Publications by authors named "Bellington Vwalika"

95 Publications

Planned early delivery for late preterm pre-eclampsia in a low- and middle-income setting: a feasibility study.

Reprod Health 2021 Jun 2;18(1):110. Epub 2021 Jun 2.

Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.

Background: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity globally. Planned delivery between 34 and 36 weeks may reduce adverse pregnancy outcomes but is yet to be evaluated in a low and middle-income setting. Prior to designing a randomised controlled trial to evaluate this in India and Zambia, we carried out a 6-month feasibility study in order to better understand the proposed trial environment and guide development of our intervention.

Methods: We used mixed methods to understand the disease burden and current management of pre-eclampsia at our proposed trial sites and explore the acceptability of the intervention. We undertook a case notes review of women with pre-eclampsia who delivered at the proposed trial sites over a 3-month period, alongside facilitating focus group discussions with women and partners and conducting semi-structured interviews with healthcare providers. Descriptive statistics were used to analyse audit data. A thematic framework analysis was used for qualitative data.

Results: Case notes data (n = 326) showed that in our settings, 19.5% (n = 44) of women with pre-eclampsia delivering beyond 34 weeks experienced an adverse outcome. In women delivering between 34 and 36 weeks, there were similar numbers of antenatal stillbirths [n = 3 (3.3%)] and neonatal deaths [n = 3 (3.4%)]; median infant birthweight was 2.2 kg and 1.9 kg in Zambia and India respectively. Lived experience of women and healthcare providers was an important facilitator to the proposed intervention, highlighting the serious consequences of pre-eclampsia. A preference for spontaneous labour and limited neonatal resources were identified as potential barriers.

Conclusions: This study demonstrated a clear need to evaluate the intervention and highlighted several challenges relating to trial context that enabled us to adapt our protocol and design an acceptable intervention. Our study demonstrates the importance of assessing feasibility when developing complex interventions, particularly in a low-resource setting. Additionally, it provides a unique insight into the management of pre-eclampsia at our trial settings and an understanding of the knowledge, attitudes and beliefs underpinning the acceptability of planned early delivery.
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http://dx.doi.org/10.1186/s12978-021-01159-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8173959PMC
June 2021

Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings.

Proc Natl Acad Sci U S A 2021 May;118(20)

Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599;

Vital signs monitoring is a fundamental component of ensuring the health and safety of women and newborns during pregnancy, labor, and childbirth. This monitoring is often the first step in early detection of pregnancy abnormalities, providing an opportunity for prompt, effective intervention to prevent maternal and neonatal morbidity and mortality. Contemporary pregnancy monitoring systems require numerous devices wired to large base units; at least five separate devices with distinct user interfaces are commonly used to detect uterine contractility, maternal blood oxygenation, temperature, heart rate, blood pressure, and fetal heart rate. Current monitoring technologies are expensive and complex with implementation challenges in low-resource settings where maternal morbidity and mortality is the greatest. We present an integrated monitoring platform leveraging advanced flexible electronics, wireless connectivity, and compatibility with a wide range of low-cost mobile devices. Three flexible, soft, and low-profile sensors offer comprehensive vital signs monitoring for both women and fetuses with time-synchronized operation, including advanced parameters such as continuous cuffless blood pressure, electrohysterography-derived uterine monitoring, and automated body position classification. Successful field trials of pregnant women between 25 and 41 wk of gestation in both high-resource settings ( = 91) and low-resource settings ( = 485) demonstrate the system's performance, usability, and safety.
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http://dx.doi.org/10.1073/pnas.2100466118DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8157941PMC
May 2021

An automated framework for image classification and segmentation of fetal ultrasound images for gestational age estimation.

Proc SPIE Int Soc Opt Eng 2021 Feb 15;11596. Epub 2021 Feb 15.

Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill.

Accurate assessment of fetal gestational age (GA) is critical to the clinical management of pregnancy. Industrialized countries rely upon obstetric ultrasound (US) to make this estimate. In low- and middle- income countries, automatic measurement of fetal structures using a low-cost obstetric US may assist in establishing GA without the need for skilled sonographers. In this report, we leverage a large database of obstetric US images acquired, stored and annotated by expert sonographers to train algorithms to classify, segment, and measure several fetal structures: biparietal diameter (BPD), head circumference (HC), crown rump length (CRL), abdominal circumference (AC), and femur length (FL). We present a technique for generating raw images suitable for model training by removing caliper and text annotation and describe a fully automated pipeline for image classification, segmentation, and structure measurement to estimate the GA. The resulting framework achieves an average accuracy of 93% in classification tasks, a mean Intersection over Union accuracy of 0.91 during segmentation tasks, and a mean measurement error of 1.89 centimeters, finally leading to a 1.4 day mean average error in the predicted GA compared to expert sonographer GA estimate using the Hadlock equation.
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http://dx.doi.org/10.1117/12.2582243DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8086527PMC
February 2021

Wireless skin sensors for physiological monitoring of infants in low-income and middle-income countries.

Lancet Digit Health 2021 04 24;3(4):e266-e273. Epub 2021 Feb 24.

Querrey Simpson Institute for Bioelectronics, Northwestern University, Evanston, IL, USA; Department of Chemistry, Northwestern University, Evanston, IL, USA; Department of Biomedical Engineering, McCormick School of Engineering, Northwestern University, Evanston, IL, USA; Department of Materials Science and Engineering, McCormick School of Engineering, Northwestern University, Evanston, IL, USA; Department of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address:

Globally, neonatal mortality remains unacceptability high. Physiological monitoring is foundational to the care of these vulnerable patients to assess neonatal cardiopulmonary status, guide medical intervention, and determine readiness for safe discharge. However, most existing physiological monitoring systems require multiple electrodes and sensors, which are linked to wires tethered to wall-mounted display units, to adhere to the skin. For neonates, these systems can cause skin injury, prevent kangaroo mother care, and complicate basic clinical care. Novel, wireless, and biointegrated sensors provide opportunities to enhance monitoring capabilities, reduce iatrogenic injuries, and promote family-centric care. Early validation data have shown performance equivalent to (and sometimes exceeding) standard-of-care monitoring systems in premature neonates cared for in high-income countries. The reusable nature of these sensors and compatibility with low-cost mobile phones have the future potential to enable substantially lower monitoring costs compared with existing systems. Deployment at scale, in low-income countries, holds the promise of substantial improvements in neonatal outcomes.
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http://dx.doi.org/10.1016/S2589-7500(21)00001-7DOI Listing
April 2021

Maternal HIV Infection and Spontaneous Versus Provider-Initiated Preterm Birth in an Urban Zambian Cohort.

J Acquir Immune Defic Syndr 2021 06;87(2):860-868

University of North Carolina Global Projects Zambia, Lusaka, Zambia; and.

Objective: We investigated the effect of maternal HIV and its treatment on spontaneous and provider-initiated preterm birth (PTB) in an urban African cohort.

Methods: The Zambian Preterm Birth Prevention Study enrolled pregnant women at their first antenatal visit in Lusaka. Participants underwent ultrasound, laboratory testing, and clinical phenotyping of delivery outcomes. Key exposures were maternal HIV serostatus and timing of antiretroviral therapy initiation. We defined the primary outcome, PTB, as delivery between 16 and 37 weeks' gestational age, and differentiated spontaneous from provider-initiated parturition.

