ClinicalTrials.gg
RecruitingNCT06783400WW-M-SASA!Updated Feb 12, 2026

What Works - Malawi SASA! Together

An interventional study of SASA! Together in Intimate Partner Violence (IPV), Norms, Social and Gender Inequitable Behavior, sponsored by George Washington University. Recruiting at 1 site in Malawi. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by George Washington University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2024, registered Jan 2025).
  • Started Aug 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4,800
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intimate Partner Violence (IPV)
  • Norms, Social
  • Gender Inequitable Behavior

Keywords

  • intimate partner violence
  • gender
  • social norms
  • community mobilization
  • behavior change
03

In context

Lead sponsor

George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,800 participants (estimated)

Study arms

  • No intervention
    Control

    In control communities SASA! Together will not be implemented.

  • Experimental
    SASA! Together

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

    Behavioral: SASA! Together

Interventions

  • BehavioralSASA! 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 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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

    Time frame: From time of implementation to endline assessment is 3 years

Secondary outcomes

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

    An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Slapped you or thrown something at you (ii)Pushed or shoved you (iii) Hit you with his fist or with something else (iv) Kicked, dragged or beaten you (v) Choked or burnt you and (vi) Threatened you with, or actually used, a knife or other weapon against you

    Time frame: 12 months

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

    An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Physically forced you to have sexual intercourse (ii) Physically forced you to perform any other sexual acts (iii) Force you with threats to perform sexual acts

    Time frame: 12 months

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

    An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Insulted you or made you feel bad about yourself (ii) Destroyed things that are important to you (iii) Did things that made you feel scared or intimidated (iv) Threatened to harm you or someone you care about (v) Thrown you out of the house (vi) Taken away your phone or controlled how you use it

    Time frame: 12 months

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

    An indicator equal 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

    Time frame: 12 months

  5. Indicator for Past year experience of controlling behaviour from a partner (among women who have had an intimate partner in the past year)

    An indicator equal to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Tries to stop you from meeting your friends (ii) Tries to limit contact with your family of birth (iii) Insists on knowing where you are at all times (iv) Gets jealous or angry if you talk with another man (v) Frequently accuses you of being unfaithful (vi) Checks your cellphone/WhatsApp logs/messages to see who you have called or messaged/who has called or messaged you

    Time frame: 12 months

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

    This measure is a summation of the responses to each of 4 relationship attitudes, with a possible maximum score of 4. Higher scores will indicate more restrictive attitudes towards violence. Components are: * Indicator for Agrees that violence between husband and wife is a private matter and others should not intervene * Indicator for Agrees that a woman should tolerate violence to keep her family together * Indicator for Agrees that if a woman is raped, she has usually done something careless * Indicator for Agrees that if a woman doesn't physically fight back, you can't really call it rape

    Time frame: From time of implementation to endline assessment is 3 years

  7. Index of Appropriate community response to women experiencing IPV in past year (among all women and men separately)

    This measure is a summation of two indicators: * Indicator witnessed/heard and helped when violence was happening between husbands and wives in the community * Indicator for was told and helped a woman in community told who experienced violence from her partner

    Time frame: From time of implementation to endline assessment is 3 years

07

Study locations

1 of 1 sites recruiting
  • Women's Legal Resources Center (WOLREC)
    Blantyre, Malawi
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — We will share de-identified individual-level data sets

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Information will be made available upon request after primary manuscripts have been published

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2024 (actual). Primary completion is estimated for Dec 2028, 52 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2025
First posted
Jan 20, 2025
StartActual
Aug 27, 2024
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2029
Last update
Feb 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06783400
Collaborators
Global Women's Institute, University of Cape Town
Responsible party
Sponsor
First posted
Jan 20, 2025
Start date
Aug 27, 2024
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Feb 12, 2026

Study contacts

Jennifer Seager, PhD
Contact
jseager@gwu.edu
202-994-4455

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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