Intimate Partner Violence (IPV)WW-M-MONCT07502183
What Works to Prevent Violence - Malawi Moyo Olemekeza
A study testing SASA! Together and MO in people with Intimate Partner Violence (IPV) and Earning Outcomes, 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 years, women only
- Conditions the study is for
- Intimate Partner Violence (IPV), Earning Outcomes, Norms, Social
- What is being tested?
- SASA! Together and MO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteMalawi
- Study dates
- 15 Oct 2025to Jan 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
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
Imani Consulting, 6256+F3H, Jacaranda Rd, Mandala, Blantyre, Malawi
Blantyre, PO Box 2873
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
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.
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. Overall, 41% of all women (whether they have ever been married or not) have experienced physical or sexual violence. Despite these high levels of violence against women and girls (VAWG), there are a limited number of evidence-based interventions focused on preventing VAW adapted and evaluated in Malawi.
The PKN programme in Malawi will implement two evidence based prevention models. The first is SASA! Together, the most recent revision of the SASA! Activist Kit, an evidence-based community mobilisation approach developed by Raising Voices in 2008. It aims to change social norms across the community, impacting how community members think about violence against women and about how they use their power in their intimate relationships and in the broader community. The institutional strengthening components create an enabling environment. The second is the MO approach which is a family-based, women's economic and social empowerment approach. It has been adapted from Zindagii Shoista, another evidence-based approach implemented and evaluated in Tajikistan, which comprises a combination of gender norm, behavioural change and income-generating activities.
This protocol outlines the parameters of an evaluation of the added effect of the economic empowerment component, MO, on levels of violence against women in aged 18-49 in two districts of Malawi that are also receiving SASA! Together.
The primary research question in this study is:
- What is the additional value of adding a women's social and economic empowerment programme (MO) for (randomly selected eligible) households with a female aged 18-49 in a heterosexual couple in communities that are already receiving SASA! Together across two districts in Malawi (Balaka and Lilongwe)?
To answer this research question, the study will implement a 2-arm quasi-experimental cRCT designed to capture the added value of the MO program (intervention households) over the SASA! Together program (control households). Implementation of SASA! Together has begun in 7 GVHs across Chadza and Nkaya in April 2025. For operational ease, the research and implementation team will split their activities in GVH Nkaya into two sub-GVHs - Nkaya North and South - effectively giving us 8 GVHs.
- Being tested
- SASA! Together, MO
- Keywords
- Intimate Partner Violence, Economic Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SASA! TogetherBehavioural
SASA! Together is an evidence-based community mobilisation approach
MOBehavioural
MO is a family-based, women's economic and social empowerment approach.
| Study group | Role | What they receive |
|---|---|---|
| SASA! Together | Active comparator | 400 women + 200 men will be sampled for comparison group Receives: Behavioral: SASA! Together |
| SASA! Together + MO | Experimental | 600 women + 300 men sampled for the evaluation of MO Receives: Behavioral: SASA! Together; Behavioral: MO |
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
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 respondent from earning money (ii) Takes earnings from respondent against her will (iii) Refuses to give money for household expenses (iv) Keeps respondent from getting a loan (v) ) Not let respondent participate in deciding how the family finances are spend.
Measured: 12 months
Indicator for engaged in any income generating activity in the past 3 months (among all women and men separately)
Measured: 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)
This indicator equals to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Slapped respondent or thrown something at respondent (ii)Pushed or shoved respondent (iii) Hit respondent with his fist or with something else (iv) Kicked, dragged or beaten respondent (v) Choked or burnt respondent and (vi) Threatened respondent
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)
This indicator equals to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Physically forced respondent to have sexual intercourse (ii) Physically forced respondent to perform any other sexual acts (iii) Force respondent 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)
This indicator equals to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Insulted respondent or made her feel bad about herself (ii) Destroyed her things (iii) Did things that made respondent feel scared or intimidated (iv) Threatened to harm respondent or someone she cares about (v) Thrown respondent out of the house (vi) Taken away respondent's phone or controlled how she uses it
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)
This indicator equals to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Tries to stop respondent from meeting her friends (ii) Tries to limit contact with her family of birth (iii) Insists on knowing where respondent is at all times (iv) Gets jealous or angry if respondent talks with another man (v) Frequently accuses respondent of being unfaithful (vi) Checks her cellphone/WhatsApp logs/messages to see who she has called or messaged/who has called or messaged her
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 : (1) Indicator equal to 1 for Agrees that violence between husband and wife is a private matter and others should not intervene (2) Indicator equal to 1 for Agrees that a woman should tolerate violence to keep her family together (3) Indicator equal to 1 for Agrees that if a woman is raped, she has usually done something careless (4) Indicator equal to 1 for Agrees that if a woman doesn't physically fight back, one 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 with a maximum possible score of 2: (1) Indicator equal to 1 if witnessed/heard and helped when violence was happening between husbands and wives in the community (2) Indicator equal to 1 if was told and helped a woman who experienced violence from her partner in their community
Measured: From time of implementation to endline assessment is 3 years
Food Insecurity Index using the Household Food Insecurity Access Scale (among all women and men separately)
Defined using the Household Food Insecurity Access Scale (HFIAS) for Measurement of Food Access, version 3. Possible score 0-9 with higher scores meaning worse food security.
Measured: 4 weeks
Index of Income Earned in the past 4 weeks (among all women and men separately)
Defined as logarithmic value of the money earned from all jobs or sales in USD
Measured: 4 weeks
Indicators of Mental Health
This will be constructed as representing mild, moderate or severe levels of depression from the Patient Health Questionnaire-9 scale of depression (among all women and men separately). Scores can range from 0-27, with 5-9 indicating mild, 10-14 as moderate and 20-27 as severe levels of depression.
Measured: From time of implementation to endline assessment is 3 years
Index of Women's equal decision-making power over the generation and use of income and assets (among all women and men separately).
This measure is a summation of 2 indicators with the highest possible score of 2: (1) Indicator equal to 1 for Agrees that "respondent alone has control over how she uses the money she earns" (2) Indicator equal to 1 for respondent herself "made the decision to start doing [ACTIVITY]"
Measured: From time of implementation to endline assessment is 3 years
Index of Acceptability of women working outside the home (among all women and men separately).
This measure is a summation of 2 indicators with a maximum possible score of 2: (1) Indicator equal to 1 for Agrees with the statement "I think the husbands in my family should allow their wives to have a job to contribute to the family budget" (2) Indicator equal to 1 for Agrees with the statement "In this community many people think that husbands should allow their wives to have a job to contribute to the family budget"
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 posted30 Mar 2026
- Study start15 Oct 2025
- Primary completionDec 2028 (estimated)
- Study completionJan 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.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Model description
- 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, the investigators 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. The investigators 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.
- Masking
- None (open label)
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Saini Das, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502183
- Sponsor's protocol ID
- NCR245830
- Acronym
- WW-M-MO
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 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
- ClinicalTrials.gov ID
- NCT07502183
- Acronym / sponsor ID
- WW-M-MO / NCR245830
- Keywords
- Intimate Partner Violence, Economic Empowerment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 30 Mar 2026 (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). 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.
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. Overall, 41% of all women (whether they have ever been married or not) have experienced physical or sexual violence. Despite these high levels of violence against women and girls (VAWG), there are a limited number of evidence-based interventions focused on preventing VAW adapted and evaluated in Malawi.
The PKN programme in Malawi will implement two evidence based prevention models. The first is SASA! Together, the most recent revision of the SASA! Activist Kit, an evidence-based community mobilisation approach developed by Raising Voices in 2008. It aims to change social norms across the community, impacting how community members think about violence against women and about how they use their power in their intimate relationships and in the broader community. The institutional strengthening components create an enabling environment. The second is the MO approach which is a family-based, women's economic and social empowerment approach. It has been adapted from Zindagii Shoista, another evidence-based approach implemented and evaluated in Tajikistan, which comprises a combination of gender norm, behavioural change and income-generating activities.
This protocol outlines the parameters of an evaluation of the added effect of the economic empowerment component, MO, on levels of violence against women in aged 18-49 in two districts of Malawi that are also receiving SASA! Together.
The primary research question in this study is:
- What is the additional value of adding a women's social and economic empowerment programme (MO) for (randomly selected eligible) households with a female aged 18-49 in a heterosexual couple in communities that are already receiving SASA! Together across two districts in Malawi (Balaka and Lilongwe)?
To answer this research question, the study will implement a 2-arm quasi-experimental cRCT designed to capture the added value of the MO program (intervention households) over the SASA! Together program (control households). Implementation of SASA! Together has begun in 7 GVHs across Chadza and Nkaya in April 2025. For operational ease, the research and implementation team will split their activities in GVH Nkaya into two sub-GVHs - Nkaya North and South - effectively giving us 8 GVHs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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, the investigators 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. The investigators 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.
| Arm | Type | Receives |
|---|---|---|
| SASA! Together | Active comparator | Behavioral: SASA! Together400 women + 200 men will be sampled for comparison group |
| SASA! Together + MO | Experimental | Behavioral: SASA! Together, Behavioral: MO600 women + 300 men sampled for the evaluation of MO |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
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 an evidence-based community mobilisation approach | Behavioural | SASA! Together, SASA! Together + MO |
| MOMO is a family-based, women's economic and social empowerment approach. | Behavioural | SASA! Together + MO |
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.
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
This indicator equals to one if the respondent reports a partner perpetrated any of the following behaviors in the past 12 months: (i) Prohibits respondent from earning money (ii) Takes earnings from respondent against her will (iii) Refuses to give money for household expenses (iv) Keeps respondent from getting a loan (v) ) Not let respondent participate in deciding how the family finances are spend.
Indicator for engaged in any income generating activity in the past 3 months (among all women and men separately)
Time frame: From time of implementation to endline assessment is 3 years
11 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 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
Food Insecurity Index using the Household Food Insecurity Access Scale (among all women and men separately)
Time frame: 4 weeks
Index of Income Earned in the past 4 weeks (among all women and men separately)
Time frame: 4 weeks
Indicators of Mental Health
Time frame: From time of implementation to endline assessment is 3 years
Index of Women's equal decision-making power over the generation and use of income and assets (among all women and men separately).
Time frame: From time of implementation to endline assessment is 3 years
Index of Acceptability of women working outside the home (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 3 Apr 2026.
- Individual participant dataSharing planned: No
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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 and MO in people with Intimate Partner Violence (IPV) and Earning Outcomes, 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 4 inclusion and 0 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 3 Apr 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 Saini Das, Ph.D. (+1 (405) 679-7754, saini.das@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 3 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 3 Apr 2026.