Condition category
Not Applicable
Date applied
19/02/2018
Date assigned
22/02/2018
Last edited
22/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
One in three women in India have survived physical or sexual violence, making it a major public health burden. Reviews recommend community mobilisation to address violence, but evidence is limited. The aim of this study is to test the effects of community mobilisation through groups and individual volunteers on the prevalence of violence against women and girls in informal settlements in Mumbai.

Who can participate?
Residents of informal settlements in Mumbai

What does the study involve?
Participating areas are randomly allocated to the control group or the intervention group. Residents in control group areas receive unrestricted access to services provided by the implementing organisation: crisis intervention, counselling, police liaison, medical attention, mental health intervention, family interventions, and legal recourse. Residents in intervention group areas receive the same services as the control group, with the addition of community mobilisation activities with groups of women, men, and adolescents, and with individual women volunteers. A salaried community mobiliser convenes three women’s groups, one men’s group, and one mixed-sex adolescent group monthly, following manuals over three years. Community mobilisers and group members organise local campaigns and events. Group members who show leadership are trained and supported to undertake identification of survivors of violence, crisis intervention and preliminary counseling, referral, and collective community campaigns. These community mobilisation activities are assessed through a follow-up survey after three years. Prevalence of domestic physical or sexual violence, and prevalence of domestic emotional or economic violence, control or neglect, are both measured by survey interview at 3 years after the start of intervention, along with disclosure of violence to support services, community attitudes to violence, bystander intervention, gender equality, common mental disorders, and prevalence of non-partner sexual violence.

What are the possible benefits and risks of participating?
Benefits to participants in interviews include information on support services, confidential disclosure, and access to crisis counselling and support services, including medical care, police intervention, and legal support. Participants in community activities have access to the same services, and benefit from joining support groups of women and men. Minimised by confidentiality procedures and response protocols, a woman’s disclosure of violence may lead to family tensions and possible escalation, or denial of access to support services. There is a small possibility of resistance from community members. Protocols are in place for response to disclosure, crisis, and threat.

Where is the study run from?
1. UCL Institute for Global Health (UK)
2. SNEHA (Society for Nutrition, Education and Health Action) (India)

When is the study starting and how long is it expected to run for?
July 2017 to June 2022

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
1. Prof. David Osrin
d.osrin@ucl.ac.uk
2. Dr Nayreen Daruwalla
nayreen@snehamumbai.org

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Osrin

ORCID ID

http://orcid.org/0000-0001-9691-9684

Contact details

Institute for Global Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)2079052122
d.osrin@ucl.ac.uk

Type

Scientific

Additional contact

Dr Nayreen Daruwalla

ORCID ID

http://orcid.org/0000-0002-5716-1281

Contact details

SNEHA
Urban Health Centre
Room 310
60 Feet Road
Dharavi
Mumbai
400017
India
+91 (0)224040045
nayreen@snehamumbai.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Wellcome 206417/Z/17/Z

Study information

Scientific title

Community interventions to prevent violence against women and girls in informal settlements in Mumbai: the SNEHA-TARA pragmatic cluster randomised controlled trial

Acronym

SNEHA-TARA

Study hypothesis

Over and above a package of crisis intervention, counselling, and support services, a community mobilisation intervention delivered in informal settlements for three years and involving groups and volunteers will reduce the reported prevalence of domestic physical or sexual violence, and of domestic emotional or economic violence, control or neglect.

Ethics approval

1. UCL Research Ethics Committee, 27/09/2017, ref: 3546/003
2. PUKAR (Partners for Urban Knowledge, Action, and Research) Institutional Ethics Committee, 25/12/2017

Study design

Single-centre parallel-group phased analyst-masked cluster randomised controlled superiority trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Violence against women and girls

Intervention

Computer pseudorandomised 1:1 allocation of 48 clusters blocked in 4 phases of 12 each. 24 areas receive support services, community group, and volunteer activities, and 24 areas receive support services only.

Intervention: as control, with the addition of community mobilisation activities with groups of women, men, and adolescents, and with individual women volunteers.
1. In each cluster, a salaried community mobiliser will convene three women’s groups, one men’s group, and one mixed-sex adolescent group monthly, following manuals over three years.
2. Community mobilisers and group members will organise local campaigns and events.
3. Group members who show leadership will be trained and supported to undertake identification of survivors of violence, crisis intervention and preliminary counseling, referral, and collective community campaigns.

Control: unrestricted access to services provided by the implementing organisation: crisis intervention, counselling, police liaison, medical attention, mental health intervention, family interventions, and legal recourse.

These community mobilisation activities will be evaluated through a follow-up survey after three years.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Measured by survey interview at 3 years after the start of intervention:
1. Prevalence of physical or sexual domestic violence against women 15-49 years in the preceding 12 months, based on Demographic and Health Survey (DHS) and WHO perpetration modules
2. Prevalence of emotional or economic domestic violence or gender-based household maltreatment of women 15-49 years in the preceding 12 months, based on DHS and WHO modules and the new Indian Family Violence and Control scale

Secondary outcome measures

Measured by survey interview at 3 years after the start of intervention:
1. Disclosure of violence against women and girls to support services (non government organisations, police, healthcare, government programmes)
2. Community attitudes to violence against women and girls, based on the National Community Attitudes towards Violence Against Women Survey
3. Bystander intervention, based on the Mentors in Violence Prevention Efficacy Scale
4. Gender equality, based on WHO modules
5. Prevalence of non-partner sexual violence in preceding 12 months, based on DHS and WHO modules
6. Prevalence of anxiety (GAD-7) and depression (PHQ-9)

Overall trial start date

01/07/2017

Overall trial end date

30/06/2022

Reason abandoned

Eligibility

Participant inclusion criteria

Any resident of an intervention cluster may participate in the intervention

Survey 1 after 3 years of intervention:
200 women aged 18-49 in each of 48 clusters of 500 households will be asked about their health, wellbeing, common mental disorder, household decision-making, household power and control, neglect, experience of economic, emotional, physical, and sexual violence, disclosure and support (9600 participants)

Survey 2 after 3 years of intervention:
100 women and men aged 18-65 in each of 48 clusters, in different households from respondents to Survey 1, will be asked about gender roles, gender equality, ambivalent sexism, violence in their locality, attitudes to and justifiability of violence against women, bystander intervention, and potential sources of support (4800 participants)

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

48 clusters of 300 evaluation participants (9600 women for Survey 1)

Participant exclusion criteria

1. Aged under 18 or over 65
2. Unwilling to give consent for interview

Recruitment start date

05/03/2018

Recruitment end date

04/03/2022

Locations

Countries of recruitment

India

Trial participating centre

UCL Institute for Global Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Trial participating centre

SNEHA (Society for Nutrition, Education and Health Action)
Urban Health Centre, 60 Feet Road, Dharavi
Mumbai
400017
India

Sponsor information

Organisation

UCL Institute for Global Health

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/igh

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Protocol to be published in 2018, analysis plan to be finalised at third meeting of Trial Steering Committee
2. Theory of change to be published in 2018
3. Planned trial publication in high-impact open-access peer reviewed journal in 2022

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes