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Cohort Profile
Epidemiology
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Cohort profile: Rahima Moosa Mother and Child Hospital maternal HIV cohort, Johannesburg, South Africa
http://orcid.org/0000-0001-7367-7512
Technau Karl-Günter 1Karl-Gunter.Technau@wits.ac.za

http://orcid.org/0000-0003-4238-0200
Maskew Mhairi 2mmaskew@heroza.org

http://orcid.org/0000-0002-8272-9529
Nattey Cornelius 2cnattey@heroza.org

http://orcid.org/0000-0001-7811-3492
Hwang Candice 23xyhwang@stanford.edu

http://orcid.org/0000-0003-4574-8453
van Dongen Nicola 1nicola.vandongen@wits.ac.za

http://orcid.org/0009-0007-2058-1390
Ferreira Brizido Thalia 1thalia.ferreira@wits.ac.za

Wise Amy 14amyjulietwise@yahoo.co.uk

1 Empilweni Services and Research Unit, Department of Paediatrics and Child Health, Rahima Moosa Mother and Child Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
2 Health Economics and Epidemiology Research Office, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, Gauteng, South Africa
3 Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
4 Department of Obstetrics and Gynaecology, Rahima Moosa Mother and Child Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
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None declared.

DrMhairiMaskew; mmaskew@heroza.org
2024
20 9 2024
14 9 e08508205 2 2024
15 8 2024
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2024
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Abstract

Purpose

The Rahima Moosa Mother and Child Hospital (RMMCH) maternal HIV cohort originated from data systems that were developed to support HIV-related birth care and track outcomes of a complete birth cohort of HIV-exposed infants at Rahima Moosa Hospital and their mothers living with HIV.

Participants

Supported by the Empilweni Services and Research Unit, maternal and infant data from 13 654 pregnant women living with HIV who delivered their infants (and a subset also attended antenatal care) were collected at RMMCH in Johannesburg, South Africa since 2013. Maternal data were collected using counsellor-administered interviews and the 2013–2018 subset of this cohort was linked to the National Health Laboratory Services (NHLS) national HIV cohort—a longitudinal cohort of people living with HIV accessing care in the public sector antiretroviral therapy programme in South Africa that can observe national access to HIV care through laboratory testing data.

Findings to date

Topics addressed by the cohort include antenatal care history, HIV treatment exposure, delivery/birth management, prophylaxis and maternal blood results relevant to HIV captured at delivery. The cohort was also one of the first to describe implementation of early infant diagnosis procedures in South Africa including evaluations of novel point-of-care testing strategies demonstrating improvements in uptake of HIV care among infants accessing point-of-care services.

Future plans

Annual linkage of infant delivery and testing data to longitudinal laboratory test data in the NHLS national HIV cohort is planned to allow for analysis of both infant continuity of care outcomes and as well as evaluation of maternal-infant pair treatment and mobility outcomes in the post partum and later period.

HIV and AIDS
Maternal medicine
EPIDEMIOLOGIC STUDIES
Paediatric infectious disease & immunisation
Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institute of Allergy and Infectious Disease, National Institutes of Health R01 HD103466 R01 HD103466-04S1 U01HD080441 NIH NIH grant number U01AI069924 D43 TW010543
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pmcSTRENGTHS AND LIMITATIONS OF THIS STUDY

The high-quality data collected systematically by trained data collection teams with oversight from clinicians are able to support the management of maternal antiretroviral treatment and infant prophylaxis for several years.

The cohort collects a rich set of data including antenatal care history, HIV treatment exposure, delivery/birth management, early infant diagnosis, prophylaxis and maternal blood results relevant to HIV captured at the point of delivery.

Linkage to the National Health Laboratory Services laboratory datasets also allows for longitudinal outcome ascertainment robust to clinical transfer and national HIV policy changes.

Due to periods of insufficient resources, recruitment occurred through convenience sampling resulting in the somewhat lower coverage and enrolment rates observed in 2018 and 2020.

Coverage of PCR birth testing was high but incomplete and thus we cannot differentiate those who did not have a test from infants for whom tests were conducted but results not available in the dataset.

