NCT07502183

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). The institutional strengthening component of these evaluations is meant to create an enabling environment. The cRCT described in this protocol will assess the added value of the women's social and economic empowerment programme (MO) when layered on top of SASA! Together for eligible at-risk households.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,700

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Oct 2025

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress17%
Oct 2025Jan 2029

Study Start

First participant enrolled

October 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

March 18, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Intimate Partner ViolenceEconomic Empowerment

Outcome Measures

Primary Outcomes (3)

  • 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

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

    This indicator equals 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.

    12 months

  • Indicator for engaged in any income generating activity in the past 3 months (among all women and men separately)

    From time of implementation to endline assessment is 3 years

Secondary Outcomes (11)

  • 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 controlling behaviour from a partner (among women who have had an intimate partner in the past year)

    12 months

  • Index for Acceptability of intimate partner violence (among all women and men separately).

    From time of implementation to endline assessment is 3 years

  • +6 more secondary outcomes

Study Arms (2)

SASA! Together

ACTIVE COMPARATOR

400 women + 200 men will be sampled for comparison group

Behavioral: SASA! Together

SASA! Together + MO

EXPERIMENTAL

600 women + 300 men sampled for the evaluation of MO

Behavioral: SASA! TogetherBehavioral: MO

Interventions

SASA! TogetherBEHAVIORAL

SASA! Together is an evidence-based community mobilisation approach

SASA! TogetherSASA! Together + MO
MOBEHAVIORAL

MO is a family-based, women's economic and social empowerment approach.

SASA! Together + MO

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The household has a woman aged 18-49 who are in monogamous relationships
  • The household is food insecure, where food insecurity is scored on a scale of (0-7) and constructed from responses on 3 questions related to the household's food sufficiency (a) How does the household meet its food needs (b) How often does the household has food surplus and (c) How many times do you eat a full meal on a typical day over a year.
  • The primary decision maker of the household is male
  • Household is willing to participate in community meetings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imani Consulting, 6256+F3H, Jacaranda Rd, Mandala, Blantyre, Malawi

Blantyre, PO Box 2873, Malawi

RECRUITING

Central Study Contacts

Saini Das, Ph.D.

CONTACT

Jennifer Seager, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Implementation of SASA! Together has begun in 8 GVHs across Chadza and Nkaya in April 2025. The comparison group will only receive the SASA! Together component. The intervention arm for this study will receive SASA! Together + MO approach. The 8 GVHs where SASA implementation is ongoing will be randomly allocated to intervention and control. From each GVH based on relative population size and an eligibility criterion, we will sample approximately 50-250 MO-eligible households for a total of 1,000 households. The intervention itself will be rolled out in two phases to 600 women aged 18-49 and their families. Each phase of intervention will constitute 300 women at a time. Due to budget considerations, for every 2 female interviews, an interview with 1 male partner will be conducted. We will also sample 200 additional women across the intervention GVHs for an exploratory analysis of spillovers. Total sample size is 1200 women and 500 men.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 30, 2026

Study Start

October 15, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations