data with future co-investigators at the NIH Peds HIV observational cohort study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No