The economic burden of cervical cancer on women in Uganda: Findings from a cross-sectional study conducted at two public cervical cancer clinics.

There is limited research on how a cervical cancer diagnosis financially impacts women and their families in Uganda. This analysis aimed to describe the economic impact of cervical cancer treatment, including how it differs by socio-economic status (SES) in Uganda. We conducted a cross-sectional study from September 19, 2022 to January 17, 2023. Women were recruited from the Uganda Cancer Institute and Jinja Regional Referral Hospital, and were eligible if they were ≥ of 18 years and being treated for cervical cancer. Participants completed a survey that included questions about their out-of-pocket costs, unpaid labor, and family's economic situation. A wealth index was constructed to determine their SES. Descriptive statistics were reported. Of the 338 participants, 183 were from the lower SES. Women from the lower SES were significantly more likely to be older, have ≤ primary school education, and have a more advanced stage of cervical cancer. Over 90% of participants in both groups reported paying out-of-pocket for cervical cancer. Only 15 participants stopped treatment because they could not afford it. Women of a lower SES were significantly more likely to report borrowing money (higher SES n = 47, 30.5%; lower SES n = 84, 46.4%; p-value = 0.004) and selling possessions (higher SES n = 47, 30.5%; lower SES n = 90, 49.7%; p-value = 0.006) to pay for care. Both SES groups reported a decrease in the amount of time that they spent caring for their children since their cervical cancer diagnosis (higher SES n = 34, 31.2%; lower SES n = 36, 29.8%). Regardless of their SES, women in Uganda incur out-of-pocket costs related to their cervical cancer treatment. However, there are inequities as women from the lower SES groups were more likely to borrow funds to afford treatment. Alternative payment models and further economic support could help alleviate the financial burden of cervical cancer care in Uganda.

Machine learning-enabled maternal risk assessment for women with pre-eclampsia (the PIERS-ML model): a modelling study.

BACKGROUND: Affecting 2-4% of pregnancies, pre-eclampsia is a leading cause of maternal death and morbidity worldwide. Using routinely available data, we aimed to develop and validate a novel machine learning-based and clinical setting-responsive time-of-disease model to rule out and rule in adverse maternal outcomes in women presenting with pre-eclampsia. METHODS: We used health system, demographic, and clinical data from the day of first assessment with pre-eclampsia to predict a Delphi-derived composite outcome of maternal mortality or severe morbidity within 2 days. Machine learning methods, multiple imputation, and ten-fold cross-validation were used to fit models on a development dataset (75% of combined published data of 8843 patients from 11 low-income, middle-income, and high-income countries). Validation was undertaken on the unseen 25%, and an additional external validation was performed in 2901 inpatient women admitted with pre-eclampsia to two hospitals in south-east England. Predictive risk accuracy was determined by area-under-the-receiver-operator characteristic (AUROC), and risk categories were data-driven and defined by negative (-LR) and positive (+LR) likelihood ratios. FINDINGS: Of 8843 participants, 590 (6·7%) developed the composite adverse maternal outcome within 2 days, 813 (9·2%) within 7 days, and 1083 (12·2%) at any time. An 18-variable random forest-based prediction model, PIERS-ML, was accurate (AUROC 0·80 [95% CI 0·76-0·84] vs the currently used logistic regression model, fullPIERS: AUROC 0·68 [0·63-0·74]) and categorised women into very low risk (-LR <0·1; eight [0·7%] of 1103 women), low risk (-LR 0·1 to 0·2; 321 [29·1%] women), moderate risk (-LR >0·2 and +LR <5·0; 676 [61·3%] women), high risk (+LR 5·0 to 10·0, 87 [7·9%] women), and very high risk (+LR >10·0; 11 [1·0%] women). Adverse maternal event rates were 0% for very low risk, 2% for low risk, 5% for moderate risk, 26% for high risk, and 91% for very high risk within 48 h. The 2901 women in the external validation dataset were accurately classified as being at very low risk (0% with outcomes), low risk (1%), moderate risk (4%), high risk (33%), or very high risk (67%). INTERPRETATION: The PIERS-ML model improves identification of women with pre-eclampsia who are at lowest and greatest risk of severe adverse maternal outcomes within 2 days of assessment, and can support provision of accurate guidance to women, their families, and their maternity care providers. FUNDING: University of Strathclyde Diversity in Data Linkage Centre for Doctoral Training, the Fetal Medicine Foundation, The Canadian Institutes of Health Research, and the Bill & Melinda Gates Foundation.

Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonisation (OPSiP trial): study protocol for a double-blind parallel group randomised placebo trial.

INTRODUCTION: Group B streptococcus (GBS), or Streptococcus agalactiae, remains a leading cause of neonatal morbidity and mortality. Canadian guidelines advise universal maternal screening for GBS colonisation in pregnancy in conjunction with selective antibiotic therapy. This results in over 1000 pregnant individuals receiving antibiotic therapy to prevent one case of early-onset neonatal GBS disease, and over 20 000 pregnant individuals receiving antibiotic therapy to prevent one neonatal death. Given the growing concern regarding the risk of negative sequela from antibiotic exposure, it is vital that alternative approaches to reduce maternal GBS colonisation are explored.Preliminary studies suggest some probiotic strains could confer protection in pregnancy against GBS colonisation. METHODS AND ANALYSIS: This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks' gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis. PATIENT OR PUBLIC INVOLVEMENT: There was no patient or public involvement in the design of the study protocol. ETHICS AND DISSEMINATION: This study protocol received ethics approval from the University of British Columbia's Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03407157.

Acceptability of Integrated Community-Based HIV and Cervical Cancer Screening in Mayuge District, Uganda.

PURPOSE: To assess the acceptability of integrated screening for cervical cancer and HIV in the community setting. METHODS: We developed surveys for patients and community health workers (CHWs) who participated in the Advances in Screening and Prevention in Reproductive Cancers (ASPIRE) Mayuge trial that compared self-collected human papillomavirus testing at home versus community health meetings in Mayuge district, Uganda. Quantitative data were summarized using descriptive statistics. Open-ended questions were analyzed using an inductive approach with thematic content analysis. RESULTS: We conducted 102 patient surveys and 31 CHW surveys between June and August 2021. Ninety-nine percent of patients and 100% of CHWs indicated that they would find the addition of an HIV test to their self-collected cervical cancer test acceptable. The most frequently stated reasons in favor of adding an HIV test to the ASPIRE Mayuge cervical cancer screening pathways were time-saving, privacy, and support from other women and CHWs. The most frequently stated reasons against integrated screening were related to concerns about confidentiality, most often in reference to women's family members and other women in their village. CONCLUSION: Integrated community-based cervical cancer and HIV testing would be highly acceptable to both women and CHWs.

The burden of travelling for cervical cancer treatment in Uganda: A mixed-method study.

BACKGROUND: Uganda has one of the highest rates of cervical cancer in the world. Many women are diagnosed and treated with advanced stages of the disease. With only one facility offering comprehensive cervical cancer care in Uganda, many women are required to travel significant distances and spend time away from their homes to receive cervical cancer care. It is important to understand the burden of time away from home while attending treatment because it can inform the expansion of cervical cancer treatment programmes. The aim of this mixed-methods paper is to describe how the distance to cervical cancer treatment locations impacts women in Uganda. METHODS: Women were recruited from 19 September, 2022, to 17 January, 2023, at the Uganda Cancer Institute (UCI) and the cancer clinic at Jinja Regional Referral Hospital (JRRF). Women were eligible for the study if they were (i) aged ≥18 years with a histopathologic diagnosis of cervical cancer; (ii) being treated at the UCI or JRRF for cervical cancer; and (iii) able to provide consent to participate in the study in English, Luganda, Lusoga, Luo, or Runyankole. All participants completed a quantitative survey and a selected group was sampled for semi-structured interviews. Data were analysed using the convergent parallel mixed-methods approach. Descriptive statistics were reported for the quantitative data and qualitative data using an inductive-deductive thematic analysis approach. RESULTS: In all, 351 women participated in the quantitative section of the study and 24 in the qualitative. The quantitative and qualitative findings largely aligned and supported one another. Women reported travelling up to 14 h to receive treatment and 20% noted that they would spend three or more nights away from home during their current visit. Major themes of the qualitative include means of transportation, spending the night away from home, and financial factors. CONCLUSION: Our findings show that travelling to obtain cervical cancer care can be a significant burden for women in Uganda. Approaches should be considered to reduce this burden such as additional satellite cervical cancer clinics or subsidised transportation options.

Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial.

