Clinical trial NCT06783400: What Works - Malawi SASA! Together
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intimate Partner Violence (IPV)
Norms, Social
Gender Inequitable Behavior
Keywords: intimate partner violence
gender
social norms
community mobilization
behavior change
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Global Women's Institute
name: University of Cape Town
First posted: 2025-01-20
Enrollment: 4800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 12 months
measure: Acceptability of violence (personal belief; among men and women separately)
timeFrame: From time of implementation to endline assessment is 3 years
Secondary outcomes:
measure: Indicator for Past year experience of physical violence from a partner (among women who have had an intimate partner in the past year)
timeFrame: 12 months
measure: Indicator for Past year experience of sexual violence from a partner (among women who have had an intimate partner in the past year)
timeFrame: 12 months
measure: Indicator for Past year experience of emotional violence from a partner (among women who have had an intimate partner in the past year)
timeFrame: 12 months
measure: Indicator for Past year experience of economic violence from a partner (among women who have had an intimate partner in the past year)
timeFrame: 12 months
measure: Indicator for Past year experience of controlling behaviour from a partner (among women who have had an intimate partner in the past year)
timeFrame: 12 months
measure: Index for Acceptability of intimate partner violence (among all women and men separately)
timeFrame: From time of implementation to endline assessment is 3 years
measure: Index of Appropriate community response to women experiencing IPV in past year (among all women and men separately)
timeFrame: From time of implementation to endline assessment is 3 years
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Women's Legal Resources Center (WOLREC)
Study officials:
References: