Study protocol for a cluster-randomized controlled trial of an NCD access to medicines initative: Evaluation of Novartis Access in Kenya

INTRODUCTION: Novartis recently launched Novartis Access, an initiative to provide a basket of reduced price medicines for non-communicable diseases (NCDs) to be sold through the public and private nonprofit sectors in programme countries. This study will evaluate the impact of Novartis Access on the availability and price of NCD medicines at health facilities and households in Kenya, the first country to receive the programme. METHODS: This study will be a cluster randomised controlled trial. 8 counties in Kenya will be randomly assigned to the intervention or control group using a covariate constrained randomisation method to maximise balance on demographic and health characteristics. In intervention counties, public and private non-profit health facilities will be able to order Novartis Access NCD medicines from the Mission for Essential Drugs and Supplies (MEDS). Data will be collected from a random sample of 384 health facilities and 800 households at baseline, midline after 1-year of intervention, and end-line after 2 years. Quarterly surveillance data will also be collected from health facilities and a subsample of households through phone-based interviews. Households will be eligible if at least one resident has been previously diagnosed and prescribed a medicine for an NCD addressed by Novartis Access, including hypertension and diabetes. The primary outcomes will be availability and price of NCD medicines at health facilities, and availability, price, and expenditures on NCD medicines at households. Impacts will be estimated using intention-to-treat analysis. ETHICS AND DISSEMINATION: This protocol was approved by the Institutional Review Boards at Strathmore University and at Boston University. Informed consent will be obtained from all participants at the start of the trial. The findings of the trial will be disseminated through peer-reviewed journals, international conferences, and meetings and events organised with local stakeholders

Evaluation of pharmaceutical industry led access programmes: A standardised framework

Pharmaceutical industry-led access programmes are increasing in number and scope worldwide. We present a new standardised framework for evaluation of these programmes that includes three components: a taxonomy of 11 access programme strategies; a series of logic models, one for each strategy and a set of measurement indicators. The logic models describe pathways of potential programme impact. Concepts relevant across a broad range of strategies were prioritised for inclusion in logic models to ensure consistency and to facilitate synthesis and learning across programmes. Each concept has at least one corresponding measurement indicator with metadata that includes the definition, details on how it should be measured and recommended data sources. The framework establishes a shared language for the collection and reporting of meaningful industry-led access programme information

Household access to non-communicable disease medicines during universal health care roll-out in Kenya: A time series analysis

This study aims to describe trends and estimate impact of county-level universal health coverage expansion in Kenya on household availability of non-communicable disease medicines, medicine obtainment at public hospitals and proportion of medicines obtained free of charge. Data from phone surveillance of households in eight Kenyan counties between December 2016 and September 2019 were used. Three primary outcomes related to access were assessed based on patient report: availability of non-communicable disease medicines at the household; non-communicable disease medicine obtainment at a public hospital versus a different outlet; and non-communicable disease medicine obtainment free of cost versus at a non-zero price. Mixed models adjusting for fixed and random effects were used to estimate associations between outcomes of interest and UHC exposure

Public reporting on pharmaceutical industry-led access programs: Alignment with the WHO medicine programs evaluation checklist

There has been increased demand for greater public accountability and transparency of private sector-led global health partnership programs. This study critically reviews and pilot tests the World Health Organization (WHO) medicine program checklist as a framework for public reporting and assessing of programs

Availability and prices of medicines for non-communicable diseases at health facilities and retail drug outlets in Kenya: A cross-sectional survey in eight counties

