Safety of Janssen Ad26.COV.S and Astra Zeneca AZD1222 COVID-19 Vaccines among Mobile Phone Users in Malawi: Findings from a National Mobile-Based Syndromic Surveillance Survey, July 2021 to December 2021.

The safety profiles of the Ad26.COV2.S and AZD1222 COVID-19 vaccines have not been described in the general population in Malawi. We present self-reported adverse events (AE) following the receipt of these vaccines in Malawi as part of a national syndromic surveillance survey. We conducted phone-based syndromic surveillance surveys among adults (≥18 years) with verbal consent. We used secure tablets through random digit dialing to select mobile phone numbers and collected data electronically. Survey questions included whether the respondent had received the COVID-19 vaccines, whether they had experienced any AE following vaccination, and the severity of the AE. We used multivariable analysis to identify factors associated with self-reported AE post-COVID-19 vaccination. A total of 11,924 (36.0%) out of 33,150 respondents reported receiving at least one dose of either Ad26.COV2.S or AZD1222 between July-December 2021; of those, 65.1% were female. About 49.2% of the vaccine recipients reported at least one AE, 90.6% of which were mild, and 2.6% were severe. Higher education level and concern about the safety of COVID-19 vaccines were associated with AE self-report (Adjusted Odds Ratio [AOR] 2.63 [95% CI 1.96-3.53] and 1.44, [95% CI 1.30-1.61], respectively), while male gender and older age were associated with reduced likelihood of AE self-report (AORs 0.81, [95% CI 0.75-0.88], 0.62 [95% CI 0.50-0.77], respectively). Ad26.COV2.S and AZD1222 vaccines are well-tolerated, with primarily mild and few severe AE among adults living in Malawi. Self-reporting of AE following COVID-19 vaccination is associated with gender, age, education, and concern about the safety of the vaccines. Recognizing these associations is key when designing and implementing COVID-19 vaccination communication messages to increase vaccination coverage.

Elevated soluble vascular cell adhesion molecule-1, elevated Homocyst(e)inemia, and hypertriglyceridemia in relation to preeclampsia risk.

BACKGROUND: We examined the relationship of maternal plasma concentrations of soluble vascular cell adhesion molecule-1 (sVCAM-1), a specific marker of endothelial dysfunction, and risk of preeclampsia. We also evaluated the relationship in the presence and absence of maternal hypertriglyceridemia and hyperhomocystein(e)mia. METHODS: A total of 170 women with preeclampsia and 184 control subjects were included in this case-control study analysis. Maternal postdiagnosis plasma sVCAM-1 concentrations were determined using immunoassays. Total plasma homocysteine (tHcy) was measured using high-performance liquid chromatography with electrochemical detection procedures; and triglyceride concentrations were determined using standard enzymatic procedures. Logistic regression procedures were used to estimate odds ratios (OR) and 95% confidence intervals (CI) adjusted for confounders. RESULTS: The relative risk of preeclampsia (as estimated by the OR) was increased 3.6-fold for women with sVCAM-1 concentrations >/=842 ng/mL compared with women who had lower concentrations (OR = 3.6; 95% CI 1.8 to 7.4). Of the three biological markers investigated, elevated sVCAM-1 concentrations was most strongly related to preeclampsia risk (OR = 4.6, 95% CI 1.6 to 13.5), followed by hyperhomocysten(e)mia (OR = 2.4, 95% CI 0.8 to 7.4) and hypertriglyceridemia (OR = 2.1, 95% CI 0.9 to 5.0). Compared with women who did not have any of the three risk factors, those with all three risk factors had an extremely high risk of preeclampsia (OR = 26.4; 95% CI 8.5 to 81.9). CONCLUSIONS: These findings suggest that elevated sVCAM-1 concentrations are associated with an increased risk of preeclampsia. Our findings extend the literature by documenting progressively increased risk with increasing numbers of biological markers of dyslipidemia and endothelial dysfunction.

Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial.

BACKGROUND: Efforts to scale up and improve programs for prevention of mother-to-child transmission of HIV (PMTCT) have focused primarily at the health facility level, and limited attention has been paid to defining an effective set of community interventions to improve demand and uptake of services and retention. Many barriers to PMTCT are also barriers to pregnancy, childbirth, and postnatal care faced by mothers regardless of HIV status. Demand for maternal and child health (MCH) and PMTCT services can be limited by critical social, cultural, and structural barriers. Yet, rigorous evaluation has shown limited evidence of effectiveness of multilevel community-wide interventions aimed at improving MCH and HIV outcomes for pregnant women living with HIV. We propose to assess the effect of a package of multilevel community interventions: a social learning and action component, community dialogues, and peer-led discussion groups, on the demand for, uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services. METHODS/DESIGN: This study will undertake a three-arm randomized trial in Swaziland, Uganda, and Zimbabwe. Districts/regions (n = 9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7,300-27,500) will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEIs) returning to the health facility within 2 months for early infant diagnosis (EID) of HIV. Secondary study outcomes include gestational age of women attending for first antenatal care, male partners tested for HIV, and HEIs receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices, and beliefs on MCH/PMTCT will be assessed through household surveys. DISCUSSION: Implementation of the protocol necessitated changes in the original study design. We purposively selected facilities in the districts/regions though originally the study clusters were to be randomly selected. Lifelong antiretroviral therapy for all HIV positive pregnant and lactating women, Option B+, was implemented in the three countries during the study period, with the potential for a differential impact by study arm. Implementation however, was rapidly done across the districts/regions, so that there is unlikely be this potential confounding. We developed a system of monitoring and documentation of potential confounding activities or actions, and these data will be incorporated into analyses at the conclusion of the project. Strengthens of the study are that it tests multilevel interventions, utilizes program as well as study specific and individual data, and it is conducted under "real conditions" leading to more robust findings. Limitations of the protocol include the lack of a true control arm and inadequate control for the potential effect of Option B+, such as the intensification of messages as the importance of early ANC and male partner testing. TRIAL REGISTRATION: ClinicalTrials.gov (study ID: NCT01971710) Protocol version 5, 30 July 2013, registered 13 August 2013.

Opportunities and challenges in conducting secondary analysis of HIV programmes using data from routine health information systems and personal health information.

INTRODUCTION: HIV programme data from routine health information systems (RHIS) and personal health information (PHI) provide ample opportunities for secondary data analysis. However, these data pose unique opportunities and challenges for use in health system monitoring, along with process and impact evaluations. METHODS: Analyses focused on retrospective case reviews of four of the HIV-related studies published in this JIAS supplement. We identify specific opportunities and challenges with respect to the secondary analysis of RHIS and PHI data. RESULTS: Challenges working with both HIV-related RHIS and PHI included missing, inconsistent and implausible data; rapidly changing indicators; systematic differences in the utilization of services; and patient linkages over time and different data sources. Specific challenges among RHIS data included numerous registries and indicators, inconsistent data entry, gaps in data transmission, duplicate registry of information, numerator-denominator incompatibility and infrequent use of data for decision-making. Challenges specific to PHI included the time burden for busy providers, the culture of lax charting, overflowing archives for paper charts and infrequent chart review. CONCLUSIONS: Many of the challenges that undermine effective use of RHIS and PHI data for analyses are related to the processes and context of collecting the data, excessive data requirements, lack of knowledge of the purpose of data and the limited use of data among those generating the data. Recommendations include simplifying data sources, analysis and reporting; conducting systematic data quality audits; enhancing the use of data for decision-making; promoting routine chart review linked with simple patient tracking systems; and encouraging open access to RHIS and PHI data for increased use.

Retention of mothers and infants in the prevention of mother-to-child transmission of HIV programme is associated with individual and facility-level factors in Rwanda.

OBJECTIVES: Investigate levels of retention at specified time periods along the prevention of mother-to-child transmission (PMTCT) cascade among mother-infant pairs as well as individual- and facility-level factors associated with retention. METHODS: A retrospective cohort of HIV-positive pregnant women and their infants attending five health centres from November 2010 to February 2012 in the Option B programme in Rwanda was established. Data were collected from several health registers and patient follow-up files. Additionally, informant interviews were conducted to ascertain health facility characteristics. Generalized estimating equation methods and modelling were utilized to estimate the number of mothers attending each antenatal care visit and assess factors associated with retention. RESULTS: Data from 457 pregnant women and 462 infants were collected at five different health centres (three urban and two rural facilities). Retention at 30 days after registration and retention at 6 weeks, 3, 6, 9 and 12 months post-delivery were analyzed. Based on an analytical sample of 348, we found that 58% of women and 81% of infants were retained in care within the same health facility at 12 months post-delivery, respectively. However, for mother-infant paired mothers, retention at 12 months was 74% and 79% for their infants. Loss to facility occurred early, with 26% to 33% being lost within 30 days post-registration. In a multivariable model retention was associated with being married, adjusted relative risk (ARR): 1.26, (95% confidence intervals: 1.11, 1.43); antiretroviral therapy eligible, ARR: 1.39, (1.12, 1.73) and CD4 count per 50 mm(3), ARR: 1.02, (1.01, 1.03). CONCLUSIONS: These findings demonstrate varying retention levels among mother-infant pairs along the PMTCT cascade in addition to potential determinants of retention to such programmes. Unmarried, apparently healthy, HIV-positive pregnant women need additional support for programme retention. With the significantly increased workload resulting from lifelong antiretroviral treatment for all HIV-positive pregnant women, strategies need to be developed to identify, provide support and trace these women at risk of loss to follow-up. This study provides further evidence for the need for such a targeted supportive approach.

Experiences in implementation and publication of operations research interventions: gaps and a way forward.

INTRODUCTION: According to UNAIDS, the world currently has an adequate collection of proven HIV prevention, treatment and diagnostic tools, which, if scaled up, can lay the foundation for ending the AIDS epidemic. HIV operations research (OR) tests and promotes the use of interventions that can increase the demand for and supply of these tools. However, current publications of OR mainly focus on outcomes, leaving gaps in reporting of intervention characteristics, which are essential to address for the utilization of OR findings. This has prompted WHO and other international public health agencies to issue reporting requirements for OR studies. The objective of this commentary is to review experiences in HIV OR intervention design, implementation, process data collection and publication in order to identify gaps, contribute to the body of knowledge and propose a way forward to improve the focus on "implementation" in implementation research. DISCUSSION: Interventions in OR, like ordinary service delivery programmes, are subject to the programme cycle, which continually uses insights from implementation and the local context to modify service delivery modalities. Given that some of these modifications in the intervention may influence study outcomes, the documentation of process data becomes vital in OR. However, a key challenge is that study resources tend to be skewed towards documentation and the reporting of study outcomes to the detriment of process data, even though process data is vital for understanding factors influencing the outcomes. CONCLUSIONS: Interventions in OR should be viewed using the lens of programme evaluation, which includes formative assessment (to determine concept and design), followed by process evaluation (to monitor inputs and outputs) and effectiveness evaluation (to assess outcomes and effectiveness). Study resources should be equitably used between process evaluation and outcome measurement to facilitate inclusion of data about fidelity and dose in publications in order to enable explanation of the relationship between dosing and study outcomes for purposes of scaling up and further refinement through research.

Maternal plasma transforming growth factor-beta1 concentrations in preeclamptic and normotensive pregnant Zimbabwean women.

OBJECTIVE: We examined the relationship between maternal plasma transforming growth factor-beta1 (TGF-beta1) concentrations and risk of preeclampsia among women delivering at Harare Maternity Hospital in Zimbabwe. We evaluated the relationship in the context of maternal systemic inflammation using plasma tumor necrosis factor-a soluble receptor p55 (sTNFp55) as a marker. METHODS: 132 women with preeclampsia and 180 controls were included in this case-control study analysis. Maternal post-diagnosis plasma TGF-beta1 and sTNFp55 concentrations were determined using immunoassays. Logistic regression procedures were used to estimate odds ratios (OR) and 95% confidence intervals (CI) adjusted for confounders. RESULTS: A linear increase in preeclampsia risk was observed with increasing quartiles of TGF-beta1 concentrations (p<0.01). Women whose TGF-beta1 concentrations were >or=25.1 ng/ml (quartile 4) had a 2.5-fold (95% CI 1.2-5.6) increased risk of preeclampsia as compared with those women whose concentrations were <11.2 ng/ml (quartile 1). Relative to women with no evidence of systemic inflammation and no elevated TGF-beta1 concentrations, those women who were jointly positive for elevated TGF-beta1 and sTNFp55 concentrations experienced a 5.3-fold (95% CI 2.3-12.0) increased risk of preeclampsia. CONCLUSION: Overall, we noted that elevated TGF-beta1 is associated with an increased risk of preeclampsia. We also noted that the preeclampsia risk is exaggerated in the presence of maternal systemic inflammation.

Risk Factors for Low Birthweight in Zimbabwean Women: A Secondary Data Analysis.

BACKGROUND: Low birth weight (LBW) remains the main cause of mortality and morbidity in infants, and a problem in the care of pregnant women world-wide particularly in developing countries. The purpose of this study was to describe the socio-demographic, nutritional, reproductive, medical and obstetrical risk factors for delivering a live LBW infant at Harare Maternity Hospital, Zimbabwe. METHODS: A secondary data analysis from data obtained through a questionnaire and delivery records was conducted. Linear regression models with a complimentary log-log link function were used to estimate the relative risks for all LBW, term LBW and preterm LBW. RESULTS: The frequency of LBW was 16.7%. Lack of prenatal care (adjusted relative risk [ARR] 1.69, 95% CI 1.44, 1.98), mother's mid-arm circumference below 28.5 cm, (ARR 1.35, 95% CI 1.19, 1.54) and rural residence (ARR 1.22, 95% CI 1.04, 1.40) increased the risk of LBW. Eclampsia, anemia, and ante-partum hemorrhage, were associated with LBW (ARR 2.64, 95% CI 1.30, 5.35; ARR = 2.63, 95% CI 1.16, 5.97; and ARR = 2.39, 95% CI 1.55, 3.68), respectively. Malaria increased the risk of LBW (ARR = 1.89, 95% CI 1.21, 2.96). Prenatal care, infant sex, anemia, antepartum hemorrhage, premature rapture of membranes and preterm labor were associated with the three LBW categories. History of abortion or stillbirth, history of LBW, malaria, eclampsia, and placenta Previa, were associated with all LBW and preterm LBW, while pregnancy induced hypertension, and number of children alive were associated with all LBW and term LBW. CONCLUSIONS: LBW frequency remains high and is associated with nutritive, reproductive, medical and obstetrical factors. Preterm LBW and term LBW have similar and also different risk factors. Understanding the role of different risk factors in these different LBW categories is important if the goal is to reduce LBW frequency, and its complications, in Zimbabwe.

Risk factors for prematurity at Harare Maternity Hospital, Zimbabwe.

BACKGROUND: Prematurity remains the main cause of mortality and morbidity in infants and a problem in the care of pregnant women world-wide. This preliminary study describes the socio-demographic, reproductive, medical, and obstetrical risk factors for having a live pre-term delivery (PTD) in Zimbabwe. METHODS: This case-control study examined risk factors for PTD, at Harare Maternity Hospital between March and June 1999. RESULTS: The frequency of PTD among live birth was 16.4%. Prior history of stillbirth or abortion was associated with PTD (adjusted relative risk [ARR] 1.50; 95% CI: 1.06, 2.11). Nutritional factors, including drinking a local non-alcoholic beverage (mahewu) during pregnancy and mother's increasing mid-arm circumference reduced the risk of PTD (ARR = 0.75; 95% CI: 0.60, 0.93 and ARR = 0.95; 95% CI: 0.92, 0.99 per cm of circumference, respectively). Obstetric conditions including eclampsia, anaemia, ante-partum haemorrhage, and placenta praevia were infrequent, but when present, were strongly associated with PTD (ARR = 3.57; 95% CI: 1.67, 7.63; ARR = 4.12; 95% CI: 1.80, 9.43; ARR = 3.05; 95% CI: 1.86, 5.00 and ARR = 3.30; 95% CI: 1.34, 8.14, respectively). Malaria, although less frequent, nonetheless was associated with an increased risk of PTD (ARR = 2.93; 95% CI: 1.70, 5.04). These results suggest that in addition to established obstetric risk factors, nutrition and malarial infection are important. About 43% of the mothers initiated prenatal care after 28 weeks of gestation. CONCLUSION: Addressing prematurity in this population will require earlier initiation of prenatal care to allow for early detection and management of complications of pregnancy, and improving nutritional status of reproductive age with locally available foods. Further exploration of the potential benefits of mahewu, is warranted.