Introduction

Despite a persistently high antenatal HIV prevalence of around 30% among pregnant women,1 South Africa has made great progress in reducing the vertical transmission of HIV in the first 2 months of life from 23% in 2003 to 0.7% in 2019.2 In January 2015, the vertical transmission prevention (VTP) ‘Option B+’ policy was implemented in South Africa. This policy included the provision of lifelong antiretroviral therapy (ART) irrespective of CD4 count or clinical disease severity, significantly expanding access to ART for pregnant women in the public sector.3 4 As a result, >95% of women with unknown HIV status were tested for HIV during antenatal care (ANC) in 2015–2016, and >90% of women living with HIV were on ART.5 The ‘VTP cascade’, a sequence of key steps that pregnant women living with HIV need to complete in order to minimise the risk of HIV transmission to their babies, includes engaging in ANC, consenting to an HIV test and receiving the HIV test result, initiating and adhering to ART, early HIV diagnosis and ART initiation of HIV-exposed children, adhering to infant antiretroviral (ARV) prophylaxis and treatment.6

Early HIV diagnosis of HIV-exposed children and ART initiation for HIV-infected children depends on early HIV diagnosis in the mother as well as retention of mother–child pairs in HIV care.7 Until recently, the VTP cascade focused primarily on pregnant women who tested HIV positive in initial ANC visits.8 Yet pregnancy and the postpartum period are times of continued high HIV risk for women who initially test HIV negative early in ANC.6911 High HIV viral load in acutely infected women substantially increases the risk of vertical transmission of HIV both during pregnancy and while the baby is breastfed.12 In an effort to identify women who seroconvert after the initial HIV test in ANC, the 2015 South African VTP Option B+ guidelines specify that all pregnant and breastfeeding women are to be included in the VTP programme until breastfeeding stops and that HIV-negative women are offered a repeat HIV test at 3-month intervals during pregnancy and while breastfeeding as well as at delivery and 6 weeks after delivery.7 13 Therefore, optimal uptake of repeat HIV testing during pregnancy and post partum is required as delays in maternal HIV diagnosis both ante-postpartum and postpartum severely limit VTP achievements by curtailing prevention opportunities. In 2013, only 56% of HIV-negative pregnant women retested for HIV by 32 weeks.14 Failures to detect HIV seroconversions in pregnant and breastfeeding women double the risk of vertical transmission and account for nearly 30% of mother-to-child transmission (MTCT) of HIV.11 12 In this regard, attrition at every step of the VTP cascade of all pregnant women and new mothers is an important barrier to VTP.

Cohort description

Participant enrolment and data collection

Rahima Moosa Mother and Child Hospital (RMMCH), supported by the Empilweni Services and Research Unit, collected maternal and infant data from women delivering (and a subset also attending ANC) at the facility in Johannesburg, South Africa over the period 2013–2020 (table 1). The primary outcomes of interest to the HIV-exposed children component of this study were the linking of mothers to their infants in the context of prevention of vertical transmission activities (eg, provision of prophylaxis, maternal antiretroviral treatment and early infant diagnosis (EID)). The RMMCH cohort originated from the need to support and track the outcomes of HIV-exposed infants at Rahima Moosa Hospital and their mothers. Initially, from 2006, the basis of data collection was the infant follow-up clinic where HIV PCR testing at 6 weeks was done for all HIV-exposed infants. Subsequently, with the integration of 6-week HIV PCR testing into routine local clinical care in 2009, data collection efforts shifted towards the delivery and postnatal wards, where maternal testing at delivery was supported. With the low uptake of high-risk birth testing in 2013 and towards universal birth testing in 2014, the cohort and data system were developed to focus on the mother living with HIV and the package of HIV-related care at birth, ultimately to capture a complete RMMCH birth cohort of HIV-exposed infants.

Table 1 Number of mother–infant pairs entering into cohort from 2013 to April 2020 (n=13 318)

Year of delivery	Mother–infant pairs enrolled* (n=13 318)	Mothers on ART at delivery* (n=10 495)	% on ART at delivery	% HIV viral load (VL) suppressed (<400 copies/mL)	
2013	770	592	78%	76%	
2014	2020	1881	89%	55%	
2015	2548	2211	87%	59%	
2016	2591	1836	71%	50%	
2017	2163	1676	77%	51%	
2018†	156	122	79%	42%	
2019	2066	1422	69%	41%	
2020	1012	755	75%	52%	
* 336 records were missing delivery dates and could not be stratified by year

† In 2018, decreased capacity for consenting and interviewing limited enrolment of mother-infant pairs

ARTantiretroviral therapy

The cohort currently includes maternal and infant data for 13 654 women delivering at RMMCH from April 2013 to April 2020; 13 318 of these with positive HIV test results (table 1). Patients admitted to the delivery wards are screened for inclusion in the cohort by trained counsellors conducting HIV testing among mothers at delivery. Mothers known to be living with HIV or newly testing positive for HIV at delivery or thereafter are interviewed by the counsellor and consent for data to be used for research purposes is requested. From April to August 2013, potentially eligible participants were identified through interviewing women needing counselling. From September 2013 to May 2014, recruitment focused on finding all high-risk babies who qualified for birth PCR testing as well as other mothers being interviewed and counselled. Since the implementation of universal birth testing in June 2014, recruitment is aimed at every exposed baby. Data are collected using REDCap (Research Electronic Data Capture), a web application for designing research databases. On average, between 2000 and 2500 women per year were recruited into the cohort. Enrolment peaked in 2016 with 2591 pairs, while the highest percentage of mothers on ART was in 2014 (89%).

Data collected to date

Each year, between 2000 and 2500 births occurred to women living with HIV enrolled in the study. Of the 13 654 women included in the cohort, 45.8% had newly tested positive for HIV during pregnancy and overall 10 786 (79%) were receiving ART (table 1) at the time of delivery with 50% (1394/2781) overall virally supressed. Table 2 summarises the characteristics of these women at enrolment into the cohort. Roughly half of the cohort are South African women (54%), with a median age of 31 years (IQR 26–35 years). Median CD4 count during ANC visit was 390 cells/mm3 (IQR 253–550 cells/mm3). We noted little overall change in median CD4 count category by calendar year of entry to ANC (figure 1), though the proportion entering care with a CD4 count >500 cells/mm3 increased from 29% in 2013 to 34% in 2017.

Table 2 Characteristics of mothers and infants in the RMMCH maternal cohort in Johannesburg, South Africa

Maternal characteristics	Total (n=13 654)	
Nationality		
 South Africa	7302 (53.5%)	
 Non-South African	5375 (39.4%)	
 Unknown	977 (7.1%)	
Age category		
 ≤24 years	2352 (17.2%)	
 25–34 years	7735 (56.7%)	
  >35 years	3222 (23.6%)	
 Missing	345 (2.5%)	
Age, median (IQR)	31 (26–35 years)	
Parity 0	11 (0.1%)	
 1	2734 (20.0%)	
 2–3	8671 (63.5%)	
 4–5	2064 (15.1%)	
  >5	174 (1.3%)	
 Median (IQR)	2.0 (2.0, 3.0)	
Gravidity 1	2233 (16.4%)	
 2–3	8358 (61.2%)	
 4–5	2760 (20.2%)	
  >5	303 (2.2%)	
 Median (IQR)	3.0 (2.0, 3.0)	
Timing of maternal HIV diagnosis		
 Before this pregnancy	5767 (44.2%)	
 During this pregnancy	6252 (45.8%)	
 During labour or after this pregnancy	361 (2.6%)	
 Timing not associated with pregnancy	363 (2.7%)	
 Unknown timing	81 (0.6%)	
 Missing	830 (6.1%)	
Receiving ART?		
 Yes	10 786 (79.0%)	
 No	2868 (21.0%)	
Regimen at initiation		
 Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz (fixed dose combination)	8977 (65.7%)	
 Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz	657 (4.8%)	
 Tenofovir Disoproxil Fumarate/Lamivudine/Aluvia	98 (0.7%)	
 Tenofovir Disoproxil Fumarate/Lamivudine/Nevirapine	242 (1.8%)	
 Zidovudine/Lamivudine/Efavirenz	78 (0.6%)	
 Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir (fixed dose combination)	11 (0.1%)	
 Other	723 (5.3%)	
 Missing	2868 (21.0%)	
CD4 count category during antenatal care		
 Median (IQR)	390 (253–550)	
 <200 cells/mm3	1212 (8.9%)	
 200–<350 cells/mm3	1789 (13.1%)	
 350–500 cells/mm3	1861 (13.6%)	
 >500 cells/mm3	2199 (16.1%)	
 Missing	6593 (48.3%)	
Maternal viral load test available		
 yes (%)	2781 (20.4%)	
 missing (%)	10 873 (79.6%)	
Maternal viral load suppression (among those with a VL test result)	
  ≤1000 copies/mL	1740/2781 (62.6%)	
  <50 copies/mL	375/2781 (13.5%)	
 50–399 copies/mL	1019/2781 (36.6%)	
 400–1000 copies/mL	346/2781 (12.4%)	
  >1000 copies/mL	1041/2781 (37.4%)	
Infant characteristics	Total (n=13 746)	
Sex		
 Female	6566 (47.9%)	
 Male	6820 (49.6%)	
 Missing	360 (2.6%)	
Mode of delivery		
 Normal vaginal delivery	8531 (62.1%)	
 Caesarean section	4403 (32.0%)	
 Missing	812 (5.9%)	
Gestational age at birth (weeks)		
  <28	76 (0.6%)	
 28–31	204 (1.4%)	
 32–36	1128 (8.2%)	
 37–40	6865 (49.9%)	
  >40	1722 (12.5%)	
 Missing	3763 (27.4%)	
 Median gestational age at birth (IQR)	39.0 (38.0, 40.0)	
Birth weight (kg)		
  <1.5 kg	451 (3.3%)	
 1.5–2.5 kg	2171 (15.8%)	
  >2.5 kg	10 621 (77.3%)	
  Missing	503 (3.7)	
 Median birth weight (IQR)	3.0 (2.6, 3.3)	
Birth length (cm) Median (IQR)	50.0 (47.0, 51.0)	
Head circumference (cm) median (IQR)	34.0 (33.0, 35.0)	
RMMCHRahima Moosa Mother and Child Hospital

