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Promoting Interventions for Climate Change to Upscale Resilience in District Badin (PICCTURE)

6 mai 2026 mis à jour par: Dr Jai Kumar Das

Promoting Interventions for Climate Change to Upscale Resilience (PICCTURE) Trial in District Badin

The PICCTURE trial is a cluster randomized controlled study which will be conducted in District Badin, Pakistan, to evaluate the effectiveness of community-based interventions in improving resilience to climate-related hazards. The study compares community-led adaptation and resilience strategies and community interventions integrated with primary healthcare engagement against a control group. The objective is to determine whether these approaches improve household-level resilience, adaptive capacity, and health-related outcomes in a coastal, climate-vulnerable population.

Aperçu de l'étude

Description détaillée

District Badin, located in the lower Indus delta of Pakistan, is highly exposed to recurrent climate-related hazards, including riverine and coastal flooding, cyclones, saline water intrusion, and increasing temperatures. These hazards interact with underlying structural vulnerabilities such as low-lying topography, reliance on agriculture and fisheries, and constrained access to health and social services-resulting in compounded risks to health, nutrition, and livelihoods. This context provides a suitable setting to evaluate integrated, community-based strategies aimed at strengthening resilience to climate-related shocks.

This study is guided by a multidimensional resilience framework that conceptualizes resilience as a function of coping, adaptive, and transformative capacities across social, economic, environmental, and health domains. The intervention package is informed by prior vulnerability assessments and designed to address key modifiable determinants of resilience, including disaster preparedness, livelihood security, financial risk management, and access to essential health services.

The intervention is delivered through two implementation models that differ in the degree of health system integration. The first model utilizes community-led platforms established through Village Management Committees (VMCs), which are locally constituted groups representing diverse segments of the community. These committees facilitate participatory learning and action processes, enabling communities to identify risks, prioritize solutions, and implement locally appropriate adaptation strategies. Core components include structured training on disaster risk reduction, development of community hazard maps and early warning mechanisms, promotion of climate-resilient livelihood options, and strengthening of household-level financial planning and emergency preparedness.

The second model builds on the community platform by incorporating structured engagement with Lady Health Workers (LHWs) and primary healthcare providers. This integrated approach is intended to strengthen linkages between communities and the formal health system, enhance delivery of climate-sensitive health messaging, improve identification and support of high-risk households, and facilitate continuity of care during climate-related events. Health system engagement also includes co-facilitation of selected community sessions, alignment of community preparedness plans with facility-level response mechanisms, and promotion of climate-responsive service delivery practices.

Intervention activities are implemented over a 12-month period using a standardized curriculum adapted to the local context. Delivery follows a phased approach, with more intensive engagement during the initial months followed by reinforcement sessions. Participatory group sessions, simulation exercises, and community mobilization activities are used to enhance knowledge, build skills, and support behavior change. Implementation fidelity is supported through structured training of facilitators, supervision, routine monitoring, and the use of standardized tools and materials.

Evaluation is conducted using repeated cross-sectional household surveys administered at baseline and endline to assess changes in resilience and vulnerability across multiple domains. Data collection includes measures of household preparedness, livelihood strategies, financial coping mechanisms, health-seeking behavior, and selected health and nutrition indicators. Process evaluation is embedded within the study to assess intervention delivery, including coverage, participation, adherence to planned activities, and functionality of community-level preparedness mechanisms such as emergency plans and early warning systems. These measures enable assessment of both implementation fidelity and intermediate pathways of impact.

To capture the effectiveness of interventions under real-world stress conditions, a rapid assessment component is incorporated. In the event of a major climate-related hazard affecting study areas during the implementation period, targeted data collection will be conducted shortly after the event to document community responses, functioning of preparedness systems, and access to essential services. This component is intended to complement routine evaluation by providing insight into intervention performance during actual shocks.

The analytical approach follows an intention-to-treat framework, whereby all households are analyzed according to their assigned study group regardless of level of participation. Intervention effects will be estimated using mixed-effects regression models to account for clustering at the community level and potential intra-cluster correlation. A difference-in-differences specification will be applied to compare changes over time between study groups, enabling estimation of intervention effects while controlling for baseline differences and secular trends. Models will incorporate fixed effects for time and study group, as well as interaction terms to estimate differential changes attributable to the intervention. Relevant household- and cluster-level covariates will be included to improve precision and adjust for residual confounding.

Sensitivity analyses will be conducted to assess the robustness of findings to model specification and potential sources of bias, including differential attrition and variation in intervention exposure. Process indicators will be analyzed descriptively and, where appropriate, linked to outcome measures to explore potential mechanisms of effect.

This study is designed to generate rigorous evidence on the effectiveness of integrated community-based and health system-linked approaches to strengthening climate resilience in vulnerable populations. Findings are expected to inform the design and scale-up of adaptation strategies in similar climate-affected, resource-constrained settings.

Type d'étude

Interventionnel

Inscription (Estimé)

1800

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Akber Ali, Masters
  • Numéro de téléphone: +92-307-777-1403
  • E-mail: akber.ali@aku.edu

Sauvegarde des contacts de l'étude

  • Nom: Dr. Jai Kumar Das, PhD
  • Numéro de téléphone: 0213486 69826
  • E-mail: jai.das@aku.edu

Lieux d'étude

    • Sindh
      • Karachi, Sindh, Pakistan
        • Aga Khan University
        • Contact:
          • Akber Ali, Masters
          • Numéro de téléphone: +92-307-777-1403
          • E-mail: akber.ali@aku.edu
        • Contact:
          • Dr. Jai Kumar Das, PhD
          • Numéro de téléphone: 0213486 69826
          • E-mail: jai.das@aku.edu
        • Chercheur principal:
          • Dr. Jai Das, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Permanent residents of the selected study area
  2. Aged 18 years and above
  3. Willing to provide informed consent

Exclusion Criteria:

1-Temporary residents or non-residents of the study area

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Interventions Communautaires (IC)
Les clusters reçoivent un ensemble structuré d'interventions d'adaptation et de résilience menées par la communauté, délivrées par les comités de gestion villageois (VMCs). Les activités comprennent des formations et des sessions participatives sur la réduction des risques de catastrophe, la diversification des moyens de subsistance, la littératie financière et la sensibilisation à la santé. Les sessions sont menées en utilisant des approches d'apprentissage participatif pour renforcer la capacité d'adaptation des ménages et des communautés.
A structured package of community-led activities delivered through Village Management Committees, including participatory training on disaster risk reduction, livelihood diversification, financial literacy, and health awareness to strengthen household and community resilience.
Expérimental: Intervention de soins de santé communautaire + primaires (CHI)
Les clusters reçoivent les mêmes interventions communautaires que le Bras 1, avec une implication supplémentaire des agents de santé communautaires et des prestataires de soins de santé primaires.
Les acteurs du système de santé soutiennent la prestation des composantes liées à la santé, favorisent la recherche de soins et renforcent les liens entre les communautés et les services de santé pour améliorer les résultats en matière de résilience.
A structured package of community-led activities delivered through Village Management Committees, including participatory training on disaster risk reduction, livelihood diversification, financial literacy, and health awareness to strengthen household and community resilience.
Lady Health Workers and primary healthcare providers to reinforce interventions delivered through VMCs and strengthen linkages between communities and health services.
Aucune intervention: Groupe témoin
Les clusters ne reçoivent aucune intervention supplémentaire au-delà des services existants et des conditions standard pendant la période d'étude.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Household disaster resilience
Délai: At baseline and endline (12 month)
Household disaster resilience will be assessed using the Disaster Resilience Index (DRI), a validated multidimensional composite measure of a household's ability to withstand, adapt to, and recover from shocks. The DRI comprises three domains: Coping Capacity, reflecting baseline resources and conditions that enable immediate response; Adaptive Capacity, capturing the ability to adjust and respond effectively through access to systems, resources, and support; and Transformative Capacity, measuring longer-term potential to learn, improve, and strengthen resilience over time. The score ranges from 0 to 1, with higher values indicating greater household resilience.
At baseline and endline (12 month)
Household vulnerability
Délai: At baseline and endline (12 month)
Household vulnerability will be assessed using the Multidimensional Livelihood Vulnerability Index (MLVI), a validated composite measure capturing susceptibility to shocks across three domains. Adaptive Capacity reflects the ability to cope with and adjust to stressors, including access to resources, livelihood diversity, and social support. Sensitivity captures the degree to which households are affected by shocks, based on their wellbeing, health, food and water security, and environmental conditions. Exposure measures the extent to which households experience environmental and socio-economic shocks that threaten livelihoods. The score ranges from 0 to 1, with higher values indicating greater household vulnerability.
At baseline and endline (12 month)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sécurité alimentaire
Délai: At baseline and endline (12 month)
La sécurité alimentaire sera évaluée à l'aide de l'échelle d'insécurité alimentaire des ménages (HFIAS), développée par le projet Food and Nutrition Technical Assistance (FANTA).
Le HFIAS est un outil standardisé qui mesure l'accès des ménages à la nourriture au cours des quatre dernières semaines, générant un score continu (plage : 0-27), les scores les plus élevés indiquant une plus grande insécurité alimentaire.
At baseline and endline (12 month)
Mental Health
Délai: At baseline and endline (12 month)

Mental health and psychological resilience will be accessed by Psychological Trauma index focused on post-traumatic stressful symptoms following climate related shocks. Mental health and psychological resilience will be assessed using the Psychological Trauma Index, a structured questionnaire measuring post-traumatic stress symptoms following climate related shocks. The index includes six items covering intrusive memories, emotional distress, avoidance, social withdrawal, irritability, and concentration difficulties.

Each item is scored on a 5-point Likert scale (1 = Not at all, 5 = Very Frequently). Total scores range from 6 to 30, with higher scores indicating worse outcomes (greater severity of trauma symptoms). Lower scores reflect fewer symptoms and better psychological resilience.

At baseline and endline (12 month)
Household dietary diversity
Délai: At baseline and endline (12 month)

Dietary diversity will be measured using the Household Dietary Diversity Score (HDDS), following FAO guidelines. The HDDS is based on a 24 hour recall of foods consumed from 12 standard food groups (cereals, roots/tubers, vegetables, fruits, meat, eggs, fish, legumes/nuts, milk/dairy, oils/fats, sugar/honey, and miscellaneous).

Scores on the Household Dietary Diversity Score range from 0 to 12, with higher values indicating better outcomes (greater dietary diversity and improved household food access). A score of 0 reflects no food group consumption in the recall period, while a score of 12 reflects consumption from all food groups.

At baseline and endline (12 month)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Financial Literacy
Délai: At baseline and endline (12 month)
Financial literacy will be assessed through structured survey questions on access to financial services (e.g., household members with bank accounts), insurance coverage, savings and borrowing practices, bill payment regularity, expense planning, and ability to meet emergency needs. Outcomes will be reported as individual indicators (counts and proportions)
At baseline and endline (12 month)
Household Disaster Preparedness
Délai: At baseline and endline (12 month)
Household disaster preparedness will be assessed through structured survey questions covering awareness of disaster management, integration of preparedness knowledge into household plans, availability of emergency supplies, evacuation knowledge, prior preparedness actions, and exposure to community training or organizations involved in disaster response. Outcomes will be reported as individual indicators (counts and proportions)
At baseline and endline (12 month)
Health Knowledge and Practices
Délai: At baseline and endline (12 month)
Health knowledge and practices will be assessed using a structured questionnaire evaluating knowledge and reported practices related to climate-sensitive health risks. Responses will be summarized at the item level as counts and proportions. No composite score or scale will be generated for this outcome; results will be presented as individual indicators.
At baseline and endline (12 month)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

20 avril 2026

Achèvement primaire (Estimé)

30 avril 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

13 avril 2026

Première soumission répondant aux critères de contrôle qualité

3 mai 2026

Première publication (Réel)

7 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2026-12334-39680

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

We will do this on individual reasonable requests after seeking approval from the institute and the funders and would do so after a formal data transfer agreement.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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