Plasma carotenoids, retinol, tocopherols, and lipoproteins in preeclamptic and normotensive pregnant Zimbabwean women.

BACKGROUND: We examined the relationship between maternal plasma lipoprotein and antioxidant status with risk of preeclampsia among women delivering at Harare Maternity Hospital, Zimbabwe. METHODS: One hundred seventy-three pregnant women with preeclampsia and 186 controls were included in a case-control study. Maternal plasma total cholesterol, high-density lipoprotein (HDL), and total triglycerides were measured using enzymatic methods. Plasma carotenoids (alpha-carotene, beta-carotene, lycopene, lutein, beta-cryptoxanthin, zeaxanthin), retinol, and tocopherols (alpha-tocopherol and gamma-tocopherol) were determined using high performance liquid chromatography. We used logistic regression to calculate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Preeclampsia risk increased with successively higher quartiles of plasma triglyceride (OR: 1.00, 1.70, 2.00, 5.26, with the lowest quartile as referent; P for trend <.001). We noted an inverse association between preeclampsia risk and HDL cholesterol concentrations (OR: 1.00, 0.87, 0.66, 0.68, with the first quartile as the referent group; P for trend =.169), although the trend was not statistically significant. After adjusting for confounders, we noted decreases in preeclampsia risk with increasing concentrations of alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, and zeaxanthin, respectively. Women with beta-carotene concentrations in the highest quartile, as compared with those in the lowest quartile experienced a 50% decreased risk of preeclampsia (OR = 0.50, 95% CI 0.25-1.00). There was no clear pattern of preeclampsia risk with lycopene concentrations or with concentrations of gamma- and alpha-tocopherol. CONCLUSIONS: Our results are consistent with some, although not all, previous reports. Prospective studies are needed to determine the temporal relationship between observed alterations in lipid and antioxidant concentrations in preeclamptic pregnancies.

Maternal mid-arm circumference and other anthropometric measures of adiposity in relation to infant birth size among Zimbabwean women.

BACKGROUND: To examine relationships between maternal anthropometric measures in Zimbabwean women and indices of infant birth size. METHODS: We conducted a cross-sectional study of pregnant women admitted for labor and delivery at the Harare Maternity Hospital from July 1998 to March 1999. The study population was comprised of 498 participants who delivered singleton infants. Anthropometric measures (height, weight, and mid-arm circumference) were taken during participants' postpartum hospital stay. Logistic regression and least-squares regression procedures were used to assess the association of maternal measures with infant size. RESULTS: Women in the highest weight quartile (>67 kg) were 58% less likely to have a low-birth-weight infant when compared to women in the lowest quartile (<57 kg) (OR = 0.42, 95% CI 0.19-0.90). Women in the highest body mass index quartile were 75% less likely to have a low-birth-weight infant compared to women in the lowest quartile (>27 versus <23 kg/m2: OR = 0.25, 95%CI 0.10-0.60). Similar trends were seen for risk of low birth weight in relation to mid-arm circumference. Maternal mid-arm circumference was most strongly related with the four infant size indices measured. Each unit increase in maternal mid-arm circumference resulted in a 36.1-g increase in infant birth weight (p<0.001). In general, women who were heavier at the time of delivery were less likely to have a low-birth-weight infant than women who were lighter. CONCLUSIONS: In areas where food security is a public health concern, as it is in most parts of the developing world, pregnant women may not be meeting their own nutritional needs and those of their fetus.