Child DevelopmentZICS-BOOSTNCT05119959
Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving
A study testing ECD intervention for CHEUs in people with Child Development, run by Boston University at 2 sites in 2 countries.
Trial summary
Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Child Development
- What is being tested?
- ECD intervention for CHEUs
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Apr 2022to 31 Oct 2024
- 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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Zambia Infant Cohort Study (ZICS) cohort participants who are >18 years old AND are still pregnant OR whose infants are less than 9 months of age by February 2022.
- ZICS inclusion criteria were pregnant women (1:1, HIV+:HIV-) presenting for antenatal care at Chawama First Level Hospital and intending to deliver at Chawama First Level Hospital and less than 26 weeks gestation by ultrasound
Who cannot join
- Mother-infant dyads not enrolled in ZICS
- Mother-infant dyads where mother is <18 years of age
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted.
There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months.
Read more
In this RCT the investigators will test the following hypotheses:
Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs.
Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure.
This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).
- Conditions
- Child Development
- Being tested
- ECD intervention for CHEUs, Usual care for CHEUs
- Keywords
- Children exposed to HIV in-utero but uninfected (CHEUs), Early childhood developmental (ECD) interventions, Community health workers, Home visits, Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECD intervention for CHEUsOther
The bi-weekly community health worker-delivered ECD 1 hour intervention using the modules from the SUPERCDZ curriculum which is a Zambian adaptation of UNICEF's Nurturing Care Framework
Usual care for CHEUsOther
No ECD interventions will be provided by community health workers. Children will be followed at clinics for growth and monitoring, vaccinations on a MoH approved schedule.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- CHEU + ECD intervention | Experimental | Participants randomized to this arm will receive a bi-weekly community health worker-delivered ECD intervention for CHEUs Receives: Other: ECD intervention for CHEUs |
| Arm 2- CHEU without ECD intervention | Active comparator | Participants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment. Receives: Other: Usual care for CHEUs |
| Arm 3- HIV Unexposed (HUU) without ECD intervention | Active comparator | Participants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment. Receives: Other: Usual care for CHEUs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopment at 18 months post enrollment
The Malawi Developmental Assessment Tool (MDAT) will be used to assess neurodevelopment. MDAT provides an independent evaluation of development in the domains of gross motor, fine motor, language and social skills. The MDAT can be administered in any environment as it requires minimal equipment and is more culturally relevant to our context. The scores from the MDAT are relatable and comparable to those obtained from the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III). Primary outcomes will be z-scores from four neurodevelopmental domain measurements-gross motor, fine motor, language, and social.
Measured: 18 months
Secondary outcomes (4)
Neurodevelopment at 6 months post enrollment
The Malawi Developmental Assessment Tool (MDAT) will be used to assess neurodevelopment. MDAT provides an independent evaluation of development in the domains of gross motor, fine motor, language and social skills. The MDAT can be administered in any environment as it requires minimal equipment and is more culturally relevant to our context. The scores from the MDAT are relatable and comparable to those obtained from the BSID-III. Primary outcomes will be z-scores from four neurodevelopmental domain measurements-gross motor, fine motor, language, and social.
Measured: 6 months
Language development at 6, 12, and 18 months post enrollment
Children's language development will be assessed at 12 and 24 months using an adapted MacArthur-Bates Communicative Development Inventories (CDI) tool.
Measured: 6 months. 12 months, 18 months
Child's age-specific tasks at 6, 12, and 18 months post enrollment
The Caregiver Reported Early Development Instrument (CREDI) will be used to assess age-specific tasks for early childhood 0-36 months. It is intended to be used at a population level to detect developmental delay, not as an individual diagnostic tool. This open-source, psychometrically sound tool has been tested in over 15 low-and-middle-income countries and is culturally and linguistically neutral. When deployed in its long form it can be analyzed by specific developmental domains including (motor, language and cognitive, socio-emotional). CREDI scores per arm will be described in z-scores from four neurodevelopmental domain measurements.
Measured: 6 months, 12 months, 18 months
Caregiver mental health and wellbeing at 6, 12 and 18months post enrollment
The Self-Reporting Questionnaire 20 (SQR-20) will be used to assess Caregiver mental health and wellbeing. The SQR-20 has 20 questions that assess for common mental health conditions and common physical manifestations of depression or anxiety (e.g., poor appetite, poor sleep, anhedonia). There are 20 questions and more yes answers correlate with higher risk for mental health concerns.
Measured: 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start14 Apr 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Julie M Herlihy, MD MPH, Principal investigator, BU School of Public HealthEthan Zulu, MBChB MSc, Principal investigator, Right to Care - Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119959
- Sponsor's protocol ID
- H-42282
- Acronym
- ZICS-BOOST
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2021
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving
- ClinicalTrials.gov ID
- NCT05119959
- Acronym / sponsor ID
- ZICS-BOOST / H-42282
- Conditions
- Child Development
- Keywords
- Children exposed to HIV in-utero but uninfected (CHEUs), Early childhood developmental (ECD) interventions, Community health workers, Home visits, Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 15 Nov 2021 (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 exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted.
There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months.
In this RCT the investigators will test the following hypotheses:
Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs.
Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure.
This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1- CHEU + ECD intervention | Experimental | Other: ECD intervention for CHEUsParticipants randomized to this arm will receive a bi-weekly community health worker-delivered ECD intervention for CHEUs |
| Arm 2- CHEU without ECD intervention | Active comparator | Other: Usual care for CHEUsParticipants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment. |
| Arm 3- HIV Unexposed (HUU) without ECD intervention | Active comparator | Other: Usual care for CHEUsParticipants randomized to this arm will receive the current Ministry of Health (MoH) standard of care with no formalized routine assessment of neurodevelopment. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Zambia Infant Cohort Study (ZICS) cohort participants who are >18 years old AND are still pregnant OR whose infants are less than 9 months of age by February 2022.
- ZICS inclusion criteria were pregnant women (1:1, HIV+:HIV-) presenting for antenatal care at Chawama First Level Hospital and intending to deliver at Chawama First Level Hospital and less than 26 weeks gestation by ultrasound
Key exclusion criteria (2 listed)
- Mother-infant dyads not enrolled in ZICS
- Mother-infant dyads where mother is <18 years of age
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 |
|---|---|---|
| ECD intervention for CHEUsThe bi-weekly community health worker-delivered ECD 1 hour intervention using the modules from the SUPERCDZ curriculum which is a Zambian adaptation of UNICEF's Nurturing Care Framework | Other | Arm 1- CHEU + ECD intervention |
| Usual care for CHEUsNo ECD interventions will be provided by community health workers. Children will be followed at clinics for growth and monitoring, vaccinations on a MoH approved schedule. | Other | Arm 2- CHEU without ECD intervention, Arm 3- HIV Unexposed (HUU) without ECD intervention |
Primary outcome
Neurodevelopment at 18 months post enrollment
Time frame: 18 months
The Malawi Developmental Assessment Tool (MDAT) will be used to assess neurodevelopment. MDAT provides an independent evaluation of development in the domains of gross motor, fine motor, language and social skills. The MDAT can be administered in any environment as it requires minimal equipment and is more culturally relevant to our context. The scores from the MDAT are relatable and comparable to those obtained from the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III). Primary outcomes will be z-scores from four neurodevelopmental domain measurements-gross motor, fine motor, language, and social.
4 secondary outcomes
Neurodevelopment at 6 months post enrollment
Time frame: 6 months
Language development at 6, 12, and 18 months post enrollment
Time frame: 6 months. 12 months, 18 months
Child's age-specific tasks at 6, 12, and 18 months post enrollment
Time frame: 6 months, 12 months, 18 months
Caregiver mental health and wellbeing at 6, 12 and 18months post enrollment
Time frame: 6 months, 12 months, 18 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 1 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Julie M Herlihy, MD MPH principal investigator
BU School of Public Health
Ethan Zulu, MBChB MSc principal investigator
Right to Care - Zambia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECD intervention for CHEUs in people with Child Development, run by Boston University at 2 sites in 2 countries.
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 2 inclusion and 2 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Neurodevelopment at 18 months post enrollment (time frame: 18 months). 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 1 Nov 2024.