- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783400
What Works - Malawi SASA! Together (WW-M-SASA!)
What Works to Prevent Violence Against Women and Girls: Impact at Scale: A Cluster Randomized Controlled Trial to Assess the Effectiveness of a Community-mobilisation Intervention to Prevent Violence Against Women in Malawi - SASA! Together
Violence against women is complex and must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote their rights. It is in this context that the Pamodzi Kuthetsa Nkhanza (PKN) consortium will implement a programme to facilitate the prevention of intimate partner violence (IPV) in Malawi as one of the most common forms of VAW experienced in Malawi. The programme takes a whole community approach and uses gender transformative approaches at different levels of society to address the root causes of IPV. It will draw primarily on two existing, evidence-based prevention models, namely SASA! Together (community mobilisation model) and Moyo Olemekeza (MO) (gender norms and behaviour change and economic empowerment approach).
A cluster randomised controlled trial (cRCT) will evaluate the effectiveness of the PKN programme, assessing the effectiveness of the SASA! Together programme at shifting individual behaviours and reducing violence in intimate relationships while also tackling community norms that drive these forms of violence against women. The cRCT will also assess the added value of combining SASA! Together and a women's social and economic empowerment programme (MO) for most at-risk households.
This protocol focuses on the evaluation of the SASA! Together programme.
Study Overview
Status
Intervention / Treatment
Detailed Description
According to the 2016 Malawi Demographic and Health Survey, 42% of ever-married women aged 15 - 49 have experienced spousal physical, sexual, or emotional violence by their current or most recent spouse, and a third (33%) of ever-married women experienced at least one of these forms of violence in the 12 months before the survey [1]. Overall, 41% of all women (whether they have ever been married or not) have experienced physical or sexual violence [1]. Despite these high levels of violence against women and girls (VAWG), there are a limited number of evidence-based interventions focused on preventing VAW in Malawi.
Violence against women must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote their rights. It is in this context that the Pamodzi Kuthetsa Nkhanza (PKN) consortium will implement a programme to facilitate the prevention of intimate partner violence (IPV) in Malawi. The programme takes a whole community approach and uses gender transformative approaches at different levels of society to address the root causes of IPV. It will draw primarily on two existing, evidence-based prevention models, namely SASA! Together and Moyo Olemekeza (MO).
This cRCT forms part of a broader mixed methods research design. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, the overall research design consists of five distinct components, all contributing to evidence on the efficacy of the programme and the contextual factors around the programme and its implementation that will guide the interpretation of the cRCT.
This protocol refers to the cRCT evaluation of SASA! Together only. Specifically, the cRCT aims to evaluate the community level impact of SASA! Together on experiences of IPV among women aged 18 - 49 in two districts in Malawi (Balaka and Lilongwe districts).
The specific aim for understanding the efficacy of the SASA! Together programme is:
1) To estimate the community-level causal impact of SASA! Together (compared to a control) on the primary and secondary outcomes among women and men aged 18 - 49 in Lilongwe and Balaka districts, Malawi.
The overall goal of this study is to add to the evidence base on effective, comprehensive interventions to reduce violence against women in Malawi.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Seager, PhD
- Phone Number: 202-994-4455
- Email: jseager@gwu.edu
Study Locations
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Blantyre, Malawi
- Recruiting
- Women's Legal Resources Center (WOLREC)
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Contact:
- Maggie Banda, LLB
- Phone Number: +265994501434
- Email: maggiebanda@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women and men aged 18-49 who have ever been in an intimate (romantic) relationship.
- Living in selected Group Village Heads (GVHs) in Lilongwe or Balaka districts for at least a year. The specific Traditional Authorities (TAs) in Lilongwe are: Kalolo, Chimutu, Kabudula; The TAs in Balaka are: Msamala and Nyanyala.
Exclusion Criteria:
- Women and men younger than 18 years or older than 49 years old
- Women who have never had an intimate relationship.
- Not living in selected TAs and GVHs in Lilongwe or Balaka districts, or living in selected GVHs for less than one year
- Paid employees of the PKN programme (any element), including SASA! Together community activists who deliver the programme activities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
In control communities SASA! Together will not be implemented.
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Experimental: SASA! Together
The SASA! Together programme will be implemented in communities in this arm.
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SASA! Together is a community mobilisation approach that engages communities to create positive and sustainable changes around norms and behaviors that perpetuate violence against women. Some new features in this revision of SASA! include a distinct focus on IPV, including sexual decision-making; three strategies aligned to the socio-ecological model that reach across the whole community (individuals, groups, and institutions); and more support to get organisations and communities started and to sustain change. The evidence- and theory-based SASA! approach is grounded in: (1) benefits-based activism, (2) a gender-power analysis, (3) four phases of change (start, awareness, support, action) according to the stages of behaviour change, (4) holistic community engagement, (5) local activism, (6) community leadership, and (7) institutional strengthening. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Indicator for Past year experience of any violence (physical, sexual, or emotional) from a partner (among women who have had an intimate partner in the past year)
Time Frame: 12 months
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Defining past year experience of intimate partner violence using the World Health Organization's "Multi-country study measure for intimate partner violence" module.
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12 months
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Acceptability of violence (personal belief; among men and women separately)
Time Frame: From time of implementation to endline assessment is 3 years
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Sum of indicators that the respondent agrees that a man/husband has a good reason to hit or beat his wife/partner if she (1) goes out without telling him; (2) she neglects the children; (3) she argues with him; (4) she refuses to have sex with him; (5) she burns the food; (6) he suspects that she has been unfaithful
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From time of implementation to endline assessment is 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Indicator for Past year experience of physical violence from a partner (among women who have had an intimate partner in the past year)
Time Frame: 12 months
|
An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Slapped you or thrown something at you (ii)Pushed or shoved you (iii) Hit you with his fist or with something else (iv) Kicked, dragged or beaten you (v) Choked or burnt you and (vi) Threatened you with, or actually used, a knife or other weapon against you
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12 months
|
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Indicator for Past year experience of sexual violence from a partner (among women who have had an intimate partner in the past year)
Time Frame: 12 months
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An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Physically forced you to have sexual intercourse (ii) Physically forced you to perform any other sexual acts (iii) Force you with threats to perform sexual acts
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12 months
|
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Indicator for Past year experience of emotional violence from a partner (among women who have had an intimate partner in the past year)
Time Frame: 12 months
|
An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Insulted you or made you feel bad about yourself (ii) Destroyed things that are important to you (iii) Did things that made you feel scared or intimidated (iv) Threatened to harm you or someone you care about (v) Thrown you out of the house (vi) Taken away your phone or controlled how you use it
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12 months
|
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Indicator for Past year experience of economic violence from a partner (among women who have had an intimate partner in the past year)
Time Frame: 12 months
|
An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Prohibits you from earning money (ii) Takes earnings from you against your will (iii) Refuses to give money for household expenses (iv) Keeps you from getting a loan (v) Not let you participate in deciding how the family finances are spend
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12 months
|
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Indicator for Past year experience of controlling behaviour from a partner (among women who have had an intimate partner in the past year)
Time Frame: 12 months
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An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Tries to stop you from meeting your friends (ii) Tries to limit contact with your family of birth (iii) Insists on knowing where you are at all times (iv) Gets jealous or angry if you talk with another man (v) Frequently accuses you of being unfaithful (vi) Checks your cellphone/WhatsApp logs/messages to see who you have called or messaged/who has called or messaged you
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12 months
|
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Index for Acceptability of intimate partner violence (among all women and men separately)
Time Frame: From time of implementation to endline assessment is 3 years
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This measure is a summation of the responses to each of 4 relationship attitudes, with a possible maximum score of 4. Higher scores will indicate more restrictive attitudes towards violence. Components are:
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From time of implementation to endline assessment is 3 years
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Index of Appropriate community response to women experiencing IPV in past year (among all women and men separately)
Time Frame: From time of implementation to endline assessment is 3 years
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This measure is a summation of two indicators:
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From time of implementation to endline assessment is 3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCR245830SASA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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