Improving the quality of maternal and newborn health outcomes through a clinical mentorship program in the Democratic Republic of the Congo: study protocol.

BACKGROUND: The Democratic Republic of the Congo (DRC) boasts one of the highest rates of institutional deliveries in sub-Saharan Africa (80%), with eight out of every ten births also assisted by a skilled provider. However, the maternal and neonatal mortality are still among the highest in the world, which demonstrates the poor in-facility quality of maternal and newborn care. The objective of this ongoing project is to design, implement, and evaluate a clinical mentorship program in 72 health facilities in two rural provinces of Kwango and Kwilu, DRC. METHODS: This is an ongoing quasi-experimental study. In the 72 facilities, 48 facilities were assigned to the group where the clinical mentorship program is being implemented (intervention group), and 24 facilities were assigned to the group where the clinical mentorship program is not being implemented (control group). The groups were selected and assigned based on administrative criteria, taking into account the number of deliveries in each facility, the coverage of health zones, accessibility, and ease of implementation of a clinical mentorship program. The main activities are organizing and training a national team of mentors (including senior midwives, obstetricians, and pediatricians) in clinical mentoring, deploying them to mentor all health providers (mentees) performing maternal and newborn health (MNH) services, and providing in-service training in routine and Emergency Obstetrical and Newborn Care (EmONC) to the mentees in health facilities over an 18-month period. Baseline and endline assessments are carried out to evaluate the effectiveness of the clinical mentorship program on the quality of MNH care and the effective coverage of key interventions to reduce maternal and neonatal mortality. Findings will be disseminated nationwide and internationally, as scientific evidence is scarce. A national strategy, guidelines, and tools for clinical mentorship in MNH will be developed for replication in other provinces, thus benefitting the entire country. DISCUSSION: This is the largest project on clinical mentorship aimed to improving the quality of MNH care in Africa. This program is expected to generate one of the first pieces of scientific evidence on the effectiveness of a clinical mentorship program in MNH on a scientifically designed and sustainable model.

Shortages of benzathine penicillin for prevention of mother-to-child transmission of syphilis: An evaluation from multi-country surveys and stakeholder interviews.

BACKGROUND: Benzathine penicillin G (BPG) is the only recommended treatment to prevent mother-to-child transmission of syphilis. Due to recent reports of country-level shortages of BPG, an evaluation was undertaken to quantify countries that have experienced shortages in the past 2 years and to describe factors contributing to these shortages. METHODS AND FINDINGS: Country-level data about BPG shortages were collected using 3 survey approaches. First, a survey designed by the WHO Department of Reproductive Health and Research was distributed to 41 countries and territories in the Americas and 41 more in Africa. Second, WHO conducted an email survey of 28 US Centers for Disease Control and Prevention country directors. An additional 13 countries were in contact with WHO for related congenital syphilis prevention activities and also reported on BPG shortages. Third, the Clinton Health Access Initiative (CHAI) collected data from 14 countries (where it has active operations) to understand the extent of stock-outs, in-country purchasing, usage behavior, and breadth of available purchasing options to identify stock-outs worldwide. CHAI also conducted in-person interviews in the same 14 countries to understand the extent of stock-outs, in-country purchasing and usage behavior, and available purchasing options. CHAI also completed a desk review of 10 additional high-income countries, which were also included. BPG shortages were attributable to shortfalls in supply, demand, and procurement in the countries assessed. This assessment should not be considered globally representative as countries not surveyed may also have experienced BPG shortages. Country contacts may not have been aware of BPG shortages when surveyed or may have underreported medication substitutions due to desirability bias. Funding for the purchase of BPG by countries was not evaluated. In all, 114 countries and territories were approached to provide information on BPG shortages occurring during 2014-2016. Of unique countries and territories, 95 (83%) responded or had information evaluable from public records. Of these 95 countries and territories, 39 (41%) reported a BPG shortage, and 56 (59%) reported no BPG shortage; 10 (12%) countries with and without BPG shortages reported use of antibiotic alternatives to BPG for treatment of maternal syphilis. Market exits, inflexible production cycles, and minimum order quantities affect BPG supply. On the demand side, inaccurate forecasts and sole sourcing lead to under-procurement. Clinicians may also incorrectly prescribe BPG substitutes due to misperceptions of quality or of the likelihood of adverse outcomes. CONCLUSIONS: Targets for improvement include drug forecasting and procurement, and addressing provider reluctance to use BPG. Opportunities to improve global supply, demand, and use of BPG should be prioritized alongside congenital syphilis elimination efforts.

A multi-country implementation research initiative to jump-start scale-up of outpatient management of possible serious bacterial infections (PSBI) when a referral is not feasible: Summary findings and implications for programs.

INTRODUCTION: Research on simplified antibiotic regimens for outpatient treatment of 'Possible Serious Bacterial Infection' (PSBI) and the subsequent World Health Organization (WHO) guidelines provide an opportunity to increase treatment coverage. This multi-country implementation research initiative aimed to learn how to implement the WHO guideline in diverse contexts. These experiences have been individually published; this overview paper provides a summary of results and lessons learned across sites. METHODS SUMMARY: A common mixed qualitative and quantitative methods protocol for implementation research was used in eleven sites in the Democratic Republic of Congo (Equateur province), Ethiopia (Tigray and Oromia regions), India (Haryana, Himachal Pradesh, Maharashtra, and Uttar Pradesh states), Malawi (Central Region), Nigeria (Kaduna and Oyo states), and Pakistan (Sindh province). Key steps in implementation research were: i) policy dialogue with the national government and key stakeholders, ii) the establishment of a 'Technical Support Unit' with the research team and district level managers, and iii) development of an implementation strategy and its refinement using an iterative process of implementation, programme learning and evaluation. RESULTS SUMMARY: All sites successfully developed and evaluated an implementation strategy to increase coverage of PSBI treatment. During the study period, a total of 6677 young infants from the study catchment area were identified and treated at health facilities in the study area as inpatients or outpatients among 88179 live births identified. The estimated coverage of PSBI treatment was 75.7% (95% CI 74.8% to 78.6%), assuming a 10% incidence of PSBI among all live births. The treatment coverage was variable, ranging from 53.3% in Lucknow, India to 97.3% in Ibadan, Nigeria. The coverage of inpatient treatment ranged from 1.9% in Zaria, Nigeria, to 33.9% in Tigray, Ethiopia. The outpatient treatment coverage ranged from 30.6% in Pune, India, to 93.6% in Zaria, Nigeria. Overall, the case fatality rate (CFR) was 14.6% (95% CI 11.5% to 18.2%) for 0-59-day old infants with critical illness, 1.9% (95% CI 1.5% to 2.4%) for 0-59-day old infants with clinical severe infection and 0.1% for fast breathing in 7-59 days old. Among infants treated as outpatients, CFR was 13.7% (95% CI 8.7% to 20.2%) for 0-59-day old infants with critical illness, 0.9% (95% CI 0.6% to 1.2%) for 0-59-day old infants with clinical severe infection, and 0.1% for infants 7-59 days old with fast breathing. CONCLUSION: Important lessons on how to conduct each step of implementation research, and the challenges and facilitators for implementation of PSBI management guideline in routine health systems are summarised and discussed. These lessons will be used to introduce and scale-up implementation in relevant Low- and middle-income countries.

The consequences of post-election violence on antiretroviral HIV therapy in Kenya.

Over 1000 individuals were killed and 600,000 were displaced during post-election violence (PEV) in Kenya in 2008. Antiretroviral therapy (ART) depends on continuous access to medications which may have been interrupted due to PEV. In a mixed-methods retrospective review, treatment interruption of ART during PEV was measured among 2534 HIV-positive adults attending the Coptic Hope Center for Infectious Diseases in Nairobi, Kenya. Clients experiencing treatment interruption were compared between the PEV period (30 December 2007 to 28 February 2008) and the same time period one year earlier. Treatment interruption was defined as visiting the pharmacy ≥48 hours after antiretrovirals were calculated to have been completed. Despite clinical services remaining open throughout the PEV period, more clients (16.1%) experienced treatment interruption than during the comparison period (10.2%). Mean daily pharmacy visits were significantly lower (87 vs. 104; p < 0.006) and more variable (p = 0.03) during PEV. Among clients present at both periods (n = 1605), the odds of treatment interruption were 71% higher during PEV (95% confidence interval [CI], 34-118%). In multivariate analysis, men (odds ratio [OR], 1.37; 95% CI, 1.07-1.76) and clients traveling ≥3 hours to clinic (OR, 1.86; 95% CI, 1.28-2.71) were significantly more likely to experience treatment interruption. Clients affected by PEV were interviewed about factors associated with treatment interruption using semi-structured methods. Clients described fear, lack of transportation, and violence as contributing to treatment interruption. Widespread violence associated with the 2007 election in Kenya revealed the dependence of HIV patients on a stable civil society and infrastructure to access medications. Without the ability to maintain consistent HIV therapy, some patients face rapid treatment failure. HIV programs should have appropriate contingency plans wherever political instability may occur. Peace may be one of the most effective and most important public health interventions in Africa.

Facility conditions, obstetric and neonatal care practices, and availability of emergency obstetric and neonatal care in 72 rural health facilities in the Democratic Republic of the Congo: A cross-sectional study.

Background: Current facility conditions, obstetric and neonatal care practices, and availability of emergency obstetric and neonatal care (EmONC) were assessed in the Kwango and Kwilu provinces of the Democratic Republic of the Congo (DRC). Methods: This is an analysis of the baseline survey data from an ongoing clinical mentoring program among 72 rural health facilities in the DRC. Data collectors visited each of the facilities and collected data through a pre-programmed smartphone. Frequencies of selected indicators were calculated by province and facility type-general referral hospital (GRH) and primary health centers (HC). Results: Facility conditions varied across province and facility type. Maternity wards and delivery rooms were available in the highest frequency of rooms assessed (>95% of all facilities). Drinking water was available in 25.0% of all facilities; electricity was available in 49.2% of labor rooms and 67.6% of delivery rooms in all facilities. Antenatal, delivery, and postnatal care services were available but varied across facilities. While the proportion of blood pressure measured during antenatal care was high (94.9%), the antenatal screening rate for proteinuria was low (14.7%). The use of uterotonics immediately after birth was observed in high numbers across both provinces (94.4% in Kwango and 75.6% in Kwilu) and facility type (91.3% in GRH and 81.4% in HC). The provision of immediate postnatal care to mothers every 15 minutes was provided in less than 50% of all facilities. GRH facilities generally had higher frequencies of available equipment and more services available than HC. GRH facilities provided an average of 6 EmONC signal functions (range: 2-9). Conclusions: Despite poor facility conditions and a lack of supplies, GRH and HC facilities were able to provide EmONC care in rural DRC. These findings could guide the provision of essential needs to the health facilities for better delivery of maternal and neonatal care.

A multifaceted intervention to improve syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cluster randomised controlled trial.

BACKGROUND: Despite international recommendations, coverage of syphilis testing in pregnant women and treatment of those found seropositive remains limited in sub-Saharan Africa. We assessed whether combining the provision of supplies with a behavioural intervention was more effective than providing supplies only, to improve syphilis screening and treatment during antenatal care. METHODS: In this 18-month, cluster randomised controlled trial, we randomly assigned (1:1) 26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group). The primary outcomes were proportion of pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit. This trial is registered at ClinicalTrials.gov, number NCT02353117. FINDINGS: The 18-month study period was Feb 1, 2016, to July 14, 2017. 18 357 women were enrolled at the 13 intervention clinics and 17 679 women were enrolled at the 13 control clinics at their first antenatal care visit. Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092). Syphilis treatment at the first visit was done in a median of 100% (IQR 99·7-100·0) of seropositive women in intervention clinics and 43·2% (2·6-83·2) of seropositive women in control clinics (absolute difference 56·8% [12·8-99·0]; p=0·0028). INTERPRETATION: A behavioural intervention, together with the provision of supplies, can lead to more than 95% of women being screened and treated for syphilis. The sole provision of supplies is sufficient to reach such levels of screening coverage but is not sufficient to ensure high levels of treatment. FUNDING: Bill & Melinda Gates Foundation.

Moving beyond silos: How do we provide distributed personalized medicine to pregnant women everywhere at scale? Insights from PRE-EMPT.

While we believe that pre-eclampsia matters-because it remains a leading cause of maternal and perinatal morbidity and mortality worldwide-we are convinced that the time has come to look beyond single clinical entities (e.g. pre-eclampsia, postpartum hemorrhage, obstetric sepsis) and to look for an integrated approach that will provide evidence-based personalized care to women wherever they encounter the health system. Accurate outcome prediction models are a powerful way to identify individuals at incrementally increased (and decreased) risks associated with a given condition. Integrating models with decision algorithms into mobile health (mHealth) applications could support community and first level facility healthcare providers to identify those women, fetuses, and newborns most at need of facility-based care, and to initiate lifesaving interventions in their communities prior to transportation. In our opinion, this offers the greatest opportunity to provide distributed individualized care at scale, and soon.

Engaging communities in tuberculosis research.

According to a growing consensus among biomedical researchers, community engagement can improve the ethics and outcomes of clinical trials. Although successful efforts to develop community engagement practices in HIV/AIDS research have been reported, little attention has been given to engagement with the community in tuberculosis research. This article aims to draw attention to some existing community engagement initiatives in tuberculosis research and to resources that might help tuberculosis researchers to establish and implement community engagement programmes for their trials. One of these resources-the good participatory practice guidelines for tuberculosis drug trials-offers a conceptual framework and practical guidance for community engagement in tuberculosis research. To build momentum and to improve community engagement, lessons need to be shared, and formal assessment strategies for community engagement initiatives need to be developed. To build successfully on the promising activities described in this personal view, research funders and sponsors should show leadership in allocation of resources for the implementation and assessment of community engagement programmes in tuberculosis trials.