- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07557199
Promoting Interventions for Climate Change to Upscale Resilience in District Astore (PICCTURE)
Promoting Interventions for Climate Change to Upscale Resilience (PICCTURE) Trial in District Astore
Study Overview
Status
Intervention / Treatment
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 outcomes are changes in the Disaster Resilience Index (DRI) and Multidimensional Livelihood Vulnerability Index (MLVI), assessed at baseline and endline. Secondary outcomes include 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 Type
Enrollment (Estimated)
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
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74800
- 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 Kumar Das, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Permanent residents of the selected study area
- Aged 18 years and above
- Willing to provide informed consent
Exclusion Criteria:
1- Temporary residents or non-residents of the study are
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
|
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.
|
|
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 vulnerability
Time Frame: 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)
|
|
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.
|
At baseline and endline (12 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food security
Time Frame: At baseline and endline (12 month)
|
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
Time Frame: 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
Time Frame: 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Financial Literacy
Time Frame: 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
Time Frame: 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
Time Frame: 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 as count and proportions
|
At baseline and endline (12 month)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6200101665/ R19954/53732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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