Results: Of 1450 pregnant women enrolled, 350 (24%) had HIV. About 1216 (84%) were retained at delivery, 3 of whom delivered <16 weeks. Of 181 (15%) preterm deliveries, 120 (66%) were spontaneous, 56 (31%) were provider-initiated, and 5 (3%) were unclassified. In standardized analyses using inverse probability weighting, maternal HIV increased the risk of spontaneous PTB [RR 1.68; 95% confidence interval (CI): 1.12 to 2.52], but this effect was mitigated on overall PTB [risk ratio (RR) 1.31; 95% CI: 0.92 to 1.86] owing to a protective effect against provider-initiated PTB. HIV reduced the risk of preeclampsia (RR 0.32; 95% CI: 0.11 to 0.91), which strongly predicted provider-initiated PTB (RR 17.92; 95% CI: 8.13 to 39.53). The timing of antiretroviral therapy start did not affect the relationship between HIV and PTB.

Conclusion: The risk of HIV on spontaneous PTB seems to be opposed by a protective effect of HIV on provider-initiated PTB. These findings support an inflammatory mechanism underlying HIV-related PTB and suggest that published estimates of PTB risk overall underestimate the risk of spontaneous PTB.
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http://dx.doi.org/10.1097/QAI.0000000000002654DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8131221PMC
June 2021

Maternal HIV, antiretroviral timing, and spontaneous preterm birth in an urban Zambian cohort: the role of local and systemic inflammation.

AIDS 2021 03;35(4):555-565

University of North Carolina at Chapel Hill, Chapel Hill, USA.

Objective: To assess plasma and vaginal inflammation in three antenatal groups (HIV-uninfected women, HIV-infected women entering care on preconceptional ART, and HIV-infected women not on preconceptional ART) and whether these measures are associated with spontaneous preterm birth (sPTB).

Design: Case--control study nested within a pregnancy cohort in Lusaka, Zambia.

Methods: We analyzed 11 pro-inflammatory and two anti-inflammatory markers in 207 women with paired plasma and vaginal specimens collected between 16 and 20 gestational weeks. Among 51 HIV-infected women, we repeated the assays in 24-34-week samples. We used confirmatory factor analysis to create inflammation scores and compared them among the three groups.

Results: At baseline, HIV-infected women not on ART had higher vaginal pro-inflammatory scores than HIV-uninfected women [mean 0.37 (95% CI -0.06 to 0.80) vs. -0.02 (-0.32 to 0.27), P = 0.02]. In repeat testing, women not on preconceptional ART had an increase in vaginal inflammation between the baseline and 24-34-week visits compared with those continuing preconceptional ART [mean 0.62 (95% CI -0.80 to 4.20) vs. -0.07 (-2.78 to 2.11), P = 0.04]. In multivariate analyses, baseline vaginal inflammation predicted sPTB (aOR 1.5; 95% CI 1.0-2.3; P = 0.02). Plasma inflammation did not differ by HIV or ART exposure and was not associated with sPTB.

Conclusion: Women not receiving ART at entry into pregnancy care had more vaginal inflammation than women entering on treatment. They also experienced an increase in vaginal inflammation between the two sampling timepoints, possibly as a consequence of ART initiation. Vaginal (but not systemic) inflammation was associated with sPTB and offers a potential mechanistic insight into this important adverse birth outcome.
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http://dx.doi.org/10.1097/QAD.0000000000002808DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7944942PMC
March 2021

Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial).

Trials 2020 Nov 23;21(1):960. Epub 2020 Nov 23.

Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.

Background: Pre-eclampsia is a pregnancy complication characterised by high blood pressure and multi-organ dysfunction in the mother. It is a leading contributor to maternal and perinatal mortality, with 99% of these deaths occurring in low- and middle-income countries (LMIC). Whilst clear guidelines exist for management of early-onset (< 34 weeks) and term (≥ 37 weeks) disease, the optimal timing of delivery in pre-eclampsia between 34 and 36 weeks is less clear. In a high-income setting, delivery may improve maternal outcomes without detriment to the baby, but this intervention is yet to be evaluated in LMIC.

Methods: The CRADLE-4 Trial is a non-masked, randomised controlled trial comparing planned early delivery (initiation of delivery within 48 h of randomisation) with routine care (expectant management) in women with pre-eclampsia between 34 and 36 weeks' gestation in India and Zambia. The primary objective is to establish whether a policy of planned early delivery can reduce adverse maternal outcomes, without increasing severe neonatal morbidity.

Discussion: The World Health Organization recommends delivery for all women with pre-eclampsia from 37 weeks onwards, based on evidence showing clear maternal benefit without increased neonatal risk. Before 34 weeks, watchful waiting is preferred, with delivery recommended only when there is severe maternal or fetal compromise, due to the neonatal risks associated with early preterm delivery. Currently, there is a lack of guidance for clinicians managing women with pre-eclampsia between 34 and 36 weeks. Early delivery benefits the mother but may increase the need for neonatal unit admission in the infant (albeit without serious morbidity at this gestation). On the other hand, waiting to deliver may increase the risk of stillbirth, fetal growth restriction and hypoxic brain injury in the neonate as a result of severe maternal complications. This is especially true for LMIC where there is a higher prevalence of adverse events. The balance of risks and benefits therefore needs to be carefully assessed before making firm recommendations. This is the first trial evaluating the optimal timing of delivery in pre-eclampsia in LMIC, where resources and disease burden are considerably different.

Trial Registration: ISRCTN 10672137 . Registered on 28 November 2019.
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http://dx.doi.org/10.1186/s13063-020-04888-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7684962PMC
November 2020

Management of Postpartum Hemorrhage With a Mini-Sponge Tamponade Device.

Obstet Gynecol 2020 11;136(5):876-881

Department of Obstetrics and Gynecology and the Center for Regenerative Medicine, Oregon Health & Sciences University, Portland, and OBSTETRX, Inc., Wilsonville, Oregon; the Department of Obstetrics and Gynecology, University of Zambia School of Medicine, Lusaka, Zambia; and Intellectual Ventures Laboratory, Seattle, Washington.

Background: Postpartum hemorrhage is a leading cause of maternal mortality globally. A tamponade agent that can be quickly and easily placed in a range of settings could advance the treatment of atonic hemorrhage.

Method: We adapted a highly effective trauma dressing for use in postpartum hemorrhage. This mini-sponge tamponade device is comprised of two components: compressed mini-sponges contained within a strong mesh pouch and a tubular applicator. Compressed mini-sponges rapidly absorb blood, expand within seconds, and exert sustained pressure uniformly to bleeding sites. The sponges are deployed within a mesh pouch to facilitate simple vaginal removal.

Experience: We successfully placed the mini-sponge device in nine patients experiencing postpartum hemorrhage after vaginal birth, with resolution of bleeding within 1 minute. The mean time to place the device was 62 seconds. Uterine fill was documented in all cases by ultrasound scan, and device placement was rated as "easy" to "very easy." Mini-sponges were left in place on average for 1 hour (0.5 hours-14 hours). Bleeding did not recur. There were no adverse events; all patients remained afebrile and did not require subsequent surgical intervention.

Conclusion: This study supports further evaluation of the mini-sponge device for the management of postpartum hemorrhage.

Funding: This study was funded by OBSTETRX, Inc.
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http://dx.doi.org/10.1097/AOG.0000000000004135DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7575022PMC
November 2020

Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study.

PLoS One 2020 24;15(9):e0238748. Epub 2020 Sep 24.

Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.

Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238748PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7514015PMC
November 2020

Herbal medicine use among pregnant women attending antenatal clinics in Lusaka Province, Zambia: A cross-sectional, multicentre study.

Complement Ther Clin Pract 2020 Aug 7;40:101218. Epub 2020 Jul 7.

Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway; Centre for Pharmacy, University of Bergen, Bergen, Norway.

BACKGROUND AND PURPOSE: The study of herbal medicine (HM) use which is related to maternal health, a public health priority in many sub-Saharan African countries including Zambia, has been limited. Accordingly, we aimed to determine the prevalence and patterns of HM use during pregnancy in Lusaka Province, Zambia.

Materials And Methods: A survey-based (interviewer-administered), cross-sectional, multicentre study was conducted in 446 adult pregnant women attending antenatal clinics in June/July 2019.

Results: Overall, 57.8% of participants reported using HM during their current pregnancy, with a mean of 2.0 ± 1.5 remedies/woman. Logistic regression analysis showed that HM use was significantly associated with HM use in prior pregnancies (p < 0.001) and willingness to use HM in the future (p < 0.001). The most commonly used herbs were lemon for nausea/vomiting and common cold, soybean to boost energy, ginger for common cold and nausea/vomiting, and Aloe vera for skin care. The perceived safety of HM (37.6%) and its complementary action with conventional medicines (35.3%) were the main reasons for HM use.

Conclusion: HM use among pregnant women attending antenatal clinics in Lusaka Province, Zambia is common, and a wide range of herbs is used.
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http://dx.doi.org/10.1016/j.ctcp.2020.101218DOI Listing
August 2020

"Back to Eden": An explorative qualitative study on traditional medicine use during pregnancy among selected women in Lusaka Province, Zambia.

Complement Ther Clin Pract 2020 Aug 5;40:101225. Epub 2020 Aug 5.

Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway; Centre for Pharmacy, University of Bergen, Bergen, Norway.

Background And Purpose: No qualitative study on traditional medicine use among Zambian pregnant women has ever been conducted. Accordingly, this study was performed to explore the perceptions, motivations and experiences of Zambian women with regard to traditional medicine use during pregnancy.

Materials And Methods: In-depth, semi-structured interviews were conducted in June/July 2019 with 8 adult women residing in Lusaka, Zambia, who used traditional remedies during their pregnancies, and who were recruited through purposive and snowball sampling.

Results: Reported reasons behind traditional medicine use during pregnancy included labour induction, prevention of childbirth complications in case of sexual infidelity by either spouse, and prevention and/or treatment of anaemia. In addition, family members and faith leaders played an important role in influencing traditional medicine use.

Conclusion: Multiple, interconnecting factors influence traditional medicine use among pregnant women in Lusaka, Zambia. Traditional medicine use during pregnancy will likely continue to be widespread across Zambia.
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http://dx.doi.org/10.1016/j.ctcp.2020.101225DOI Listing
August 2020

Cost-effectiveness of integrated HIV prevention and family planning services for Zambian couples.

AIDS 2020 09;34(11):1633-1642

Rwanda Zambia HIV Research Group, Department of Pathology & Laboratory Medicine, School of Medicine and Hubert Department of Global Health.

Objective: To present the incremental cost from the payer's perspective and effectiveness of couples' family planning counseling (CFPC) with long-acting reversible contraception (LARC) access integrated with couples' voluntary HIV counseling and testing (CVCT) in Zambia. This integrated program is evaluated incremental to existing individual HIV counseling and testing and family planning services.

Design: Implementation and modelling.

Setting: Fifty-five government health facilities in Zambia.

Subjects: Patients in government health facilities.

Intervention: Community health workers and personnel promoted and delivered integrated CVCT+CFPC from March 2013 to September 2015.

Main Outcome Measures: We report financial costs of actual expenditures during integrated program implementation and outcomes of CVCT+CFPC uptake and LARC uptake. We model primary outcomes of cost-per-: adult HIV infections averted by CVCT, unintended pregnancies averted by LARC, couple-years of protection against unintended pregnancy by LARC, and perinatal HIV infections averted by LARC. Costs and outcomes were discounted at 3% per year.

Results: Integrated program costs were $3 582 186 (2015 USD), 82 231 couples received CVCT+CFPC, and 56 409 women received LARC insertions. The program averted an estimated 7165 adult HIV infections at $384 per adult HIV infection averted over a 5-year time horizon. The program also averted 62 265 unintended pregnancies and was cost-saving for measures of cost-per-unintended pregnancy averted, cost-per-couple-year of protection against unintended pregnancy, and cost-per-perinatal HIV infection averted assuming 3 years of LARC use.

Conclusion: Our intervention was cost-savings for CFPC outcomes and CVCT was effective and affordable in Zambia. Integrated couples-focused HIV and family planning was feasible, affordable, and leveraged HIV and unintended pregnancy prevention.
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http://dx.doi.org/10.1097/QAD.0000000000002584DOI Listing
September 2020

The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries.

BMC Pregnancy Childbirth 2020 Jul 16;20(1):409. Epub 2020 Jul 16.

Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.

Background: Post-partum haemorrhage (PPH) is a leading cause of maternal death worldwide. The WOMAN trial assessed the effects of tranexamic acid (TXA) on death and surgical morbidity in women with PPH. The trial recorded 483 maternal deaths. We report the circumstances of the women who died.

Methods: The WOMAN trial recruited 20,060 women with a clinical diagnosis of PPH after a vaginal birth or caesarean section. We randomly allocated women to receive TXA or placebo. When a woman died, we asked participating clinicians to report the cause of death and to provide a short narrative of the events surrounding the death. We collated and edited for clarity the narrative data.

Results: Case fatality rates were 3.0% in Africa and 1.7% in Asia. Nearly three quarters of deaths were within 3 h of delivery and 91% of these deaths were from bleeding. Women who delivered outside a participating hospital (12%) were three times more likely to die (OR = 3.12, 95%CI 2.55-3.81) than those who delivered in hospital. Blood was often unavailable due to shortages or because relatives could not afford to buy it. Clinicians highlighted late presentation, maternal anaemia and poor infrastructure as key contributory factors.

Conclusions: Although TXA use reduces bleeding deaths by almost one third, mortality rates similar to those in high income countries will not be achieved without tackling late presentation, maternal anaemia, availability of blood for transfusion and poor infrastructure.
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http://dx.doi.org/10.1186/s12884-020-03091-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7364536PMC
July 2020

Cost-effectiveness of couples' voluntary HIV counselling and testing in six African countries: a modelling study guided by an HIV prevention cascade framework.

J Int AIDS Soc 2020 06;23 Suppl 3:e25522

Rwanda Zambia HIV Research Group, Department of Pathology & Laboratory Medicine, School of Medicine and Hubert Department of Global Health, Rollins School of Public Health, Laney Graduate School, Emory University, Atlanta, GA, USA.

Introduction: Couples' voluntary HIV counselling and testing (CVCT) is a high-impact HIV prevention intervention in Rwanda and Zambia. Our objective was to model the cost-per-HIV infection averted by CVCT in six African countries guided by an HIV prevention cascade framework. The HIV prevention cascade as yet to be applied to evaluating CVCT effectiveness or cost-effectiveness.

Methods: We defined a priority population for CVCT in Africa as heterosexual adults in stable couples. Based on our previous experience nationalizing CVCT in Rwanda and scaling-up CVCT in 73 clinics in Zambia, we estimated HIV prevention cascade domains of motivation for use, access and effectiveness of CVCT as model parameters. Costs-per-couple tested were also estimated based on our previous studies. We used these parameters as well as country-specific inputs to model the impact of CVCT over a five-year time horizon in a previously developed and tested deterministic compartmental model. We consider six countries across Africa with varied HIV epidemics (South Africa, Zimbabwe, Kenya, Tanzania, Ivory Coast and Sierra Leone). Outcomes of interest were the proportion of HIV infections averted by CVCT, nationwide CVCT implementation costs and costs-per-HIV infection averted by CVCT. We applied 3%/year discounting to costs and outcomes. Univariate and Monte Carlo multivariate sensitivity analyses were conducted.

Results: We estimated that CVCT could avert between 54% (Sierra Leone) and 62% (South Africa) of adult HIV infections. Average costs-per-HIV infection averted were lowest in Zimbabwe ($550) and highest in South Africa ($1272). Nationwide implementations would cost between 7% (Kenya) and 21% (Ivory Coast) of a country's President's Emergency Plan for AIDS Relief (PEPFAR) budget over five years. In sensitivity analyses, model outputs were most sensitive to estimates of cost-per-couple tested; the proportion of adults in heterosexual couples and HIV prevention cascade domains of CVCT motivation and access.

Conclusions: Our model indicates that nationalized CVCT could prevent over half of adult HIV infections for 7% to 21% of the modelled countries' five-year PEPFAR budgets. While other studies have indicated that CVCT motivation is high given locally relevant promotional and educational efforts, without required indicators, targets and dedicated budgets, access remains low.
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http://dx.doi.org/10.1002/jia2.25522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325504PMC
June 2020

Adherence to antiretroviral therapy among HIV infected pregnant women in public health sectors: a pilot of Chilenje level one Hospital Lusaka, Zambia.

Pan Afr Med J 2020 19;35:49. Epub 2020 Feb 19.

Department of Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia.

Introduction: regular use of Antiretroviral Therapy (ART) in pregnancy and breastfeeding reduces the odds of Mother-to-Child HIV Transmission (MTCT). However, adherence to ART is critical for MTCT to be successful. The present study investigated factors that influence adherence to ART among HIV infected pregnant women in Zambia.

Methods: a cross-sectional study design was conducted involving 71 HIV infected pregnant women who were advised to join the Prevention of Mother-to-Child HIV Transmission (PMTCT) program during their routine Antenatal clinic (ANC) visit and were on ART for more than six months. We used the Medication Possession Ratio (MPR) to quantify adherence levels. We used logistic regression to establish factors that influence adherence to ART.

Results: a total of 71 HIV infected pregnant women with a median age of 27years (IQR, 25-30) were enrolled in the study. There was evidence of a difference in adherence levels between pregnant women above 30 years and ones between 15 years and 30 years (P<0.001). Median adherence levels in this group were found to be at 96%(IQR 89-97). The main predictor of adherence in this population was marital status (being on separation) and age. The women who were on separation were 0.14 times less likely to adhere to option B+ compared to married women.

Conclusion: adherence to option B+ among pregnant women is low. Adherence was significantly influenced by marital status (being on separation) and age. Efforts to improve adherence should be directed towards women on separation and young adults (< 30 years of age).
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http://dx.doi.org/10.11604/pamj.2020.35.49.20078DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7250199PMC
December 2020

Journey of vulnerability: a mixed-methods study to understand intrapartum transfers in Tanzania and Zambia.

BMC Pregnancy Childbirth 2020 May 14;20(1):292. Epub 2020 May 14.

Archbishop Antony Mayala School of Nursing, Catholic University of Health and Allied Health Sciences, Mwanza, Tanzania.

Background: Timely intrapartum referral between facilities is pivotal in reducing maternal/neonatal mortality and morbidity but is distressing to women, resource-intensive and likely to cause delays in care provision. We explored the complexities around referrals to gain understanding of the characteristics, experiences and outcomes of those being transferred.

Methods: We used a mixed-method parallel convergent design, in Tanzania and Zambia. Quantitative data were collected from a consecutive, retrospective case-note review (target, n = 2000); intrapartum transfers and stillbirths were the outcomes of interest. A grounded theory approach was adopted for the qualitative element; data were collected from semi-structured interviews (n = 85) with women, partners and health providers. Observations (n = 33) of transfer were also conducted. Quantitative data were analysed descriptively, followed by binary logistic regression models, with multiple imputation for missing data. Qualitative data were analysed using Strauss's constant comparative approach.

Results: Intrapartum transfer rates were 11% (111/998; 2 unknown) in Tanzania and 37% (373/996; 1 unknown) in Zambia. Main reasons for transfer were prolonged/obstructed labour and pre-eclampsia/eclampsia. Women most likely to be transferred were from Zambia (as opposed to Tanzania), HIV positive, attended antenatal clinic < 4 times and living > 30 min away from the referral hospital. Differences were observed between countries. Of those transferred, delays in care were common and an increase in poor outcomes was observed. Qualitative findings identified three categories: social threats to successful transfer, barriers to timely intrapartum care and reparative interventions which were linked to a core category: journey of vulnerability.

Conclusion: Although intrapartum transfers are inevitable, modifiable factors exist with the potential to improve the experience and outcomes for women. Effective transfers rely on adequate resources, effective transport infrastructures, social support and appropriate decision-making. However, women's (and families) vulnerability can be reduced by empathic communication, timely assessment and a positive birth outcome; this can improve women's resilience and influence positive decision-making, for the index and future pregnancy.
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http://dx.doi.org/10.1186/s12884-020-02996-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7222428PMC
May 2020

Adverse birth outcomes and their clinical phenotypes in an urban Zambian cohort.

Gates Open Res 2019 24;3:1533. Epub 2020 Jan 24.

Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina, School of Medicine, Chapel Hill, NC, USA.

