Study design and rationale for the PAASIM project: a matched cohort study on urban water supply improvements and infant enteric pathogen infection, gut microbiome development and health in Mozambique.

INTRODUCTION: Despite clear linkages between provision of clean water and improvements in child health, limited information exists about the health impacts of large water infrastructure improvements in low-income settings. Billions of dollars are spent annually to improve urban water supply, and rigorous evaluation of these improvements, especially targeting informal settlements, is critical to guide policy and investment strategies. Objective measures of infection and exposure to pathogens, and measures of gut function, are needed to understand the effectiveness and impact of water supply improvements. METHODS AND ANALYSIS: In the PAASIM study, we examine the impact of water system improvements on acute and chronic health outcomes in children in a low-income urban area of Beira, Mozambique, comprising 62 sub-neighbourhoods and ~26 300 households. This prospective matched cohort study follows 548 mother-child dyads from late pregnancy through 12 months of age. Primary outcomes include measures of enteric pathogen infections, gut microbiome composition and source drinking water microbiological quality, measured at the child's 12-month visit. Additional outcomes include diarrhoea prevalence, child growth, previous enteric pathogen exposure, child mortality and various measures of water access and quality. Our analyses will compare (1) subjects living in sub-neighbourhoods with the improved water to those living in sub-neighbourhoods without these improvements; and (2) subjects with household water connections on their premises to those without such a connection. This study will provide critical information to understand how to optimise investments for improving child health, filling the information gap about the impact of piped water provision to low-income urban households, using novel gastrointestinal disease outcomes. ETHICS AND DISSEMINATION: This study was approved by the Emory University Institutional Review Board and the National Bio-Ethics Committee for Health in Mozambique. The pre-analysis plan is published on the Open Science Framework platform (https://osf.io/4rkn6/). Results will be shared with relevant stakeholders locally, and through publications.

HIV-exposed infant follow-up in Mozambique: formative research findings for the design of a cluster randomized controlled trial to improve testing and ART initiation.

BACKGROUND: Early infant diagnosis (EID) of HIV-exposed and initiation of HIV-positive infants on anti-retroviral therapy (ART) requires a well-coordinated cascade of care. Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods. The objective of this research was to conduct formative research to guide the development of an intervention to improve the pediatric HIV care cascade in central Mozambique. The study was conducted in Manica and Sofala Provinces where the adult HIV burden is higher than the national average. The research focused on 3 large clinics in each province, along the highly populated Beira corridor. METHODS: The research was conducted in 2014 over 3 months at six facilities and consisted of 1) patient flow mapping and collection of health systems data from postpartum, child-at-risk, and ART service registries, 2) measurement of clinic waiting times, and 3) patient and health worker focus groups. RESULTS: HIV testing and ART initiation coverage for mothers tends to be high, but EID and pediatric ART initiation are hampered by lack of patient tracking, long waiting times, and inadequate counseling to navigate the care cascade. About 76% of HIV-positive infants were LTFU and did not initiate ART. CONCLUSIONS: Effective interventions to reduce LTFU in EID and improve pediatric ART initiation should focus on patient tracking, active follow-up of defaulting patients, reduction in EID turn-around times for PCR results, and initiation of ART by nurses in child-at-risk services. TRIAL REGISTRATION: Retrospectively registered, ISRCTN67747315, July 24, 2019.

Usability and Feasibility of an Innovative mLearning Approach for Nurses Providing Option B+ Services in Manica and Sofala Provinces, Mozambique.

The scaling of Option B+ services, whereby all pregnant women who test HIV positive are started on lifelong antiretroviral therapy upon diagnosis regardless of CD4 T-cell count, is ongoing in many high HIV burden, low-resource countries. We developed and evaluated a tablet-based mobile learning (mLearning) training approach to build Option B+ competencies in frontline nurses in central Mozambique. Its acceptability and impact on clinical skills were assessed in maternal child health nurses and managers at 20 intervention and 10 control clinics. Results show that skill and knowledge of nurses at intervention clinics improved threefold compared with control clinics (p = .04), nurse managers at intervention clinics demonstrated a 9- to 10-fold improvement, and nurses reported strong acceptance of this approach. "mLearning" is one viable modality to enhance nurses' clinical competencies in areas with limited health workforce and training budgets. This study's findings may guide future scaling and investments in commercially viable mLearning solutions.

Depressive symptoms, suicidal ideation, and mental health care-seeking in central Mozambique.

PURPOSE: There is scant research on depressive symptoms (DS), suicidal ideation (SI), and mental health care-seeking in Mozambique. METHODS: Generalized estimating equations were used to assess factors associated with DS, SI, and mental health care-seeking among 3080 individuals interviewed in a representative household survey in Sofala and Manica provinces, Mozambique. RESULTS: 19% (CI 17-21%) of respondents reported DS in the past year and 17% (CI 15-18%) lifetime SI. Overall, only 10% (CI 8-11%) of respondents ever sought any care for mental illness, though 26% (CI 23-29%) of those reporting DS and/or SI sought care. 90% of those who sought care for DS received treatment; however, only 46% of those who sought care for SI received treatment. Factors associated with DS and SI include: female gender, divorced/separated, widowed, and > 55 years old. Respondents in the bottom wealth quintile reported lower DS, while those in upper wealth quintiles reported higher prevalence of SI. Individuals with DS or SI had significantly elevated measures of disability-especially in doing household chores, work/school activities, standing for long periods, and walking long distances. Factors associated with care-seeking include: female gender, rural residence, divorced/separated, and > 45 years old. Individuals in lower wealth quintiles and with no religious affiliation had lower odds of seeking care. CONCLUSIONS: DS and SI are prevalent in central Mozambique and treatment gaps are high (68% and 89%, respectively). An urgent need exists for demand- and supply-side interventions to optimize the delivery of comprehensive community-based mental healthcare in Mozambique.

Assessment of linkages from HIV testing to enrolment and retention in HIV care in Central Mozambique.

INTRODUCTION: Effectiveness of the rapid expansion of antiretroviral therapy (ART) throughout sub-Saharan Africa is highly dependent on adequate enrolment and retention in HIV care. However, the measurement of both has been challenging in these settings. This study aimed to assess enrolment and retention in HIV care (pre-ART and ART) among HIV-positive adults in Central Mozambique, including identification of barriers and facilitators. METHODS: We assessed linkages to and retention in HIV care using a mixed quantitative and qualitative approach in six districts of Manica and Sofala provinces. We analyzed routine district and health facility monthly reports and HIV care registries from April 2012 to March 2013 and used single imputation and trimmed means to adjust for missing values. In eight health facilities in the same districts and period, we assessed retention in HIV care among 795 randomly selected adult patient charts (15 years and older). We also conducted 25 focus group discussions and 53 in-depth interviews with HIV-positive adults, healthcare providers and community members to identify facilitators and barriers to enrolment and retention in HIV care. RESULTS: Overall, 46% of the monthly HIV testing reports expected at the district level were missing, compared to 6.4% of the pre-ART registry reports. After adjustment for missing values, we estimated that the aggregate numbers of adults registered in pre-ART was 75% of the number of persons tested HIV-positive in the six districts. In the eight health facilities, 40% of the patient charts for adults enrolled in pre-ART and 44% in ART were missing. Of those on ART for whom charts were found, retention in treatment within 90 and 60 days prior to the study team visit was 34 and 25%, respectively. Combining these multiple data sources, the overall estimated retention was 18% in our sample. Individual-level factors were perceived to be key influences to enrolment in HIV care, while health facility and structural-level factors were perceived to be key influences of retention. CONCLUSIONS: Efforts to increase linkages to and retention in HIV care should address individual, health facility, and structural-level factors in Central Mozambique. However, their outcomes cannot be reliably assessed without improving the quality of routine health information systems.

Evaluation of a Systems Analysis and Improvement Approach to Optimize Prevention of Mother-To-Child Transmission of HIV Using the Consolidated Framework for Implementation Research.

BACKGROUND: Despite large investments to prevent mother-to-child-transmission (PMTCT), pediatric HIV elimination goals are not on track in many countries. The Systems Analysis and Improvement Approach (SAIA) study was a cluster randomized trial to test whether a package of systems engineering tools could strengthen PMTCT programs. We sought to (1) define core and adaptable components of the SAIA intervention, and (2) explain the heterogeneity in SAIA's success between facilities. METHODS: The Consolidated Framework for Implementation Research (CFIR) guided all data collection efforts. CFIR constructs were assessed in focus group discussions and interviews with study and facility staff in 6 health facilities (1 high-performing and 1 low-performing site per country, identified by study staff) in December 2014 at the end of the intervention period. SAIA staff identified the intervention's core and adaptable components at an end-of-study meeting in August 2015. Two independent analysts used CFIR constructs to code transcripts before reaching consensus. RESULTS: Flow mapping and continuous quality improvement were the core to the SAIA in all settings, whereas the PMTCT cascade analysis tool was the core in high HIV prevalence settings. Five CFIR constructs distinguished strongly between high and low performers: 2 in inner setting (networks and communication, available resources) and 3 in process (external change agents, executing, reflecting and evaluating). DISCUSSION: The CFIR is a valuable tool to categorize elements of an intervention as core versus adaptable, and to understand heterogeneity in study implementation. Future intervention studies should apply evidence-based implementation science frameworks, like the CFIR, to provide salient data to expand implementation to other settings.

Effects of a health information system data quality intervention on concordance in Mozambique: time-series analyses from 2009-2012.

BACKGROUND: We assessed the effects of a three-year national-level, ministry-led health information system (HIS) data quality intervention and identified associated health facility factors. METHODS: Monthly summary HIS data concordance between a gold standard data quality audit and routine HIS data was assessed in 26 health facilities in Sofala Province, Mozambique across four indicators (outpatient consults, institutional births, first antenatal care visits, and third dose of diphtheria, pertussis, and tetanus vaccination) and five levels of health system data aggregation (daily facility paper registers, monthly paper facility reports, monthly paper district reports, monthly electronic district reports, and monthly electronic provincial reports) through retrospective yearly audits conducted July-August 2010-2013. We used mixed-effects linear models to quantify changes in data quality over time and associated health system determinants. RESULTS: Median concordance increased from 56.3% during the baseline period (2009-2010) to 87.5% during 2012-2013. Concordance improved by 1.0% (confidence interval [CI]: 0.60, 1.5) per month during the intervention period of 2010-2011 and 1.6% (CI: 0.89, 2.2) per month from 2011-2012. No significant improvements were observed from 2009-2010 (during baseline period) or 2012-2013. Facilities with more technical staff (aß: 0.71; CI: 0.14, 1.3), more first antenatal care visits (aß: 3.3; CI: 0.43, 6.2), and fewer clinic beds (aß: -0.94; CI: -1.7, -0.20) showed more improvements. Compared to facilities with no stock-outs, facilities with five essential drugs stocked out had 51.7% (CI: -64.8 -38.6) lower data concordance. CONCLUSIONS: A data quality intervention was associated with significant improvements in health information system data concordance across public-sector health facilities in rural and urban Mozambique. Concordance was higher at those facilities with more human resources for health and was associated with fewer clinic-level stock-outs of essential medicines. Increased investments should be made in data audit and feedback activities alongside targeted efforts to improve HIS data in low- and middle-income countries.

Stock-outs of essential health products in Mozambique - longitudinal analyses from 2011 to 2013.

OBJECTIVES: To assess the relationship between health system factors and facility-level EHP stock-outs in Mozambique. METHODS: Service provisions were assessed in 26 health facilities and 13 district warehouses in Sofala Province, Mozambique, from July to August in 2011-2013. Generalised estimating equations were used to model factors associated with facility-level availability of essential drugs, supplies and equipment. RESULTS: Stock-out rates for drugs ranged from 1.3% for oral rehydration solution to 20.5% for Depo-Provera and condoms, with a mean stock-out rate of 9.1%; mean stock-out rates were 15.4% for supplies and 4.1% for equipment. Stock-outs at the district level accounted for 27.1% (29/107) of facility-level drug stock-outs and 44.0% (37/84) of supply stock-outs. Each 10-km increase in the distance from district distribution warehouses was associated with a 31% (CI: 22-42%), 28% (CI: 17-40%) or 27% (CI: 7-50%) increase in rates of drug, supply or equipment stock-outs, respectively. The number of heath facility staff was consistently negatively associated with the occurrence of stock-outs. CONCLUSIONS: Facility-level stock-outs of EHPs in Mozambique are common and appear to disproportionately affect those living far from district capitals and near facilities with few health staff. The majority of facility-level EHP stock-outs in Mozambique occur when stock exists at the district distribution centre. Innovative methods are urgently needed to improve EHP supply chains, requesting and ordering of drugs, facility and district communication, and forecasting of future EHP needs in Mozambique. Increased investments in public-sector human resources for health could potentially decrease the occurrence of EHP stock-outs.

Strengthening integrated primary health care in Sofala, Mozambique.

BACKGROUND: Large increases in health sector investment and policies favoring upgrading and expanding the public sector health network have prioritized maternal and child health in Mozambique and, over the past decade, Mozambique has achieved substantial improvements in maternal and child health indicators. Over this same period, the government of Mozambique has continued to decentralize the management of public sector resources to the district level, including in the health sector, with the aim of bringing decision-making and resources closer to service beneficiaries. Weak district level management capacity has hindered the decentralization process, and building this capacity is an important link to ensure that resources translate to improved service delivery and further improvements in population health. A consortium of the Ministry of Health, Health Alliance International, Eduardo Mondlane University, and the University of Washington are implementing a health systems strengthening model in Sofala Province, central Mozambique. DESCRIPTION OF IMPLEMENTATION: The Mozambique Population Health Implementation and Training (PHIT) Partnership focuses on improving the quality of routine data and its use through appropriate tools to facilitate decision making by health system managers; strengthening management and planning capacity and funding district health plans; and building capacity for operations research to guide system-strengthening efforts. This seven-year effort covers all 13 districts and 146 health facilities in Sofala Province. EVALUATION DESIGN: A quasi-experimental controlled time-series design will be used to assess the overall impact of the partnership strategy on under-5 mortality by examining changes in mortality pre- and post-implementation in Sofala Province compared with neighboring Manica Province. The evaluation will compare a broad range of input, process, output, and outcome variables to strengthen the plausibility that the partnership strategy led to health system improvements and subsequent population health impact. DISCUSSION: The Mozambique PHIT Partnership expects to provide evidence on the effect of efforts to improve data quality coupled with the introduction of tools, training, and supervision to improve evidence-based decision making. This contribution to the knowledge base on what works to enhance health systems is highly replicable for rapid scale-up to other provinces in Mozambique, as well as other sub-Saharan African countries with limited resources and a commitment to comprehensive primary health care.