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Study Overview

Title:
A cluster randomised controlled trial to evaluate the impact of microfinance and participatory gender training on intimate partner violence
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-52546f0039f52
Initial Registration Date:
10/08/2013
Last Update Date:
03/20/2019
Study Status:
Ongoing
Location(s):
Tanzania
Change History for Location(s)
Changed On Previous Value
03/11/2019 United Kingdom
03/11/2019 Tanzania, United Republic of
Abstract:
The overall goal of the current study is to design and implement a cluster randomized controlled trial to assess the impact of adding a participatory gender training programme to an existing microfinance intervention for women, and the impact of a participatory gender training programme for women not receiving microfinance in reducing intimate partner violence. The evaluation will assess whether the intervention has an impact on participants’ experience of past year physical and/or sexual intimate partner violence, as well as other gender-empowerment, economic, and health related outcomes.
Change History for Abstract
Changed On Previous Value
03/20/2019 The overall goal of the current study is to design and implement a cluster randomized controlled trial to assess the impact of adding participatory gender training for women to existing micro-finance loan groups, and the impact of a participatory gender training programme alone for women and their partners. In both cases, the evaluation will assess whether the intervention has a significant impact on participants’ experience of physical and/or sexual intimate partner violence, as well as other gender-empowerment, economic, and health related outcomes.
Categories:
Health, Nutrition, and Population
Additional Keywords:
intimate partner violence, economic empowerment, social empowerment
Change History for Additional Keywords
Changed On Previous Value
03/20/2019 gender based violence, empowerment
Secondary ID Number(s):
ClinicalTrials.gov ID: NCT02592252

Principal Investigator(s)

Name of First PI:
Shelley Lees
Change History for Name of First PI
Changed On Previous Value
03/11/2019 Charlotte Watts
Affiliation:
London School of Hygiene & Tropical Medicine
Change History for Affiliation
Changed On Previous Value
03/20/2019 London School of Hygiene and Tropical Medicine
Name of Second PI:
Sheila Harvey
Change History for Name of Second PI
Changed On Previous Value
03/11/2019 Shelley Lees
Affiliation:
London School of Hygiene & Tropical Medicine
Change History for Affiliation
Changed On Previous Value
03/20/2019 LSHTM

Research Partner

Name of Partner Institution:
Mwanza Intervention Trials Unit and National Institute for Medical Research, Mwanza, Tanzania
Change History for Name of Partner Institution
Changed On Previous Value
03/20/2019 Mwanza Intervention Trials Unit, National Institute for Medical Research
Type of Organization:
Government agency (eg., statistics office, Ministry of Health)
Location:
Tanzania
Intervention

Intervention Overview

Intervention:
The intervention is a 10-session participatory social empowerment intervention delivered to women in groups. Groups of women in the comparator arm are wait-listed for the intervention following completion of study activities. The intervention follows the Wanawake na Maisha (which means “women and life” in Kiswahili) curriculum, which was developed by EngenderHealth in collaboration with the study team drawing on other published curricula, such as the Sisters for Life curriculum which forms part of the IMAGE intervention in South Africa. The intervention is designed to be participatory and reflective, and aims to empower women, prevent intimate partner violence, and promote healthy relationships by: increasing knowledge and awareness (e.g. of the consequences of normative attitudes to gender and intimate partner violence); developing relationship skills (e.g. communication and conflict resolution); and creating group dynamics and stability (e.g. increased peer support and social capital). The intervention is delivered on alternate weeks over a 20-week period. Each of the 10 sessions is approximately an hour and a half to two hours giving a total time of about 15-20 hours.
Change History for Intervention
Changed On Previous Value
03/20/2019 The intervention is a 10-session participatory social empowerment intervention delivered to women in groups. Groups of women in the comparator arm are wait-listed for the intervention following completion of study activities. The intervention follows the Wanawake na Maisha (which means “women and life” in Kiswahili) curriculum, which was developed by EngenderHealth in collaboration with the study team drawing on other published curricula, such as the Sisters for Life curriculum which forms part of the IMAGE intervention in South Africa. The MAISHA intervention is designed to be participatory and reflective, and aims to empower women, prevent IPV, and promote healthy relationships by: increasing knowledge and awareness (e.g. of the consequences of normative attitudes to gender and IPV); developing relationship skills (e.g. communication and conflict resolution); and creating group dynamics and stability (e.g. increased peer support and social capital).
03/20/2019 The main activities to be conducted during the trial period include the development of a short participatory gender training intervention for women and for their partners that involves attending 10 sessions addressing gender norms and healthy relationships; the design and implementation of a cluster-randomized controlled trial, on-going qualitative research in the intervention communities, and an economic evaluation to assess the unit costs and cost-effectiveness of the different intervention arms.
Theory of Change:
Multiple Treatment Arms Evaluated?
Yes

