Climate ChangePICCTURENCT07557199
Promoting Interventions for Climate Change to Upscale Resilience in District Astore
A study testing Community Interventions and Primary Healthcare Intervention in people with Climate Change and Health Behavior / Well-Being, run by Dr Jai Kumar Das at 1 site in Pakistan.
Trial summary
The PICCTURE trial is a cluster randomized controlled study that will be conducted in District Astore, 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
- Conditions the study is for
- Climate Change, Health Behavior / Well-Being, Disaster Planning
- What is being tested?
- Community Interventions and Primary Healthcare Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 sitePakistan
- 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 are
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Dr. Jai Kumar Das, PhD, 0213486 69826, jai.das@aku.edu
Akber Ali, Masters, +92-307-777-1403, akber.ali@aku.edu
About this study
Official title: Promoting Interventions for Climate Change to Upscale Resilience (PICCTURE) Trial in District Astore
The PICCTURE trial is a cluster randomized controlled study that will be conducted in District Astore, 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 mountainous, climate-vulnerable population.
Read the detailed description
District Astore, located in the mountainous region of Gilgit-Baltistan, is highly vulnerable to climate-related risks, including glacial lake outburst floods (GLOFs), landslides, extreme weather events, and rising temperatures. Its rugged terrain, geographic isolation, dependence on climate-sensitive livelihoods, and limited infrastructure exacerbate the impact of environmental shocks on health and socioeconomic conditions. These vulnerabilities make Astore an appropriate setting to evaluate scalable interventions aimed at strengthening community resilience.
This study is a three-arm cluster randomized controlled trial conducted, where cluster is a village or group of villages. From total available clusters, 30 clusters will be randomly selected and allocated equally across three study arms. Within each cluster, households will be selected through simple random sampling following a complete household listing.
Two intervention arms and one control arm are included. The first intervention arm delivers structured, community-led adaptation and resilience activities through Village Management Committees (VMCs), formed with representation from local stakeholders including elders, teachers, and vulnerable households. The second intervention arm builds upon this approach by incorporating formal engagement of Lady Health Workers and primary healthcare providers to strengthen health-related components, improve service linkage, and enhance outreach to high-risk populations. The control arm does not receive additional inputs.
Intervention components, informed by prior vulnerability assessments, include training and capacity-building on disaster preparedness and response, livelihood diversification, financial literacy, and health awareness. These are delivered through participatory group sessions, simulation exercises, and community mobilization activities over a one-year period. Training sessions are conducted monthly during the initial six months and bi-monthly thereafter, using standardized curricula adapted to the local context.
Primary outcome is change in the Disaster Resilience Index (DRI), assessed at baseline and endline. Secondary outcomes include changes in Multidimensional livelihood vulnerability index (MLVI), health care-seeking, morbidity and mortality, nutrition, environmental resilience, and mental health. Process indicators evaluate intervention delivery, participation, and preparedness mechanisms such as emergency planning, financial coping strategies, and household disaster preparedness. A rapid assessment will be conducted if a major climate-related hazard occurs during the study period to estimate real-world impact under disaster conditions.
Analysis follows an intention-to-treat approach, applying mixed-effects regression models to account for clustering at the community level. Difference-in-differences (DID) estimation will be used to assess intervention effects over time while adjusting for relevant covariates.
This trial will generate context-specific evidence on the effectiveness of integrated community and health system approaches in enhancing resilience in coastal, climate-affected populations, with potential implications for scale-up in similar settings.
- Being tested
- Community Interventions, Primary Healthcare Intervention
- Keywords
- Climate change adaptation, Disaster resilience, Community-based intervention
- Medical subject headings
- Health Behavior
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 group | Role | What they receive |
|---|---|---|
| Community Interventions (CI) | Experimental | 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. Receives: Other: Community Interventions |
| Community + Primary Healthcare Intervention (CHI) | Experimental | 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. Receives: Other: Community Interventions; Other: Primary Healthcare Intervention |
| Control | No intervention | Clusters 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.
Household disaster resilience (DRI)
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)
Household Vulnerability Index (MLVI)
Household vulnerability measured using the Multidimensional Livelihood Vulnerability Index (MLVI), a composite measure comprising exposure, sensitivity, and adaptive capacity domains. Scores range from 0 to 1, with higher scores indicating greater household vulnerability to climate-related shocks.
Measured: At baseline and endline (12 month)
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)
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.
- First posted29 Apr 2026
- Study start1 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climate ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 conducted in District Astore. Clusters are defined as villages or groups of villages to reflect the local geographic and administrative structure and to minimize contamination across study arms. A total of 30 clusters will be randomly selected from all eligible clusters and allocated in a 1:1:1 ratio to: (1) community-based intervention, (2) community-based intervention plus primary healthcare engagement, and (3) control. This design enables estimation of both the independent effect of community-based interventions and the incremental benefit of integrating primary healthcare providers and Lady Health Workers.
- Masking
- None (open label)
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Jai Kumar Das
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, International Development Research Centre, Canada
- Responsible party
- Sponsor-investigator, Dr Jai Kumar Das, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557199
- Sponsor's protocol ID
- 6200101665/ R19954/53732
- Acronym
- PICCTURE
- Status last verified
- Oct 2026
- First submitted
- 23 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Interventions for Climate Change to Upscale Resilience (PICCTURE) Trial in District Astore
- ClinicalTrials.gov ID
- NCT07557199
- Acronym / sponsor ID
- PICCTURE / 6200101665/ R19954/53732
- Keywords
- Climate change adaptation, Disaster resilience, Community-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Dr Jai Kumar DasUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, International Development Research Centre, Canada
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PICCTURE trial is a cluster randomized controlled study that will be conducted in District Astore, 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 mountainous, climate-vulnerable population.
Detailed description
District Astore, located in the mountainous region of Gilgit-Baltistan, is highly vulnerable to climate-related risks, including glacial lake outburst floods (GLOFs), landslides, extreme weather events, and rising temperatures. Its rugged terrain, geographic isolation, dependence on climate-sensitive livelihoods, and limited infrastructure exacerbate the impact of environmental shocks on health and socioeconomic conditions. These vulnerabilities make Astore an appropriate setting to evaluate scalable interventions aimed at strengthening community resilience.
This study is a three-arm cluster randomized controlled trial conducted, where cluster is a village or group of villages. From total available clusters, 30 clusters will be randomly selected and allocated equally across three study arms. Within each cluster, households will be selected through simple random sampling following a complete household listing.
Two intervention arms and one control arm are included. The first intervention arm delivers structured, community-led adaptation and resilience activities through Village Management Committees (VMCs), formed with representation from local stakeholders including elders, teachers, and vulnerable households. The second intervention arm builds upon this approach by incorporating formal engagement of Lady Health Workers and primary healthcare providers to strengthen health-related components, improve service linkage, and enhance outreach to high-risk populations. The control arm does not receive additional inputs.
Intervention components, informed by prior vulnerability assessments, include training and capacity-building on disaster preparedness and response, livelihood diversification, financial literacy, and health awareness. These are delivered through participatory group sessions, simulation exercises, and community mobilization activities over a one-year period. Training sessions are conducted monthly during the initial six months and bi-monthly thereafter, using standardized curricula adapted to the local context.
Primary outcome is change in the Disaster Resilience Index (DRI), assessed at baseline and endline. Secondary outcomes include changes in Multidimensional livelihood vulnerability index (MLVI), health care-seeking, morbidity and mortality, nutrition, environmental resilience, and mental health. Process indicators evaluate intervention delivery, participation, and preparedness mechanisms such as emergency planning, financial coping strategies, and household disaster preparedness. A rapid assessment will be conducted if a major climate-related hazard occurs during the study period to estimate real-world impact under disaster conditions.
Analysis follows an intention-to-treat approach, applying mixed-effects regression models to account for clustering at the community level. Difference-in-differences (DID) estimation will be used to assess intervention effects over time while adjusting for relevant covariates.
This trial will generate context-specific evidence on the effectiveness of integrated community and health system approaches in enhancing resilience in coastal, climate-affected populations, with potential implications for scale-up in similar settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a three-arm, parallel-group cluster randomized controlled trial conducted in District Astore. Clusters are defined as villages or groups of villages to reflect the local geographic and administrative structure and to minimize contamination across study arms. A total of 30 clusters will be randomly selected from all eligible clusters and allocated in a 1:1:1 ratio to: (1) community-based intervention, (2) community-based intervention plus primary healthcare engagement, and (3) control. This design enables estimation of both the independent effect of community-based interventions and the incremental benefit of integrating primary healthcare providers and Lady Health Workers.
| Arm | Type | Receives |
|---|---|---|
| Community Interventions (CI) | Experimental | Other: Community InterventionsClusters 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. |
| Community + Primary Healthcare Intervention (CHI) | Experimental | Other: Community Interventions, Other: Primary Healthcare InterventionClusters 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. |
| Control | No intervention | –Clusters do not receive any additional intervention beyond existing services and standard conditions during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Permanent residents of the selected study area
- Aged 18 years and above
- Willing to provide informed consent
Key exclusion criteria (1 listed)
- 1- Temporary residents or non-residents of the study are
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community InterventionsA 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 | Community + Primary Healthcare Intervention (CHI), Community Interventions (CI) |
| Primary Healthcare InterventionLady Health Workers and primary healthcare providers to reinforce interventions delivered through VMCs and strengthen linkages between communities and health services. | Other | Community + Primary Healthcare Intervention (CHI) |
Primary outcome
Household disaster resilience (DRI)
Time frame: 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.
3 secondary outcomes
Household Vulnerability Index (MLVI)
Time frame: At baseline and endline (12 month)
Food security
Time frame: At baseline and endline (12 month)
Mental Health
Time frame: At baseline and endline (12 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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 Behavior / Well-Being, run by Dr Jai Kumar Das at 1 site 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 1 site 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 (DRI) (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.