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Economic Evaluation of the MEWE Intervention (MEWE-EE)

Primary Purpose

Depression, Mental Health Issue, Intimate Partner Violence

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Life Skills Building (LSB) curriculum for males
Life Skills Building (LSB) curriculum for females
Cash transfer to adult females
Sponsored by
London School of Economics and Political Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring violence, abuse, coercion, assault, aggression, gender, women, girl, wife, partner, spouse, sexual, physical, psychological, economic

Eligibility Criteria

15 Years - 49 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mirpur Sakro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Cash Transfers only

Cash Transfers + LSB curriculum for females clients only

Cash Transfers + LSB curriculum for females clients and their husbands

Arm Description

Participants allocated to this arm receive cash transfers. They are clients of a nation-wide cash transfer program.

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.

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.

Outcomes

Primary Outcome Measures

Incremental cost incurred per disability adjusted life year (DALY) averted: provider perspective
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.
Incremental cost incurred per disability adjusted life year (DALY) averted: societal perspective
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.

Secondary Outcome Measures

Mean cost of intervention delivery
Cost of intervention delivery for different intervention models per patient, by category, annuitised
Mean cost of LSB session
Average cost of LSB session delivery for different intervention models, annuitised
Total incremental cost of the intervention in a research setting
Total additional cost of the intervention compared to the BISP-CT only for the study population and by intervention type during the research period.
Total incremental cost of the intervention in the modelling cohort
Total additional cost of the intervention for the modelling cohort by intervention type over a ten-year period.
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: provider perspective
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a provider perspective at scale.
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: societal perspective
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a societal perspective at scale.

Full Information

First Posted
October 25, 2022
Last Updated
October 25, 2022
Sponsor
London School of Economics and Political Science
Collaborators
Aga Khan University, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05598697
Brief Title
Economic Evaluation of the MEWE Intervention
Acronym
MEWE-EE
Official Title
Economic Evaluation of the Men Engagement in Women Empowerment (MEWE) Intervention (MEWE-EE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Economics and Political Science
Collaborators
Aga Khan University, Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cash transfers have shown promise in preventing intimate partner violence, and in reducing recipients' stress levels. Cash transfers with behavioral or psychological interventions have shown limited effectiveness at reducing stress in some African countries. Little is known of the cost-effectiveness of interventions delivered alongside cash transfer programs. The MEWE economic evaluation sub-study (MEWE-EE) runs alongside MEWE, a three-arm cluster-randomized controlled trial in Sindh, Pakistan. MEWE-EE will assess the costs and cost-effectiveness of delivering a cash-transfer program (BISP-CT) combined with a life-skills building curriculum (LSB curriculum), compared to the BISP-CT alone. The LSB curriculum is offered to either women who receive BISP-CT, or to women who receive BISP-CT and their husbands.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Mental Health Issue, Intimate Partner Violence, Domestic Violence, Gender-based Violence, Rape Sexual Assault, Battered Women
Keywords
violence, abuse, coercion, assault, aggression, gender, women, girl, wife, partner, spouse, sexual, physical, psychological, economic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cash Transfers only
Arm Type
Active Comparator
Arm Description
Participants allocated to this arm receive cash transfers. They are clients of a nation-wide cash transfer program.
Arm Title
Cash Transfers + LSB curriculum for females clients only
Arm Type
Experimental
Arm Description
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.
Arm Title
Cash Transfers + LSB curriculum for females clients and their husbands
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Life Skills Building (LSB) curriculum for males
Other Intervention Name(s)
MEWE males
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Life Skills Building (LSB) curriculum for females
Other Intervention Name(s)
MEWE females
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cash transfer to adult females
Other Intervention Name(s)
BISP-CT
Intervention Description
The BISP intervention offers access to quarterly unconditional cash transfers to adult females.
Primary Outcome Measure Information:
Title
Incremental cost incurred per disability adjusted life year (DALY) averted: provider perspective
Description
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.
Time Frame
12 months post randomisation
Title
Incremental cost incurred per disability adjusted life year (DALY) averted: societal perspective
Description
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.
Time Frame
12 months post randomisation
Secondary Outcome Measure Information:
Title
Mean cost of intervention delivery
Description
Cost of intervention delivery for different intervention models per patient, by category, annuitised
Time Frame
12 months post randomisation
Title
Mean cost of LSB session
Description
Average cost of LSB session delivery for different intervention models, annuitised
Time Frame
12 months post randomisation
Title
Total incremental cost of the intervention in a research setting
Description
Total additional cost of the intervention compared to the BISP-CT only for the study population and by intervention type during the research period.
Time Frame
12 months post randomisation
Title
Total incremental cost of the intervention in the modelling cohort
Description
Total additional cost of the intervention for the modelling cohort by intervention type over a ten-year period.
Time Frame
12 months post randomisation
Title
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: provider perspective
Description
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a provider perspective at scale.
Time Frame
12 months post randomisation
Title
Incremental cost incurred per disability adjusted life year (DALY) averted at scale: societal perspective
Description
Incremental cost per disability-adjusted life year (DALY) averted by the intervention compared to the control group from a societal perspective at scale.
Time Frame
12 months post randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulia Ferrari, PhD
Organizational Affiliation
London School of Economics & Political Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mirpur Sakro
City
Thatta
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Economic Evaluation of the MEWE Intervention

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