The impact of a demand-side sanitation and hygiene promotion intervention on sustained behavior change and health in Amhara, Ethiopia: A cluster-randomized trial.

Behaviors related to water, sanitation, and hygiene (WASH) are key drivers of infectious disease transmission, and experiences of WASH are potential influencers of mental well-being. Important knowledge gaps exist related to the content and delivery of effective WASH programs and their associated health impacts, particularly within the contexts of government programs implemented at scale. We developed and tested a demand-side intervention called Andilaye, which aimed to change behaviors related to sanitation, personal hygiene, and household environmental sanitation. This theory-informed intervention was delivered through the existing Ethiopian Health Extension Programme (HEP). It was a multilevel intervention with a catalyzing event at the community level and behavior change activities at group and household levels. We randomly selected and assigned 50 kebeles (sub-districts) from three woredas (districts), half to receive the Andilaye intervention, and half the standard of care sanitation and hygiene programming (i.e., community-led total sanitation and hygiene [CLTSH]). We collected data on WASH access, behavioral outcomes, and mental well-being. A total of 1,589 households were enrolled into the study at baseline; 1,472 households (94%) participated in an endline assessment two years after baseline, and approximately 14 months after the initiation of a multi-level intervention. The intervention did not improve construction of latrines (prevalence ratio [PR]: 0.99; 95% CI: 0.82, 1.21) or handwashing stations with water (PR: 0.96; 95% CI: 0.72, 1.26), or the removal of animal feces from the compound (PR: 1.10; 95% CI: 0.95, 1.28). Nor did it impact anxiety (PR: 0.90; 95% CI: 0.72, 1.11), depression (PR: 0.83; 95% CI: 0.64, 1.07), emotional distress (PR: 0.86; 95% CI: 0.67, 1.09) or well-being (PR: 0.90; 95% CI: 0.74, 1.10) scores. We report limited impact of the intervention, as delivered, on changes in behavior and mental well-being. The effectiveness of the intervention was limited by poor intervention fidelity. While sanitation and hygiene improvements have been documented in Ethiopia, behavioral slippage, or regression to unimproved practices, in communities previously declared open defecation free is widespread. Evidence from this trial may help address knowledge gaps related to challenges associated with scalable alternatives to CLTSH and inform sanitation and hygiene programming and policy in Ethiopia and beyond. Trial registration: This trial was registered with clinicaltrials.gov (NCT03075436) on March 9, 2017.

Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study.

OBJECTIVES: Kangaroo Mother Care (KMC), prolonged skin-to-skin care of the low birth weight baby with the mother plus exclusive breastfeeding reduces neonatal mortality. Global KMC coverage is low. This study was conducted to develop and evaluate context-adapted implementation models to achieve improved coverage. DESIGN: This study used mixed-methods applying implementation science to develop an adaptable strategy to improve implementation. Formative research informed the initial model which was refined in three iterative cycles. The models included three components: (1) maximising access to KMC-implementing facilities, (2) ensuring KMC initiation and maintenance in facilities and (3) supporting continuation at home postdischarge. PARTICIPANTS: 3804 infants of birth weight under 2000 g who survived the first 3 days, were available in the study area and whose mother resided in the study area. MAIN OUTCOME MEASURES: The primary outcomes were coverage of KMC during the 24 hours prior to discharge and at 7 days postdischarge. RESULTS: Key barriers and solutions were identified for scaling up KMC. The resulting implementation model achieved high population-based coverage. KMC initiation reached 68%-86% of infants in Ethiopian sites and 87% in Indian sites. At discharge, KMC was provided to 68% of infants in Ethiopia and 55% in India. At 7 days postdischarge, KMC was provided to 53%-65% of infants in all sites, except Oromia (38%) and Karnataka (36%). CONCLUSIONS: This study shows how high coverage of KMC can be achieved using context-adapted models based on implementation science. They were supported by government leadership, health workers' conviction that KMC is the standard of care, women's and families' acceptance of KMC, and changes in infrastructure, policy, skills and practice. TRIAL REGISTRATION NUMBERS: ISRCTN12286667; CTRI/2017/07/008988; NCT03098069; NCT03419416; NCT03506698.

Kangaroo Mother Care implementation research to develop models for accelerating scale-up in India and Ethiopia: study protocol for an adequacy evaluation.

INTRODUCTION: Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. Consequently, only a small fraction of newborns that could benefit from KMC receive it. METHODS AND ANALYSIS: This implementation research project aims to develop and evaluate district-level models for scaling up KMC in India and Ethiopia that can achieve high population coverage. The project includes formative research to identify barriers and contextual factors that affect implementation and utilisation of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. Implementation actions would happen at three levels: 'pre-KMC facility'-to maximise the number of newborns getting to a facility that provides KMC; 'KMC facility'-for initiation and maintenance of KMC; and 'post-KMC facility'-for continuation of KMC at home. Stable infants with birth weight<2000 g and born in the catchment population of the study KMC facilities would form the eligible population. The primary outcome will be coverage of KMC in the preceding 24 hours and will be measured at discharge from the KMC facility and 7 days after hospital discharge. ETHICS AND DISSEMINATION: Ethics approval was obtained in all the project sites, and centrally by the Research Ethics Review Committee at the WHO. Results of the project will be submitted to a peer-reviewed journal for publication, in addition to national and global level dissemination. STUDY STATUS: WHO approved protocol: V.4-12 May 2016-Protocol ID: ERC 2716. Study implementation beginning: April 2017. Study end: expected March 2019. TRIAL REGISTRATION NUMBER: Community Empowerment Laboratory, Uttar Pradesh, India (ISRCTN12286667); St John's National Academy of Health Sciences, Bangalore, India and Karnataka Health Promotion Trust, Bangalore, India (CTRI/2017/07/008988); Society for Applied Studies, Delhi (NCT03098069); Oromia, Ethiopia (NCT03419416); Amhara, SNNPR and Tigray, Ethiopia (NCT03506698).

Design of a parallel cluster-randomized trial assessing the impact of a demand-side sanitation and hygiene intervention on sustained behavior change and mental well-being in rural and peri-urban Amhara, Ethiopia: Andilaye study protocol.

BACKGROUND: Unimproved water, sanitation, and hygiene (WASH) behaviors are key drivers of infectious disease transmission and influencers of mental well-being. While WASH is seen as a critical enabler of health, important knowledge gaps related to the content and delivery of effective, holistic WASH programming exist. Corresponding impacts of WASH on mental well-being are also underexplored. There is a need for more robust implementation research that yields information regarding whether and how community-based, demand-side interventions facilitate progressive and sustained adoption of improved sanitation and hygiene behaviors and downstream health impacts. The purpose of this protocol is to detail the rationale and design of a cluster-randomized trial evaluating the impact of a demand-side sanitation and hygiene intervention on sustained behavior change and mental well-being in rural and peri-urban Amhara, Ethiopia. METHODS: Together with partners, we developed a theoretically-informed, evidence-based behavioral intervention called Andilaye. We randomly selected and assigned 50 sub-districts (kebeles) from three purposively selected districts (woredas); half to receive the Andilaye intervention, and half the standard of care sanitation and hygiene programming (i.e., community-led total sanitation and hygiene [CLTSH]). During baseline, midline, and endline, we will collect data on an array of behavioral factors, potential moderators (e.g., water and sanitation insecurity, collective efficacy), and our primary study outcomes: sanitation and hygiene behaviors and mental well-being. We will perform a process evaluation to assess intervention fidelity and related attributes. DISCUSSION: While CLTSH has fostered sanitation and hygiene improvements in Ethiopia, evidence of behavioral slippage, or regression to unimproved practices in communities previously declared open defecation free exists. Other limitations of CLTSH, such as its focus on disgust, poor triggering, and over-saturation of Health Extension Workers have been documented. We employed rigorous formative research and practically applied social and behavioral theory to develop Andilaye, a scalable intervention designed to address these issues and complement existing service delivery within Ethiopia's Health Extension Program. Evidence from this trial may help address knowledge gaps related to scalable alternatives to CLTSH and inform sanitation and hygiene programming and policy in Ethiopia and beyond. TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov ( NCT03075436 ) on March 9, 2017.

Appropriateness and timeliness of care-seeking for complications of pregnancy and childbirth in rural Ethiopia: a case study of the Maternal and Newborn Health in Ethiopia Partnership.

BACKGROUND: In 2014, USAID and University Research Co., LLC, initiated a new project under the broader Translating Research into Action portfolio of projects. This new project was entitled Systematic Documentation of Illness Recognition and Appropriate Care Seeking for Maternal and Newborn Complications. This project used a common protocol involving descriptive mixed-methods case studies of community projects in six low- and middle-income countries, including Ethiopia. In this paper, we present the Maternal and Newborn Health in Ethiopia Partnership (MaNHEP) case study. METHODS: Methods included secondary analysis of data from MaNHEP's 2010 baseline and 2012 end line surveys, health program inventory and facility mapping to contextualize care-seeking, and illness narratives to identify factors influencing illness recognition and care-seeking. Analyses used descriptive statistics, bivariate tests, multivariate logistic regression, and thematic content analysis. RESULTS: Maternal illness awareness increased between 2010 and 2012 for major obstetric complications. In 2012, 45% of women who experienced a major complication sought biomedical care. Factors associated with care-seeking were MaNHEP CMNH Family Meetings, health facility birth, birth with a skilled provider, or health extension worker. Between 2012 and 2014, the Ministry of Health introduced nationwide initiatives including performance review, ambulance service, increased posting of midwives, pregnant women's conferences, user-friendly services, and maternal death surveillance. By 2014, most facilities were able to provide emergency obstetric and newborn care. Yet in 2014, biomedical care-seeking for perceived maternal illness occurred more often compared with care-seeking for newborn illness-a difference notable in cases in which the mother or newborn died. Most families sought care within 1 day of illness recognition. Facilitating factors were health extension worker advice and ability to refer upward, and health facility proximity; impeding factors were time of day, weather, road conditions, distance, poor cell phone connectivity (to call for an ambulance), lack of transportation or money for transport, perceived spiritual or physical vulnerability of the mother and newborn and associated culturally determined postnatal restrictions on the mother or newborn's movement outside of the home, and preference for traditional care. Some families sought care despite disrespectful, poor quality care. CONCLUSIONS: Improvements in illness recognition and care-seeking observed during MaNHEP have been reinforced since that time and appear to be successful. There is still need for a concerted effort focusing on reducing identified barriers, improve quality of care and provider counseling, and contextualize messaging behavior change communications and provider counseling.