Design and rationale of the Longitudinal Evaluation of Norms and Networks Study (LENNS): A cluster-randomized trial assessing the impact of a norms-centric intervention on exclusive toilet use and maintenance in peri urban communities of Tamil Nadu

AbstractIntroductionInconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norms-centric behavior change interventions to increase toilet use in low-income settings. This protocol details the rationale and design of an ex-ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norms-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India.Methods and AnalysisFollowing two years of formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “Our wellbeing”). The multi-level intervention aims to shift collective beliefs by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to build, consistently use and maintain their toilets. This trial includes 76 wards in Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining serve as counterfactuals. During baseline and endline (conducted one year after the initiation of intervention) assessments, we collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, wellbeing outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We will also conduct a process evaluation to understand the extent to which the intervention was implemented, as designed.Ethics and DisseminationThe study protocol has been reviewed and approved by the ethics board at the University of Pennsylvania, USA and the Catalyst Foundation, India. Research findings will be disseminated through open access peer reviewed publications and presentations to stakeholders, government officials and conferences.Trial registrationNCT04269824.Strengths and limitations of this studyThis ex-ante, parallel cluster randomized trial assesses the impact of a norm-centric behavior change intervention strategy to improve sanitation practices. These behavior change techniques are novel to the sanitation sector but has been effective in changing a variety of behaviors, such as water use, drinking behavior, and energy consumption.The study outcomes include health, wellbeing outcomes, and a careful assessment of changes in social beliefs, expectations, and social determinants of collective sanitation behaviors.This study is being rolled out during the ongoing COVID-19 pandemic. This can potentially impact the effectiveness of this intervention package that uses community and network-based group activities. However, through a detailed process monitoring and evaluation we will be able to assess the impact on delivery, and subsequent behavior change in this unique setting.

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Norms and Social Network–Centric Behavior Change Intervention (Nam Nalavazhvu) for Improved Toilet Usage in Peri-Urban Communities of Tamil Nadu: Protocol for a Cluster-Randomized Controlled Trial (Preprint)

10.2196/preprints.24407 ◽

2020 ◽

Author(s):

Sania Ashraf ◽

Cristina Bicchieri ◽

Maryann G Delea ◽

Upasak Das ◽

Kavita Chauhan ◽

...

Keyword(s):

Behavior Change ◽

Low Income ◽

Tamil Nadu ◽

Controlled Trial ◽

Well Being ◽

Baseline Survey ◽

Behavior Change Intervention ◽

Behavior Change Interventions ◽

Cluster Randomized ◽

The Impact

BACKGROUND Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. OBJECTIVE The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. METHODS Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “our well-being”). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. RESULTS We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. CONCLUSIONS Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. CLINICALTRIAL ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24407

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Norms and Social Network–Centric Behavior Change Intervention (Nam Nalavazhvu) for Improved Toilet Usage in Peri-Urban Communities of Tamil Nadu: Protocol for a Cluster-Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/24407 ◽

2021 ◽

Vol 10 (5) ◽

pp. e24407

Author(s):

Sania Ashraf ◽

Cristina Bicchieri ◽

Maryann G Delea ◽

Upasak Das ◽

Kavita Chauhan ◽

...

Keyword(s):

Behavior Change ◽

Low Income ◽

Tamil Nadu ◽

Controlled Trial ◽

Well Being ◽

Baseline Survey ◽

Behavior Change Intervention ◽

Behavior Change Interventions ◽

Cluster Randomized ◽

The Impact

Background Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. Objective The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. Methods Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “our well-being”). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. Results We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. Conclusions Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. Trial Registration ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824 International Registered Report Identifier (IRRID) DERR1-10.2196/24407

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Cluster Randomized Trial to Facilitate Breast Cancer Early Diagnosis in a Rural District of Rwanda

Journal of Global Oncology ◽

10.1200/jgo.19.00209 ◽

2019 ◽

pp. 1-13

Author(s):

Lydia E. Pace ◽

Jean Marie Vianney Dusengimana ◽

Lawrence N. Shulman ◽

Lauren E. Schleimer ◽

Cyprien Shyirambere ◽

...

Keyword(s):

Breast Cancer ◽

Randomized Trial ◽

Low Income ◽

Early Stage ◽

Cluster Randomized Trial ◽

Early Stage Disease ◽

Catchment Areas ◽

Hospital Visits ◽

Cluster Randomized ◽

The Impact

PURPOSE Feasible and effective strategies are needed to facilitate earlier diagnosis of breast cancer in low-income countries. The goal of this study was to examine the impact of health worker breast health training on health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district. METHODS We conducted a cluster randomized trial of a training intervention at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases. We evaluated the trainings’ impact on the volume of patient visits for breast concerns using difference-in-difference models. We used generalized estimating equations to evaluate incidence of HC and hospital visits for breast concerns, biopsies, benign breast diagnoses, breast cancer, and early-stage disease in catchment areas served by intervention versus control HCs. RESULTS From April 2015 to April 2017, 1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns. The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P = .001) and 7.9 visits/month for phase 2 HCs ( P = .007) compared with control HCs. The population served by intervention HCs had more hospital visits (115.1 v 20.5/100,000 person-years, P < .001) and biopsies (36.6 v 8.9/100,000 person-years, P < .001) and higher breast cancer incidence (6.9 v 3.3/100,000 person-years; P = .28). The incidence of early-stage breast cancer was 3.3 per 100,000 in intervention areas and 0.7 per 100,000 in control areas ( P = .048). CONCLUSION In this cluster randomized trial in rural Rwanda, the training of health workers and establishment of regular breast clinics were associated with increased numbers of patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers.

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A Cluster Randomized Trial of the Impact of Education through Listening (a Novel Behavior Change Technique) on Household Water Treatment with Chlorine in Vihiga District, Kenya, 2010–2011

American Journal of Tropical Medicine and Hygiene ◽

10.4269/ajtmh.20-0215 ◽

2021 ◽

Vol 104 (1) ◽

pp. 382-390

Author(s):

Christine E. Stauber ◽

Bobbie Person ◽

Ronald Otieno ◽

Jared Oremo ◽

Katharine Schilling ◽

...

Keyword(s):

Water Treatment ◽

Behavior Change ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Household Water Treatment ◽

Change Technique ◽

Household Water ◽

Cluster Randomized ◽

Behavior Change Technique ◽

The Impact

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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

BMC Public Health ◽

10.1186/s12889-019-7040-6 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Maryann G. Delea ◽

Jedidiah S. Snyder ◽

Mulusew Belew ◽

Bethany A. Caruso ◽

Joshua V. Garn ◽

...

Keyword(s):

Behavior Change ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Well Being ◽

Demand Side ◽

Sanitation And Hygiene ◽

Hygiene Intervention ◽

Cluster Randomized ◽

The Impact ◽

Mental Well Being

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

BMC Public Health ◽

10.1186/s12889-021-12405-0 ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

Gloria D. Sclar ◽

Valerie Bauza ◽

Hans-Joachim Mosler ◽

Alokananda Bisoyi ◽

Howard H. Chang ◽

...

Keyword(s):

Behavior Change ◽

Randomized Trial ◽

Study Design ◽

Low Income ◽

Fecal Contamination ◽

Cluster Randomized Trial ◽

Change Strategies ◽

Safe Disposal ◽

Safe Management ◽

Cluster Randomized

Abstract 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.

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The Impact of Intensive Versus Standard Anthelminthic Treatment on Allergy-related Outcomes, Helminth Infection Intensity, and Helminth-related Morbidity in Lake Victoria Fishing Communities, Uganda: Results From the LaVIISWA Cluster-randomized Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciy761 ◽

2018 ◽

Vol 68 (10) ◽

pp. 1665-1674 ◽

Cited By ~ 7

Author(s):

Richard E Sanya ◽

Gyaviira Nkurunungi ◽

Remy Hoek Spaans ◽

Margaret Nampijja ◽

Geraldine O’Hara ◽

...

Keyword(s):

Single Dose ◽

Randomized Trial ◽

Low Income ◽

Immunoglobulin E ◽

Lake Victoria ◽

Infection Intensity ◽

Cluster Randomized Trial ◽

Fishing Communities ◽

Cluster Randomized ◽

The Impact

Abstract Background The prevalence of allergy-related diseases is increasing in low-income countries. Parasitic helminths, common in these settings, may be protective. We hypothesized that intensive, community-wide, anthelminthic mass drug administration (MDA) would increase allergy-related diseases, while reducing helminth-related morbidity. Methods In an open, cluster-randomized trial (ISRCTN47196031), we randomized 26 high-schistosomiasis-transmission fishing villages in Lake Victoria, Uganda, in a 1:1 ratio to receive community-wide intensive (quarterly single-dose praziquantel plus albendazole daily for 3 days) or standard (annual praziquantel plus 6 monthly single-dose albendazole) MDA. Primary outcomes were recent wheezing, skin prick test positivity (SPT), and allergen-specific immunoglobulin E (asIgE) after 3 years of intervention. Secondary outcomes included helminths, haemoglobin, and hepatosplenomegaly. Results The outcome survey comprised 3350 individuals. Intensive MDA had no effect on wheezing (risk ratio [RR] 1.11, 95% confidence interval [CI] 0.64–1.93), SPT (RR 1.10, 95% CI 0.85–1.42), or asIgE (RR 0.96, 95% CI 0.82–1.12). Intensive MDA reduced Schistosoma mansoni infection intensity: the prevalence from Kato Katz examinations of single stool samples from each patient was 23% versus 39% (RR 0.70, 95% CI 0.55–0.88), but the urine circulating cathodic antigen test remained positive in 85% participants in both trial arms. Hookworm prevalence was 8% versus 11% (RR 0.55, 95% CI 0.31–1.00). There were no differences in anemia or hepatospenomegaly between trial arms. Conclusions Despite reductions in S. mansoni intensity and hookworm prevalence, intensive MDA had no effect on atopy, allergy-related diseases, or helminth-related pathology. This could be due to sustained low-intensity infections; thus, a causal link between helminths and allergy outcomes cannot be discounted. Intensive community-based MDA has a limited impact in high-schistosomiasis-transmission fishing communities, in the absence of other interventions. Clinical Trials Registration ISRCTN47196031.

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