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Neuropsychological performance in African children with HIV enrolled in a multi-site anti-retroviral clinical trial PowerPoint Presentation

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Description : Neuropsychological performance in African children with HIV enrolled in a multi-site anti-retroviral clinical trial.

Tags : Pediatrics, Child Health, pediatric practice, pediatrician, health providers, HIV-infected infants, Adolescent Transition, HIV-infected adolescents, Neuropsychological

Published on : Jul 18, 2020 | Views : 1028 | Downloads : 1

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Slide 1-

Neuropsychological performance in African children with HIV enrolled in a multi-site anti-retroviral clinical trial is poorer than non-infected children at those study sites Michael Boivin1, Miriam Chernoff2, Bonnie Zimmer3, Barbara Laughton4, Celeste Joyce5, Katie McCarthy6, Pim Brouwers7, Patrick Jean-Philippe8, Sonia Lee9, Joan Coetzee4, Avy Violari5, Mark Cotton4, Paul Palumbo10 and the IMPAACT P1104s Study Team 1Michigan State University, 2Harvard University, 3Frontier Science, 4Stellenbosch University, 5University of Witwatersrand , 6FHI360, 7NIH/NIMH, 8NIH/NIAID, 9NIH/NICHD, 10Dartmouth University
Slide 2-

Acknowledging the P1104s Study Leadership Protocol Chair: Study Statistician: Data Manager: Michael Boivin, Ph.D., M.P.H. Miriam Chernoff, Ph.D. Bonnie Zimmer, B.S. NIAID Medical Officer: NICHD Medical Officer: NIMH Medical Officer: Clinical Trials Specialists: Patrick Jean-Philippe, M.D. Sonia Lee, Ph.D. Pim Brouwers, Ph.D. Katie McCarthy, MPH, J.L. Ariansen, MS Study Investigators: Paul Palumbo, M.D., Avy Violari, M.D., Mark Cotton, M.D., Barbara Laughton, M.D. Site Representatives: Linda Barlow-Mosha, Nasreen Abrahams, Lee Fairlie, Hermien Gous, Portia Kamthunzi, Mutsa Bwakura- Dangarembizi Assessment Center Personnel: Agatha Kuteesa, Ssesanga Titus Triks, Mariah Namubiru Kateete SOP development: Mary Nyakato (University of Chester, UK) Field Representative: Lab Data Coordinator: Joan Coetzee, C.P.N. Brittany White, B.S.
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P1104S Primary Objectives Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 To assess the feasibility, reliability, validity of administering a neuropsychological assessment battery in HIV-infected (HIV), HIV-uninfected perinatally-exposed (HEU), and HIV- uninfected non-perinatally-exposed (HUU) children 5 to 11 years of age at clinical sites in resource-limited settings in sub-Sahara Africa. To compare neuropsychological outcomes between the perinatally HIV, HEU and HUU children cross-sectionally and longitudinally with 3 assessments over two years.
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Participating P1060 Study Sites for P1104s Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 UNC Lilongwe CRS – Lilongwe, Malawi Shandukani Research CRS – Johannesburg, SA Soweto IMPAACT CRS – Johannesburg, SA FAM-CRU, Stellenbosch University – Cape Town, SA MU-JHU Research Collaboration – Kampala, Uganda Harare Family Care CRS – Harare, Zimbabwe
Slide 5-

HIV exposure/ infection Kaletra versus Nevirapine Behavior Problems: BRIEF Cognitive Ability KABC-II Overall Assessment Model Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 Adapted from Waller et al., 2007 and Engle et al., 2007
Slide 6-

Child School-Age Assessment Tests and the Relevant Developmental Domains Children (KABC-II) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 Rebus Tests of Variables of Attention (TOVA) Simple reaction time (RT) for correct response RT Speed and Variability on Signal Detection task Impulsivity Bruininks- Oseretsky Test of Motor Proficiency (BOT-2) Gross and Fine Motor Proficiency Behavior Rating Inventory for Executive Functions (BRIEF) Attention Problems Metacognition scale Behavior Regulation
Slide 7-

Statistical Methods Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 Linear regression analyses compared differences among study cohorts using generalized estimating equations (GEE models) Adjusted means were compared using pairwise contrasts Only covariates with p < 0.20 in univariable analyses were included in a multivariable model; p < 0.20 required to retain effect in final model. Key outcomes in each domain were used for final models, which were then used for other related outcomes in the domain
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Statistical Methods (contd) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Child and Caregiver Characteristics (N=611) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Child and Caregiver Characteristics (cont.) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Kaufman Assessment Battery for Children Adjusted HUU, HEU, HIV Differences (KABC-II) Cognitive Performance Domains Sequential Processing (working memory) (P<0.001) Simultaneous Processing (visual- spatial problem solving) (P=0.01) Learning (P<0.001) Delayed Recall (P<0.001) Planning (reasoning) (P=0.01) Global Performance Indices Nonverbal Index (P<0.001) Mental Processing Index (P<0.001) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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*Adjusted Standardized Scores on KABC-II Cognitive Performance for all Study Sites Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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*Adjusted Raw Scale Scores on KABC-II Performance for all Study Sites Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Test of Variables of Attention (TOVA) visual
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Test of Variables of Attention (TOVA) visual Target Non Target Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Comparing the HIV, HEU, and HUU Groups on the Tests of Variables of Attention (TOVA) visual Attention Performance Domains Percent Omission Errors (P<0.001) Response Time Variability (P<0.001) Response Time (P<0.001) Impulsivity Performance Domains Percent Commission Errors (P=0.09) Global Performance Indices D Prime Signal Detection (P<0.001) ADHD Index (P<0.001) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Attention Performance Scores on TOVA D Prime (standardized) and ADHD index, by Study TOVA ADHD and D-Prime TOVA Errors Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition (BOT-2 short version) Fine Motor Precision Fine Motor Integrity Manual Dexterity Bilateral Coordination Balance Upper-Limb Coordination Speed and Agility Strength Total Standard Score (P<0.001) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
Slide 19-

Standardized Performance Scores on BOT-2 (total score) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
Slide 20-

Behavior Rating Inventory of Executive Function (BRIEF) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 The eight non-overlapping clinical scales form two broader indices: Behavior Regulation (three scales) and Metacognition (five scales). These are combined into the Global Executive Composite Index, whereby the higher the score, the greater the number of problems. The Parent version of the Preschool BRIEF was administered in the local language to the principal caregiver. BRIEF Behavior Regulation Index (P=0.97) BRIEF Metacognition Index (P=0.07) BRIEF Global Executive Composite Index (P=0.34)
Slide 21-

Standardized Performance Scores on BRIEF (BRI, MI, GEC) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
Slide 22-

For pairwise comparisons between groups, whereas the HIV group performed significantly more poorly than either the HEU or HUU groups, the HEU and HUU groups did not differ from one another. For the KABC Mental processing index score (MPI, the HIV group scored , on average, 5-6 points lower (~ ½ SD). There were significant differences among sites for the principal test outcomes, making it necessary to adjust by site when comparing the HIV, HEU, and HUU groups. However, HIV, HEU, and HUU between-group differences on the neuropsychological outcomes were consistent across all six study sites. Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 Summary of Principal Statistical Findings for Neuropsychological Outcomes (construct validity)
Slide 23-

Associations between child, caregiver, home environment characteristics and study group for KABC-II MPI scores Females have about 1.6 point higher scores than males. For each additional year of age, participants score about 1.4 points lower and those not yet in school score on average about 3.25 points lower. Children whose caregivers did not complete high school score about 2 points lower, while children of those who receive social grants score almost 4 points lower. Participants living in urban areas score higher than those living in peri- urban or rural settings, the latter contrast being significant. Those children with higher disability scores have lower scores; for each additional point on the disability scale, there is a decrease of 0.21 points. Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 Summary of Principal Statistical Findings (cont’d)
Slide 24-

Feasibility/Validity/QA of P1104s Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 Between 91.5-95.6% of the cohort children completed all three tests (KABC-II, TOVA, BOT-2) in one day with high overall completion rates (TOVA 95-98%; BOT-2 and KABC close to 100%), and only 3% being invalid (KABC by cohort). Only 3% of entered scores were possibly invalid (KABC by cohort), mostly due to out-of-limit or extreme outlier designations. These were queried and have been corrected. First time a quality assurance plan involving monthly video- taping and review has been implemented in a multi-site neuropsychological study of this sort in African pediatric HIV, with scores averaging above 90% at 5/6 sites.
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Limited Statistical Power : Exploratory Analyses Only P1060 HIVpos (N=452) In 1104S (N=246) NVP Exposed (N=86) NVP (N=44) LVP (N=42) NVP Unexposed (N=160) NVP (N=82) LPV (N=78) Not in 1104S (N=206) NVP Exposed (N=78) NVP (N=38) LPV (N=40) NVP Unexposed (N=128*) NVP (N=65) LPV (N=62) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
Slide 27-

P1060 “Intent to Treat” analysis: NVP and LPV/r, in HIV-infected children (Year 1) Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 In the HIV cohort, the NVP arm had lower median KABC-II Planning and Nonverbal Index scores (by 3 points each, P=0.04, 0.05 resp.) The NVP arm had lower median BOT-2 standardized scores (by 1.5 points, P=0.03) than the LPVr arm No differences between treatment arms on any other KABC-II or TOVA outcomes.
Slide 28-

Scott Letendre, 10-Oct-2008 British HIV Association Meeting “Antiretroviral drug penetration into the central nervous system: implication for HIV control” Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 28 Neuropsychological outcomes in response to the CNS pharmacokinetics, pharmacodynamics, and pharmacogenetics of cARV treatment options
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Conclusions from Year 1 of P1104s Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 We established the feasibility of obtaining multi-site neuropsychological measures in African children with HIV along with appropriate control comparisons; with significant performance deficits for the HIV group across all 6 sites despite language and cultural differences. Still, significant differences by site for our cognitive test outcomes evidence the importance of considering site-specific contextual and sampling features (e.g., adjusting between-group differences by site). Even with early treatment intervention through P1060, the HIV performance deficits demonstrate the need for neuropsychological monitoring and rehabilitative interventions. P1104s children have been assessed for a 2nd time (week 48), are now being assessed for a third time (2/3 completed week 96 assessment as of June, 2016), providing a neuropsychological evaluation at several time points over a two-year period in order to further gauge the brain/behavior developmental trajectory of early and ongoing pediatric HIV treatment/care options in the African context.
Slide 30-

Kampala MU-JHU UNC Lilongwe Malawi PHRU SOWETO, RSA SHANDUKANI, Jhburg, RSA FAM-CRU, Cape Town, RSA UZ CRC, Zimbabwe Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016
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Some men see things as that are and say why. Others dream things that never were and ask why not? George Bernard Shaw Can we do neuropsychological evaluation of pediatric HIV as a core aspect of morbidity and quality-of-life for African children as part of the IMPAACT clinical trials program? Yes we can! Presentation to the 8th Annual HIV Pediatrics Workshop: Durban, RSA; 16-July-2016 Final Conclusion after Years 1 & 2 of P1104s

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