Figure 1 CD4 count category at entry to antenatal care stratified by calendar year.

We also stratified sociodemographic characteristics of mothers by the timing of maternal HIV diagnosis, comparing women diagnosed with HIV before the index pregnancy to those diagnosed during pregnancy or delivery (online supplemental table 1). We found that women diagnosed before pregnancy have higher gravidity and parity medians compared with those diagnosed during pregnancy or delivery, likely related to HIV testing during prior pregnancies. There were also notable differences in CD4 count and viral load test results. Women diagnosed during pregnancy were more likely to present with lower CD4 counts (<200 and 200–<349 cells/mm3) and were less likely to have a viral load suppressed to <50 copies/mL compared with those diagnosed prior to pregnancy.

The women in this cohort gave birth to 13 746 infants (table 2). Roughly one-third of deliveries (32%) were via caesarean section, slightly higher than reported caesarean section rates for public sector hospitals in Gauteng province (27%) as well as nationally (26%) in 2017.15 Most women with a known gestational age at delivery, did in fact deliver at term (86%) and fewer than 3% delivered very or extremely preterm. There were very few infants with a very low birth weight (3%).

While birth testing was not implemented widely in South Africa prior to 2015, the RMMCH site piloted universal PCR birth testing for infants exposed to HIV during the second half of 2014 and into 2015. Overall, birth tests were observed for 85% of the cohort (n=11 686), with the bulk of missingness accounted for during 2013 and 2014 when PCR testing was being conducted on high-risk infants only (table 3). The estimated overall birth positive rate for infants in the cohort was 1.1%. The peak of 3.2% noted in 2018 occurred during a period of limited enrolment of mother–infant pairs which may have resulted in prioritisation of high-risk pairs and subsequently higher birth positive rates during that time.

Table 3 Estimated birth positive rate stratified by year of delivery (n=13 746)

	HIV PCR birth testing results	
Year of delivery	HIV-positive	HIV-negative	Inconclusive/error	No result observed	
2013	7 (0.9%)	67 (8.7%)	3 (0.4%)	693 (90.0%)	
2014	23 (1.1%)	1340 (66.3%)	18 (0.9%)	639 (31.6%)	
2015	29 (1.1%)	2441 (95.8%)	28 (1.1%)	50 (2.0%)	
2016	39 (1.5%)	2507 (96.8%)	32 (1.2%)	13 (0.5%)	
2017	28 (1.3%)	1942 (89.8%)	35 (1.6%)	158 (7.3%)	
2018*	5 (3.2%)	129 (82.7%)	5 (3.2%)	17 (10.9%)	
2019	18 (0.9%)	1905 (90.1%)	113 (5.3%)	79 (3.7%)	
2020	4 (0.4%)	916 (88.1%)	37 (3.6%)	83 (8.0%)	
Overall	155 (1.1%)	11 260 (81.9%)	271 (2.0%)	2060 (15.0%)	
* In 2018, decreased capacity for consenting and interviewing limited the enrolment of mother-–infant pairs.