Effective approaches to improve coverage of self-collected human papillomavirus (HPV)-based cervix screening (SCS) as well as attendance at treatment for HPV-positive participants are needed to inform policy on optimal integration of cervical cancer screening programs within existing infrastructure in low-resource settings. ASPIRE Mayuge was a pragmatic cluster-randomized trial in rural Mayuge district, Uganda, comparing the superiority of two recruitment implementation strategies for SCS: Door-to-Door versus Community Health Day. Villages were randomized (unblinded) to a strategy, and participants aged 25-49 years with no previous history of hysterectomy or treatment for cervical cancer or pre-cancer were eligible. Participants completed a survey and participated in SCS. The primary outcome was rate of attendance at treatment after a positive SCS. The trial randomized 31 villages and 2,019 participants included in these analyses (Door-to-Door: 16 clusters, 1,055 participants; Community Health Day: 15 clusters, 964 participants). Among HPV-positive participants, attendance at treatment rates were 75% (Door-to-Door) and 67% (Community Health Day) (P = 0.049). Participants in the Community Health Day intervention were less likely to attend treatment compared to Door-to-Door (risk ratio = 0.78, 95% confidence interval: 0.64-0.96). No adverse events were reported. Policymakers in low-resource settings can use these results to guide implementation of SCS programs. ISRCTN registration: 12767014 . ClinicalTrials.gov registration: NCT04000503 .

Risk factors for postpartum maternal mortality and hospital readmission in low- and middle-income countries: a systematic review.

BACKGROUND: In low- and middle-income countries, approximately two thirds of maternal deaths occur in the postpartum period. Yet, care for women beyond 24 h after discharge is limited. The objective of this systematic review is to summarize current evidence on socio-demographic and clinical risk factors for (1) postpartum mortality and (2) postpartum hospital readmission. METHODS: A combination of keywords and subject headings (i.e. MeSH terms) for postpartum maternal mortality or readmission were searched. Articles published up to January 9, 2021 were identified in MEDLINE, EMBASE, and CINAHL databases, without language restrictions. Studies reporting socio-demographic or clinical risk factors for postpartum mortality or readmission within six weeks of delivery among women who delivered a livebirth in a low- or middle-income country were included. Data were extracted independently by two reviewers based on study characteristics, population, and outcomes. Included studies were assessed for quality and risk of bias using the Downs and Black checklist for ratings of randomized and non-randomized studies. RESULTS: Of 8783 abstracts screened, seven studies were included (total N = 387,786). Risk factors for postpartum mortality included Caesarean mode of delivery, nulliparity, low or very low birthweight, and shock upon admission. Risk factors for postpartum readmission included Caesarean mode of delivery, HIV positive serostatus, and abnormal body temperature. CONCLUSIONS: Few studies reported individual socio-demographic or clinical risk factors for mortality or readmission after delivery in low- and middle-income countries; only Caesarean delivery was consistently reported. Further research is needed to identify factors that put women at greatest risk of post-discharge complications and mortality. Understanding post-discharge risk would facilitate targeted postpartum care and reduce adverse outcomes in women after delivery. TRIAL REGISTRATION: PROSPERO registration number: CRD42018103955.

Impact of free maternity services on outcomes related to hypertensive disorders of pregnancy at Moi Teaching and Referral Hospital in Kenya: a retrospective analysis.

BACKGROUND: Preeclampsia is a major contributor to maternal and neonatal mortality worldwide. Ninety-nine percent of these deaths occur in resource limited settings. One of the greatest barriers to women seeking medical attention remains the cost of care. Kenya implemented a nation-wide policy change in 2013, offering free inpatient maternity services to all women to address this concern. Here, we explore the impact of this policy change on maternal and neonatal outcomes specific to the hypertensive disorders of pregnancy. METHODS: We conducted a retrospective cross-sectional chart review of patients discharged or deceased with a diagnosis of gestational hypertension, preeclampsia, eclampsia or HELLP syndrome at a tertiary referral center in western Kenya one year before (June 1, 2012-May 31, 2013) and one year after (June 1, 2013-May 31, 2014) free maternity services were introduced at public facilities across the country. Demographic information, obstetric history, medical history, details of the current pregnancy, diagnosis on admission and at discharge, antepartum treatment, maternal outcomes, and neonatal outcomes were collected and comparisons were made between the time points. RESULTS: There were more in hospital births after policy change was introduced. The proportion of women diagnosed with a hypertensive disorder of pregnancy was higher in the year before free maternity care although there was a statistically significant increase in the proportion of women diagnosed with gestational hypertension after policy change. Among those diagnosed with hypertensive disorders, there was no difference in the proportion who developed obstetric or medical complications. Of concern, there was a statistically significant increase in the proportion of women dying as a result of their condition. There was a statistically significant increase in the use of magnesium sulfate for seizure prophylaxis. There was no overall difference in the use of anti-hypertensives between groups and no overall difference in the proportion of women who received dexamethasone for fetal lung maturity. CONCLUSIONS: Free maternity services, however necessary, are insufficient to improve maternal and neonatal outcomes related to the hypertensive disorders of pregnancy at a tertiary referral center in western Kenya. Multiple complementary strategies acting in unison are urgently needed.

Experiences with thermal ablation for cervical precancer treatment after self-collection HPV-based screening in the ASPIRE Mayuge randomized trial.

Cervical cancer remains a significant public health burden in low-resourced countries. Thus, the WHO prioritized cervix screening, and recently recommended thermal ablation treatment for cervical precancer. However, there is limited information on side effects during treatment and recovery, and acceptability among those treated. The ASPIRE Mayuge trial recruited women to participate in self-collection cervix screening between 2019 and 2020 (N = 2019). Screen-positive women (N = 531, 26.3%) were referred for visual inspection with acetic acid and thermal ablation treatment, per Uganda Ministry of Health recommendations; 71.2% of those referred attended follow-up. Six months post-screening, a subset of trial participants were recontacted. Those who received thermal ablation completed a survey assessing side effects during and after the procedure, and willingness to recommend the treatment to others. We summarized the results to describe the side effects and acceptability of thermal ablation treatment. Of 2019 participants, 349 (17%) received thermal ablation. A subset of 135 completed the follow-up survey, where 90% reported pain during treatment; however, intensity and duration were low. Over a third of women reported problems with recovery for reasons including pain, discharge and bleeding. Regardless, 98% reported they would recommend the treatment to others. The use of thermal ablation to treat cervical precancer appears to be highly acceptable in this population. While many women reported side effects during the procedure and recovery, the majority said they would recommend the treatment to others. However, given the substantial proportion who reported problems with recovery, efforts should be made to provide additional resources to women after receiving thermal ablation treatment for cervical precancer.

Understanding the association between informed choice and long-term reversible contraception among Ugandan women: Findings from the 2016 Demographic Health Survey.

OBJECTIVES: To understand the relationship between informed choice and long-acting reversible contraceptive (LARC) use among women aged 15-49 years in Uganda after adjusting for potential confounding. METHODS: This cross-sectional study uses data from the 2016 Uganda Standard Demographic and Health Survey. Thomas-Rao corrections to a χ2 test were used for the bivariable analysis. A design-adjusted multivariable logistic regression was used to estimate the association between informed choice and LARC use. Propensity score matching was conducted as a sensitivity analysis. RESULTS: In all, 3646 women were included in the analysis and 975 reported using a LARC. In the design-adjusted multivariable analysis, the odds of reporting LARC usage were 1.98 (95% confidence interval 1.61-2.43) times higher among women who reported informed choice compared with those who did not. The subsequent propensity score analysis reported similar findings. CONCLUSION: Providing informed choice can help to increase the number of women who use LARC in Uganda. As such, the Ugandan Ministry of Health should further expand access to family planning counseling as it could contribute to the reduction of unplanned pregnancies across Uganda with the use of LARC.

"We Shall Tell them with Love, Inform them what we have Learnt and then Allow them to go" - Men's Perspectives of Self-Collected Cervical Cancer Screening in Rural Uganda: A Qualitative Inquiry.

Uganda has high incidence rates of cervical cancer (47.5/100,000/year) due to limited screening access. In settings where men hold most of the decision-making power, they play an important role in women's uptake of cervical cancer screening. We aimed to capture men's knowledge, beliefs and perspectives about cervical cancer, community-based screening and health system barriers. Focus group discussions were conducted with men in rural Uganda. Data were verbatim translated and transcribed into English. Transcripts were analysed in ATLAS.ti using a deductive approach of thematic content analysis and applied to an implementation research framework. Twenty-three men participated in focus groups. Men held poor knowledge of cervical cancer, its causes and treatment. Men felt screening would be acceptable by women if men and women were educated. Men highlighted health system barriers to accessing screening including: 1) poor-quality health services, 2) large distances to facilities/lack of affordable transportation and 3) lack of health workers/mistreatment by health workers. Men described supporting women through assisting with transportation, psychosocial support and sharing information. They requested services for men to be decentralized alongside community outreaches for cervical cancer screening. Engaging men in the implementation, education and planning of community-based cervical cancer screening programs is critical. Not engaging men is a missed opportunity to provide them with services and education. Concerted efforts must be made in educating men and reducing health system barriers to ensure rural women receive cervical cancer screening and follow-up care in low-income settings. Clinicaltrials.gov, NCT04000503; Registered 27 June 2019.

The social and economic impacts of cervical cancer on women and children in low- and middle-income countries: A systematic review.

BACKGROUND: There is limited knowledge on the social and economic impacts of a diagnosis of cervical cancer on women and children in low- and middle-income countries (LMICs). OBJECTIVES: To determine the social and economic impacts associated with cervical cancer among women and children living in LMICs. SEARCH STRATEGY: The MEDLINE, PsychInfo, CINAHL, Pais International, and CAB Global Health databases were systematically searched to retrieve studies up to June 2021. SELECTION CRITERIA: Studies were included if they reported on either the social or economic impacts of women or children in a LMIC. DATA COLLECTION AND ANALYSIS: Data was independently extracted by two co-authors. The authors performed a quality assessment on all included articles. MAIN RESULTS: In all, 53 studies were included in the final review. Social impacts identified included social support, education, and independence. Economic impacts included employment and financial security. No study reported the economic impact on children. Studies that utilized quantitative methods typically reported more positive results than those that utilized qualitative methods. CONCLUSIONS: Additional mixed-methods research is needed to further understand the social support needs of women with cervical cancer. Furthermore, research is needed on the impact of a mother's diagnosis of cervical cancer on her children.

Prognostic algorithms for post-discharge readmission and mortality among mother-infant dyads: an observational study protocol.

Introduction: In low-income country settings, the first six weeks after birth remain a critical period of vulnerability for both mother and newborn. Despite recommendations for routine follow-up after delivery and facility discharge, few mothers and newborns receive guideline recommended care during this period. Prediction modelling of post-delivery outcomes has the potential to improve outcomes for both mother and newborn by identifying high-risk dyads, improving risk communication, and informing a patient-centered approach to postnatal care interventions. This study aims to derive post-discharge risk prediction algorithms that identify mother-newborn dyads who are at risk of re-admission or death in the first six weeks after delivery at a health facility. Methods: This prospective observational study will enroll 7,000 mother-newborn dyads from two regional referral hospitals in southwestern and eastern Uganda. Women and adolescent girls aged 12 and above delivering singletons and twins at the study hospitals will be eligible to participate. Candidate predictor variables will be collected prospectively by research nurses. Outcomes will be captured six weeks following delivery through a follow-up phone call, or an in-person visit if not reachable by phone. Two separate sets of prediction models will be built, one set of models for newborn outcomes and one set for maternal outcomes. Derivation of models will be based on optimization of the area under the receiver operator curve (AUROC) and specificity using an elastic net regression modelling approach. Internal validation will be conducted using 10-fold cross-validation. Our focus will be on the development of parsimonious models (5-10 predictor variables) with high sensitivity (>80%). AUROC, sensitivity, and specificity will be reported for each model, along with positive and negative predictive values. Discussion: The current recommendations for routine postnatal care are largely absent of benefit to most mothers and newborns due to poor adherence. Data-driven improvements to postnatal care can facilitate a more patient-centered approach to such care. Increasing digitization of facility care across low-income settings can further facilitate the integration of prediction algorithms as decision support tools for routine care, leading to improved quality and efficiency. Such strategies are urgently required to improve newborn and maternal postnatal outcomes. Clinical trial registration: https://clinicaltrials.gov/, identifier (NCT05730387).

Side effects and acceptability measures for thermal ablation as a treatment for cervical precancer in low-income and middle-income countries: a systematic review and meta-synthesis.

OBJECTIVE: Understanding the side effects and acceptability of thermal ablation (TA) is necessary before large-scale application in screen-and-treat programmes can be justified in low-income and middle-income countries (LMICs). DESIGN: Articles were selected for inclusion by two independent reviewers. Risk of bias was assessed using the Downs and Black's criteria. Summary data were extracted, and authors contacted for data when necessary. Proportions of interest and 95% CIs were estimated using a random effects model. Subgroup analysis was performed based on place of treatment and timing of post-treatment follow-up. Heterogeneity was estimated using the I2. ELIGIBILITY CRITERIA: Studies that reported one or more side effects or patient acceptability measures after treatment of the cervix using TA in women living in LMICs who completed a cervical cancer screening test. Included articles were clinical trials or observational studies available in English and published before 18 December 2020. INFORMATION SOURCES: Ovid MEDLINE, EMBASE, CINAHL, CAB Global Health and WHO Global Index Medicus were searched for this systematic review and meta-synthesis. RESULTS: A total of 1590 abstracts were screened, 84 full text papers reviewed and 15 papers selected for inclusion in the qualitative review, 10 for meta-synthesis (N=2039). Significant heterogeneity was found in screening tests used to identify women eligible for TA and in methods to ascertain side effects. The most commonly reported side effect during treatment was pain (70%, 95% CI 52% to 85%; I2=98.01%) (8 studies; n=1454). No women discontinued treatment due to pain. At treatment follow-up, common side effects included vaginal discharge (72%, 95% CI 18% to 100%; I2=99.55%) (5 studies; n=771) and bleeding (38%, 95% CI 15% to 64%; I2=98.14%) (4 studies; n=856). Satisfaction with treatment was high in 99% (95% CI 98% to 100%; I2=0.00%) of women (3 studies; n=679). CONCLUSIONS: TA results in a number of common side effects, though acceptability remains high among women treated in LMICs. Standardised side effect and acceptability reporting are needed as TA becomes more readily available. PROSPERO REGISTRATION NUMBER: CRD42020197605.

How Gender Influenced the Experience of Using a mHealth Intervention in Rural Mozambique: Secondary Qualitative Analysis of Community Health Worker Survey Data.

Background: The mixed-gender community health worker (CHW) program in Mozambique is a window into the different experiences that male and female CHWs may face in their work. The objective of this study is to investigate how gender influenced the experiences of community health workers using the PIERS on the Move (POM) mHealth app in Mozambique. Methods: This is a secondary analysis by gender of health care workers involved in the Mozambique Community Level Intervention for Pre-eclampsia (CLIP) cluster randomized trial (NCT01911494). A structured survey with 10 open-ended questions was used to elicit CHW experiences using the POM app. Data collection took place in 2017 after completion of the CLIP trial. This analysis examined emergent themes to consider how experiences may have been shaped by health worker gender. Results: Of the 43 CHWs who used the POM app, there were 31 (72%) women and 12 (28%) men. Gender differences emerged in descriptions of how using POM increased their value and respect by pregnant women and community members. Fifty-eight percent of female CHWs (18/31) said that POM positively influenced their status in the community in comparison to 33% of their male counterparts (4/12). While the small sample sizes, particularly of male CHWs who used POM, preclude conclusions, these findings were supported by qualitative results. Female CHWs tended to elaborate more about community perceptions of their increased value and status as health care providers than male CHWs. Conclusion: CHWs work within existing gender norms. While gender norms are perceived to support the comfort of women to speak to another woman about their maternal and child health issues, gender norms also work against female CHWs as their professionalism may be questioned more than for their male counterparts. CHW's narratives suggested that the mHealth intervention was valued beyond the technology itself because it also added symbolic clinical value and demonstrated a tangible investment in their professional capacities, which may have been especially appreciated by the female CHWs.

Prognostic Value of an Estimate-of-Risk Model in Critically Ill Obstetric Patients in Brazil.

OBJECTIVE: To externally validate the CIPHER (Collaborative Integrated Pregnancy High-Dependency Estimate of Risk) prognostic model for pregnant and postpartum women admitted to the intensive care unit. METHODS: A retrospective and a prospective validation study were conducted at two reference centers in Brazil. A composite outcome was defined as maternal death or need for prolonged organ support (more than 7 days) or acute lifesaving intervention. To evaluate the performance of the CIPHER model, a receiver operating characteristic curve was used and score calibration was assessed by the Hosmer-Lemeshow test. We conducted a descriptive analysis comparing the results of the current study with the results of the model development study. RESULTS: A total of 590 women were included. The composite outcome was observed in 90 (15.2%) women. Of these, 13 (2.2%) were maternal deaths and 77 (13%) required one or more component of organ support or lifesaving intervention. The CIPHER model's area under the curve (AOC) did not show significant predictive ability (AOC 0.53, 95% CI 0.46-0.60), and consequently its calibration was poor (Hosmer-Lemeshow test P<.05). CONCLUSION: The CIPHER model for prediction of mortality and need for interventions in critically ill obstetric patients did not perform well in our Brazilian population. Different predictors of morbidity and mortality may need to be used for patients receiving care in public hospitals in low- and middle-income countries.

Community Health Worker Evaluation of Implementing an mHealth Application to Support Maternal Health Care in Rural India.

Introduction: PIERS on the Move (POM) is a mobile health (mHealth) application developed for a smartphone to support community health workers (CHWs) for identification and management of women at risk of adverse outcomes from pre-eclampsia. POM was implemented as an addition to routine antenatal care by accredited social health activists (ASHAs) and auxiliary nurse midwives (ANMs) during the community level intervention for pre-eclampsia (CLIP) Trial in Karnataka state, India (NCT01911494). The objective of this study was to evaluate the experiences of CHWs of using POM in rural India and their perceptions of acceptability and feasibility of this mHealth intervention. Methods: A posttrial mixed-methods evaluation was designed to measure CHW knowledge and self-efficacy regarding the care of women with pre-eclampsia and perceptions of CHWs on the ease of use and usefulness of POM. A structured survey with open-ended questions was conducted between October and November 2017. The median values on a 5-point Likert scale for knowledge and self-efficacy questions were compared between trial arms by Mann-Whitney U test (p < 0.05 significant). Qualitative analysis was undertaken on NVivo 12 (QSR International, Melbourne, Australia). Results: A total of 48 ASHAs and ANMs were interviewed, including 24 who used POM (intervention arm) and 24 who did not (control arm). Self-reported knowledge and self-efficacy for the care of women with pre-eclampsia did not differ between groups. The qualitative analysis highlighted that health workers who used POM reported improved interactions with women and families in their communities. POM strengthened the role of ASHA as a CHW beyond a "link-worker" accompanying women to health services. With training, the mHealth application was easy to use even for CHWs who did not have much experience with smartphones. Conclusions: Community health workers found the POM app easy to use, useful, and well-received by women and their families. POM did not improve care through increased knowledge but built capacity by increasing the recognition of the ASHA and ANM as critical members of the continuum of antenatal healthcare within their communities. These findings support the important role that mHealth technologies can play in strengthening health systems to reach rural, remote, and marginalized populations to reduce disparities in health.

"Now You Have Become Doctors": Lady Health Workers' Experiences Implementing an mHealth Application in Rural Pakistan.

Background: PIERS on the Move (POM) is a mobile health application developed to support community health workers identification and management of women at risk of adverse outcomes from pre-eclampsia. The objective of this study was to evaluate the impact of using POM in Pakistan on Lady Health Workers' (LHWs) knowledge and self-efficacy related to caring for women with pre-eclampsia, and their perception of usefulness of the tool. Methodology: An evaluation was designed for health care workers involved in the Community-Level Intervention for Pre-eclampsia (CLIP) cluster randomized trial from 2014 to 2016 in Sindh Province, Pakistan (NCT01911494). A semi-structured focus group guide was developed based on the Technology Acceptance Model (TAM), which theorizes that an individual's behavioral intention to use a system is determined by perceived usefulness and ease of use. Preliminary qualitative analysis was undertaken by the Pakistan and Canadian teams to create a coding framework for full qualitative analysis, which was completed using NVivo12. Results: Three key informant interviews were conducted with two Lady Health Supervisors and one Senior Medical Officer. Sixty-two LHWs were included in three focus group discussions. LHWs found the POM app easy to use and useful for their work as a helpful repository for maternal health information and guiding counseling and management of pre-eclampsia. LHWs reported increased knowledge and confidence in their work. Availability of clinical homecare, including postpartum, was felt to positively impact healthcare provided to pregnant and postpartum women. Potential community level impacts included strengthening relationships between health care providers and communities and between LHWs and the health system. LHWs shared reports of earlier care-seeking and increased awareness of maternal health issues by community members. Conclusions: LHWs carry a large burden of responsibility for community health in rural Pakistan and appreciated the investment in their skills and capacity during the CLIP trial with the POM app. Investing in communications technology for community health workers through improved referrals and follow up may strengthen cohesiveness of the health system overall.

