- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05598697
Economic Evaluation of the MEWE Intervention (MEWE-EE)
Economic Evaluation of the Men Engagement in Women Empowerment (MEWE) Intervention (MEWE-EE)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Thatta, Sindh, Pakistan
- Mirpur Sakro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- In receipt of Benazir Income Support Program (BISP) cash transfers (CTs)
- Parity: have at least one child, at least 18 months old
Exclusion Criteria:
- Plan for the family to migrate out of the village within the next 2 years
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 |
---|---|
Active Comparator: Cash Transfers only
Participants allocated to this arm receive cash transfers.
They are clients of a nation-wide cash transfer program.
|
The BISP intervention offers access to quarterly unconditional cash transfers to adult females.
Other Names:
|
Experimental: Cash Transfers + LSB curriculum for females clients only
Participants allocated to this arm receive cash transfers and access to LSB curriculum training.
Female cash transfer recipients attend 10 life-skills building sessions.
Sessions are held weekly and are 90 minutes long.
Two trained facilitators run the session for groups of 10 women over a ten-week period.
|
The BISP intervention offers access to quarterly unconditional cash transfers to adult females.
Other Names:
The LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions. All female study participants attending LSB curriculum classes are BISP-CT clients. For females, the MEWE intervention comprises access to LSB curriculum + BISP CTs.
Other Names:
|
Experimental: Cash Transfers + LSB curriculum for females clients and their husbands
Participants allocated to this arm receive cash transfers and access to LSB curriculum training in gender-segregated groups.
Men and women attend 10 life-skills building sessions in parallel.
Sessions are held weekly and are 90 minutes long.
Two trained facilitators, whose gender matches the participants', run the session for groups of 10 women or men over a ten-week period.
|
The BISP intervention offers access to quarterly unconditional cash transfers to adult females.
Other Names:
The LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions. All female study participants attending LSB curriculum classes are BISP-CT clients. For females, the MEWE intervention comprises access to LSB curriculum + BISP CTs.
Other Names:
The LSB curriculum offers ten weekly 90-minute sessions. Topics include effective communication, gender roles, power dynamics in the household; work-life balance and time management; conflict resolution; household decision making. The LSB teachers are trained in facilitation techniques to deliver the sessions. All male study participants attending LSB curriculum classes are married to BISP-CT clients. For men, the MEWE intervention provides access to the LSB curriculum only.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental cost incurred per disability adjusted life year (DALY) averted: provider perspective
Time Frame: 12 months post randomisation
|
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a provider perspective at 12 months from baseline.
DALYs and costs will also be modelled up to a ten-year horizon using a Markov model.
|
12 months post randomisation
|
Incremental cost incurred per disability adjusted life year (DALY) averted: societal perspective
Time Frame: 12 months post randomisation
|
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a societal perspective at 12 months from baseline.
DALYs and costs will also be modelled up to a ten-year horizon using a Markov model.
|
12 months post randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean cost of intervention delivery
Time Frame: 12 months post randomisation
|
Cost of intervention delivery for different intervention models per patient, by category, annuitised
|
12 months post randomisation
|
Mean cost of LSB session
Time Frame: 12 months post randomisation
|
Average cost of LSB session delivery for different intervention models, annuitised
|
12 months post randomisation
|
Total incremental cost of the intervention in a research setting
Time Frame: 12 months post randomisation
|
Total additional cost of the intervention compared to the BISP-CT only for the study population and by intervention type during the research period.
|
12 months post randomisation
|
Total incremental cost of the intervention in the modelling cohort
Time Frame: 12 months post randomisation
|
Total additional cost of the intervention for the modelling cohort by intervention type over a ten-year period.
|
12 months post randomisation
|
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: provider perspective
Time Frame: 12 months post randomisation
|
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a provider perspective at scale.
|
12 months post randomisation
|
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: societal perspective
Time Frame: 12 months post randomisation
|
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a societal perspective at scale.
|
12 months post randomisation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giulia Ferrari, PhD, London School of Economics & Political Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108137
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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