Evaluation of a protein-to-creatinine dipstick diagnostic test for proteinuria screening in selected antenatal care clinics in three Districts in the Bono-East Region of Ghana.

BACKGROUND: Preeclampsia and eclampsia contribute significantly to maternal and newborn deaths worldwide. Early and accurate identification of pregnant women at risk can avert these deaths, but the necessary diagnostics are not widely available. A protein and creatinine ratio, rather than a measurement of protein alone, may provide better identification of proteinuria. The objective of this study was to assess the operational and performance characteristics of the LifeAssay Diagnostics (LAD) Test-it™ protein-to-creatinine ratio (PrCr) urinalysis dipstick test in a representative antenatal care setting (ANC). METHODS: Mixed methods were used to assess the operational and performance characteristics of the PrCr test, including a usability study with 25 participants, a prospective cross-sectional diagnostic accuracy study (N = 1483), and a targeted reassessment of discordant frozen samples (N = 200). Several other commonly used proteinuria tests were included for comparison. RESULTS: The test demonstrated improved clinical performance for detection of proteinuria over the current standard-of-care tests widely used in Ghana. The LAD PrCr test showed a sensitivity of 50.7% and specificity of 69.2% when run at the point of care. In contrast, the standard-of-care Accu-Tell® protein dipstick test was found to have a sensitivity of 32.4% and a specificity of 82.2%. The LAD test shows minor improvement over the tests currently used in Ghana to detect proteinuria. CONCLUSIONS: The PrCr test offers the potential for improved detection of proteinuria over the standard-of-care tests used in ANC. However, this test and the others evaluated for this study demonstrate limited performance, particularly among samples with a low level of proteinuria. Additional exploration in other clinical use cases, such as triage among high-risk populations, is warranted. The LAD test can also be considered a transition product, as health systems consider adopting next-generation biomarker tests when more readily available.

Are verbatim transcripts necessary in applied qualitative research: experiences from two community-based intervention trials in Ghana.

Conducting qualitative research within public health trials requires balancing timely data collection with the need to maintain data quality. Verbatim transcription of interviews is the conventional way of recording qualitative data, but is time consuming and can severely delay the availability of research findings. Expanding field notes into fair notes is a quicker alternative method, but is not usually recommended as interviewers select and interpret what they record. We used the fair note methodology in Ghana, and found that where research questions are relatively simple, and interviewers undergo sufficient training and supervision, fair notes can decrease data collection and analysis time, while still providing detailed and relevant information to the study team. Interviewers liked the method and felt it made them more reflective and analytical and improved their interview technique. The exception was focus group discussions, where the fair note approach failed to capture the interaction and richness of discussions, capturing group consensus rather than the discussions leading to this consensus.

Implementing effective community-based surveillance in research studies of maternal, newborn and infant outcomes in low resource settings.

BACKGROUND: Globally adopted health and development milestones have not only encouraged improvements in the health and wellbeing of women and infants worldwide, but also a better understanding of the epidemiology of key outcomes and the development of effective interventions in these vulnerable groups. Monitoring of maternal and child health outcomes for milestone tracking requires the collection of good quality data over the long term, which can be particularly challenging in poorly-resourced settings. Despite the wealth of general advice on conducting field trials, there is a lack of specific guidance on designing and implementing studies on mothers and infants. Additional considerations are required when establishing surveillance systems to capture real-time information at scale on pregnancies, pregnancy outcomes, and maternal and infant health outcomes. MAIN BODY: Based on two decades of collaborative research experience between the Kintampo Health Research Centre in Ghana and the London School of Hygiene and Tropical Medicine, we propose a checklist of key items to consider when designing and implementing systems for pregnancy surveillance and the identification and classification of maternal and infant outcomes in research studies. These are summarised under four key headings: understanding your population; planning data collection cycles; enhancing routine surveillance with additional data collection methods; and designing data collection and management systems that are adaptable in real-time. CONCLUSION: High-quality population-based research studies in low resource communities are essential to ensure continued improvement in health metrics and a reduction in inequalities in maternal and infant outcomes. We hope that the lessons learnt described in this paper will help researchers when planning and implementing their studies.

Health service provider education and/or training in infant male circumcision to improve short- and long-term morbidity outcomes: A systematic review.

AIM: To systematically review the effectiveness of education and/or training for traditional (informal) and formal health service providers in infant male circumcision on morbidity or mortality outcomes. METHODS: We searched Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, Global Health, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects and clinical trial registries in all languages from January 1985 to June 2018. Our primary outcomes were all-cause morbidity and all-cause mortality. RESULTS: We identified 1399 publications. Only four non-controlled before and after studies from the USA and Uganda satisfied our criteria, all of which examined the effect of training on the skills and knowledge of medical doctors, midwives and clinical officers. No study involved informal traditional circumcision providers. All included studies were low quality. CONCLUSIONS: High-quality studies of simple training packages to improve education and training of circumcision providers, especially informal non-medical providers in low income countries are needed.

The Risk of Sexually Transmitted Infection and Its Influence on Condom Use among Pregnant Women in the Kintampo North Municipality of Ghana.

Sexually transmitted infection (STI) affects the reproductive health of both men and women worldwide. Condoms are important part of the available preventive strategies for STI control. The lack of proper risk-perception continues to impede women's ability to negotiate condom use with their partners. This paper is the outcome of secondary analysis of data collected in a cross-sectional survey that explored the perception of risk of STI and its influence on condom use among 504 pregnant women attending antenatal clinic at two health facilities in the Kintampo North Municipality. Consecutively, three Focus Group Discussions were conducted among 22 pregnant women which was analyzed using thematic analysis technique. Multivariate logistic regression analysis was used to identify possible predictors of condom use and risk of STI. Respondents mean age was 26.0 ± 5.9 years. 47% of respondents self-identified themselves as high risk for contracting STI, 50% of whom were married. High risk status (OR = 2.1, 95% CI: 1.1-4.4), ability to ask for condoms during sex (OR = 0.3, 95% CI: 0.1-0.73), and partner's approval of condom use (OR = 0.2, 95% CI: 0.01-0.05) were independent predictors of condom use. Condom use (OR 2.9 (1.5-5.7); p = 0.001) and marital status (engaged, OR 2.6 (1.5-4.5); p = 0.001) were independent predictors of risk of STI. Women who self-identified themselves as high risk for STI successfully negotiated condom use with their partners. This is however influenced by partner's approval and ability to convince partner to use condoms. Self-assessment of STI risk by women and the cooperation of male partners remain critical.

Determinants of morbidity associated with infant male circumcision: community-level population-based study in rural Ghana.

OBJECTIVE: Male circumcision services have expanded throughout Africa as part of a long-term HIV prevention strategy. We assessed the effect of type of service provider (formal and informal) and hygiene practices on circumcision-related morbidities in rural Ghana. METHODS: Population-based, cross-sectional study conducted between May and December 2012 involving 2850 circumcised infant males aged under 12 weeks. Multivariable logistic regression models were adjusted for maternal age, maternal education, income, birthweight and site of circumcision. RESULTS: A total of 2850 (90.7%) infant males were circumcised. Overall, the risk of experiencing a morbidity (defined as complications occurring during or after the circumcision procedure as reported by the primary caregiver) was 8.1% (230). Risk was not significantly increased if the circumcision was performed by informal providers (121, 7.2%) vs. formal health service providers (109, 9.8%) [adjusted odds ratio (aOR) 1.11, 95% CI 0.80-1.47, P = 0.456]. Poor hygiene practices were associated with significantly increased risk of morbidity: no handwashing [148 (11.7%)] (aOR 1.78, 95% CI 1.27-2.52, P = 0.001); not cleaning circumcision instruments [174 (10.6%)] (aOR 1.80, 95% CI 1.27-2.54, P = 0.001); and uncleaned penile area [190 (10.0%)] (aOR 1.84, 95% CI 1.25-2.70, P = 0.002). CONCLUSION: The risk of morbidity after infant male circumcision in rural Ghana is high, chiefly due to poor hygiene practices. Governmental and non-governmental organisations need to improve training of circumcision providers in hygiene practices in sub-Saharan Africa.

mPneumonia, an Innovation for Diagnosing and Treating Childhood Pneumonia in Low-Resource Settings: A Feasibility, Usability and Acceptability Study in Ghana.

Pneumonia is the leading cause of infectious disease mortality in children. Currently, health care providers (HCPs) are trained to use World Health Organization Integrated Management of Childhood Illness (IMCI) paper-based protocols and manually assess respiratory rate to diagnose pneumonia in low-resource settings (LRS). However, this approach of relying on clinical signs alone has proven problematic. Hypoxemia, a diagnostic indicator of pneumonia severity associated with an increased risk of death, is not assessed because pulse oximetry is often not available in LRS. To improve HCPs' ability to diagnose, classify, and manage pneumonia and other childhood illnesses, "mPneumonia" was developed. mPneumonia is a mobile health application that integrates a digital version of the IMCI algorithm with a software-based breath counter and a pulse oximeter. A design-stage qualitative pilot study was conducted to assess feasibility, usability, and acceptability of mPneumonia in six health centers and five community-based health planning and services centers in Ghana. Nine health administrators, 30 HCPs, and 30 caregivers were interviewed. Transcribed interview audio recordings were coded and analyzed for common themes. Health administrators reported mPneumonia would be feasible to implement with approval and buy-in from national and regional decision makers. HCPs felt using the mPneumonia application would be feasible to integrate into their work with the potential to improve accurate patient care. They reported it was "easy to use" and provided confidence in diagnosis and treatment recommendations. HCPs and caregivers viewed the pulse oximeter and breath counter favorably. Challenges included electricity requirements for charging and the time needed to complete the application. Some caregivers saw mPneumonia as a sign of modernity, increasing their trust in the care received. Other caregivers were hesitant or confused about the new technology. Overall, this technology was valued by users and is a promising innovation for improving quality of care in frontline health facilities.

Increasing access to care for sick newborns: evidence from the Ghana Newhints cluster-randomised controlled trial.

OBJECTIVES: To evaluate the impact of Newhints community-based surveillance volunteer (CBSV) assessments and referrals on access to care for sick newborns and on existing inequities in access. DESIGN: We evaluated a prospective cohort nested within the Newhints cluster-randomised controlled trial. SETTING: Community-based intervention involving more than 750 000, predominantly rural, population in seven contiguous districts in the Brong-Ahafo Region, Ghana. PARTICIPANTS: Participants were recently delivered women (from more than 120 000 women under surveillance) and their 16 168 liveborn babies. Qualitative in-depth interviews with referral narratives (IDIs) were conducted with 92 mothers, CBSVs and health facility front-desk and maternity/paediatrics ward staff. INTERVENTIONS: Newhints trained and effectively supervised 475 CBSVs (existing within the Ghana Health Service) in 49 of 98 supervisory zones (clusters) to assess and refer newborns with any of the 10-key-danger signs to health facilities within the first week after birth; promote independent care seeking for sick newborns and problem-solve around barriers between November 2008 and December 2009. PRIMARY OUTCOMES: The main evaluation outcomes were rates of compliance with referrals and independent care seeking for newborn illnesses. RESULTS: Of 4006 sampled, 2795 (69.8%) recently delivered women received CBSV assessment visits and 279 (10.0%) newborns were referred with danger signs. Compliance with referrals was unprecedentedly high (86.0%) with women in the poorest quintile (Q1) complying better than the least poor (Q5):87.5%(Q1) vs 69.7%(Q5); p=0.038. Three-quarters went to hospitals; 18% were admitted and 58% received outpatient treatment. Some (24%) mothers were turned away at facilities and follow-on IDIs showed that some of these untreated babies subsequently died. Independent care seeking for severe newborn illness increased from 55.4% in control to 77.3% in Newhints zones, especially among Q1 where care seeking almost doubled (95.0% vs 48.6%; RR=1.94 (1.32, 2.84); p=0.001). Rates were the highest among rural residents but urban residents complied quicker. CONCLUSIONS: Home visits are feasible and a potentially pro-poor approach to link sick newborns to facilities. Its effectiveness in improving survival hinges on matched improvement in facility quality of care. TRIAL REGISTRATION NUMBER: NCT00623337.

Vaccination timing of low-birth-weight infants in rural Ghana: a population-based, prospective cohort study.

OBJECTIVE: To investigate delays in first and third dose diphtheria-tetanus-pertussis (DTP1 and DTP3) vaccination in low-birth-weight infants in Ghana, and the associated determinants. METHODS: We used data from a large, population-based vitamin A trial in 2010-2013, with 22 955 enrolled infants. We measured vaccination rate and maternal and infant characteristics and compared three categories of low-birth-weight infants (2.0-2.4 kg; 1.5-1.9 kg; and < 1.5 kg) with infants weighing ≥ 2.5 kg. Poisson regression was used to calculate vaccination rate ratios for DTP1 at 10, 14 and 18 weeks after birth, and for DTP3 at 18, 22 and 24 weeks (equivalent to 1, 2 and 3 months after the respective vaccination due dates of 6 and 14 weeks). FINDINGS: Compared with non-low-birth-weight infants (n = 18 979), those with low birth weight (n = 3382) had an almost 40% lower DTP1 vaccination rate at age 10 weeks (adjusted rate ratio, aRR: 0.58; 95% confidence interval, CI: 0.43-0.77) and at age 18 weeks (aRR: 0.63; 95% CI: 0.50-0.80). Infants weighing 1.5-1.9 kg (n = 386) had vaccination rates approximately 25% lower than infants weighing ≥ 2.5 kg at these time points. Similar results were observed for DTP3. Lower maternal age, educational attainment and longer distance to the nearest health facility were associated with lower DTP1 and DTP3 vaccination rates. CONCLUSION: Low-birth-weight infants are a high-risk group for delayed vaccination in Ghana. Efforts to improve the vaccination of these infants are warranted, alongside further research to understand the reasons for the delays.

Health service provider education and/or training in infant male circumcision to improve short- and long-term morbidity outcomes: protocol for systematic review.

BACKGROUND: There has been an expansion of circumcision services in Africa as part of a long-term HIV prevention strategy. However, the effect of infant male circumcision on morbidity and mortality still remains unclear. Acute morbidities associated with circumcision include pain, bleeding, swelling, infection, tetanus or inadequate skin removal. Scale-up of circumcision services could lead to a rise in these associated morbidities that could have significant impact on health service delivery and the safety of infants. Multidisciplinary training programmes have been developed to improve skills of health service providers, but very little is known about the effectiveness of health service provider education and/or training for infant male circumcision on short- and long-term morbidity outcomes. This review aims to evaluate the effectiveness of health service provider education and/or training for infant male circumcision on short- and long-term morbidity outcomes. METHODS/DESIGN: The review will include studies comparing health service providers who have received education and/or training to improve their skills for infant male circumcision with those who have not received education and/or training. Randomised controlled trials (RCTs) and cluster RCTs will be included. The outcomes of interest are short-term morbidities of the male infant including pain, infection, tetanus, bleeding, excess skin removal, glans amputation and fistula. Long-term morbidities include urinary tract infection (UTI), HIV infection and abnormalities of urination. Databases such as MEDLINE (OVID), PsycINFO (OVID), EMBASE (OVID), CINAHL, Cochrane Library (including CENTRAL and DARE), WHO databases and reference list of papers will be searched for relevant articles. Study selection, data extraction and synthesis and risk of bias assessment using the Cochrane risk of bias assessment tool will be conducted. We will calculate the pooled estimates of the difference in means and risk ratios using random effects models. If insufficient data are available, we will present results descriptively. DISCUSSION: This review appears to be the first to be conducted in this area. The findings will have important implications for infant male circumcision programmes and policy. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015029345.

Cost and cost-effectiveness of newborn home visits: findings from the Newhints cluster-randomised controlled trial in rural Ghana.

BACKGROUND: Every year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5-18). We aimed to estimate the costs and cost-effectiveness of newborn home visits in a programme setting. METHODS: We prospectively collected detailed cost data alongside the Newhints trial, which tested the effect of a home-visits intervention in seven districts in rural Ghana and showed a reduction of 8% (95% CI -12 to 25%) in neonatal mortality. The intervention consisted of a package of home visits to pregnant women and their babies in the first week of life by community-based surveillance volunteers. We calculated incremental cost-effectiveness ratios (ICERs) with Monte Carlo simulation and one-way sensitivity analyses and characterised uncertainty with cost-effectiveness planes and cost-effectiveness acceptability curves. We then modelled the potential cost-effectiveness for baseline neonatal mortality rates of 20-60 deaths per 1000 livebirths with use of a meta-analysis of effectiveness estimates. FINDINGS: In the 49 zones randomly allocated to receive the Newhints intervention, a mean of 407 (SD 18) community-based surveillance volunteers undertook home visits for 7848 pregnant women who gave birth to 7786 live babies in 2009. Annual economic cost of implementation was US$203 998, or $0·53 per person. In the base-case analysis, the Newhints intervention cost a mean of $10 343 (95% CI 2963 to -7674) per newborn life saved, or $352 (95% CI 104 to -268) per discounted life-year saved, and had a 72% chance of being highly cost effective with respect to Ghana's 2009 gross domestic product per person. Key determinants of cost-effectiveness were the discount rate, protective effectiveness, baseline neonatal mortality rate, and implementation costs. In the scenarios modelled with the meta-analysis results, the ICER increased from $127 per life-year saved at a neonatal mortality rate of 60 deaths per 1000 livebirths, to $379 per life-year saved at a rate of 20 deaths per 1000 livebirths. The strategy had at least a 99% probability of being highly cost effective for lower-middle-income countries in all neonatal mortality rate scenarios modelled, and at least a 95% probability of being highly cost effective for low-income countries at neonatal mortality rates of 30 or more deaths per 1000 livebirths. INTERPRETATION: Our findings show that the seemingly modest mortality reductions achieved by a newborn home-visit strategy might in fact be cost effective. In Ghana, such strategies are also likely to be affordable. Our findings support recommendations from WHO and UNICEF that low-income and middle-income countries implement newborn home visits. FUNDING: The Bill & Melinda Gates Foundation, UK Department for International Development, WHO.

mPneumonia: Development of an Innovative mHealth Application for Diagnosing and Treating Childhood Pneumonia and Other Childhood Illnesses in Low-Resource Settings.

Pneumonia is the leading infectious cause of death in children worldwide. Each year, pneumonia kills an estimated 935,000 children under five years of age, with most of these deaths occurring in developing countries. The current approach for pneumonia diagnosis in low-resource settings--using the World Health Organization Integrated Management of Childhood Illness (IMCI) paper-based protocols and relying on a health care provider's ability to manually count respiratory rate--has proven inadequate. Furthermore, hypoxemia--a diagnostic indicator of the presence and severity of pneumonia often associated with an increased risk of death--is not assessed because pulse oximetry is frequently not available in low-resource settings. In an effort to address childhood pneumonia mortality and improve frontline health care providers' ability to diagnose, classify, and manage pneumonia and other childhood illnesses, PATH collaborated with the University of Washington to develop "mPneumonia," an innovative mobile health application using an Android tablet. mPneumonia integrates a digital version of the IMCI algorithm with a software-based breath counter and a pediatric pulse oximeter. We conducted a design-stage usability field test of mPneumonia in Ghana, with the goal of creating a user-friendly diagnostic and management tool for childhood pneumonia and other childhood illnesses that would improve diagnostic accuracy and facilitate adherence by health care providers to established guidelines in low-resource settings. The results of the field test provided valuable information for understanding the usability and acceptability of mPneumonia among health care providers, and identifying approaches to iterate and improve. This critical feedback helped ascertain the common failure modes related to the user interface design, navigation, and accessibility of mPneumonia and the modifications required to improve user experience and create a tool aimed at decreasing mortality from pneumonia and other childhood illnesses in low-resource settings.

What can we learn about postnatal care in Ghana if we ask the right questions? A qualitative study.

BACKGROUND: There are increasing efforts to monitor progress in maternal and neonatal care, with household surveys the main mode of data collection. Postnatal care (PNC) is considered a priority indicator yet few countries report on it, and the need to improve the construct validity associated with PNC questions is recognized. OBJECTIVES: To determine women's knowledge of what happens to the baby after delivery, women's comprehension of terms and question phrasing related to PNC, and issues with recall periods. DESIGN: Forty qualitative interviews and four focus group discussions were conducted with mothers, and 10 interviews with health workers in rural Ghana. Data were collected on knowledge and recall of postnatal health checks and language used to describe these health checks. RESULTS: Mothers required specific probing using appropriate language to report postnatal checks. They only had adequate knowledge of postnatal checks, which were easily observed or required asking them a question. Respondents reported that health workers rarely communicated with mothers about what they were doing, and most women did not know the purpose of the equipment used during health checks, such as why a thermometer was being used. Knowledge of neonatal checks in the first hours after a facility delivery was low if the mother and child were separated, or if the mother was tired or weak. Many women reported that they could remember events clearly, but long recall periods affected reporting for some, especially those who had multiple checks or for those with no problems. CONCLUSIONS: Direct questions about PNC or health checks are likely to underestimate coverage. Validity of inferences can be enhanced by using appropriate verbal probes during surveys on commonly performed checks that are clear and visible to the mother.

Effect of early neonatal vitamin A supplementation on mortality during infancy in Ghana (Neovita): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Results of randomised controlled trials of newborn (age 1-3 days) vitamin A supplementation have been inconclusive. The WHO is coordinating three large randomised trials in Ghana, India, and Tanzania (Neovita trials). We present the findings of the Neovita trial in Ghana. METHODS: This study was a population-based, individually randomised, double-blind, placebo-controlled trial in the Brong Ahafo region of Ghana. The trial participants were infants aged at least 2 h, identified at home or facilities on the day of birth or in the next 2 days, able to feed orally, and likely to stay in the study area for at least 6 months. They were randomly assigned (ratio 1:1) to receive either one oral dose of vitamin A (50,000 IU) or placebo immediately after recruitment. The research team and parents of the infants were masked to treatment assignment. Follow-up home visits were undertaken every 4 weeks, when data were recorded for deaths, facility use, and care seeking. The primary outcome was post-supplementation mortality to 6 months of age. Analysis was by intention to treat. Potential adverse events were recorded at 1 and 3 days after supplementation. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)CTRN12610000582055. FINDINGS: We assessed 26,414 livebirths for eligibility between Aug 16, 2010, and Nov 7, 2011. We recruited 22,955 newborn infants, with 11,474 randomly assigned to receive vitamin A and 11,481 to receive placebo. Loss to follow-up was low with vital status at 6 months of age reported for 22,698 (98·9%) infants. We recorded 278 post-supplementation deaths to 6 months of age in the vitamin A group (mortality risk 24·5 in 1000 supplemented infants) and 248 deaths in the placebo group (mortality risk 21·8 per 1000 supplemented infants), relative risk (RR) 1·12 (95% CI 0·95-1·33; p=0·183) and risk difference (RD) 2·66 (95% CI -1·25 to 6·57; p=0·18). Adverse events within 3 days of supplementation did not differ by trial group. 122 infants died in the first 3 days after supplementation; 70 (0·6%) in the vitamin A and 52 (0·5%) in the placebo group (risk ratio [RR] 1·35, 95% CI 0·94-1·93, p=0·102). 53 infants were reported to have a bulging fontanelle; 32 (0·3%) in the vitamin A group and 21 (0·2%) in the placebo group (RR 1·53, 0·88-2·62, p=0·130). INTERPRETATION: The results of this trial do not support inclusion of newborn vitamin A supplementation as a child survival strategy in Ghana. FUNDING: Bill & Melinda Gates Foundation grant to the WHO.

Evaluating the implementation of community volunteer assessment and referral of sick babies: lessons learned from the Ghana Newhints home visits cluster randomized controlled trial.

A World Health Organization (WHO)/United Nations Children's Fund (UNICEF) (2009) joint statement recommended home visits by community-based agents as a strategy to improve newborn survival, based on promising results from Asia. This article presents detailed evaluation of community volunteer assessment and referral implemented within the Ghana Newhints home visits cluster-Randomized Controlled Trial (RCT). It highlights the lessons learned to inform implementation/scale-up of this model in similar settings. The evaluation used a conceptual framework adopted for increasing access to care for sick newborns and involves three main steps, each with a specific goal and key requirements to achieving this. These steps are: sick newborns are identified within communities and referred; families comply with referrals and referred babies receive appropriate management at health facilities. Evaluation data included interviews with 4006 recently delivered mothers; records on 759 directly observed volunteer assessments and 52 validation of supervisors' assessments; newborn care quality assessment in 86 health facilities and in-depth interviews (IDIs) with 55 mothers, 21 volunteers and 15 health professionals. Assessment accuracy of volunteers against supervisors and physician was assessed using Kappa (agreement coefficient). IDIs were analysed by generating and indexing into themes, and exploring relationships between themes and their contextual interpretations. This evaluation demonstrated that identifying, understanding and implementing the key requirements for success in each step of volunteer assessment and referrals was pivotal to success. In Newhints, volunteers (CBSVs) were trusted by families, their visits were acceptable and they engaged mothers/families in decisions, resulting in unprecedented 86% referral compliance and increased (55-77%) care seeking for sick newborns. Poor facility care quality, characterized by poor health worker attitudes, limited the mortality reduction. The important implication for future implementation of home visits in similar settings is that, with 100% specificity but 80% sensitivity of referral decisions, volunteers might miss some danger signs but if successful implementation must translate into mortality reductions, concurrent improvement in facility newborn care quality is imperative.

Perceptions of, attitudes towards and barriers to male involvement in newborn care in rural Ghana, West Africa: a qualitative analysis.

BACKGROUND: Male involvement in various health practices is recognized as an important factor in improving maternal and child health outcomes. Male involvement interventions involve men in a variety of ways, at varying levels of inclusion and use a range of outcome measures. There is little agreement on how male involvement should be measured and some authors contend that male involvement may actually be detrimental to women's empowerment and autonomy. Few studies explore the realities, perceptions, determinants and efficacy of male involvement in newborn care, especially in African contexts. METHODS: Birth narratives of recent mothers (n = 25), in-depth interviews with recent fathers (n = 12) and two focus group discussions with fathers (n = 22) were conducted during the formative research phase of a community-based newborn care trial. Secondary analysis of this qualitative data identified emergent themes and established overall associations related to male involvement, newborn care and household roles in a rural African setting. RESULTS: Data revealed that gender dictates many of the perceptions and politics surrounding newborn care in this context. The influence of mother-in-laws and generational power dynamics were also identified as significant. Women alone perform almost all tasks related to newborn care whereas men take on the traditional responsibilities of economic providers and decision makers, especially concerning their wives' and children's health. Most men were interested in being more involved in newborn care but identified barriers to increased involvement, many of which related to gendered and generational divisions of labour and space. CONCLUSIONS: Men defined involvement in a variety of ways, even if they were not physically involved in carrying out newborn care tasks. Some participant comments revealed potential risks of increasing male involvement suggesting that male involvement alone should not be an outcome in future interventions. Rather, the effect of male involvement on women's autonomy, the dynamics of senior women's influence and power and the real impact on health outcomes should be considered in intervention design and implementation. Any male involvement intervention should integrate a detailed understanding of context and strategies to include men in maternal and child health should be mutually empowering for both women and men.

Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial.

BACKGROUND: Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births. METHODS AND FINDINGS: This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27-0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18-0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7-72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls. CONCLUSION: Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births. TRIAL REGISTRATION: ClinicalTrials.gov NCT01108289 Please see later in the article for the Editors' Summary.

Promoting skin-to-skin care for low birthweight babies: findings from the Ghana Newhints cluster-randomised trial.

OBJECTIVE: To evaluate whether the Newhints home visits intervention increased the adoption of skin-to-skin care (SSC), in particular, among low birthweight (LBW) (<2.5 kg) babies. METHODS: A cluster-randomised trial, with 49 Newhints zones and 49 control zones, was conducted in seven districts in the Brong Ahafo Region, Ghana. It included all live births between November 2008 and December 2009. In Newhints zones, existing community-based surveillance volunteers were trained to conduct home visits during which they weighed babies and counselled mothers of LBW babies on SSC. Performance of any SSC and SSC for more than 2 h was evaluated. RESULTS: Of 15,615 live births, 68.5% had recorded birthweights; 10.1% were LBW. Any SSC was 19.4% higher among babies in Newhints vs. control zones (risk ratio, RR: 1.81; 95% confidence interval, CI: 1.40-2.35). Performance of SSC for more than 2 h was, however, low, at only 7.5%, although more than double compared with control zones (RR: 2.72; 95% CI: 1.80-4.10). LBW babies visited and weighed by a volunteer were more likely to receive SSC (PA ny  = 0.005; P >  2 h  = 0.021), greater for LBW babies, particularly for more than 2 h of SSC (Pinteraction  = 0.050). CONCLUSION: Newhints successfully promoted the uptake of SSC in rural Ghana. Although findings are encouraging, promotion in rural community settings in sub-Saharan Africa is challenging. Lessons learned can help shape SSC promotion in efforts to increase adoption and save newborn lives.

Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial.

BACKGROUND: In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices. METHODS: The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337. FINDINGS: 16,168 (99%) of 16,329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15,619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96-1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81-1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17-1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03-1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05-1·12; p<0·0001), transport arranged in advance for facility (2496 [37%] vs 2061 [30%], respectively; 1·30, 1·12-1·49; p=0·0004), birth assistant for home delivery washed hands with soap (1853 [93%] of 1992 vs 1817 [87%] of 2091, respectively; 1·05, 1·02-1·09; p=0·001), initiation of breastfeeding in less than 1 h of birth (3743 [49%] of 7673 vs 3280 [41%] of 7921, respectively; 1·22, 1·07-1·40; p=0·004), skin to skin contact (3355 [44%] vs 1931 [24%], respectively; 2·30, 1·85-2·87; p=0·0002), first bath delayed for longer than 6 h (3131 [41%] vs 2269 [29%], respectively; 1·65, 1·27-2·13; p<0·0001), exclusive breastfeeding for 26-32 days (1217 [86%] of 1414 vs 1091 [80%] of 1371; 1·10, 1·04-1·16; p=0·001), and baby sleeping under bednet for 8-56 days (4548 [79%] of 5756 vs 4291 [73%] of 5846; 1·09, 1·03-1·15; p=0·002). There were 230 neonatal deaths in the Newhints zones compared with 252 in the control zones. The overall NMRs per 1000 livebirths were 29·8 and 31·9, respectively (0·92, 0·75-1·12; p=0·405). INTERPRETATION: The reduction in NMR with Newhints is consistent with the reductions achieved in three trials undertaken in programme settings in south Asia. Because there is no suggestion of any heterogeneity (p=0·850) between these trials and Newhints, the meta-analysis summary estimate of a reduction of 12% (95% CI 5-18) provides the best evidence for the likely effect of the home-visits strategy delivered within programmes in sub-Saharan Africa and in south Asia. Improvements in the quality of delivery and neonatal care in health facilities and development of innovative, effective strategies to increase coverage of home visits on the day of birth could lead to the achievement of more substantial reductions. FUNDING: WHO, Bill & Melinda Gates Foundation, and UK Department for International Development.