Implementation of the PIERS on the Move mHealth Application From the Perspective of Community Health Workers and Nurses in Rural Mozambique.

Background:mHealth is increasingly regarded as having the potential to support service delivery by health workers in low-resource settings. PIERS on the Move (POM) is a mobile health application developed to support community health workers identification and management of women at risk of adverse outcomes from pre-eclampsia. The objective of this study was to evaluate the impact of using POM in Mozambique on community health care workers' knowledge and self-efficacy related to caring for women with pre-eclampsia, and their perception of usefulness of the tool to inform implementation. Method: An evaluation was conducted for health care workers in the Mozambique Community Level Intervention for Pre-eclampsia (CLIP) cluster randomized trial from 2014 to 2016 in Maputo and Gaza provinces (NCT01911494). A structured survey was designed using themes from the Technology Acceptance Model, which describes the likelihood of adopting the technology based on perceived usefulness and perceived ease of use. Surveys were conducted in Portuguese and translated verbatim to English for analysis. Preliminary analysis of open-ended responses was conducted to develop a coding framework for full qualitative analysis, which was completed using NVivo12 (QSR International, Melbourne, Australia). Results: Overall, 118 community health workers (44 intervention; 74 control) and 55 nurses (23 intervention; 32 control) were surveyed regarding their experiences. Many community health workers found the POM app easy to use (80%; 35/44), useful in guiding their activities (68%; 30/44) and pregnant women received their counseling more seriously because of the POM app (75%; 33/44). Almost a third CHWs reported some challenges using the POM app (30%; 13/44), including battery depletion after a full day's activity. Community health workers reported increases in knowledge about pre-eclampsia and other pregnancy complications and increases in confidence, comfort and capacity to advise women on health conditions and deliver services. Nurses recognized the increased capacity of community health workers and were more confident in their clinical and technological skills to identify women at risk of obstetric complications. Conclusions: Many of the community health workers reported that POM improved knowledge, self-efficacy and strengthened relationships with the communities they serve and local nurses. This helped to strengthen the link between community and health facility. However, findings highlight the need to consider program and systematic challenges to implementation.

Role of community engagement in maternal health in rural Pakistan: Findings from the CLIP randomized trial.

BACKGROUND: Community-based strategies to promote maternal health can help raise awareness of pregnancy danger signs and preparations for emergencies. The objective of this study was to assess change in birth preparedness and complication readiness (BPCR) and pregnant women's knowledge about pre-eclampsia as part of community engagement (CE) activities in rural Pakistan during the Community Level Interventions for Pre-eclampsia (CLIP) Trial. METHODS: The CLIP Trial was a cluster randomized controlled trial that aimed to reduce maternal and perinatal morbidity and mortality using CE strategies alongside mobile health-supported care by community health care providers. CE activities engaged pregnant women at their homes and male stakeholders through village meetings in Hyderabad and Matiari in Sindh, Pakistan. These sessions covered pregnancy complications, particularly pre-eclampsia/eclampsia, BPCR and details of the CLIP intervention package. BPCR was assessed using questions related to transport arrangement, permission for care, emergency funds, and choice of facility birth attendant for delivery during quarterly household surveys. Outcomes were assessed via multilevel logistic regression with adjustment for relevant confounders with effects summarized as odds ratios and 95% confidence intervals. RESULTS: There were 15 137 home-based CE sessions with pregnant women and families (n = 46 614) and 695 village meetings with male stakeholders (n = 7784) over two years. The composite outcomes for BPCR and pre-eclampsia knowledge did not differ significantly between trial arms. However, CE activities were associated with improved pre-eclampsia knowledge in some areas. Specifically, pregnant women in the intervention clusters were twice as likely to know that seizures could be a complication of pregnancy (odds ratio (OR) = 2.17, 95% confidence interval (CI) = 1.11, 4.23) and 2.5 times more likely to know that high blood pressure is potentially life-threatening during pregnancy (OR = 2.52, 95% CI = 1.31, 4.83) vs control clusters. CONCLUSIONS: The findings suggested that a CE strategy for male and female community stakeholders increased some measures of knowledge regarding complications of pre-eclampsia in low-resource settings. However, the effect of this intervention on long-term health outcomes needs further study. TRIAL REGISTRATION: Clinical Trials.gov - INCT01911494.