NCT06783400

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,800

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Aug 2024Dec 2029

Study Start

First participant enrolled

August 27, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

January 14, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

intimate partner violencegendersocial normscommunity mobilizationbehavior change

Outcome Measures

Primary Outcomes (2)

  • 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)

    Defining past year experience of intimate partner violence using the World Health Organization's "Multi-country study measure for intimate partner violence" module.

    12 months

  • Acceptability of violence (personal belief; among men and women separately)

    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

    From time of implementation to endline assessment is 3 years

Secondary Outcomes (7)

  • Indicator for Past year experience of physical violence from a partner (among women who have had an intimate partner in the past year)

    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)

    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)

    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)

    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)

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

In control communities SASA! Together will not be implemented.

SASA! Together

EXPERIMENTAL

The SASA! Together programme will be implemented in communities in this arm.

Behavioral: SASA! Together

Interventions

SASA! TogetherBEHAVIORAL

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.

SASA! Together

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Legal Resources Center (WOLREC)

Blantyre, Malawi

RECRUITING

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Central Study Contacts

Jennifer Seager, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

August 27, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

We will share de-identified individual-level data sets

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Information will be made available upon request after primary manuscripts have been published

Locations