Study design and rationale for a cluster randomized trial of a safe child feces management intervention in rural Odisha, India

Background Poor child feces management (CFM) is believed to be an important source of exposure to enteric pathogens that contribute to a large disease burden in low-income settings. While access to sanitation facilities is improving, national surveys indicate that even households with latrines often do not safely dispose of their child’s feces. Working with caregivers in rural Odisha, India, we co-developed an intervention aimed at improving safe disposal of child feces and encouraging child latrine use at an earlier age. We describe the rationale for the intervention and summarize the protocol for a cluster randomized trial (CRT) to evaluate its effectiveness at changing CFM practices. Methods The intervention consists of six behavior change strategies together with hardware provision: wash basin and bucket with lid to aid safe management of soiled nappies and a novel latrine training mat to aid safe disposal and latrine training. The intervention will be offered at the village level to interested caregivers of children < 5 years of age by a community-based organization. Following a baseline survey, 74 villages were randomly allocated to either intervention or control arm. The primary outcome is caregiver reported safe disposal of child feces after last defecation, either by the caregiver disposing of the child’s feces into the latrine or the child using the latrine, measured approximately four to six months following intervention delivery. Secondary outcomes include fecal contamination of household drinking water and the childs’ hands. A process evaluation will also be conducted to assess intervention fidelity and reach, and explore implementer and participant feedback. Discussion This study addresses a crucial knowledge gap in sanitation by developing a scalable intervention to improve safe management of child feces. The behavior change strategies were designed following the Risks, Attitudes, Norms, Abilities and Self-Regulation (RANAS) approach, which has shown to be effective for other environmental behavior change interventions in low-income settings. The latrine training mat hardware is a novel design developed cooperatively and manufactured locally. The evaluation follows a rigorous CRT study design assessing the impact of the intervention on CFM behavior change, as well as fecal contamination of two sources of potential exposure. Trial registration This trial is registered at ISRCTN: ISRCTN15831099.

Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach

Background In pragmatic trials, on-site partners, rather than researchers, lead intervention delivery, which may result in implementation variation. There is a need to quantitatively measure this variation. Applying the Framework for Implementation Fidelity (FIF), we develop an approach for measuring variability in site-level implementation fidelity. This approach is then applied to measure site-level fidelity in a cluster-randomized pragmatic trial of Music & MemorySM (M&M), a personalized music intervention targeting agitated behaviors in residents living with dementia, in US nursing homes (NHs). Methods Intervention NHs (N = 27) implemented M&M using a standardized manual, utilizing provided staff trainings and iPods for participating residents. Quantitative implementation data, including iPod metadata (i.e., song title, duration, number of plays), were collected during baseline, 4-month, and 8-month site visits. Three researchers developed four FIF adherence dimension scores. For Details of Content, we independently reviewed the implementation manual and reached consensus on six core M&M components. Coverage was the total number of residents exposed to the music at each NH. Frequency was the percent of participating residents in each NH exposed to M&M at least weekly. Duration was the median minutes of music received per resident day exposed. Data elements were scaled and summed to generate dimension-level NH scores, which were then summed to create a Composite adherence score. NHs were grouped by tercile (low-, medium-, high-fidelity). Results The 27 NHs differed in size, resident composition, and publicly reported quality rating. The Composite score demonstrated significant variation across NHs, ranging from 4.0 to 12.0 [8.0, standard deviation (SD) 2.1]. Scaled dimension scores were significantly correlated with the Composite score. However, dimension scores were not highly correlated with each other; for example, the correlation of the Details of Content score with Coverage was τb = 0.11 (p = 0.59) and with Duration was τb = − 0.05 (p = 0.78). The Composite score correlated with CMS quality star rating and presence of an Alzheimer’s unit, suggesting face validity. Conclusions Guided by the FIF, we developed and used an approach to quantitatively measure overall site-level fidelity in a multi-site pragmatic trial. Future pragmatic trials, particularly in the long-term care environment, may benefit from this approach. Trial registration Clinicaltrials.gov NCT03821844. Registered on 30 January 2019, https://clinicaltrials.gov/ct2/show/NCT03821844.

Impact of community masking on COVID-19: A cluster-randomized trial in Bangladesh

Persuading people to mask Even in places where it is obligatory, people tend to optimistically overstate their compliance for mask wearing. How then can we persuade more of the population at large to act for the greater good? Abaluck et al . undertook a large, cluster-randomized trial in Bangladesh involving hundreds of thousands of people (although mostly men) over a 2-month period. Colored masks of various construction were handed out free of charge, accompanied by a range of mask-wearing promotional activities inspired by marketing research. Using a grassroots network of volunteers to help conduct the study and gather data, the authors discovered that mask wearing averaged 13.3% in villages where no interventions took place but increased to 42.3% in villages where in-person interventions were introduced. Villages where in-person reinforcement of mask wearing occurred also showed a reduction in reporting COVID-like illness, particularly in high-risk individuals. —CA

Support Models for Addiction Related Treatment (SMART) for pregnant women: Study protocol of a cluster randomized trial of two treatment models for opioid use disorder in prenatal clinics

Introduction The prevalence of opioid use disorder (OUD) in pregnancy increased nearly five-fold over the past decade. Despite this, obstetric providers are less likely to treat pregnant women with medication for OUD than non-obstetric providers (75% vs 91%). A major reason is many obstetricians feel unprepared to prescribe medication for opioid use disorder (MOUD). Education and support may increase prescribing and overall comfort in delivering care for pregnant women with OUD, but optimal models of education and support are yet to be determined. Methods and analysis We describe the rationale and conduct of a matched-pair cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with OUD. The primary outcomes of this trial are patient treatment engagement and retention in OUD treatment. This study compares two support models: 1) a collaborative care approach, based upon the Massachusetts Office-Based-Opioid Treatment Model, that provides practice-level training and support to providers and patients through the use of care managers, versus 2) a telesupport approach based on the Project Extension for Community Healthcare Outcomes, a remote education model that provides mentorship, guided practice, and participation in a learning community, via video conferencing. Discussion This clustered randomized clinical trial aims to test the effectiveness of two approaches to support practitioners who care for pregnant women with an OUD. The results of this trial will help determine the best model to improve the capacity of obstetrical providers to deliver treatment for OUD in prenatal clinics. Trial registration Clinicaltrials.gov trial registration number: NCT0424039.

Dengue surveillance using gravid oviposition sticky (GOS) trap and dengue non-structural 1 (NS1) antigen test in Malaysia: randomized controlled trial

Dengue remains a major public threat and existing dengue control/surveillance programs lack sensitivity and proactivity. More efficient methods are needed. A cluster randomized controlled trial was conducted for 18 months to determine the efficacy of using a combination of gravid oviposition sticky (GOS) traps and dengue non-structural 1 (NS1) antigen for early surveillance of dengue among Aedes mosquito. Eight residential apartments were randomly assigned into intervention and control groups. GOS traps were placed at the intervention apartments weekly to trap Aedes mosquitoes and these tested for dengue NS1 antigen. When dengue-positive pool was detected, the community were notified and advised to execute protective measures. Fewer dengue cases were recorded in the intervention group than the control. Detection of NS1-positive mosquitoes was significantly associated with GOS Aedes index (rs = 0.68, P < 0.01) and occurrence of dengue cases (rs = 0.31, P < 0.01). Participants’ knowledge, attitude, and practice (KAP) toward dengue control indicated significant improvement for knowledge (P < 0.01), practice (P < 0.01) and total scores (P < 0.01). Most respondents thought this surveillance method is good (81.2%) and supported its use nationwide. Thus, GOS trap and dengue NS1 antigen test can supplement the current dengue surveillance/control, in alignment with the advocated integrated vector management for reducing Aedes-borne diseases.

Effects of a Water, Sanitation and Hygiene Mobile Health Program on Respiratory Illness in Bangladesh: A Cluster-Randomized Controlled Trial of the CHoBI7 Mobile Health Program

Acute respiratory infections are a leading cause of morbidity and mortality among young children globally. The objective of this study was to evaluate the impact of the Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) handwashing with soap and water treatment mobile health (mHealth) program on respiratory illness among diarrhea patients and their household members in urban Dhaka, Bangladesh. A cluster-randomized controlled trial of the CHoBI7 mHealth program was conducted among diarrhea patient households in Dhaka, Bangladesh. Patients were randomized to three arms: standard recommendation on oral rehydration solution use, health facility delivery of CHoBI7 plus mHealth (weekly voice and text messages) (no home visits), and health facility delivery of CHoBI7 plus two home visits and mHealth. Respiratory symptoms were assessed during monthly clinical surveillance over the 12-month surveillance period. Respiratory illness was defined as rapid breathing, difficulty breathing, wheezing, or coughing. Two thousand six hundred twenty-six participants in 769 households were randomly allocated to three arms: 849 participants to the standard message arm, 886 to mHealth with no home visits arm, and 891 to the mHealth with two home visits. Compared with the standard message arm, participants in the mHealth with no home visits arm (Prevalence Ratio [PR]: 0.88 [95% CI: 0.79, 0.98]), and the mHealth with two home visits arm (PR: 0.88 [95% CI: 0.79, 0.98]) had significantly lower respiratory illness prevalence over the 12-month program period. Our findings demonstrate that the CHoBI7 mHealth program is effective in reducing respiratory illness among diarrhea patient households.

PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial

Background Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation. Methods A stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed. Discussion The effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice. Trial registration ClinicalTrials.govNCT04678752. Registered on December 21, 2020.