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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Climate Change and Health; Disaster Preparedness
• Intervention / Treatment: Other: Community Interventions; Other: Primary Healthcare Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akber Ali, Masters; Phone Number: +92-307-777-1403; Email: akber.ali@aku.edu
• Study Contact Backup: Name: Dr. Jai Kumar Das, PhD; Phone Number: 0213486 69826; Email: jai.das@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Aga Khan University
      • Contact: Akber Ali, Masters; Phone Number: +92-307-777-1403; Email: akber.ali@aku.edu
      • Contact: Dr. Jai Kumar Das, PhD; Phone Number: 0213486 69826; Email: jai.das@aku.edu
      • Principal Investigator: Dr. Jai Das, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Interventions (CI); Clusters receive a structured package of community-led adaptation and resilience interventions delivered through Village Management Committees (VMCs). Activities include training and participatory sessions on disaster risk reduction, livelihood diversification, financial literacy, and health awareness. Sessions are conducted using participatory learning approaches to strengthen household and community adaptive capacity.	Other: Community Interventions; 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.
Experimental: Community + Primary Healthcare Intervention (CHI); Clusters receive the same community-based interventions as Arm 1, with additional engagement of Lady Health Workers and primary healthcare providers. Health system actors support delivery of health-related components, promote care-seeking, and strengthen linkages between communities and health services to enhance resilience outcomes.	Other: Community Interventions; 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.; Other: Primary Healthcare Intervention; Lady Health Workers and primary healthcare providers to reinforce interventions delivered through VMCs and strengthen linkages between communities and health services.
No Intervention: Control; Clusters do not receive any additional intervention beyond existing services and standard conditions during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Household disaster resilience	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food security	Food security will be assessed using the Household Food Insecurity Access Scale (HFIAS), developed by the Food and Nutrition Technical Assistance (FANTA) project. The HFIAS is a standardized tool that measures household access to food over the past four weeks, generating a continuous score (range: 0-27), with higher scores indicating greater food insecurity	At baseline and endline (12 month)
Mental Health	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	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Financial Literacy	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	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	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)

Collaborators and Investigators

• Sponsor: Dr Jai Kumar Das
• Collaborators: The Hospital for Sick Children; International Development Research Centre, Canada

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Community-based intervention; Climate change adaptation; Disaster resilience
• Other Study ID Numbers: 2026-12334-39680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No