NeurodevelopmentBONDSNCT07430826
Building Opportunities for Nurturing Care to Enhance Child Development in Eastern and Southern Africa
A study testing Friendship Bench, Infant and Young Child Feeding (IYCF) Curriculum and Play-Based Curriculum in people with Neurodevelopment and Child Growth, run by University of Washington.
Trial summary
The goal of this randomized controlled trial is to adapt and test a package of interventions to provide nurturing care for children aged 0-2 years in three countries (Botswana, Kenya, Zimbabwe). Mothers living with and without HIV will be enrolled in pregnancy, and their children will be followed for two years. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopment, Child Growth
- What is being tested?
- Friendship Bench, Infant and Young Child Feeding (IYCF) Curriculum and Play-Based Curriculum
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman attending participating clinics
- ≥15 years of age
- Willing to disclose a known positive HIV status or undergo HIV testing if serostatus is unknown or negative
- Willing to attend follow up visits
- Resides inside of the study catchment area and does not plan to move within the next 2 years
Who cannot join
- Incarcerated individuals
- Pregnant women and mothers who participated in the Aim 1 pilot of the BONDS interventions or has previously participated in the BONDS interventions during the trial
- Any pregnant women and mothers who live in a home in which a BONDS participant has already been enrolled
- Pregnant women, mothers, and babies who have any acute or chronic condition which, in the opinion of the study team, means enrollment in the trial would not be advisable
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Building Opportunities for Nurturing Care to Enhance Development in Eastern and Southern Africa
The goal of this randomized controlled trial is to adapt and test a package of interventions to provide nurturing care for children aged 0-2 years in three countries (Botswana, Kenya, Zimbabwe). Mothers living with and without HIV will be enrolled in pregnancy, and their children will be followed for two years. The main objectives of this study are to:
- Determine whether the adapted package of interventions improves neurodevelopment among children with and without in utero HIV exposure
- Identify why the intervention does or does not impact children's neurodevelopment.
Read more
Researchers will compare children who receive the intervention package and those who do not to see if the interventions improve child neurodevelopment and growth. Researchers will also compare children with and without HIV exposure to see if there are improvements in neurodevelopment and growth for children who were exposed to HIV.
All participants will attend regular prenatal and postnatal care appointments. Participants who are randomized to receive the package of interventions will attend regularly scheduled visits where they will discuss problem-solving strategies, receive information on healthy foods for children, and learn about how to play with their children. Mothers receiving the intervention package will also have the opportunity to meet with other mothers and babies in small groups where their children can play together.
Read the detailed description
Prior to enrollment for the clinical trial, the three interventions will be culturally adapted and refined in Botswana and Kenya using a user-centered co-design approach. A 3-day participatory workshop will be held to select appropriate adaptations to the three interventions while maintaining core components. Following these adaptations, ~80 pregnant women/mother-infant pairs will be recruited for a formative pilot to further refine the three interventions. The workshop and pilot activities have already been completed in Zimbabwe under a different protocol.
Following the clinical trial, we will determine how the package of interventions works (or if it does not work, why) to improve child development. Hypothesized causal biological and behavioral pathways include maternal health, including mental health; infant health and nutrition; caregiving quality; and maternal-child interactions. Throughout the clinical trial, both quantitative and qualitative data will be collected to identify determinants of implementation, acceptability, feasibility, appropriateness, and cost of incorporating the intervention package and neurodevelopmental evaluations into regular maternal and child health services across the three countries. Costing data will also be collected from time and motion cards and study budget records to determine the incremental costs of incorporating the intervention package and neurodevelopmental evaluations in the three participating countries.
- Conditions
- Neurodevelopment, Child Growth
- Being tested
- Friendship Bench, Infant and Young Child Feeding (IYCF) Curriculum, Play-Based Curriculum
- Keywords
- Nurturing Care Framework, CHEU, CHU, Neurodevelopment, Malawi Developmental Assessment Tool, HIV, vocabulary acquisition, functional difficulties, Breastfeeding duration, Breastfeeding initiation, Maternal mental health, stunting, wasting, underweight
- Medical subject headings
- Growth Disorders, Cachexia, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friendship BenchBehavioural
After enrollment, participants randomized to BONDS will be linked to a community health worker (CHW) who will arrange Friendship Bench (FB) sessions. During the sessions, participants identify their current stressors, and work with CHWs to consider solutions and select and implement practical solutions.
Infant and Young Child Feeding (IYCF) CurriculumBehavioural
Community health workers will deliver the infant and young child feeding (IYCF) curriculum between pregnancy and 2 years. Modules in pregnancy will focus on early breastfeeding initiation, exclusive breastfeeding (EBF), how to breastfeed and challenges with breastfeeding. Following birth, modules will reinforce education and support EBF through 6 months and then transition to the introduction of other foods and food preparation demonstrations with continued breastfeeding.
Play-Based CurriculumBehavioural
This parent-focused, play-based intervention addresses responsive caregiving and opportunities for early learning. The intervention will emphasize the importance of early learning experiences and adopting a growth mindset, with common themes including the use of scaffolding and "serve and return" activities.
| Study group | Role | What they receive |
|---|---|---|
| BONDS Intervention | Experimental | The intervention arm will combine three evidence-based interventions (Friendship Bench, infant and young child feeding curriculum, play-based learning curriculum) in a country-adapted package delivered by CHWs to participants starting in pregnancy and continuing through a child's second year of life. The intervention will be delivered at home, in the community, in a government clinic, or study clinic in the context of ongoing antenatal care and maternal and child health services for pregnant women, mothers, and children. Receives: Behavioral: Friendship Bench; Behavioral: Infant and Young Child Feeding (IYCF) Curriculum; Behavioral: Play-Based Curriculum |
| Standard of Care | No intervention | The standard of care arm includes regular antenatal care and maternal and child health services. These services across the three countries include recommended antenatal care visits during which maternal/fetal health is assessed, antenatal tests are conducted, nutrition supplements and disease prophylaxis are provided, and basic education on danger signs, breastfeeding and nutrition are provided. Postnatal and infant care include family planning, growth monitoring, immunization, and assessment of child development. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 24 months will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Secondary outcomes (11)
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 12 months will be compared between the intervention and control arms.
Measured: Study midline (child age: 12 months)
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures gross motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT gross motor domain z-score at 24 months will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures fine motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT fine motor domain z-score at 24 months will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures social development using 30 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 30 items. Mean differences in MDAT social domain z-score at 24 months will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures language development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT language domain z-score at 24 months will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Composite Scores of the MacArthur Bates Communicative Development Inventories (CDI) Vocabulary Checklist
The MacArthur Bates CDI uses caregiver-reported assessments of a child's language acquisition. Caregivers are provided a checklist of the ~100 most commonly spoken words in each language that their child speaks. Mean differences in the number of words spoken will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Presence of Functional Difficulties as Assessed by the Washington Group/UNICEF Child Functioning Module (CFM)
The CFM assess functional difficulties across eight domains (vision, hearing, mobility, dexterity, communication, learning, playing, and controlling behavior), each assessed using 1-3 four-point Likert scales. The proportion of children with at least one functional difficulty across the eight domains will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Weight-for-age z-score (WAZ) at 24 months
WAZ will be calculated for each child at 24 months. Mean differences in WAZ will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Length-for-age z-score (LAZ) at 24 months
LAZ will be calculated for each child at 24 months. Mean differences in LAZ will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Weight-for-length z-score (WLZ) at 24 months
WLZ will be calculated for each child at 24 months. Mean differences in WLZ will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Head circumference-for-age z-score (HCAZ) at 24 months
HCAZ will be calculated for each child at 24 months. Mean differences in HCAZ will be compared between the intervention and control arms.
Measured: Study endline (child age: 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NeurodevelopmentStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Grace John-Stewart, University of Washington
- Investigators
- Grace John-Stewart, Md, PhD, Principal investigator, University of WashingtonAndrew Prendergast, Principal investigator, Queen Mary University of LondonKathleen Powis, Principal investigator, Massachusetts General HospitalDalton Wamalwa, Principal investigator, University of Nairobi / Kenyatta National HospitalIrene Njuguna, Study director, Emory UniversityChristine McGrath, Study director, University of WashingtonAndrew Prendergast, Study director, Queen Mary University of LondonAdam Cassidy, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430826
- Sponsor's protocol ID
- STUDY00022343
- Other IDs
- 1U19HD118601-01
- Acronym
- BONDS
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that is not directly identifiable will be shared.
Publications
World Health Organization. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential [Internet]. Geneva: World Health Organization; 2018. 55 p. Available from: iris.who.int/handle/10665/272603
Wedderburn CJ, Evans C, Yeung S, Gibb DM, Donald KA, Prendergast AJ. Growth and Neurodevelopment of HIV-Exposed Uninfected Children: a Conceptual Framework. Curr HIV/AIDS Rep. 2019 Dec;16(6):501-513. doi: 10.1007/s11904-019-00459-0.
PubMed 31732866Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4.
PubMed 27717632Evans C, Chasekwa B, Ntozini R, Majo FD, Mutasa K, Tavengwa N, Mutasa B, Mbuya MNN, Smith LE, Stoltzfus RJ, Moulton LH, Humphrey JH, Prendergast AJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Mortality, Human Immunodeficiency Virus (HIV) Transmission, and Growth in Children Exposed to HIV in Rural Zimbabwe. Clin Infect Dis. 2021 Feb 16;72(4):586-594. doi: 10.1093/cid/ciaa076.
PubMed 31974572Jeong J, Franchett EE, Ramos de Oliveira CV, Rehmani K, Yousafzai AK. Parenting interventions to promote early child development in the first three years of life: A global systematic review and meta-analysis. PLoS Med. 2021 May 10;18(5):e1003602. doi: 10.1371/journal.pmed.1003602. eCollection 2021 May.
PubMed 33970913Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102.
PubMed 28027368
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Opportunities for Nurturing Care to Enhance Development in Eastern and Southern Africa
- ClinicalTrials.gov ID
- NCT07430826
- Acronym / sponsor ID
- BONDS / STUDY00022343
- Conditions
- Neurodevelopment, Child Growth
- Keywords
- Nurturing Care Framework, CHEU, CHU, Neurodevelopment, Malawi Developmental Assessment Tool, HIV, vocabulary acquisition, functional difficulties
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Feb 2026 (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.
The goal of this randomized controlled trial is to adapt and test a package of interventions to provide nurturing care for children aged 0-2 years in three countries (Botswana, Kenya, Zimbabwe). Mothers living with and without HIV will be enrolled in pregnancy, and their children will be followed for two years. The main objectives of this study are to:
- Determine whether the adapted package of interventions improves neurodevelopment among children with and without in utero HIV exposure
- Identify why the intervention does or does not impact children's neurodevelopment.
Researchers will compare children who receive the intervention package and those who do not to see if the interventions improve child neurodevelopment and growth. Researchers will also compare children with and without HIV exposure to see if there are improvements in neurodevelopment and growth for children who were exposed to HIV.
All participants will attend regular prenatal and postnatal care appointments. Participants who are randomized to receive the package of interventions will attend regularly scheduled visits where they will discuss problem-solving strategies, receive information on healthy foods for children, and learn about how to play with their children. Mothers receiving the intervention package will also have the opportunity to meet with other mothers and babies in small groups where their children can play together.
Detailed description
Prior to enrollment for the clinical trial, the three interventions will be culturally adapted and refined in Botswana and Kenya using a user-centered co-design approach. A 3-day participatory workshop will be held to select appropriate adaptations to the three interventions while maintaining core components. Following these adaptations, ~80 pregnant women/mother-infant pairs will be recruited for a formative pilot to further refine the three interventions. The workshop and pilot activities have already been completed in Zimbabwe under a different protocol.
Following the clinical trial, we will determine how the package of interventions works (or if it does not work, why) to improve child development. Hypothesized causal biological and behavioral pathways include maternal health, including mental health; infant health and nutrition; caregiving quality; and maternal-child interactions. Throughout the clinical trial, both quantitative and qualitative data will be collected to identify determinants of implementation, acceptability, feasibility, appropriateness, and cost of incorporating the intervention package and neurodevelopmental evaluations into regular maternal and child health services across the three countries. Costing data will also be collected from time and motion cards and study budget records to determine the incremental costs of incorporating the intervention package and neurodevelopmental evaluations in the three participating countries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BONDS Intervention | Experimental | Behavioral: Friendship Bench, Behavioral: Infant and Young Child Feeding (IYCF) Curriculum, Behavioral: Play-Based CurriculumThe intervention arm will combine three evidence-based interventions (Friendship Bench, infant and young child feeding curriculum, play-based learning curriculum) in a country-adapted package delivered by CHWs to participants starting in pregnancy and continuing through a child's second year of life. The intervention will be delivered at home, in the community, in a government clinic, or study clinic in the context of ongoing antenatal care and maternal and child health services for pregnant women, mothers, and children. |
| Standard of Care | No intervention | –The standard of care arm includes regular antenatal care and maternal and child health services. These services across the three countries include recommended antenatal care visits during which maternal/fetal health is assessed, antenatal tests are conducted, nutrition supplements and disease prophylaxis are provided, and basic education on danger signs, breastfeeding and nutrition are provided. Postnatal and infant care include family planning, growth monitoring, immunization, and assessment of child development. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant woman attending participating clinics
- ≥15 years of age
- Willing to disclose a known positive HIV status or undergo HIV testing if serostatus is unknown or negative
- Willing to attend follow up visits
- Resides inside of the study catchment area and does not plan to move within the next 2 years
Key exclusion criteria (4 listed)
- Incarcerated individuals
- Pregnant women and mothers who participated in the Aim 1 pilot of the BONDS interventions or has previously participated in the BONDS interventions during the trial
- Any pregnant women and mothers who live in a home in which a BONDS participant has already been enrolled
- Pregnant women, mothers, and babies who have any acute or chronic condition which, in the opinion of the study team, means enrollment in the trial would not be advisable
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 |
|---|---|---|
| Friendship BenchAfter enrollment, participants randomized to BONDS will be linked to a community health worker (CHW) who will arrange Friendship Bench (FB) sessions. During the sessions, participants identify their current stressors, and work with CHWs to consider solutions and select and implement practical solutions. | Behavioural | BONDS Intervention |
| Infant and Young Child Feeding (IYCF) CurriculumCommunity health workers will deliver the infant and young child feeding (IYCF) curriculum between pregnancy and 2 years. Modules in pregnancy will focus on early breastfeeding initiation, exclusive breastfeeding (EBF), how to breastfeed and challenges with breastfeeding. Following birth, modules will reinforce education and support EBF through 6 months and then transition to the introduction of other foods and food preparation demonstrations with continued breastfeeding. | Behavioural | BONDS Intervention |
| Play-Based CurriculumThis parent-focused, play-based intervention addresses responsive caregiving and opportunities for early learning. The intervention will emphasize the importance of early learning experiences and adopting a growth mindset, with common themes including the use of scaffolding and "serve and return" activities. | Behavioural | BONDS Intervention |
Primary outcome
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
Time frame: Study endline (child age: 24 months)
MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 24 months will be compared between the intervention and control arms.
11 secondary outcomes
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
Time frame: Study midline (child age: 12 months)
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
Time frame: Study endline (child age: 24 months)
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
Time frame: Study endline (child age: 24 months)
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
Time frame: Study endline (child age: 24 months)
Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
Time frame: Study endline (child age: 24 months)
Composite Scores of the MacArthur Bates Communicative Development Inventories (CDI) Vocabulary Checklist
Time frame: Study endline (child age: 24 months)
Presence of Functional Difficulties as Assessed by the Washington Group/UNICEF Child Functioning Module (CFM)
Time frame: Study endline (child age: 24 months)
Weight-for-age z-score (WAZ) at 24 months
Time frame: Study endline (child age: 24 months)
Length-for-age z-score (LAZ) at 24 months
Time frame: Study endline (child age: 24 months)
Weight-for-length z-score (WLZ) at 24 months
Time frame: Study endline (child age: 24 months)
Head circumference-for-age z-score (HCAZ) at 24 months
Time frame: Study endline (child age: 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- BackgroundWorld Health Organization. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential [Internet]. Geneva: World Health Organization; 2018. 55 p. Available from: iris.who.int/handle/10665/272603
- Background: PubMed 31732866Wedderburn CJ, Evans C, Yeung S, Gibb DM, Donald KA, Prendergast AJ. Growth and Neurodevelopment of HIV-Exposed Uninfected Children: a Conceptual Framework. Curr HIV/AIDS Rep. 2019 Dec;16(6):501-513. doi: 10.1007/s11904-019-00459-0.
- Background: PubMed 27717632Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4.
- Background: PubMed 31974572Evans C, Chasekwa B, Ntozini R, Majo FD, Mutasa K, Tavengwa N, Mutasa B, Mbuya MNN, Smith LE, Stoltzfus RJ, Moulton LH, Humphrey JH, Prendergast AJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Mortality, Human Immunodeficiency Virus (HIV) Transmission, and Growth in Children Exposed to HIV in Rural Zimbabwe. Clin Infect Dis. 2021 Feb 16;72(4):586-594. doi: 10.1093/cid/ciaa076.
- Background: PubMed 33970913Jeong J, Franchett EE, Ramos de Oliveira CV, Rehmani K, Yousafzai AK. Parenting interventions to promote early child development in the first three years of life: A global systematic review and meta-analysis. PLoS Med. 2021 May 10;18(5):e1003602. doi: 10.1371/journal.pmed.1003602. eCollection 2021 May.
- Background: PubMed 28027368Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102.
- Individual participant dataSharing planned: Yes. All IPD that is not directly identifiable will be shared.
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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.
Grace John-Stewart, Md, PhD principal investigator
University of Washington
Andrew Prendergast principal investigator
Queen Mary University of London
Kathleen Powis principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Friendship Bench, Infant and Young Child Feeding (IYCF) Curriculum and Play-Based Curriculum in people with Neurodevelopment and Child Growth, run by University of Washington.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Nyambura Njuguna (+1-206-519-1275, injugun@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months (time frame: Study endline (child age: 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430826, which also lists 6 linked publications.
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 3 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.