AzTrials
AzTrials

Climate Change and HealthPICCTURENCT07572045

Promoting Interventions for Climate Change to Upscale Resilience in District Badin

A study testing Community Interventions and Primary Healthcare Intervention in people with Climate Change and Health and Disaster Preparedness, run by Dr Jai Kumar Das at 2 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Community Interventions and Primary Healthcare Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
2 sitesPakistan
Study dates
1 Jun 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Permanent residents of the selected study area
  • Aged 18 years and above
  • Willing to provide informed consent

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Jai Kumar Das, PhD contact

0213486 69826

jai.das@aku.edu

Akber Ali, Masters contact

+92-307-777-1403

akber.ali@aku.edu

Pakistan2 sites, 2 recruiting
  • Badin

    Badin, Sindh

    Dr. Jai Das, PhD, 0213486 69826, jai.das@aku.edu

    Recruiting
  • Aga Khan University

    Karachi, Sindh

    Dr. Jai Kumar Das, PhD, 0213486 69826, jai.das@aku.edu

    Akber Ali, Masters, +92-307-777-1403, akber.ali@aku.edu

    Not yet recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Community Interventions, Primary Healthcare Intervention
Keywords
Climate change adaptation, Disaster resilience, Community-based intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community InterventionsOther

    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.

  • Primary Healthcare InterventionOther

    Lady Health Workers and primary healthcare providers to reinforce interventions delivered through VMCs and strengthen linkages between communities and health services.

Study groups in NCT07572045
Study groupRoleWhat they receive
Community Interventions (CI)ExperimentalClusters 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.
Receives: Other: Community Interventions
Community + Primary Healthcare Intervention (CHI)ExperimentalClusters 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.
Receives: Other: Community Interventions; Other: Primary Healthcare Intervention
ControlNo interventionClusters do not receive any additional intervention beyond existing services and standard conditions during the study period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and endline (12 month)

Secondary outcomes (3)
  1. Household vulnerability (MLVI)

    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.

    Measured: At baseline and endline (12 month)

  2. 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

    Measured: At baseline and endline (12 month)

  3. 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.

    Measured: At baseline and endline (12 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start1 Jun 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a three-arm, parallel-group cluster randomized controlled trial. Clusters are defined as geographically distinct 5 km × 5 km grid cells to minimize contamination across arms. A total of 30 clusters are randomly selected and allocated in a 1:1:1 ratio to: (1) community-based intervention, (2) community-based intervention plus primary healthcare engagement, and (3) control. The design allows comparison of both the independent effect of community-based interventions and the additional benefit of integrating primary healthcare providers and Lady Health Workers.
Masking
None (open label)
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07572045
Sponsor's protocol ID
2026-12334-39680
Acronym
PICCTURE
Status last verified
Oct 2026
First submitted
13 Apr 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Community Interventions and Primary Healthcare Intervention in people with Climate Change and Health and Disaster Preparedness, run by Dr Jai Kumar Das at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Jai Kumar Das, PhD (0213486 69826, jai.das@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Household disaster resilience (time frame: At baseline and endline (12 month)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in