The 2013–2018 subset of this cohort was linked to the National Health Laboratory Service (NHLS) national HIV cohort—a longitudinal cohort of people living with HIV-accessing care in the public sector ART programme in South Africa.16 Linkages were conducted through direct stochastic matching of laboratory test barcodes. Validation of a 10% manually matched sample indicated 71% (n=1188) barcodes linked this way were an exact match and a further 22% (n=373) matched on all variables except date of birth where date reversals are common. The final 7% (n=109) could not be matched. Linkage to the NHLS national HIV cohort allows for follow-up of maternal outcomes beyond the period of the original cohort as observed through laboratory tests used to monitor HIV care. As the NHLS is the sole provider of laboratory testing to the public sector in South Africa nationally, it also enables longitudinal assessment of treatment outcomes robust to transfer across facilities.17 Future plans include linkage of infant data from this cohort to the NHLS national HIV cohort to allow for the observation of repeat HIV PCR testing among exposed infants beyond birth test results observed in the RMMCH maternal cohort.

A total of 4865 records of pregnant women living with HIV delivered at RMMCH during the study period 2013–2018 were successfully linked (table 4). Overall, we found 65% of women with evidence of engagement in HIV care prior to entry to ANC. A larger proportion of women (66%) either self-reported prior HIV care or had laboratory evidence of engagement in HIV care before the first ANC visit during the Option B+ era (from 2015 onwards), compared with 55% prior to implementation of Option B+.

Table 4 Subset of the RMMCH maternal HIV cohort linked to the NHLS national HIV cohort (n=4865)

Engagement in HIV care	Prior to Option B+ (n=624)	During Option B+ (n=4241)	Overall(n=4865)	
No evidence of prior engagement in HIV care	279 (45%)	1438 (34%)	1717 (35%)	
Has evidence of prior engagement in HIV care	345 (55%)	2803 (66%)	3148 (65%)	
- Self report only	22/345 (6%)	293/2803 (10%)	315/3148 (10%)	
- Lab data only	186/345 (54%)	1037/2803 (37%)	1223/3148 (39%)	
- Self report + lab data	137/345 (40%)	1473/2803 (53%)	1610/3148 (51%)	
NHLSNational Health Laboratory ServicesRMMCHRahima Moosa Mother and Child Hospital

Patient and public involvement

Study participants and the public were not involved in the study design or conduct of the study. As participants did not consent to follow-up tracing, study results will not be disseminated directly to participants. Results are available to the clinical and data collection teams at RMMCH.

Findings to date

The cohort includes data on maternal ANC, HIV testing and treatment, virological monitoring, infant delivery, birth outcomes and infant HIV testing. The cohort has also been linked to the South African National Population Register which updates mortality data for women with valid South African national identification numbers recorded in the dataset (approximately 7000 mothers). The Rahima Moosa cohort has been used to monitor the expansion of the EID programme and outcomes in HIV-infected infants in South Africa. To date, the cohort has been used to assess several key VTP programmatic indicators:

EID programme implementation. Timely diagnosis of HIV-infected neonates is critical to avert early death. In June 2014, we implemented a universal birth HIV diagnosis programme that saw the vast majority of HIV-positive mothers’ consent to birth testing for 6467 neonates. Among neonates tested, 6210 (97.4%) tested negative, 91 (1.4%) positive, 57 (0.9%) revealed errors and 19 (0.3%) were indeterminate. In the first 2.5 years of operation, our programme successfully achieved high coverage and uptake of birth PCR testing and was able, with active tracking, to start almost all identified HIV-infected neonates on ART.18

Outcomes for HIV-infected infants. We evaluated whether different birth testing approaches were associated with improved clinical outcomes for HIV-infected infants. Different birth testing approaches were implemented in three eras: from September 2013 (era 1), only ‘high risk’ HIV-exposed infants were offered diagnostic HIV PCR tests at birth; after June 2014 (era 2), all HIV-exposed infants were offered laboratory-based diagnostic PCR tests and from October 2014 to June 2016, point-of-care (POC) diagnostic PCR tests were added if staff availability allowed. Of 5449 HIV-exposed infants tested, 88 confirmed cases of HIV infection were identified and 86 started on ART. Age at ART initiation decreased from a median of 9 days in eras 1 and 2 to 2 days in era 3, with neonates who were cotested with POC starting significantly earlier. The probability of mortality by 12 months was 0·14 (95% CI 0·08 to 0·24) and did not differ by eras.19

