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BACKGROUND: In most countries, reliable national statistics on femicide, intimate partner femicide (IPF), and non-intimate partner femicide (NIPF) are not available. Surveys are required to collect robust data on this most extreme consequence of intimate partner violence (IPV). We analysed 3 national surveys to compare femicide, IPF, and NIPF from 1999 to 2017 using age-standardised rates (ASRs) and incidence rate ratios (IRRs). METHODS AND FINDINGS: We conducted 3 national mortuary-based retrospective surveys using weighted cluster designs from proportionate random samples of medicolegal laboratories. We included females 14 years and older who were identified as having been murdered in South Africa in 1999 (n = 3,793), 2009 (n = 2,363), and 2017 (n = 2,407). Further information on the murdered cases were collected from crime dockets during interviews with police investigating officers. Our findings show that South Africa had an IPF rate of 4.9/100,000 female population in 2017. All forms of femicide among women 14 years and older declined from 1999 to 2017. For IPF, the ASR was 9.5/100,000 in 1999. Between 1999 and 2009, the decline for NIPF was greater than for IPF (IRR for NIPF 0.47 (95% confidence interval (CI) 0.42 to 0.53) compared to IRR for IPF 0.69 (95% CI 0.63 to 0.77). Rates declined from 2009 to 2017 and did not differ by femicide type. The decline in IPF was initially larger for women aged 14 to 29, and after 2009, it was more pronounced for those aged 30 to 44 years. Study limitations include missing data from the police and having to use imputation to account for missing perpetrator data. CONCLUSIONS: In this study, we observed a reduction in femicide overall and different patterns of change in IPF compared to NIPF. The explanation for the reductions may be due to social and policy interventions aimed at reducing IPV overall, coupled with increased social and economic stability. Our study shows that gender-based violence is preventable even in high-prevalence settings, and evidence-based prevention efforts must be intensified globally. We also show the value of dedicated surveys in the absence of functional information systems.
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Violência por Parceiro Íntimo , Comportamento Sexual , Humanos , Feminino , Estudos Retrospectivos , África do Sul/epidemiologia , Parceiros Sexuais , HomicídioRESUMO
School attendance or completion is important for adolescents' development. Adolescents who drop out or are regularly absent from school are at higher risk of adverse sexual and reproductive health (SRH) outcomes. However, there is little evidence evaluating SRH service coverage among adolescents in and out of school. In the context of a large-scale combination HIV and pregnancy prevention intervention funded by the Global Fund, we compared the SRH intervention coverage and SRH risks among adolescent girls who dropped out of school with those who were still in school or who had completed grade 12 in South Africa. Among those still in school, we compared the SRH intervention coverage and SRH risk profiles of those with high versus low or no absenteeism. In 2017 to 2018, we conducted a household survey of adolescent girls aged 15 to 19 years in six of the ten combination intervention districts. Of 2515 participants, 7.6% had dropped out of school. Among the 1864 participants still in school, 10.8% had high absenteeism. Ever having had sex, and condomless sex were more prevalent among dropouts compared with non-dropouts. Dropouts were more likely to access SRH services such as condoms and contraceptives, except the combination prevention intervention services which were more likely to reach those who had not dropped out and were equally likely to reach those in school with high versus low/no absenteeism. Combination SRH prevention programmes can improve the accessibility of SRH services for adolescents in school/who complete school.
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INTRODUCTION: Despite the numerous efforts and initiatives, males with HIV are still less likely than women to receive HIV treatment. Across Sub-Saharan Africa, men are tested, linked, and retained in HIV care at lower rates than women, and South Africa is no exception. This is despite the introduction of the universal test-and-treat (UTT) prevention strategy anticipated to improve the uptake of HIV services. The aim of this study was to investigate linkage to and retention in care rates of an HIV-positive cohort of men in a high HIV prevalence rural district in KwaZulu-Natal province, South Africa. METHODS: From January 2018 to July 2019, we conducted an observational cohort study in 18 primary health care institutions in the uThukela district. Patient-level survey and clinical data were collected at baseline, 4-months and 12-months, using isiZulu and English REDCap-based questionnaires. We verified data through TIER.Net, Rapid mortality survey (RMS), and the National Health Laboratory Service (NHLS) databases. Data were analyzed using STATA version 15.1, with confidence intervals and p-value of ≤0.05 considered statistically significant. RESULTS: The study sample consisted of 343 male participants diagnosed with HIV and who reside in uThukela District. The median age was 33 years (interquartile range (IQR): 29-40), and more than half (56%; n = 193) were aged 18-34 years. Almost all participants (99.7%; n = 342) were Black African, with 84.5% (n = 290) being in a romantic relationship. The majority of participants (85%; n = 292) were linked to care within three months of follow-up. Short-term retention in care (≤ 12 months) was 46% (n = 132) among men who were linked to care within three months. CONCLUSION: While the implementation of the UTT strategy has had positive influence on improving linkage to care, men's access of HIV treatment remains inconsistent and may require additional innovative strategies.
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Infecções por HIV , Adolescente , Adulto , Humanos , Masculino , Adulto Jovem , Estudos de Coortes , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Infecções por HIV/terapia , Homens , África do Sul/epidemiologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Due to its potential nephrotoxicity, screening for pre-existing renal function disorders has become a routine clinical assessment for initiating Tenofovir diphosphate fumarate (TDF)-containing antiretroviral treatment (ART) or pre-exposure prophylaxis (PrEP) in pregnant and non-pregnant adults. We aimed to establish reference values for commonly used markers of renal function in healthy pregnant women of African origin. METHODS: Pregnant women ≥18 years, not living with HIV, and at 14-28 weeks gestation were enrolled in a PrEP clinical trial in Durban, South Africa between September 2017 and December 2019. Women were monitored 4-weekly during pregnancy until six months postpartum. We measured maternal weight and serum creatinine (sCr) at each visit and calculated creatinine clearance (CrCl) rates using the Cockcroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD) formulae. Reference ranges for sCr and CrCl by CG and MDRD calculations were derived from the mean ± 2SD of values for pregnancy and postdelivery. RESULTS: Between 14--and 40 weeks gestation, 249 African women not exposed to TDF-PrEP contributed a total of 1193 renal function values. Postdelivery, 207 of these women contributed to 800 renal function values. The normal reference range for sCr was 30-57 and 32-60 umol/l in the 2nd and 3rd trimesters of pregnancy. Normal reference ranges for CrCl using the MDRD calculation were 129-282 and 119-267 ml/min/1.73m2 for the 2nd and 3rd trimesters, respectively. Using the CG method of calculation, normal reference ranges for CrCl were 120-304 and 123-309 ml/min/1.73m2 for the 2nd and 3rd trimesters respectively. In comparison, the normal reference range for sCr, CrCl by MDRD and CG calculations postpartum was 40-77 umol/l, 92-201, and 90-238 ml/min/1.73m2, respectively. CONCLUSIONS: In African women, the Upper Limit of Normal (ULN) for sCr in pregnancy is approximately 20% lower than 6 months postnatally. Inversely, the Lower Limit of Normal (LLN) for CrCl using either MDRD or CG equation is approximately 35% higher than 6 months postnatally. We provide normal reference ranges for sCr and CrCl for both methods of calculation and appropriate for the 2nd and 3rd trimesters of pregnancy in African women.
Screening for pre-existing renal function disorders has become a routine clinical assessment for initiating TDF-containing antiretroviral treatment or pre-exposure prophylaxis in adults including pregnant women. Pregnancy inherently increases renal function, hence normal reference standards for non-pregnant adults cannot be used for pregnant women. In a secondary analysis of data from a healthy pregnant population not living with HIV who participated in a PrEP clinical trial, we established reference intervals for serum creatinine (sCr) concentration and creatinine clearance (CrCl) during pregnancy and postpartum in an African population. Using sCr and CrCl values for 249 healthy pregnant African women, we can confirm that the upper limit of normal for sCr in pregnancy is 20% lower than that for the 6-month postnatal period and recommend an upper limit of 57 umol/l and 60 umol/l in the second and third trimesters respectively to determine normal renal function in pregnant African women.We further determined the lower limit of normal for creatinine clearance using two methods of calculation, which was 35% higher than that of the postnatal period. Using the modification of diet in renal disease calculation, we recommend a lower limit of 129 and 119 ml/min/1.73m2 for the second and third trimesters respectively. Using the CockcroftGault calculation, we recommend a lower limit of 120 and 123 ml/min/1.73m2 for the second and third trimesters respectively. Using current standard cut-off values estimated for adults may lead to underreporting of abnormal renal function in African pregnant women.
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Creatinina , Humanos , Feminino , Gravidez , Valores de Referência , Adulto , Creatinina/sangue , Testes de Função Renal/métodos , África do Sul , Rim/fisiopatologia , Adulto Jovem , Infecções por HIV/tratamento farmacológico , Tenofovir/efeitos adversos , Fármacos Anti-HIV/efeitos adversosRESUMO
Higher exercise heart rate (HR) and prolonged return-to-sport in athletes with SARS-CoV-2 infection are described, but the cardiovascular response to exercise during recovery is not understood. This prospective, cohort, experimental study with repeated measures evaluated the cardiovascular response to exercise over 16 weeks in athletes recovering from SARS-CoV-2 infection. Athletes (n = 82) completed 2-5 repeat assessments at regulated intervals over 16 weeks post-SARS-CoV-2 infection. Data from 287 assessments (submaximal exercise tests; Modified Bruce protocol) are included. HR (bpm), systolic blood pressure (SBP) (mmHg) and rating of perceived exertion (RPE) (Borg scale 6-20) were measured. Rates of change in HR, SBP and RPE over time are reported. Submaximal exercise HR, SBP and RPE decreased significantly over 16 weeks (p < 0.01). There was a steeper rate of decline for HR and RPE ≤30 days compared to >30 days after SARS-CoV-2 infection: HR at Stage 3: ≤30 days -0.53 (0.01); >30 days -0.06 (0.02) and Stage 5: ≤30 days -0.77 (0.12); >30 days -0.12 (0.02); RPE at Stage 3: ≤30 days -0.09 (0.02); >30 days -0.01 (0.0002) and Stage 5: ≤30 days -0.13 (0.02); >30 days -0.02 (0.004). The findings provide clinical recommendation for exercise prescription and monitoring RPE in response to exercise post-SARS-CoV-2 infection and contribute to the clinical understanding of recovery which can help manage athlete expectations.
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COVID-19 , Esforço Físico , Humanos , Estudos Prospectivos , Esforço Físico/fisiologia , SARS-CoV-2 , Teste de Esforço/métodos , Frequência Cardíaca/fisiologia , AtletasRESUMO
Background: Trauma exposure prevalence and consequent post-traumatic stress disorder among South African adolescents are significant. Sleep disturbances are among the most frequently reported difficulties faced by those dealing with PTSD. The current study examined the feasibility and preliminary efficacy of the South African Adolescence Group Sleep Intervention on PTSD symptom severity and sleep disturbance.Method: Sixty-one adolescents with PTSD diagnoses and sleep disturbance were randomly assigned (1:1) to one individual and four group sessions of a sleep intervention (SAASI) or a control group. Participants completed the Child PTSD symptom scale for DSM5 (CPSS-5) and the Pittsburgh Sleep Quality Index (PSQI) among other sleep and psychiatric measures. The trial was registered on the Pan African Trial Registry (PACTR202208559723690).Results: There was a significant but similar decrease in PSQI scores in both groups over time indicating no overall intervention effect (Wald test = -2.18, p = .029), mean slope = -0.2 (95% CI: -0.37 to -0.02) (p = .583). On the CPSS-5, interaction between groups was also not significant (p = .291). Despite this overall finding, the mean difference in CPSS-SR-5 scores increased over time, with the difference between groups post-treatment -9.10 (95%CI: -18.00 to -0.21), p = .045 and the 1-month follow-up contrast - 11.22 (95%CI: -22.43 to -0.03), p = .049 suggesting that PTSD symptom severity decreased more in the intervention group than the control group. The dropout rate was higher than expected for both the intervention (n = 10; 32%) and control (n = 8; 26.7%) groups. Dropout were mostly school commitments or travel related.Conclusions: Early findings suggest a trend towards dual improvement in sleep quality and PTSD symptom severity in adolescents with a sleep disturbance and PTSD receiving a group sleep intervention (SAASI). Further investigation in a properly powered RCT with detailed retention planning is indicated.
A four-week group sleep intervention seems feasible in adolescents with PTSD and sleep disturbances in a low-resource South African setting.Utilising less specialised mental health resources such as nurses and counsellors in intervention delivery was feasible and effective.Preliminary results are promising and support further research to establish the efficacy of the intervention.
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Transtornos do Sono-Vigília , Transtornos de Estresse Pós-Traumáticos , Humanos , Transtornos de Estresse Pós-Traumáticos/terapia , Masculino , Feminino , Adolescente , África do Sul , Projetos Piloto , Psicoterapia de Grupo , Sono/fisiologiaRESUMO
Not much is known about the perpetrators of male homicide in South Africa, which has rates seven times the global average. For the country's first ever male homicide study we describe the epidemiology of perpetrators, their relationship with victims and victim profiles of men killed by male versus female perpetrators. We conducted a retrospective descriptive study of routine data collected through forensic and police investigations, calculating victim and perpetrator homicide rates by age, sex, race, external cause, employment status and setting, stratified by victim-perpetrator relationships. For perpetrators, we reported suspected drug and alcohol use, prior convictions, gang-involvement and homicide by multiple perpetrators. Perpetrators were acquaintances in 63% of 5594 cases in which a main perpetrator was identified. Sharp objects followed by guns were the main external causes of death. The highest rates were recorded in urban informal areas among unemployed men across all victim-perpetrator relationship types. Recreational settings including bars featured prominently. Homicides clustered around festive periods and weekends, both of which are associated with heavy episodic drinking. Perpetrator alcohol use was reported in 41% of homicides by family members and 50% by acquaintances. Other drug use was less common (9% overall). Of 379 men killed by female perpetrators, 60% were killed by intimate partners. Perpetrator alcohol use was reported in approximately half of female-on-male murders. Female firearm use was exclusively against intimate partners. No men were killed by male intimate partners. Violence prevention, which in South Africa has mainly focused on women and children, needs to be integrated into an inclusive approach. Profiling victims and perpetrators of male homicide is an important and necessary first step to challenge prevailing masculine social constructs that men are neither vulnerable to, nor the victims of, trauma and to identify groups at risk of victimisation that could benefit from specific interventions and policies.
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Homicídio , Polícia , Criança , Humanos , Masculino , Feminino , África do Sul/epidemiologia , Estudos Retrospectivos , ViolênciaRESUMO
BACKGROUND: Population-based statistics on deaths from child abuse and neglect are only routinely available in countries that have reliable national statistics on child murder. For low-income and middle-income countries, relatively little is known about prevalence trends of child murder. South Africa is an exception, having conducted dedicated national studies on child murders for 2009 and 2017 to provide data on child murders overall and on child abuse and neglect-related murders. We aimed to compare child abuse and neglect-related murders in South Africa across two surveys to determine any change between 2009 and 2017. METHODS: We conducted two retrospective national mortuary-based surveys on murder of children aged 0-17 years for 2009 and 2017 from a proportionate random sample of medico-legal laboratories in South Africa. A sampling frame of medico-legal laboratories for each study year was prepared with stratification by medico-legal laboratory size. A minimum of 2 years after the crime was allowed before data collection to enable progression of the investigation process. Child abuse and neglect-related murders were identified using both medico-legal laboratory post-mortem autopsy reports and police data. To identify a child abuse and neglect-related murder, we primarily used the framework of abuse happening within the context of responsibility of care arrangements but broadened this to include all perpetrators and abuse identified from the data. We stratified age into 0-4, 5-9, 10-14, and 15-17 years and further stratified children younger than 5 years into early neonates (newborns killed within 6 days of birth), 7 days to 11 months, and 1-4 years. We calculated incidence rate ratios (IRR) with 95% CIs to compare rates between 2009 and 2017. FINDINGS: An estimated 458 (95% CI 377-539) children in 2009 and 213 (179-247) children in 2017 were murdered in circumstances of child abuse and neglect. The percentage of all child murders that were child abuse and neglect-related declined from 2009 to 2017 (458 [45·0%] of 1018 in 2009 vs 213 [25·0%] of 851 in 2017), with the overall age-standardised rate decreasing from 2·6 to 1·1 per 100 000 children aged 0-17 years (IRR 0·43 [95% CI 0·35-0·54]). Girls represented 276 (60·3%) of 458 murders in 2009, which declined to 96 (45·1%) of 213 murders in 2017, and boys represented 178 (38·9%) of 458 murders in 2009 and 109 (51·4%) of 213 murders in 2017. The decrease was statistically significant for girls in the 0-4 year (IRR 0·33 [0·22-0·49]) and 5-9 year (0·33 [0·15-0·73]) age groups and for boys in the 0-4 year age group (0·49 [0·33-0·71]). Among early neonates (within 6 days of birth), the decrease in child abuse and neglect-related murders was more pronounced among girls than among boys (IRR 0·33 [95% CI 0·19-0·56] vs 0·46 [0·28-0·77]). INTERPRETATION: Child abuse and neglect-related murders are common in South Africa but our study shows that they can be reduced. The high rate of these murders points to the need to continue research and monitoring to inform priority targeted interventions and to better understand the impact of child support policies. FUNDING: Ford Foundation and South African Medical Research Council.
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Maus-Tratos Infantis , Homicídio , Humanos , Maus-Tratos Infantis/estatística & dados numéricos , África do Sul/epidemiologia , Lactente , Criança , Homicídio/estatística & dados numéricos , Pré-Escolar , Adolescente , Feminino , Masculino , Estudos Retrospectivos , Recém-Nascido , Prevalência , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Injuries, often preventable, prompted urgent action within the United Nations' 2030 Agenda for Sustainable Development Goals (SDGs) to improve global health. South Africa (SA) has high rates of injury mortality, but accurate reporting of official national data is hindered by death misclassification. OBJECTIVE: Two nationally representative surveys for 2009 and 2017 are utilised to assess SA's progress towards SDG targets for violence and road traffic injuries, alongside changes in suicide and under-5 mortality rates for childhood injuries, and compare these estimates with those of the Global Burden of Disease for SA. METHODS: The surveys utilised multi-stage, stratified cluster sampling from eight provinces, with mortuaries as primary sampling units. Post-mortem files for non-natural deaths were reviewed, with additional data from the Western Cape. Age-standardised rates, 95% confidence intervals (CIs), and incidence rate ratios (IRRs) were calculated for manner of death rate comparisons and for age groups. RESULTS: The all-injury age-standardised mortality rate decreased significantly between 2009 and 2017. Homicide and transport remained the leading causes of injury deaths, with a significant 31% decrease in road traffic mortality (IRR = 0.69), from 36.1 to 25.0 per 100 000 population. CONCLUSIONS: Despite a reduction in SA's road traffic mortality rate, challenges to achieve targets related to young and novice drivers and male homicide persist. Achieving SA's injury mortality SDG targets requires comprehensive evaluations of programmes addressing road safety, violence reduction, and mental well-being. In the absence of reliable routine data, survey data allow to accurately assess the country's SDG progress through commitment to evidence-based policymaking.
Main findings The significant decrease in South Africa's injury mortality rates between 2009 and 2017 appears to largely be driven by the significant 31% decrease in road traffic mortality rates.Added knowledge The 2009 and 2017 survey comparison provides an enhanced understanding of the profile for injury-related deaths, compared to misclassified vital statistics data, to track progress towards reaching Sustainable Development Goals.Global health impact for policy and action The significant reduction in road traffic mortality across all age groups suggests South Africa is making progress towards Sustainable Development Goal Target 3.6 for road safety. However, reducing violence, suicide, and newborn and under-5 injury mortality requires more targeted interventions.
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Acidentes de Trânsito , Desenvolvimento Sustentável , Ferimentos e Lesões , Humanos , África do Sul/epidemiologia , Ferimentos e Lesões/mortalidade , Criança , Masculino , Feminino , Acidentes de Trânsito/mortalidade , Adulto , Pré-Escolar , Adolescente , Lactente , Pessoa de Meia-Idade , Adulto Jovem , Violência/estatística & dados numéricos , Idoso , Causas de Morte , Suicídio/estatística & dados numéricos , Recém-Nascido , Homicídio/estatística & dados numéricos , Carga Global da Doença , Inquéritos e QuestionáriosRESUMO
BACKGROUND: When caregivers live in remote settings characterised by extreme poverty, poor access to health services, and high rates of HIV/AIDS, their caregiving ability and children's development might be compromised. We aimed to test the effectiveness of a community-based child health and parenting intervention to improve child HIV testing, health, and development in rural Lesotho. METHODS: We implemented a matched cluster-randomised, controlled trial in the Mokhotlong district in northeastern Lesotho with 34 community clusters randomly assigned to intervention or wait-list control groups within a pair. Eligible clusters were villages with non-governmental organisation partner presence and an active preschool. Participants were caregiver-child dyads, where the child was 12-60 months old at baseline. The intervention consisted of eight group sessions delivered at informal preschools to all children in each village. Mobile health events were hosted for all intervention (n=17) and control (n=17) clusters, offering HIV testing and other health services to all community members. Primary outcomes were caregiver-reported child HIV testing, child language development, and child attention. Assessments were done at baseline, immediately post-intervention (3 months post-baseline), and 12 months post-intervention. We assessed child language by means of one caregiver-report measure (MacArthur-Bates Communicative Development Inventory [CDI]) and used two observational assessments of receptive language (the Mullen Scales of Early Learning receptive language subscale, and the Peabody Picture Vocabulary Test 4th edn). Child attention was assessed by means of the Early Childhood Vigilance Task. Assessors were masked to group assignment. Analysis was by intention to treat. This trial was registered with ISRCTN.com, ISRCTN16654287 and is completed. FINDINGS: Between Aug 8, 2015, and Dec 10, 2017, 1040 children (531 intervention; 509 control) and their caregivers were enrolled in 34 clusters (17 intervention; 17 control). Compared with controls, the intervention group reported significantly higher child HIV testing at the 12-month follow-up (relative risk [RR] 1·46, 95% CI 1·29 to 1·65, p<0·0001), but not immediately post-intervention. The intervention group showed significantly higher child receptive language on the caregiver report (CDI) at immediate (effect size 3·79, 95% CI 0·78 to 6·79, p=0·028) but not at 12-month follow-up (effect size 2·96, 95% CI -0·10 to 5·98, p=0·056). There were no significant group differences for the direct assessments of receptive language. Child expressive language and child attention did not differ significantly between groups. INTERPRETATION: Integrated child health and parenting interventions, delivered by trained and supervised lay health workers, can improve both child HIV testing and child development. FUNDING: United States Agency for International Development (USAID) and the President's Emergency Plan for AIDS Relief (PEPFAR).
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Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Humanos , Pré-Escolar , Criança , Lactente , Poder Familiar , Saúde da Criança , Lesoto , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Teste de HIV , População RuralRESUMO
INTRODUCTION: South Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months' post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package. METHODS AND ANALYSES: Convergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24-36 weeks' gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6-8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6-8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention. ETHICS AND DISSEMINATION: Ethics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers. PROTOCOL VERSION: 1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries. TRIAL REGISTRATION NUMBER: PAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).