: Few cohort studies of pregnancy in sub-Saharan Africa use rigorous gestational age dating and clinical phenotyping. As a result, incidence and risk factors of adverse birth outcomes are inadequately characterized. : The Zambian Preterm Birth Prevention Study (ZAPPS) is a prospective observational cohort established to investigate adverse birth outcomes at a referral hospital in urban Lusaka. This report describes ZAPPS phase I, enrolled August 2015 to September 2017. Women were followed through pregnancy and 42 days postpartum. At delivery, study staff assessed neonatal vital status, birthweight, and sex, and assigned a delivery phenotype. Primary outcomes were: (1) preterm birth (PTB; delivery <37 weeks), (2) small-for-gestational-age (SGA; <10 percentile weight-for-age at birth), and (3) stillbirth (SB; delivery of an infant without signs of life). : ZAPPS phase I enrolled 1450 women with median age 27 years (IQR 23-32). Most participants (68%) were multiparous, of whom 41% reported a prior PTB and 14% reported a prior stillbirth. Twins were present in 3% of pregnancies, 3% of women had short cervix (<25mm), 24% of women were HIV seropositive, and 5% were syphilis seropositive. Of 1216 (84%) retained at delivery, 15% were preterm, 18% small-for-gestational-age, and 4% stillborn. PTB risk was higher with prior PTB (aRR 1.88; 95%CI 1.32-2.68), short cervix (aRR 2.62; 95%CI 1.68-4.09), twins (aRR 5.22; 95%CI 3.67-7.43), and antenatal hypertension (aRR 2.04; 95%CI 1.43-2.91). SGA risk was higher with twins (aRR 2.75; 95%CI 1.81-4.18) and antenatal hypertension (aRR 1.62; 95%CI 1.16-2.26). SB risk was higher with short cervix (aRR 6.42; 95%CI 2.56-16.1). : This study confirms high rates of PTB, SGA, and SB among pregnant women in Lusaka, Zambia. Accurate gestational age dating and careful ascertainment of delivery data are critical to understanding the scope of adverse birth outcomes in low-resource settings.
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http://dx.doi.org/10.12688/gatesopenres.13046.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7047437PMC
January 2020

Vaginal progesterone to prevent preterm delivery among HIV-infected pregnant women in Zambia: A feasibility study.

PLoS One 2020 29;15(1):e0224874. Epub 2020 Jan 29.

Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.

Antenatal vaginal progesterone (VP) reduces the risk of preterm birth (PTB) in women with shortened cervical length, and we hypothesize that it may also prevent PTB in women with HIV as their primary risk factor. We conducted a pilot feasibility study in Lusaka, Zambia to investigate uptake, adherence, and retention in preparation for a future efficacy trial. This was a double-masked, placebo-controlled, randomized trial of 200mg daily self-administered VP suppository or placebo. Pregnant women with HIV who were initiating or continuing antiretroviral therapy were eligible for participation. Potential participants underwent ultrasound to assess eligibility; we excluded those ≥24 gestational weeks, with non-viable, multiple gestation, or extrauterine pregnancies, with short cervix (<2.0cm), or with prior spontaneous PTB. Participants initiated study product between 20-24 weeks of gestation and continued to 37 weeks (or delivery, if sooner). The primary outcome was adherence (proportion achieving ≥80% study product use), assessed by dye stain assay of returned single-use vaginal applicators. Secondary outcomes with pre-defined feasibility targets were: uptake (≥50% eligible participants enrolled) and retention (≥90% ascertainment of delivery outcomes). We also evaluated preliminary efficacy by comparing the risk of spontaneous PTB <37 weeks between groups. From July 2017 to June 2018, 208 HIV-infected pregnant women were eligible for screening and 140 (uptake = 67%) were randomly allocated to VP (n = 70) or placebo (n = 70). Mean adherence was 94% (SD±9.4); 91% (n = 125/137) achieved overall adherence ≥80%. Delivery outcomes were ascertained from 134 (96%) participants. Spontaneous PTB occurred in 10 participants (15%) receiving placebo and 8 (12%) receiving progesterone (RR 0.82; 95%CI:0.34-1.97). Spontaneous PTB < 34 weeks occurred in 6 (9%) receiving placebo and 4 (6%) receiving progesterone (RR 0.67; 95%CI:0.20-2.67). In contrast to findings from vaginal microbicide studies in HIV-uninfected, non-pregnant women, our trial participants were highly adherent to daily self-administered vaginal progesterone. The study's a priori criteria for uptake, adherence, and retention were met, indicating that a phase III efficacy trial would be feasible.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224874PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988922PMC
March 2020

Fertility intentions and long-acting reversible contraceptive use among HIV-negative single mothers in Zambia.

Am J Obstet Gynecol 2020 04 14;222(4S):S917.e1-S917.e15. Epub 2020 Jan 14.

Rwanda Zambia Emory HIV Research Group, Department of Pathology, Emory University School of Medicine, Atlanta, GA.

Background: Integrating family planning interventions with HIV studies in developing countries has been shown to prevent mother-to-child HIV transmission and simultaneously reduce HIV and unintended pregnancy in high-risk populations. As part of a prospective cohort study on HIV incidence and risk factors in Zambian women having unprotected sex, we also offered family planning counseling and immediate access to long-acting reversible contraceptives. Although long-acting reversible contraceptives are the most effective form of contraception, many Zambian women are limited to oral or injectable methods because of a lack of knowledge or method availability. This project offers to single mothers who are enrolled in a cohort study information about and access to long-acting reversible contraceptives at enrollment and at each follow-up visit.

Objective: This study evaluates how fertility intentions affect long-acting reversible contraceptive use in HIV-negative single mothers in Zambia. Our primary outcome was long-acting reversible contraceptive use throughout the study participation. We also estimated rates of long-acting reversible contraceptive uptake and discontinuation. We specifically studied single mothers because they are at high risk for unintended pregnancy, which can have significant negative ramifications on their financial, social, and psychologic circumstances.

Study Design: From 2012-2017, Zambia Emory HIV Research Project recruited 521 HIV-negative single mothers ages 18-45 years from government clinics in Lusaka and Ndola, Zambia's 2 largest cities. Participants were followed every 3 months for up to 5 years. At each visit, we discussed fertility goals and contraceptive options and offered a long-acting reversible method to any woman who was not pregnant or who already was using a long-acting reversible or permanent contraceptive method. Data were collected on demographic factors, sexual behavior, and reproductive history. Multivariable logistic regression was used to model baseline fertility intentions with long-acting reversible contraceptive use.

Results: We enrolled 518 women; 57 women did not return for any follow-up visits. There was a significant increase in long-acting reversible contraceptive use during the study. At baseline, 93 of 518 women (18%) were using a long-acting reversible method, and 151 of 461 women (33%) used a long-acting reversible method at the end of follow-up period (P<.0001). Four women chose an intrauterine device, and 91 women chose an implant for their first uptake event. After we adjusted the data for other confounders, we found that women in Ndola who did not desire any more children were more likely to use a long-acting reversible contraceptive (adjusted prevalence ratio, 2.02; 95% confidence interval, 1.88-3.42). During follow up, 37 of 183 long-acting reversible contraceptive users (20%) discontinued their method; women who desired future children at baseline were more likely to discontinue earlier (P=.016).

Conclusion: This study demonstrates that integrated family planning services can increase long-acting reversible contraceptive use successfully among Zambian single mothers, who are a vulnerable population that disproportionately is affected by unintended pregnancy. A steady increase in use over time confirms the importance of repeated messaging about these unfamiliar methods. Thus, it is imperative that family planning interventions target single mothers in developing countries to promote effective contraceptive use.
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http://dx.doi.org/10.1016/j.ajog.2019.12.269DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7138749PMC
April 2020

A couple-focused, integrated unplanned pregnancy and HIV prevention program in urban and rural Zambia.

Am J Obstet Gynecol 2020 04 13;222(4S):S915.e1-S915.e10. Epub 2020 Jan 13.

Rwanda Zambia HIV Research Group, the Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, GA.

Background: Zambia's total fertility rate (5 births per woman) and adult HIV prevalence (11.5%) are among the highest in the world, with heterosexual couples being the most affected group. Jointly counseling and testing couples for HIV has reduced up to 58% of new HIV infections in Zambian clinics. Married women using contraceptives in Zambia have a high (20%) unmet need for family planning and low (8.6%) uptake of cost-effective long-acting reversible contraceptives. We present an integrated counseling, testing, and family-planning program to prevent HIV and unplanned pregnancy in Zambia.

Objective: The objective of this study was to integrate effective HIV prevention and family-planning services for Zambian couples.

Study Design: A 3 year program (2013-2016) progressively integrated the promotion and provision of couples' voluntary HIV counseling and testing and long-acting reversible contraceptives. The program was based in 55 urban and 215 rural government clinics across 33 districts. In the first year, a couples' family-planning counseling training program was developed and combined with existing couples HIV counseling training materials. To avoid congestion during routine clinic hours, joint counseling services were initially provided on weekends, while nurses were trained in intrauterine device and hormonal implant insertion and removal during weekday family-planning services. Demand was created through mutual referral between weekend and weekday programs and by clinic staff, community health workers, and satisfied family-planning clients. When the bulk of integrated service training was completed, the program transitioned services to routine weekday clinic hours, ensuring access to same-day services. Performance indicators included number of staff trained, clients served, integrated service referrals, HIV infections averted, and unplanned pregnancies averted.

Results: A stepwise approach trained high-performing service providers to be trainers and used high-volume clinics for practicum training of the next generation. In total, 1201 (391 urban, 810 rural) counselors were trained and served 120,535 urban and 87,676 rural couples. In urban clinics, 236 nurses inserted 65,619 long-acting reversible contraceptives, while in rural clinics, 243 nurses inserted 35,703 implants and intrauterine devices. The program prevented an estimated 12,869 urban and 8279 rural adult HIV infections, and 98,626 unintended urban pregnancies. In the final year, the proportion of clients receiving joint counseling services on weekdays rose from 11% to 89%, with many referred from within clinics including HIV testing and treatment services (32%), outpatient department (31%), family planning (16%), and infant vaccination (15%). The largest group of clients requesting long-acting reversible contraceptives (45%) did so after joint fertility goal-based counseling, confirming the high impact of this couple-focused demand creation approach. Remaining family-planning clients responded to referrals from clinic nurses (34%), satisfied implant/intrauterine device users (13%), or community health workers (8%).

Conclusion: Integrated HIV and unplanned pregnancy prevention can be implemented in low-resource public sector facilities. Combination services offered to couples mutually leverage HIV prevention and unplanned pregnancy prevention. The addition of long-acting reversible contraceptives is an important complement to the method mix available in government clinics. Demand creation in the clinic and in the community must be coordinated with a growing supply of well-trained providers.
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http://dx.doi.org/10.1016/j.ajog.2020.01.007DOI Listing
April 2020

The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: A qualitative study.

PLoS One 2019 4;14(10):e0223487. Epub 2019 Oct 4.

Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.

High HIV incidence rates have been observed among pregnant and breastfeeding women in sub-Saharan Africa. Oral pre-exposure prophylaxis (PrEP) can effectively reduce HIV acquisition in women during these periods; however, understanding of its acceptability and feasibility in antenatal and postpartum populations remains limited. To address this gap, we conducted in-depth interviews with 90 study participants in Malawi and Zambia: 39 HIV-negative pregnant/breastfeeding women, 14 male partners, 19 healthcare workers, and 18 policymakers. Inductive and deductive approaches were used to identify themes related to PrEP. As a public health intervention, PrEP was not well-known among patients and healthcare workers; however, when it was described to participants, most expressed positive views. Concerns about safety and adherence were raised, highlighting two critical areas for community outreach. The feasibility of introducing PrEP into antenatal services was also a concern, especially if introduced within already strained health systems. Support for PrEP varied among policymakers in Malawi and Zambia, reflecting the ongoing policy discussions in their respective countries. Implementing PrEP during the pregnancy and breastfeeding periods will require addressing barriers at the individual, facility, and policy levels. Multi- level approaches should be considered in the design of new PrEP programs for antenatal and postpartum populations.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223487PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6777778PMC
March 2020

Highly diverse anaerobe-predominant vaginal microbiota among HIV-infected pregnant women in Zambia.

PLoS One 2019 2;14(10):e0223128. Epub 2019 Oct 2.

Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States of America.

Vaginal dysbiosis has been shown to increase the risk of some adverse birth outcomes. HIV infection may be associated with shifts in the vaginal microbiome. We characterized microbial communities in vaginal swabs collected between 16-20 gestational weeks in the Zambian Preterm Birth Prevention Study to investigate whether HIV and its treatment alter the microbiome in pregnancy. We quantified relative abundance and diversity of bacterial taxa by whole-genome shotgun sequencing and identified community state types (CST) by hierarchical clustering. Associations between exposures-HIV serostatus (HIV+ vs HIV-) and preconceptional ART (ART+ vs ART-)-and microbiome characteristics were tested with rank-sum, and by linear and logistic regression, accounting for sampling by inverse-probability weighting. Of 261 vaginal swabs, 256 (98%) had evaluable sequences; 98 (38%) were from HIV+ participants, 55 (56%) of whom had preconceptional ART exposure. Major CSTs were dominated by: L. crispatus (CST 1; 17%), L.] iners (CST 3; 32%), Gardnerella vaginalis (CST 4-I; 37%), G. vaginalis & Atopobium vaginae (CST 4-II; 5%), and other mixed anaerobes (CST 4-III; 9%). G. vaginalis was present in 95%; mean relative abundance was higher in HIV+ (0.46±0.29) compared to HIV- participants (0.35±0.33; rank-sum p = .01). Shannon diversity was higher in HIV+/ART+ (coeff 0.17; 95%CI (0.01,0.33), p = .04) and HIV+/ART- (coeff 0.37; 95%CI (0.19,0.55), p < .001) participants compared to HIV-. Anaerobe-dominant CSTs were more prevalent in HIV+/ART+ (63%, AOR 3.11; 95%CI: 1.48,6.55, p = .003) and HIV+/ART- (85%, AOR 7.59; 95%CI (2.80,20.6), p < .001) compared to HIV- (45%). Restricting the comparison to 111 women in either CST 3 (L. iners dominance) or CST 1 (L. crispatus dominance), CST 3 frequency was similar in HIV- (63%) and HIV+/ART- participants (67%, AOR 1.31; 95%CI: (0.25,6.90), p = .7), but higher in HIV+/ART+ (89%, AOR 6.44; 95%CI: (1.12,37.0), p = .04). Pregnant women in Zambia, particularly those with HIV, had diverse anaerobe-dominant vaginal microbiota.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223128PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6774526PMC
March 2020

The Zambian Preterm Birth Prevention Study (ZAPPS): Cohort characteristics at enrollment.

Gates Open Res 2018 15;2:25. Epub 2019 Jul 15.

University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Sub-Saharan Africa bears a disproportionate burden of preterm birth and other adverse outcomes. A better understanding of the demographic, clinical, and biologic underpinnings of these adverse outcomes is urgently needed to plan interventions and inform new discovery.  The Zambian Preterm Birth Prevention Study (ZAPPS) is a prospective observational cohort established at the Women and Newborn Hospital (WNH) in Lusaka, Zambia. We recruit pregnant women from district health centers and the WNH and offer ultrasound examination to determine eligibility. Participants receive routine obstetrical care, lab testing, midtrimester cervical length measurement, and serial fetal growth monitoring. At delivery, we assess gestational age, birthweight, vital status, and sex and assign a delivery phenotype. We collect blood, urine, and vaginal swab specimens at scheduled visits and store them in an on-site biorepository. In September 2017, enrollment of the ZAPPS Phase 1-the subject of this report-was completed. Phase 2, which is limited to HIV-uninfected women, reopened in January 2018.  Between August 2015 and September 2017, we screened 1784 women, of whom 1450 (81.2%) met inclusion criteria and were enrolled. The median age at enrollment was 27 years (IQR 23-32) and median gestational age was 16 weeks (IQR 13-18). Among women with a previous pregnancy (n=1042), 19% (n=194) reported a prior miscarriage.  Among parous women (n=992), 41% (n=411) reported a prior preterm birth and 14% (n=126) reported a prior stillbirth. The HIV seroprevalence was 24%. We have established a large cohort of pregnant women and newborns at the WNH to characterize the determinants of adverse birth outcomes in Lusaka, Zambia. Our overarching goal is to elucidate biological mechanisms in an effort to identify new strategies for early detection and prevention of adverse outcomes. We hope that findings from this cohort will help guide future studies, clinical care, and policy.
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http://dx.doi.org/10.12688/gatesopenres.12820.3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6350406PMC
July 2019

Exploring the effect of implementation and context on a stepped-wedge randomised controlled trial of a vital sign triage device in routine maternity care in low-resource settings.

Implement Sci 2019 04 18;14(1):38. Epub 2019 Apr 18.

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK.

Background: Interventions aimed at reducing maternal mortality are increasingly complex. Understanding how complex interventions are delivered, to whom, and how they work is key in ensuring their rapid scale-up. We delivered a vital signs triage intervention into routine maternity care in eight low- and middle-income countries with the aim of reducing a composite outcome of morbidity and mortality. This was a pragmatic, hybrid effectiveness-implementation stepped-wedge randomised controlled trial. In this study, we present the results of the mixed-methods process evaluation. The aim was to describe implementation and local context and integrate results to determine whether differences in the effect of the intervention across sites could be explained.

Methods: The duration and content of implementation, uptake of the intervention and its impact on clinical management were recorded. These were integrated with interviews (n = 36) and focus groups (n = 19) at 3 months and 6-9 months after implementation. In order to determine the effect of implementation on effectiveness, measures were ranked and averaged across implementation domains to create a composite implementation strength score and then correlated with the primary outcome.

Results: Overall, 61.1% (n = 2747) of health care providers were trained in the intervention (range 16.5% to 89.2%) over a mean of 10.8 days. Uptake and acceptability of the intervention was good. All clusters demonstrated improved availability of vital signs equipment. There was an increase in the proportion of women having their blood pressure measured in pregnancy following the intervention (79.2% vs. 97.6%; OR 1.30 (1.29-1.31)) and no significant change in referral rates (3.7% vs. 4.4% OR 0.89; (0.39-2.05)). Availability of resources and acceptable, effective referral systems influenced health care provider interaction with the intervention. There was no correlation between process measures within or between domains, or between the composite score and the primary outcome.

Conclusions: This process evaluation has successfully described the quantity and quality of implementation. Variation in implementation and context did not explain differences in the effectiveness of the intervention on maternal mortality and morbidity. We suggest future trials should prioritise in-depth evaluation of local context and clinical pathways.

Trial Registration: Trial registration: ISRCTN41244132 . Registered on 2 Feb 2016.
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http://dx.doi.org/10.1186/s13012-019-0885-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471783PMC
April 2019

HIV serostatus, viral load, and midtrimester cervical length in a Zambian prenatal cohort.

Int J Gynaecol Obstet 2019 Aug 29;146(2):206-211. Epub 2019 Apr 29.

Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Objective: To evaluate whether maternal HIV serostatus and plasma viral load (VL) are associated with midtrimester cervical length (CL).

Methods: The Zambian Preterm Birth Prevention Study (ZAPPS) is an ongoing prospective cohort that began enrolling in Lusaka in August 2015. Pregnant women undergo ultrasound to determine gestational age and return for CL measurement at 16-28 weeks. We evaluated crude and adjusted associations between dichotomous indicators and short cervix (≤2.5 cm) via logistic regression, and between VL and CL as a continuous variable via linear regression.

Results: This analysis includes 1171 women enrolled between August 2015 and September 2017. Of 294 (25.1%) HIV-positive women, 275 (93.5%) had viral load performed close to CL measurement; of these, 148 (53.8%) had undetectable virus. Median CL was 3.6 cm (IQR 3.5-4.0) and was similar in HIV-infected (3.7 cm, IQR 3.5-4.0) versus uninfected (3.6 cm, IQR 3.5-4.0) participants (P=0.273). The odds of short CL were similar by HIV serostatus (OR 0.64; P=0.298) and detectable VL among those infected (OR 2.37, P=0.323). We observed no association between log VL and CL via linear regression (-0.12 cm; P=0.732).

Conclusion: We found no evidence of association between HIV infection and short CL.
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http://dx.doi.org/10.1002/ijgo.12823DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610732PMC
August 2019

Reducing the global burden of preterm births.

Lancet Glob Health 2019 04;7(4):e415

Department of Obstetrics and Gynaeocology, School of Medicine, University of North Carolina, Chapel Hill, NC 27599, USA. Electronic address:

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http://dx.doi.org/10.1016/S2214-109X(19)30060-9DOI Listing
April 2019

Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial.

BMC Pregnancy Childbirth 2019 Feb 27;19(1):81. Epub 2019 Feb 27.

Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, Chapel Hill, NC, 27599-7577, USA.

Background: Each year, an estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries. Maternal HIV infection increases a woman's risk of delivering prematurely, and antiretroviral therapy (ART) may compound this risk. While prenatal progesterone prophylaxis prevents preterm birth among some high-risk women, it is unknown whether HIV-infected women could benefit from this therapy. We are studying the efficacy of progesterone supplementation to reduce the risk of preterm birth among pregnant women with HIV in Lusaka, Zambia.

Methods: The Improving Pregnancy Outcomes with Progesterone (IPOP) study is a Phase III double-masked, placebo-controlled, randomized trial of intramuscular 17-alpha hydroxprogesterone caproate (17P) to prevent preterm birth in HIV-infected women. A total of 800 women will be recruited prior to 24 weeks of gestation and randomly allocated to 17P or placebo administered by weekly intramuscular injection. The primary outcome will be a composite of live birth prior to 37 completed gestational weeks or stillbirth at any gestational age. Secondary outcomes will include very preterm birth (< 34 weeks), extreme preterm birth (< 28 weeks), small for gestational age (<10th centile), low birth weight (< 2500 g), and neonatal outcomes. In secondary analysis, we will assess whether specific HIV-related covariates, including the timing of maternal ART initiation relative to conception, is associated with progesterone's prophylactic efficacy, if any.

Discussion: We hypothesize that weekly prenatal 17P will reduce the risk of HIV-related preterm birth. An inexpensive intervention to prevent preterm birth among pregnant women with HIV could have substantial global public health impact.

Trial Registration: NCT03297216 ; September 29, 2017.
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http://dx.doi.org/10.1186/s12884-019-2224-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391830PMC
February 2019

Improving preterm newborn identification in low-resource settings with machine learning.

PLoS One 2019 27;14(2):e0198919. Epub 2019 Feb 27.

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States.

Background: Globally, preterm birth is the leading cause of neonatal death with estimated prevalence and associated mortality highest in low- and middle-income countries (LMICs). Accurate identification of preterm infants is important at the individual level for appropriate clinical intervention as well as at the population level for informed policy decisions and resource allocation. As early prenatal ultrasound is commonly not available in these settings, gestational age (GA) is often estimated using newborn assessment at birth. This approach assumes last menstrual period to be unreliable and birthweight to be unable to distinguish preterm infants from those that are small for gestational age (SGA). We sought to leverage machine learning algorithms incorporating maternal factors associated with SGA to improve accuracy of preterm newborn identification in LMIC settings.

Methods And Findings: This study uses data from an ongoing obstetrical cohort in Lusaka, Zambia that uses early pregnancy ultrasound to estimate GA. Our intent was to identify the best set of parameters commonly available at delivery to correctly categorize births as either preterm (<37 weeks) or term, compared to GA assigned by early ultrasound as the gold standard. Trained midwives conducted a newborn assessment (<72 hours) and collected maternal and neonatal data at the time of delivery or shortly thereafter. New Ballard Score (NBS), last menstrual period (LMP), and birth weight were used individually to assign GA at delivery and categorize each birth as either preterm or term. Additionally, machine learning techniques incorporated combinations of these measures with several maternal and newborn characteristics associated with prematurity and SGA to develop GA at delivery and preterm birth prediction models. The distribution and accuracy of all models were compared to early ultrasound dating. Within our live-born cohort to date (n = 862), the median GA at delivery by early ultrasound was 39.4 weeks (IQR: 38.3-40.3). Among assessed newborns with complete data included in this analysis (n = 468), the median GA by ultrasound was 39.6 weeks (IQR: 38.4-40.3). Using machine learning, we identified a combination of six accessible parameters (LMP, birth weight, twin delivery, maternal height, hypertension in labor, and HIV serostatus) that can be used by machine learning to outperform current GA prediction methods. For preterm birth prediction, this combination of covariates correctly classified >94% of newborns and achieved an area under the curve (AUC) of 0.9796.

Conclusions: We identified a parsimonious list of variables that can be used by machine learning approaches to improve accuracy of preterm newborn identification. Our best-performing model included LMP, birth weight, twin delivery, HIV serostatus, and maternal factors associated with SGA. These variables are all easily collected at delivery, reducing the skill and time required by the frontline health worker to assess GA.

Trial Registration: ClinicalTrials.gov Identifier: NCT02738892.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0198919PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6392324PMC
December 2019

National policies and care provision in pregnancy and childbirth for twins in Eastern and Southern Africa: A mixed-methods multi-country study.

PLoS Med 2019 02 19;16(2):e1002749. Epub 2019 Feb 19.

Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.

Background: High-risk pregnancies, such as twin pregnancies, deserve particular attention as mortality is very high in this group. With a view to inform policy and national guidelines development for the Sustainable Development Goals, we reviewed national training materials, guidelines, and policies underpinning the provision of care in relation to twin pregnancies and assessed care provided to twins in 8 Eastern and Southern African countries: Kenya, Malawi, Mozambique, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe.

Methods And Findings: We located policies and guidelines by reviewing national repositories and by contacting experts to systematically map country-level maternal and newborn training materials, guidelines, and policies. We extracted recommendations for care for twins spanning ante-, intra-, and postpartum care that typically should be offered during twin pregnancies and childbirth. We compared care provided for mothers of twins to that provided for mothers of singletons during the ante-, intra-, and postpartum period and computed neonatal mortality rates using the most recent Demographic and Health Surveys (DHS) data for each country. There was a paucity of guidance on care specifically for twin or multiple pregnancies: None of the countries provided clear guidance on additional number of antenatal care visits or specific antenatal content, while 7 of the 8 countries recommended twins to be delivered in a comprehensive emergency obstetric and neonatal care facility. These results were mirrored by DHS results of 73,462 live births (of which 1,360 were twin) indicating that twin pregnancies did not receive more frequent or intensified antenatal care. The percentage of twin deliveries in hospitals varied from 25.3% in Mozambique to 63.0% in Kenya, and women with twin deliveries were between 5 and 27 percentage points more likely to deliver in hospitals compared to women with singleton live births; this difference was significant in 5 of the 8 countries (t test p < 0.05). The percentage of twin deliveries by cesarean section varied from 9% in Mozambique to 36% in Rwanda. The newborn mortality rate among twins, adjusted for maternal age and parity, was 4.6 to 7.2 times higher for twins compared to singletons in all 8 countries.

Conclusions: Despite the limited sample size and the limited number of clinically relevant services evaluated, our study provided evidence that mothers of twins receive insufficient care and that mortality in twin newborns is very high in Eastern and Southern Africa. Most countries have insufficient guidelines for the care of twins. While our data do not allow us to make a causal link between insufficient guidelines and insufficient care, they call for an assessment and reconceptualisation of policies to reduce the unacceptably high mortality in twins in Eastern and Southern Africa.
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http://dx.doi.org/10.1371/journal.pmed.1002749DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6380547PMC
February 2019

A new approach to assess the capability of health facilities to provide clinical care for sexual violence against women: a pilot study.

Health Policy Plan 2019 Mar;34(2):92-101

Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK.

Several tools have been developed to collect information on health facility preparedness to provide sexual violence response services; however, little guidance exists on how this information can be used to better understand which functions a facility can perform. Our study therefore aims to propose a set of signal functions that provide a framework for monitoring the availability of clinical sexual violence services. To illustrate the potential insights that can be gained from using our proposed signal functions, we used the framework to analyse data from a health facility census conducted in Central Province, Zambia. We collected the geographic coordinates of health facilities and police stations to assess women's proximity to multi-sectoral sexual violence response services. We defined three key domains of clinical sexual violence response services, based on the timing of the visit to the health facility in relation to the most recent sexual assault: (1) core services, (2) immediate care, and (3) delayed and follow-up care. Combining information from all three domains, we estimate that just 3% of facilities were able to provide a comprehensive response to sexual violence, and only 16% could provide time-sensitive immediate care services such as HIV post-exposure prophylaxis and emergency contraception. Services were concentrated in hospitals, with few health centres and no health posts fulfilling the signal functions for any of the three domains. Only 23% of women lived within 15 km of comprehensive clinical sexual violence health services, and 38% lived within 15 km of immediate care. These findings point to a need to develop clear strategies for decentralizing sexual violence services to maximize coverage and ensure equity in access. Overall, our findings suggest that our proposed signal functions could be a simple and valuable approach for assessing the availability of clinical sexual violence response services, identifying areas for improvement and tracking improvements over time.
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http://dx.doi.org/10.1093/heapol/czy106DOI Listing
March 2019