Enhancing Ugandan HIV-Affected Child Development With Caregiver Training

NCT01640561 | Completed

• 2 other identifiers: JHU-MSU-UGANDA-2012R01HD070723-01
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief Summary

Early childhood (up to age 5 yrs) is a period of dramatic change in the cognitive, emotional, social, and behavioral domains; children continuously progress by observing and interacting with the world around them. In the face of economic instability and nutritional, medical and educational deprivation, HIV-affected very young children are the most vulnerable HIV subgroup globally because their families are often the most vulnerable, with little margin for sustaining a favorable developmental milieu for the child. Through strategic caregiver interventions during this sensitive period of child neurodevelopment, our study findings have the potential for positively re-directing the developmental trajectories of tens of millions of HIV-affected children globally.

Conditions

HIV

Keywords

HIV affected; Child Neurodevelopment; Low and Middle Income Country

Outcome Measures

Primary Outcomes (1)

• Change in Child Neurodevelopment post treatment

  Mullen Scales of Early Learning

  12 month follow up

Secondary Outcomes (4)

• Change in caregiver mental health and well being

  6-, 12-, and 24-month follow ups

• Midterm change in child neurodevelopment

  6-month follow up

• Change in long term child neurodevelopment outcomes

  24-month follow ups

• Change in child physical health and well-being

  6-, 12-, 24-month follow ups

Study Arms (2)

MISC

EXPERIMENTAL

The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor Pnina Klein (consultant) has been used to enhance the development of children throughout the developing world, with the support of such international aid agencies as the World Health Organization (WHO), UNICEF, Norwegian Agency for Development Cooperation (NORAD), and Redd Barna (Norway).

Behavioral: MISC

Enhanced Treatment as Usual

ACTIVE COMPARATOR

Behavioral: UCOBAC

Interventions

MISC BEHAVIORAL

The Mediational Interventions for Sensitizing Caregivers

MISC

UCOBAC BEHAVIORAL

This nutrition/healthcare curriculum for children in poverty and affected by HIV was developed by a non-governmental organization (NGO) operating in Uganda called Uganda Community Based Association for Child Welfare (UCOBAC) with support from UNICEF.

Enhanced Treatment as Usual

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child age 1 through 5 years of age. If more than one child in a household qualifies, they will all be included.
• HIV-infected or HIV-affected child who is an orphan (loss of one or both biological parents to HIV). In either case, child must have been born to a confirmed HIV-positive mother.
• Principal caregiver of the eligible study child is able and willing to participate in a regular treatment program. The minimum agreed to participation requirement is biweekly for entire year alternating between home and office, including regular visits at 6-month intervals to the study clinic to complete lab and developmental assessments for the study child.

You may not qualify if:

• Child illness or injury-based central nervous system (CNS) insults which are likely to overshadow the neurocognitive benefits of sensitive-period caregiver interventions.
• Medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization or continued evidence of seizure or other neurological disability.
• Current enrollment or plans for enrollment in P1 (1st grade) level of school during the first 8 months of the yearlong intervention period. Having the study child in school all day precludes necessary caregiver access to child for adequate opportunity to implement MISC training with that child. We do not expect this criterion to be problematic given that age 6 is generally the age for P1.
• Primary caregiver cannot respond to MISC or TAU intervention because of mental illness or disability.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Michigan State University: collaborator
• Global Health Uganda LTD: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Global Health Uganda

Tororo, Uganda

Location

Related Publications (9)

• Boivin MJ, Nakasujja N, Familiar-Lopez I, Murray SM, Sikorskii A, Awadu J, Shohet C, Givon D, Ruisenor-Escudero H, Schut EE, Opoka RO, Bass JK. Effect of Caregiver Training on the Neurodevelopment of HIV-Exposed Uninfected Children and Caregiver Mental Health: A Ugandan Cluster-Randomized Controlled Trial. J Dev Behav Pediatr. 2017 Nov/Dec;38(9):753-764. doi: 10.1097/DBP.0000000000000510.

  PMID: 28991146 BACKGROUND

• Bass JK, Opoka R, Familiar I, Nakasujja N, Sikorskii A, Awadu J, Givon D, Shohet C, Murray SM, Augustinavicius J, Mendelson T, Boivin M. Randomized controlled trial of caregiver training for HIV-infected child neurodevelopment and caregiver well being. AIDS. 2017 Aug 24;31(13):1877-1883. doi: 10.1097/QAD.0000000000001563.

  PMID: 28609401 BACKGROUND

• Murray SM, Familiar I, Nakasujja N, Winch PJ, Gallo JJ, Opoka R, Caesar JO, Boivin MJ, Bass JK. Caregiver mental health and HIV-infected child wellness: perspectives from Ugandan caregivers. AIDS Care. 2017 Jun;29(6):793-799. doi: 10.1080/09540121.2016.1263722. Epub 2016 Dec 13.

  PMID: 27951734 BACKGROUND

• Familiar I, Nakasujja N, Bass J, Sikorskii A, Murray S, Ruisenor-Escudero H, Bangirana P, Opoka R, Boivin MJ. Caregivers' depressive symptoms and parent-report of child executive function among young children in Uganda. Learn Individ Differ. 2016 Feb;46:17-24. doi: 10.1016/j.lindif.2015.01.012. Epub 2015 Jan 30.

  PMID: 27175052 BACKGROUND

• Familiar I, Murray S, Ruisenor-Escudero H, Sikorskii A, Nakasujja N, Boivin MJ, Opoka R, Bass JK. Socio-demographic correlates of depression and anxiety among female caregivers living with HIV in rural Uganda. AIDS Care. 2016 Dec;28(12):1541-1545. doi: 10.1080/09540121.2016.1191609. Epub 2016 May 30.

  PMID: 27240825 BACKGROUND

• Bass JK, Nakasujja N, Familiar-Lopez I, Sikorskii A, Murray SM, Opoka R, Augustinavicius J, Boivin MJ. Association of caregiver quality of care with neurocognitive outcomes in HIV-affected children aged 2-5 years in Uganda. AIDS Care. 2016;28 Suppl 1(sup1):76-83. doi: 10.1080/09540121.2016.1146215. Epub 2016 Feb 17.

  PMID: 26888568 BACKGROUND

• Seffren V, Familiar I, Murray SM, Augustinavicius J, Boivin MJ, Nakasujja N, Opoka R, Bass J. Association between coping strategies, social support, and depression and anxiety symptoms among rural Ugandan women living with HIV/AIDS. AIDS Care. 2018 Jul;30(7):888-895. doi: 10.1080/09540121.2018.1441969. Epub 2018 Feb 22.

  PMID: 29471677 BACKGROUND

• Boivin MJ, Augustinavicius JL, Familiar-Lopez I, Murray SM, Sikorskii A, Awadu J, Nakasujja N, Bass JK. Early Childhood Development Caregiver Training and Neurocognition of HIV-Exposed Ugandan Siblings. J Dev Behav Pediatr. 2020 Apr;41(3):221-229. doi: 10.1097/DBP.0000000000000753.

  PMID: 31800526 DERIVED

• Ruisenor-Escudero H, Sikorskii A, Familiar-Lopez I, Persaud D, Ziemniak C, Nakasujja N, Opoka R, Boivin M. Neruodevelopmental Outcomes in Preschool Children Living With HIV-1 Subtypes A and D in Uganda. Pediatr Infect Dis J. 2018 Dec;37(12):e298-e303. doi: 10.1097/INF.0000000000002097.

  PMID: 29746376 DERIVED

Study Officials

• Michael Boivin, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

• Judy Bass, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 13, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

UG (1)