POC HIV testing in neonates. POC testing is an innovative approach to improve early diagnosis and ART coverage in HIV-infected neonates. While the Cepheid POC testing platform (Cepheid Xpert HIV-1 qualitative test) had laboratory evaluation data, there was little field evaluation data. We demonstrated in 2238 infants with concurrent laboratory-based testing (Roche COBAS TaqMan HIV-1 qualitative test) that this POC test had a sensitivity of 100% (95% CI 88.4 to 100%) and specificity of 99.9% (95% CI 99.7 to 100%). Median time of result return for POC testing was 1 day, significantly earlier than 10 days for laboratory-based testing. ART was initiated in 30 (100%) neonates with positive POC testing compared with 24 (88.9%, p=0.10) of 27 infants who had laboratory-based testing only, with initiation occurring a median of 5 days earlier in the POC group (p<0.0001).20

Diagnostic challenges. We demonstrated the prevalence and outcomes of diagnostic challenges in universal birth testing. In 5743 HIV-exposed neonates, 104 (1.8%) received a non-negative birth PCR result, of which a quarter were indeterminate results. Half of the neonates with indeterminate results were later shown to be HIV infected on confirmatory testing.21

Association between HIV-1 PCR cycle-threshold and infant viral load. In 107 HIV-infected neonates, all had laboratory EID HIV-1 PCR performed at birth, and 59 also had POC EID testing. We found a strong correlation between the PCR cycle-threshold values of both EID assays, and for every one cycle increase there was a 0.3 log10 RNA viral load decrease in the neonate (95% CI −0.3 to −0.2).22

In addition, manuscripts detailing key relationships that could help understand the impact of the Option B+ programme and highlight gaps for improving the implementation strategy and other structures of healthcare service delivery among pregnant women living with HIV are being prepared.

supplementary material

10.1136/bmjopen-2024-085082 online supplemental file 1

Acknowledgements

We wish to acknowledge the research study teams at Rahima Moosa Mother and Child Hospital and the Empilweni Services and Research Unit who collected data on all cohort participants and provided on-going data quality support and access. We also wish to acknowledge the South African National Health Laboratory Services for access to laboratory data.

Data availability statement

Data may be obtained from a third party and are not publicly available.

Review Process File
20 09 2024

Funding: This study was funded by the US National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health & Human Development and the National Institute for Allergy and Infectious Diseases under grant R01 HD103466 and R01 HD103466-04S1. The cohort was also supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institute of Allergy and Infectious Disease, National Institutes of Health under grant U01HD080441 and U01AI069924. Research reported in this publication was also supported by the Fogarty International Center and National Institute of Mental Health, of the National Institutes of Health under Award Number D43 TW010543. The views expressed are solely those of the authors and do not necessarily represent the views of the NIH. The funding source had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data or decision to submit the results.

Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-085082).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Consent obtained directly from patient(s).

Ethics approval: Analyses of data from the Rahima Moosa Mother and Child Hospital Maternal HIV Cohort and linkage of this cohort to laboratory data from the National Health Laboratory Services approved under protocol M200237 of the Human Research Ethics Committee (Medical) of the University of the Witwatersrand.

Data availability free text: The maternal data underlying this article were provided with permission by the data gatekeeper for Rahima Moosa Mother and Child Hospital and the Empilweni Services and Research Unit. Cohort participants provided written consent for data to be used for research purposes, and requests for access can be directed to Empliweni Services and Research Unit, Johannesburg, South Africa (email: karl-Gunter.Technau@wits.ac.za). Laboratory data linked to the maternal cohort are owned by the National Health Laboratory Services and access is governed by policies and procedures in response to requests made directly to the NHLS Office of Academic Affairs and Research. As such, the corresponding author does not have authority to release the data to the public or other data-sharing repositories. However, these data can be requested by the public through standardized request forms, which are then considered in an internal review procedure.

Patient and public involvement: Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

Collaborators: The maternal data underlying this article were provided with permission by the data gatekeeper for Rahima Moosa Mother and Child Hospital and the Empilweni Services and Research Unit. Cohort participants provided written consent for data to be used for research purposes, and requests for access can be directed to Empliweni Services and Research Unit, Johannesburg, South Africa (email: karl-Gunter.Technau@wits.ac.za). Laboratory data linked to the maternal cohort are owned by the National Health Laboratory Services, and access is governed by policies and procedures in response to requests made directly to the NHLS Office of Academic Affairs and Research.
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