How Antiretroviral Therapy Affects Pregnancy Outcomes in South African Women with HIV and Their Children: Insights from the NCDART-MC Study

The Impact of Antiretroviral Therapy on Cardiometabolic Risks and Perinatal Outcomes among Pregnant Women living with HIV and their offspring in South Africa using a life course approach: The NCDART- MC Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202504553455452

Enrollment

2000

Registered

2025-04-11

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Circulatory System HIV/AIDS Mental and Behavioural Disorders Nutritional, Metabolic, Endocrine Pregnancy and Childbirth

Interventions

NCDARTMC Intervention

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Black pregnant women with singleton, uncomplicated pregnancies, aged 18-49 years Women living with HIV (pWLWH) who are on ART either prior to or during pregnancy. Women without HIV (pWWOH) who have tested negative for HIV. Mothers willing to participate in the study, provide informed consent, and commit to a 5-year follow-up with regular assessments every six months/annually with their children. Offspring of both pWLWH and pWWOH to examine the effects of HIV and ART exposure.

Exclusion criteria

Exclusion criteria: Pregnant women with major illnesses, severe mental illness, or substance abuse issues. Women who are bedridden or on any form of medication. Women under the age of 18. Women unwilling to give informed consent. Pregnant women who have eaten, smoked, or engaged in physical exercise within six hours prior to data collection. Individuals with conditions that may interfere with participation and/or the ability to consent.

Design outcomes

Primary

Measure	Time frame
Cardiometabolic Risks: Incidence of gestational hypertension, Incidence of gestational diabetes, Prevalence of dyslipidemia and insulin resistance. Perinatal Outcomes: Rates of preterm birth, Incidence of low birth weight, Frequency of small-for-gestational-age infants. Long-term Health Outcomes: Growth patterns and developmental outcomes in HIV-exposed uninfected (HEU) children, Chronic disease development in mothers and children.	—

Measure

Time frame

Cardiometabolic Risks: Incidence of gestational hypertension, Incidence of gestational diabetes, Prevalence of dyslipidemia and insulin resistance. Perinatal Outcomes: Rates of preterm birth, Incidence of low birth weight, Frequency of small-for-gestational-age infants. Long-term Health Outcomes: Growth patterns and developmental outcomes in HIV-exposed uninfected (HEU) children, Chronic disease development in mothers and children.

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Secondary

Measure	Time frame
Maternal Health: Incidence of chronic diseases postpartum (e.g., cardiovascular diseases, diabetes), Health-related quality of life (HRQoL) ssessments. Child Health: Long-term growth patterns and developmental milestones, Neurodevelopmental assessments (e.g., cognitive, motor, and language skills). Psychosocial Factors: Impact of social stigma and psychological burden on pWLWH, Coping mechanisms and support systems for pWLWH. Molecular Biomarkers: Epigenetic modifications and their association with health outcomes, Biomarker levels related to cardiometabolic risks and developmental disorders.	—

Measure

Time frame

Maternal Health: Incidence of chronic diseases postpartum (e.g., cardiovascular diseases, diabetes), Health-related quality of life (HRQoL) ssessments. Child Health: Long-term growth patterns and developmental milestones, Neurodevelopmental assessments (e.g., cognitive, motor, and language skills). Psychosocial Factors: Impact of social stigma and psychological burden on pWLWH, Coping mechanisms and support systems for pWLWH. Molecular Biomarkers: Epigenetic modifications and their association with health outcomes, Biomarker levels related to cardiometabolic risks and developmental disorders.

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Countries

South Africa

Contacts

Public ContactPerpetua Modjadji

Specialist Sceinetist SAMRC

perpetua.modjadji@mrc.ac.za+27829394363

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026