Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 12:32 PM
Study NCT ID:
NCT06783400
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Works - Malawi SASA! Together
Sponsor:
George Washington University
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WW-M-SASA!
Brief Summary:
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: