ClinicalTrials.gg
RecruitingNCT07502183WW-M-MOUpdated Apr 3, 2026

What Works to Prevent Violence - Malawi Moyo Olemekeza

An interventional study of SASA! Together and MO in Intimate Partner Violence (IPV), Earning Outcomes and Norms, Social, sponsored by George Washington University. Recruiting at 1 site in Malawi. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2025, registered Mar 2026).
  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,700
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
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). 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.

02

Conditions studied

  • Intimate Partner Violence (IPV)
  • Earning Outcomes
  • Norms, Social

Keywords

  • Intimate Partner Violence
  • Economic Empowerment
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
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. The household has a woman aged 18-49 who are in monogamous relationships
  2. 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.
  3. The primary decision maker of the household is male
  4. Household is willing to participate in community meetings
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,700 participants (estimated)

Study arms

  • Active comparator
    SASA! Together

    400 women + 200 men will be sampled for comparison group

    Behavioral: SASA! Together

  • Experimental
    SASA! Together + MO

    600 women + 300 men sampled for the evaluation of MO

    Behavioral: SASA! Together · Behavioral: MO

Interventions

  • BehavioralSASA! Together

    SASA! Together is an evidence-based community mobilisation approach

  • BehavioralMO

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

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. 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.

    Time frame: 12 months

  3. 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

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)

    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

    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)

    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

    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)

    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

    Time frame: 12 months

  4. 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

    Time frame: 12 months

  5. 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

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

  6. 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

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

  7. 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.

    Time frame: 4 weeks

  8. 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

    Time frame: 4 weeks

  9. 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.

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

  10. 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 \[ACTIVITY\]"

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

  11. 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"

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

07

Study locations

1 of 1 sites recruiting
  • Imani Consulting, 6256+F3H, Jacaranda Rd, Mandala, Blantyre, Malawi
    Blantyre, PO Box 2873, Malawi
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Dec 2028, 38 months after the start.

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

Registered
Mar 18, 2026
First posted
Mar 30, 2026
StartActual
Oct 15, 2025
Primary completionEst.
Dec 2028
CompletionEst.
Jan 2029
Last update
Apr 3, 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 Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07502183
Responsible party
Saini Das (Research Scientist, George Washington University) — Principal investigator
First posted
Mar 30, 2026
Start date
Oct 15, 2025
Primary completion
Dec 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Apr 3, 2026

Study contacts

Saini Das, Ph.D.
Contact
saini.das@gwu.edu
+1 (405) 679-7754
Jennifer Seager, Ph.D.
Contact
jseager@gwu.edu
+1 (949) 648-1765

Oversight

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

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