The objective of this study was to determine the availability and prices of medicines for non-communicable diseases (NCDs) in health facilities and private for-profit drug outlets in Kenya. Design Cross-sectional study. Methods All public and non-profit health facilities in eight counties (Embu, Kakamega, Kwale, Makueni, Narok, Nyeri, Samburu and West Pokot) that purchased medicines from the Mission for Essential Drugs and Supplies, a major wholesaler, were surveyed in September 2016. For each health facility, one nearby private for-profit drug outlet was also surveyed. Data on availability and price were analysed for 24 NCD and 8 acute medicine formulations. Availability was analysed separately for medicines in the national Essential Medicines List (EML) and those in the Standard Treatment Guidelines (STGs). Median price ratios were estimated using the International Medical Products Price Guide as a reference. Results 59 public and 78 non-profit facilities and 135 drug outlets were surveyed. Availability of NCD medicines was highest in private for-profit drug outlets (61.7% and 29.3% for medicines on the EML and STGs, respectively). Availability of STG medicines increased with increasing level of care of facilities: 16.1% at dispensaries to 31.7% at secondary referral facilities

Preferences for Working in Rural Clinics among Trainee Health Professionals in Uganda: A Discrete Choice Experiment

Background: Health facilities require teams of health workers with complementary skills and responsibilities to efficiently provide quality care. In low-income countries, failure to attract and retain health workers in rural areas reduces population access to health services and undermines facility performance, resulting in poor health outcomes. It is important that governments consider health worker preferences in crafting policies to address attraction and retention in underserved areas. Methods We investigated preferences for job characteristics among final year medical, nursing, pharmacy, and laboratory students at select universities in Uganda. Participants were administered a cadre-specific discrete choice experiment that elicited preferences for attributes of potential job postings they were likely to pursue after graduation. Job attributes included salary, facility quality, housing, length of commitment, manager support, training tuition, and dual practice opportunities. Mixed logit models were used to estimate stated preferences for these attributes. Results: Data were collected from 246 medical students, 132 nursing students, 50 pharmacy students and 57 laboratory students. For all student-groups, choice of job posting was strongly influenced by salary, facility quality and manager support, relative to other attributes. For medical and laboratory students, tuition support for future training was also important, while pharmacy students valued opportunities for dual practice. Conclusions: In Uganda, financial and non-financial incentives may be effective in attracting health workers to underserved areas. Our findings contribute to mounting evidence that salary is not the only important factor health workers consider when deciding where to work. Better quality facilities and supportive managers were important to all students. Similarities in preferences for these factors suggest that team-based, facility-level strategies for attracting health workers may be appropriate. Improving facility quality and training managers to be more supportive of facility staff may be particularly cost-effective, as investments are borne once while benefits accrue to a range of health workers at the facility

Childhood adversity and educational attainment: Evidence from Zambia on the role of personality

IntroductionWe examine whether personality traits mediate the association between childhood adversity and educational attainment using longitudinal data from a cohort in Zambia.MethodsWe fit a structural equation model using data on three forms of childhood adversity—household poverty, stunting as a measure of chronic malnutrition, and death of a parent—and data on the “Big Five” personality traits and educational attainment assessed at 15 years of age.ResultsWe find that childhood poverty and death of a parent are associated with lower openness to experience. Furthermore, openness to experience mediates 93% of the negative association between death of a parent and school enrollment and 19% of the negative association between childhood poverty and enrollment.DiscussionOur findings reinforce a diverse and growing body of evidence linking childhood adversity to educational attainment while also placing it in a new light. Future work should continue to examine the biological and psychosocial pathways that determine openness to experience and other personality traits, as well as their role in shaping important life outcomes

Varieties of Young Children’s Prosocial Behavior in Zambia: The Role of Cognitive Ability, Wealth, and Inequality Beliefs

By the 3rd year of life, young children engage in a variety of prosocial behaviors, including helping others attain their goals (instrumental helping), responding to others’ emotional needs (comforting), and sharing resources (costly giving). Recent work suggests that these behaviors emerge early, during the first 2 years of life (Svetlova et al., 2010; Thompson and Newton, 2012; Dunfield and Kuhlmeier, 2013). To date, however, work investigating early varieties of prosocial behavior has largely focused on Western samples and has not assessed the impact of poverty and inequality. In this work, we investigate prosocial behavior in 3-year-olds in Zambia, a lower-middle income country with high wealth inequality. Experiments were integrated into a larger public health study along with both objective and subjective (parent) measures of wealth and inequality. Three-hundred-seventy-seven children (Mean age = 36.77 months; SD = 2.26 months) were presented with an instrumental helping task, comforting task, and two steps of a giving task – one with higher cost (children could give away their only resource) and one with lower cost (children had three resources to give). As predicted, rates of prosociality varied hierarchically by the cost of the action: instrumental helping was the most common followed by comforting, lower cost giving, and higher cost giving. All prosocial behaviors were significantly correlated with one another (with the exception of high cost giving), and with general cognitive ability. Objective family wealth did not predict any of the child’s prosocial behaviors. However, subjective beliefs showed that mothers who believed that they had more than others in their village had children who were more likely to engage in instrumental helping, and mothers who believed that village inequality was a problem had children who were more likely to engage in low cost giving. Low cost giving was also more likely for children whose parents reported reading storybooks to them. This suggests that costly giving in the context of pretend play may relate to children’s experience with using stories as representations of real life events. The results suggest both cultural differences and universalities in the development of prosociality and point to environmental factors that influence prosociality

Evaluating implementation effectiveness and sustainability of a maternity waiting homes intervention to improve access to safe delivery in rural Zambia: A mixed-methods protocol

Background: In low-income countries such as Zambia, where maternal mortality rates are persistently high, maternity waiting homes (MWHs) represent one potential strategy to improve access to safe delivery, especially for women living in remote areas. The Maternity Homes Access in Zambia project (MAHMAZ) is evaluating the impact of a MWH model on women’s access to safe delivery in rural Zambia. There is a growing need to understand not only the effectiveness of interventions but also the effectiveness of their implementation in order to appropriately interpret outcomes. There is little evidence to guide effective implementation of MWH for both immediate uptake and to promote sustainability in this context. This protocol describes a study that aims to investigate the effectiveness of the implementation of MAHMAZ by not only documenting fidelity but also identifying factors that influence implementation success and affect longer-term sustainability. Methods: This study will use mixed methods to evaluate the implementation effectiveness and sustainability of the MAHMAZ intervention. In our study, “implementation effectiveness” means to expand beyond measuring fidelity to the MWH model and includes assessing both the adoption and uptake of the model and identifying those factors that facilitate or inhibit uptake. Sustainability is defined as the routine implementation of an intervention after external support has ended. Quantitative methods include extracting data from existing records at the MWHs and health facilities to analyze patterns of utilization, and conducting a routine health facility assessment to determine facility-level factors that may influence MWH implementation and woman-level outcomes. We will also conduct an experience survey with MWH users and apply a checklist to assess fidelity to the MWH model. Qualitative methods include in-depth interviews and focus group discussions with MWH users, community members and other stakeholders. Qualitative data will be analyzed using an integrated framework drawing constructs from the Consolidated Framework for Implementation Research and the Conceptual Framework for Sustainability. Discussion: The findings from this evaluation will be shared with policymakers formulating policy affecting the implementation of MWH and may be used as evidence for programmatic decisions by the government and supporting agencies in deciding to take this model to scale

Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

BACKGROUND: Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia. METHODS AND FINDINGS: We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads) or control (15 clusters, 258 caregiver-child dyads). Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs) and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III). In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73%) in the intervention group and 182/258 children (71%) in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028) and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039). The intervention did not significantly impact cognition (β 0.11, 95% CI -0.06 to 0.29; p = 0.196), motor skills (β -0.01, 95% CI -0.25 to 0.24; p = 0.964), adaptive behavior (β 0.21, 95% CI -0.03 to 0.44; p = 0.088), or social-emotional development (β 0.20, 95% CI -0.04 to 0.44; p = 0.098). Observed impacts may have been due in part to home visits by CDAs during the first year of the intervention. CONCLUSIONS: The results of this trial suggest that parenting groups hold promise for improving child development, particularly physical growth, in low-resource settings like Zambia. TRIAL REGISTRATION: ClinicalTrials.gov NCT02234726