NCT05598697

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,536

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

October 25, 2022

Last Update Submit

December 6, 2023

Conditions

DepressionMental Health IssueIntimate Partner ViolenceDomestic ViolenceGender-based ViolenceRape Sexual AssaultBattered Women

Keywords

violenceabusecoercionassaultaggressiongenderwomengirlwifepartnerspousesexualphysicalpsychologicaleconomic

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 months post randomisation

  • 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.

    12 months post randomisation

Secondary Outcomes (6)

  • Mean cost of intervention delivery

    12 months post randomisation

  • Mean cost of LSB session

    12 months post randomisation

  • Total incremental cost of the intervention in a research setting

    12 months post randomisation

  • Total incremental cost of the intervention in the modelling cohort

    12 months post randomisation

  • Incremental cost incurred per disability adjusted life year (DALY) averted at scale: provider perspective

    12 months post randomisation

  • +1 more secondary outcomes

Study Arms (3)

Cash Transfers only

ACTIVE COMPARATOR

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

Other: Cash transfer to adult females

Cash Transfers + LSB curriculum for females clients only

EXPERIMENTAL

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.

Behavioral: Life Skills Building (LSB) curriculum for femalesOther: Cash transfer to adult females

Cash Transfers + LSB curriculum for females clients and their husbands

EXPERIMENTAL

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.

Behavioral: Life Skills Building (LSB) curriculum for malesBehavioral: Life Skills Building (LSB) curriculum for femalesOther: Cash transfer to adult females

Interventions

Life Skills Building (LSB) curriculum for malesBEHAVIORAL

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.

Also known as: MEWE males
Cash Transfers + LSB curriculum for females clients and their husbands
Life Skills Building (LSB) curriculum for femalesBEHAVIORAL

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.

Also known as: MEWE females
Cash Transfers + LSB curriculum for females clients and their husbandsCash Transfers + LSB curriculum for females clients only
Cash transfer to adult femalesOTHER

The BISP intervention offers access to quarterly unconditional cash transfers to adult females.

Also known as: BISP-CT
Cash Transfers + LSB curriculum for females clients and their husbandsCash Transfers + LSB curriculum for females clients onlyCash Transfers only

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • In receipt of Benazir Income Support Program (BISP) cash transfers (CTs)
  • Parity: have at least one child, at least 18 months old

You may not qualify if:

  • Plan for the family to migrate out of the village within the next 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirpur Sakro

Thatta, Sindh, Pakistan

Location

MeSH Terms

Conditions

DepressionAggressionCoitus

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAberrant Motor Behavior in DementiaSocial BehaviorSexual Behavior

Study Officials

  • Giulia Ferrari, PhD

    London School of Economics & Political Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professorial Research Fellow

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

September 15, 2021

Primary Completion

June 30, 2022

Study Completion

November 30, 2022

Last Updated

December 7, 2023

Record last verified: 2023-12

Locations

PA(1)