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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05598697
Other study ID # 108137
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date November 30, 2022

Study information

Verified date December 2023
Source London School of Economics and Political Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1536
Est. completion date November 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 49 Years
Eligibility 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 Design


Intervention

Behavioral:
Life Skills Building (LSB) curriculum for males
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.
Life Skills Building (LSB) curriculum for females
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:
Cash transfer to adult females
The BISP intervention offers access to quarterly unconditional cash transfers to adult females.

Locations

Country Name City State
Pakistan Mirpur Sakro Thatta Sindh

Sponsors (3)

Lead Sponsor Collaborator
London School of Economics and Political Science Aga Khan University, Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Mean cost of intervention delivery Cost of intervention delivery for different intervention models per patient, by category, annuitised 12 months post randomisation
Secondary Mean cost of LSB session Average cost of LSB session delivery for different intervention models, annuitised 12 months post randomisation
Secondary 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. 12 months post randomisation
Secondary 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. 12 months post randomisation
Secondary 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. 12 months post randomisation
Secondary 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. 12 months post randomisation
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