Implementing Agency

Name of Organization:
Mwanza Intervention Trials Unit
Change History for Name of Organization
Changed On Previous Value
03/20/2019 BRAC Tanzania
Type of Organization:
Research Institution/University
Change History for Type of Organization
Changed On Previous Value
03/20/2019 NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
02/01/2014
End Date:
07/31/2019
Change History for End Date
Changed On Previous Value
03/11/2019 01/31/2015
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
The cluster randomised controlled trial has two components: Component A: The trial population will be women in existing microfinance groups, randomly allocated as follows: • Microfinance only with no further intervention (Arm A1) • A combined microfinance and participatory gender training intervention involving women (gender training + microfinance) (Arm A2). Component B: The trial population will be newly-formed groups of women not receiving microfinance, randomly allocated as follows: • No intervention (control) (Arm B1) • A participatory gender training intervention involving newly formed groups of women without microfinance (gender training women) (Arm B2)
Change History for Details of Evaluation Approach
Changed On Previous Value
03/20/2019 The study will involve 4 arms: A MF only arm (A1); a combined micro-finance (MF) and participatory gender training intervention involving women (gender training women + MF) (A2); No intervention (control arm) (B1), and a combined participatory gender training intervention involving both women and their partners, without micro-finance (gender training women + partners) (B2). Women assigned to Arms A2 and B2 will receive the assigned interventions, while those in Arm A1 and B1 will be the control groups. Recruitment of men for the gender training in B2 will be done post-randomization. All women recruited will take part in the baseline survey before they take part in the interventions (if assigned to Arms A2 and B2). They will also participate in the follow up study one year after the intervention is implemented. Male evaluation participants will be recruited at follow up only.
Outcomes (Endpoints):
Component A primary outcome is reported past year experience of physical and/or sexual IPV, assessed two years after delivery of the intervention. Secondary outcome will be: • Women’s experience of physical IPV during the past 12 months; • Women’s experience of sexual IPV during the past 12 months; • Women’s experience of emotional abuse during the past 12 months; • Women’s attitudes about IPV; and • Disclosure of violence to others by women who have experienced physical and/or sexual IPV during the past 12 months. Component B primary outcomes are past year experience of physical IPV and sexual IPV assessed two years after delivery of the intervention. Secondary outcomes will be: • Women’s experience of emotional abuse during the past 12 months; • Women’s attitudes about IPV; and • Disclosure of violence to others by women who have experienced physical and/or sexual IPV during the past 12 months.
Change History for Outcomes (Endpoints)
Changed On Previous Value
03/20/2019 The primary outcome in the trial will be an assessment of women’s reported past year experience of physical and/or sexual violence one year after the implementation of the interventions. To better understand the broader potential benefits of the different intervention arms, the impact of the intervention on the following measures will be assessed: Productivity of the loan groups (for the micro-finance intervention arm); household asset ownership; Different indicators of women’s social and economic empowerment; Patterns of household communication and conflict resolution; sexual and reproductive health, including reported sexual behaviour and use of services; common mental disorders; and ability to resist social pressure and challenge of injunctive gender norms.
Unit of Analysis:
Individual
Hypotheses:
The main hypothesis is that women who participate in the 10-session social empowerment intervention will experience less past year intimate partner violence two years after completing the intervention compared with women who do not participate in the intervention. This will be tested in two populations of women - women in established microfinance groups and women in newly-formed neighbourhood groups who are not receiving formal microfinance loans.
Unit of Intervention or Assignment:
Groups comprising around 15-20 women, either existing microfinance groups or new groups.
Change History for Unit of Intervention or Assignment
Changed On Previous Value
03/20/2019 Groups comprising at least 20 women, either existing microfinance groups or new groups for gender training
Number of Clusters in Sample:
For both components (A and B), each arm (A1, A2, and B1, B2) will consist of 33 clusters (groups as described above), giving a total of 66 groups in each component
Change History for Number of Clusters in Sample
Changed On Previous Value
03/20/2019 Each arm will consist of 33 clusters (groups as described above) including 33 clusters of men for Arm B2
Number of Individuals in Sample:
For each component, approximately 990-1320 women will be recruited, giving a total of around 1980-2640 women across the two components of the trial.
Change History for Number of Individuals in Sample
Changed On Previous Value
03/20/2019 Each cluster will comprise 666 women, with a total of 2664 women and 666 men
Size of Treatment, Control, or Comparison Subsamples:
For both components, there will be 33 clusters (495-660 individuals) in each of the control and intervention arms.
Change History for Size of Treatment, Control, or Comparison Subsamples
Changed On Previous Value
03/20/2019 33 clusters (666 individuals) in the control group and 99 (clusters) (1998 individual women)in the treatment groups

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
As groups are selected (A1 and A2) or set up (B1 and B2) women will be invited to participate in a face-to-face interview for a baseline survey before the intervention commences. All women will then be approached 24 months after the intervention is completed to participate in a follow up survey. During the follow-up surveys current partners of women participants (who agree) will be approached to attend a face-to-face interview as part of cross-sectional surveys with men.
Change History for Description
Changed On Previous Value
03/20/2019 As groups are selected (A1 and A2) or set up (B1 and B2) women will be invited to participate in a face to face questionnaire for a baseline survey before the gender training commences. All women will be approached 12 months after the gender training is completed to attend a follow up survey. During this survey current partners of all women participants, including men who attended gender training, will be approached to attend a face to face interview for a cross sectional survey.
03/20/2019 As groups are selected (A1 and A2) or set up (B1 and B2) women will be visited at their homes to participate in a face to face questionnaire for a baseline survey before the gender training commences. All women will be approached 12 months after the gender training is completed to attend a follow up survey. During this survey current partners of all women participants, including men who attended gender training, will be approached to attend a face to face interview for a cross sectional survey.
Data Already Collected?
No
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: