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Mphatlalatsane: Early Morning Star

Integrating early childhood care and development, HIV testing and treatment support, and nutrition information into rural informal nursery care in Mokhotlong, Lesotho, to improve HIV testing rates, treatment adherence and early childhood development : a cluster randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16654287
Enrollment
1160
Registered
2015-07-03
Start date
2015-06-29
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV testing and treatment, early childhood care and development, and nutrition Infections and Infestations Human immunodeficiency virus

Interventions

The intervention is an integrated early childhood care and development (ECCD), HIV and nutrition intervention. It is targeted at caregivers with children between the ages of 1 and 5 years. Primary ca

Sponsors

Stellenbosch University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In total, 1160 children and their primary carers living in 32 villages near Mokhotlong and their caregivers will be enrolled in the study. Villages have been selected based on them falling within two community councils, having an informal preschool, and being within the geographical area receiving services from the community-based partner of the study. Inclusion criteria for children include: 1. Ages 12-60 months at baseline 2. Has an adult primary caregiver who lives in the household who consents to participate in the study Inclusion criteria for adults include: 1. Age 18 or older 2. Serves as the primary caregiver of the child participant 3. Lives in the house at least 4 nights per week

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

MeasureTime frame
All measures will be implemented at baseline, 3 months and 12 months. 1. HIV testing rate (no. of children who have tested for HIV in past 3 months) 2. Child language (MacArthur Communication Development Inventory, Peabody Picture Vocabulary Test, Mullen Receptive Language Scale) 3. Child attention (Early Childhood Vigilance Task)

Secondary

MeasureTime frame
All measures will be implemented at baseline, 3 months and 12 months. 1. Child cognitive development (Mullen Visual Reception Scale) 2. Child growth: Z scores, based on WHO standards 3. HIV treatment uptake: Number of children initiating ART therapy after testing 4. HIV treatment adherence: ART adherence rates in children, defined as % adhering to ART within defined periods (3 days, 1 week, 1 month) 5. Child emotional and behavioural functioning: Child Behaviour Checklist (selected subscales), Strengths and Difficulties Questionnaire 6. Child executive function: Inhibitory control task, Attention shifting task, Working memory task 7. Parental discipline: Discipline and Violence Questionnaire of Lansford and Deater-Deckard, developed from the Parent-Child conflict tactics scale and the World-SAFE survey, 4. Directly observed prohibition task rated with adapted version of the Murray Global Rating Scales 8. Parenting stress: Parenting Stress Index 9. Parental sensitivity: Directly observed book sharing task rated with adapted version of the Murray Global Rating Scales 10. Caregiver mental health: Patient Health Questionnaire – 9, Self-Reporting Questionnaire – 20, Shona Symptom Questionnaire

Countries

Lesotho

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026