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BackgroundMonitoring HIV infection rates is needed to guide health interventions and assess their impact, especially in highly vulnerable groups to the infection such as pregnant women. This study describes the trends of HIV infection over 10 years in pregnant women attending antenatal care (ANC) clinics in southern Mozambique.MethodsData collected as part of three studies undertaken between 2010 and 2021 in HIV-infected pregnant women attending the ANC clinic were analysed. HIV incidence was estimated between prevalence points using two validated methods, one based on mortality rates and the other on survival information after HIV infection. Trends over time were obtained by fitting a second-order orthogonal polynomial regression model. ResultsOverall, 10392 pregnant women attending their first ANC visit were included in the analysis. There was a decrease of the HIV prevalence from 33.9% (95% CI: 30.9–36.9%) in 2010 to 21.4% (95% CI: 19.6–23.2%) in 2021, after a peak of 35.3% (95% CI: 30.1–40.8%) in 2016. Regarding maternal age, prevalence of infection was highest in women aged 20–25 in 2010 progressively increasing in older women being the highest in 35–40 year old women in 2021. HIV infection incidence increased from 3.7 per 100 person-years during 2010–2016 to 10.1 per 100 person-years in 2018–2019, decreased to 6.2 per 100 person-years in 2020–2021. ConclusionIn the last decade, there was an initial increase of the prevalence and incidence of HIV followed by a downward trend, in this area of southern Mozambique. This encouraging trend may be attributable to the massive expansion of antiretroviral therapy during 2010–2021 in Mozambique. However, the burden HIV remains unacceptably high in this particularly vulnerable group, calling for a need to strengthen HIV preventive strategies to ending HIV/AIDs in the country.

Background HIV-infected pregnant women (HIVPW) are especially susceptible to malaria infection. However, HIVPW cannot receive the recommended malaria Intermittent Preventive Treatment (IPTp) with sulphadoxine-pyrimethamine due to potential adverse reactions with cotrimoxazole, which is given to HIV-infected individuals to prevent opportunistic infections. Within the scope of a clinical trial to evaluate the safety and efficacy of dihydroartemisinin-piperaquine (DHA-PPQ) as IPTp in HIVPW, we aimed to explore pregnant women’s acceptability of DHA-PPQ in the Manhiça District Hospital, Mozambique. Methods A qualitative study was conducted from December-2019 to October-2020 including 44 HIVPW participating in the clinical trial, 35 HIV-uninfected pregnant women attending the antenatal care clinic and eight health care providers (HCPs). Information was obtained through semi-structured and in-depth interviews. The interviews were recorded, transcribed, coded, and a combination of content and thematic analysis was performed. Results All the HIVPW took monthly doses of DHA-PPQ until delivery. They stated that the main motivation for accepting DHA-PPQ was the belief that guidance from healthcare providers should not be refused. Despite some HIVPW reporting vertigo, vomiting, and malaise after taking DHA-PPQ, they expressed willingness to use it in a future pregnancy, believing it contributed to a healthy outcome. Pregnant women and HCPs indicated that factors supporting DHA-PPQ acceptability include information on the benefits of IPTp, testimonials from women who have previously taken DHA-PPQ, and home delivery of DHA-PPQ by HCPs. The perception that home dispensing of DHA-PPQ (a medication administered only for HIVPW) could affect measures taken to ensure HIV-infection confidentiality was not found to be a potential barrier to DHA-PPQ acceptability when delivered in HIVPW’s homes. Conclusion The acceptability of DHA-PPQ among HIVPW appears to be influenced more by trust in healthcare providers rather than by the perceived benefits of the medication itself. Leveraging this trust to enhance awareness and understanding of DHA-PPQ’s benefits could further improve its acceptability. Moreover, further implementation research focused on acceptability in a real-world environment is essential to deepen the understanding of DHA-PPQ acceptability beyond the clinical trial setting, and inform policy decisions accordingly.

Background Monitoring HIV infection estimates is critical to guide health interventions and assess their impact, especially in highly vulnerable groups to the infection such as African pregnant women. This study describes the trends of HIV infection over eleven years in women attending selected antenatal care (ANC) clinics from southern Mozambique. Methods We performed a secondary analysis of data registered at the ANC clinic of the Manhiça District Hospital and from the Ministry of Health's HIV National Program Registry between 2010 and 2021. HIV incidence was calculated using prevalence estimates. HIV incidence trends over time were obtained by fitting splines regression model. Results Data from 21,810 pregnant women were included in the analysis. Overall HIV prevalence was 29.3% (95% CI: 28.7–29.9), with a reduction from 28.2% (95% CI: 25.6–30.8) in 2010 to 21.7% (95% CI: 19.8–23.6) in 2021, except for a peak in prevalence (35.3%, 95% CI: 30.1–40.8) in 2016. Over the study period, by maternal age group, the largest reduction in HIV prevalence was in the 15–20 year-old group [62% reduction, from 14.3% (95% CI 10.8–18.4) to 5.3% (95% CI: 3.6–7.5)], followed by the 20–25 year old group [43% reduction, from 29.0% (95% CI: 24.2–34.5) to 16.6% (95% CI: 13.6–19.8)] and the 25–30 year old group [13% reduction, from 36.9% (95% CI: 31.0–43.1) to 32.0% (95% CI: 27.3–37.0)] ( p  < 0.001). Incidence of HIV infection increased from 12.75 per 100 person-years in 2010 to 18.65 per 100 person-years in 2018, and then decreased to 11.48 per 100 person-years in 2021. Conclusions The prevalence of HIV decreased while the overall incidence stayed similar in Mozambican pregnant women, during 2010 to 2021. However, both estimates remain unacceptably high, which indicates the need to revise current preventive policies and implement effective ones to improve HIV control among pregnant women.

Background Information on the frequency and clinical features of advanced HIV disease (AHD) in pregnancy and its effects on maternal and perinatal outcomes is limited. The objective of this study was to describe the prevalence and clinical presentation of AHD in pregnancy, and to assess the impact of AHD in maternal and perinatal outcomes in Mozambican pregnant women. Methods This is a prospective and retrospective cohort study including HIV-infected pregnant women who attended the antenatal care (ANC) clinic at the Manhiça District Hospital between 2015 and 2020. Women were followed up for 36 months. Levels of CD4 + cell count were determined to assess AHD immune-suppressive changes. Risk factors for AHD were analyzed and the immune-suppressive changes over time and the effect of AHD on pregnancy outcomes were assessed. Results A total of 2458 HIV-infected pregnant women were enrolled. The prevalence of AHD at first ANC visit was 14.2% (349/2458). Among women with AHD at enrolment, 76.2% (260/341) were on antiretroviral therapy (ART). The proportion of women with AHD increased with age reaching 20.5% in those older than 35 years of age ( p  < 0.001). Tuberculosis was the only opportunistic infection diagnosed in women with AHD [4.9% (17/349)]. There was a trend for increased CD4 + cell count in women without AHD during the follow up period; however, in women with AHD the CD4 + cell count remained below 200 cells/mm 3 ( p  < 0.001). Forty-two out of 2458 (1.7%) of the women were severely immunosuppressed (CD4 + cell count < 50 cells/mm3). No significant differences were detected between women with and without AHD in the frequency of maternal mortality, preterm birth, low birth weight and neonatal HIV infection. Conclusions After more than two decades of roll out of ART in Mozambique, over 14% and nearly 2% of HIV-infected pregnant women present at first ANC clinic visit with AHD and severe immunosuppression, respectively. Prompt HIV diagnosis in women of childbearing age, effective linkage to HIV care with an optimal ART regimen and close monitoring after ART initiation may contribute to reduce this burden and improve maternal and child survival.

IntroductionPregnant women are currently considered a vulnerable population to SARS-CoV-2 infection, with increased risk of severe COVID-19, preterm birth and maternal mortality. There is, however, a paucity of data on the burden of maternal SARS-CoV-2 infection in sub-Saharan countries. The objective of this study is to determine the prevalence and health effects of maternal SARS-CoV-2 infection in selected sites from Gabon and Mozambique.Methods and analysisMA-CoV (MAternal CoVid) is an observational, multicentre prospective cohort study where 1000 pregnant women (500 per country) will be enrolled at the antenatal clinic visits. Participants will undergo monthly follow-up at each antenatal care visit, delivery and postpartum visit. The primary study outcome is the prevalence of SARS-CoV-2 infection during pregnancy. The clinical presentation of COVID-19 in pregnancy will also be characterised, and incidence of infection during pregnancy will be evaluated, as well as the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the risk of mother to child transmission of SARS-CoV-2. SARS-CoV-2 infection screening will be performed through PCR diagnosis.Ethics and disseminationThe protocol was reviewed and approved by the Comité National d’Éthique pour la Recherche au Gabon, Comité Nacional de Bioética para Saúde de Moçambique and the Ethics Committee of the Hospital Clinic of Barcelona (Spain). Project results will be presented to all stakeholders and published in open access journals.Trial registration numberNCT05303168.

The cornerstone of malaria prevention in pregnancy, intermittent preventive treatment (IPTp) with sulfadoxine–pyrimethamine, is contraindicated in women with HIV who are receiving co-trimoxazole prophylaxis. We assessed whether IPTp with dihydroartemisinin–piperaquine is safe and effective in reducing the risk of malaria infection in women with HIV receiving co-trimoxazole prophylaxis and antiretroviral drugs. For this randomised, double-blind, placebo-controlled clinical trial, women with HIV attending the first antenatal care clinic visit, resident in the study area, and with a gestational age up to 28 weeks were enrolled at five sites in Gabon and Mozambique. Participants were randomly assigned (1:1) to receive either IPTp with dihydroartemisinin–piperaquine at each scheduled antenatal care visit plus daily co-trimoxazole (intervention group) or placebo at each scheduled antenatal care visit plus daily co-trimoxazole (control group). Randomisation was done centrally via block randomisation (block sizes of eight), stratified by country. IPTp was given over 3 days under direct observation by masked study personnel. The number of daily IPTp tablets was based on bodyweight and according to the treatment guidelines set by WHO (target dose of 4 mg/kg per day [range 2–10 mg/kg per day] of dihydroartemisinin and 18 mg/kg per day [range 16–27 mg/kg per day] of piperaquine given once a day for 3 days). At enrolment, all participants received co-trimoxazole (fixed combination drug containing 800 mg trimethoprim and 160 mg sulfamethoxazole) for daily intake. The primary study outcome was prevalence of peripheral parasitaemia detected by microscopy at delivery. The modified intention-to-treat population included all randomly assigned women who had data for the primary outcome. Secondary outcomes included frequency of adverse events, incidence of clinical malaria during pregnancy, and frequency of poor pregnancy outcomes. All study personnel, investigators, outcome assessors, data analysts, and participants were masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT03671109. From Sept 18, 2019, to Nov 26, 2021, 666 women (mean age 28·5 years [SD 6·4]) were enrolled and randomly assigned to the intervention (n=332) and control (n=334) groups. 294 women in the intervention group and 308 women in the control group had peripheral blood samples taken at delivery and were included in the primary analysis. Peripheral parasitaemia at delivery was detected in one (<1%) of 294 women in the intervention group and none of 308 women in the control group. The incidence of clinical malaria during pregnancy was lower in the intervention group than in the control group (one episode in the intervention group vs six in the control group; relative risk [RR] 0·12, 95% CI 0·03–0·52, p=0·045). In a post-hoc analysis, the composite outcome of overall malaria infection (detected by any diagnostic test during pregnancy or delivery) was lower in the intervention group than in the control group (14 [5%] of 311 women vs 31 [10%] of 320 women; RR 0·48, 95% CI 0·27–0·84, p=0·010). The frequency of serious adverse events and poor pregnancy outcomes (such as miscarriages, stillbirths, premature births, and congenital malformations) did not differ between groups. The most frequently reported drug-related adverse events were gastrointestinal disorder (reported in less than 4% of participants) and headache (reported in less than 2% of participants), with no differences between study groups. In the context of low malaria transmission, the addition of IPTp with dihydroartemisinin–piperaquine to co-trimoxazole prophylaxis in pregnant women with HIV did not reduce peripheral parasitaemia at delivery. However, the intervention was safe and associated with a decreased risk of clinical malaria and overall Plasmodium falciparum infection, so it should be considered as a strategy to protect pregnant women with HIV from malaria. European and Developing Countries Clinical Trials Partnership 2 (EDCTP2) and Medicines for Malaria Venture. For the Portuguese and French translations of the abstract see Supplementary Materials section.