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Recruiting NCT06783400

What Works - Malawi SASA! Together

No phase Interventional Intimate Partner Violence (IPV) Norms, Social Gender Inequitable Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SASA! Together.
Who it may be relevant to
Registry conditions: Intimate Partner Violence (IPV), Norms, Social, Gender Inequitable Behavior. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malawi
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral SASA! Together
    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

Primary outcome measures

  • 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]
  • Acceptability of violence (personal belief; among men and women separately) [Time frame: From time of implementation to endline assessment is 3 years]
Secondary outcome measures (7)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Malawi · 1 center
  • Women's Legal Resources Center (WOLREC) — Blantyre

Identifiers

NCT: NCT06783400 · NCR245830SASA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