NCT07557199

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,350

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026May 2027

First Submitted

Initial submission to the registry

April 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

Climate change adaptationDisaster resilienceCommunity-based intervention

Outcome Measures

Primary Outcomes (2)

  • Household disaster resilience (DRI)

    Household disaster resilience will be assessed using the Disaster Resilience Index (DRI), a 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.

    At baseline and endline (12 month)

  • Household vulnerability

    Household vulnerability will be assessed using the Multidimensional Livelihood Vulnerability Index (MLVI), a 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.

    At baseline and endline (12 month)

Secondary Outcomes (2)

  • Food security

    At baseline and endline (12 month)

  • Mental Health

    At baseline and endline (12 month)

Other Outcomes (3)

  • Financial Literacy

    At baseline and endline (12 month)

  • Household Disaster Preparedness

    At baseline and endline

  • Health Knowledge and Practices

    At baseline and endline (12 month)

Study Arms (3)

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.

Other: Community Interventions (CI)

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.

Other: Community + Primary Healthcare Intervention (CHI)

Control

NO INTERVENTION

Clusters do not receive any additional intervention beyond existing services and standard conditions during the study period.

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.

Community Interventions (CI)

The community-based resilience intervention combined with active involvement of Lady Health Workers and primary healthcare providers to reinforce interventions delivered through VMCs and strengthen linkages between communities and health services.

Community + Primary Healthcare Intervention (CHI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Individuals not providing informed consent Temporary residents or non-residents of the study are

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Interventions

Residence Characteristics

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Dr. Jai Kumar Das, PhD

CONTACT

Akber Ali, Masters

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor and Assistant Director

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 29, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations