Intimate Partner Violence (IPV)WW-M-SASA!NCT06783400
What Works - Malawi SASA! Together
A study testing SASA! Together in people with Intimate Partner Violence (IPV) and Norms, Social, run by George Washington University at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence (IPV), Norms, Social, Gender Inequitable Behavior
- What is being tested?
- SASA! Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 siteMalawi
- Study dates
- 27 Aug 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
Women's Legal Resources Center (WOLREC)
Blantyre
Maggie Banda, LLB, +265994501434, maggiebanda@hotmail.com
About this study
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
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:
- 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.
- Being tested
- SASA! Together
- Keywords
- intimate partner violence, gender, social norms, community mobilization, behavior change
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SASA! TogetherBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SASA! Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 12 months
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
Measured: 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)
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
Measured: From time of implementation to endline assessment is 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start27 Aug 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner Violence (IPV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Global Women's Institute, University of Cape Town
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783400
- Sponsor's protocol ID
- NCR245830SASA
- Acronym
- WW-M-SASA!
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual-level data sets
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06783400
- Acronym / sponsor ID
- WW-M-SASA! / NCR245830SASA
- Keywords
- intimate partner violence, gender, social norms, community mobilization, behavior change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Global Women's Institute, University of Cape Town
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In control communities SASA! Together will not be implemented. |
| SASA! Together | Experimental | Behavioral: SASA! TogetherThe SASA! Together programme will be implemented in communities in this arm. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SASA! TogetherSASA! 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. | Behavioural | SASA! Together |
Primary outcome
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
Defining past year experience of intimate partner violence using the World Health Organization's "Multi-country study measure for intimate partner violence" module.
Acceptability of violence (personal belief; among men and women separately)
Time frame: From time of implementation to endline assessment is 3 years
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. We will share de-identified individual-level data sets
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SASA! Together in people with Intimate Partner Violence (IPV) and Norms, Social, run by George Washington University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Seager, PhD (202-994-4455, jseager@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.