- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502183
What Works to Prevent Violence - Malawi Moyo Olemekeza (WW-M-MO)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Saini Das, Ph.D.
- Phone Number: +1 (405) 679-7754
- Email: saini.das@gwu.edu
Study Contact Backup
- Name: Jennifer Seager, Ph.D.
- Phone Number: +1 (949) 648-1765
- Email: jseager@gwu.edu
Study Locations
-
-
-
Blantyre, Malawi, PO Box 2873
- Recruiting
- Imani Consulting, 6256+F3H, Jacaranda Rd, Mandala, Blantyre, Malawi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SASA! Together
400 women + 200 men will be sampled for comparison group
|
SASA! Together is an evidence-based community mobilisation approach
|
|
Experimental: SASA! Together + MO
600 women + 300 men sampled for the evaluation of MO
|
SASA! Together is an evidence-based community mobilisation approach
MO is a family-based, women's economic and social empowerment approach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
|
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
|
From time of implementation to endline assessment is 3 years
|
|
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
From time of implementation to endline assessment is 3 years
|
|
Index of Income Earned in the past 4 weeks (among all women and men separately)
Time Frame: 4 weeks
|
Defined as logarithmic value of the money earned from all jobs or sales in USD
|
4 weeks
|
|
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
|
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"
|
From time of implementation to endline assessment is 3 years
|
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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.
|
4 weeks
|
|
Indicators of Mental Health
Time Frame: From time of implementation to endline assessment is 3 years
|
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.
|
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
|
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]"
|
From time of implementation to endline assessment is 3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCR245830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intimate Partner Violence (IPV)
-
Yale UniversityNational Science Foundation; Grand Challenges Canada; Weiss Foundation; World Bank... and other collaboratorsActive, not recruitingIntimate Partner Violence (IPV) | Intimate Partner Violence PreventionBangladesh
-
Yale UniversityCompletedIntimate Partner Violence (IPV)United States
-
Saini DasEmory University; The Prevention Collaborative; National Institute of Medical... and other collaboratorsRecruitingIntimate Partner Violence (IPV)Tanzania
-
University of Maryland, College ParkTufts University; University of Michigan; University of Guelph; University of Central... and other collaboratorsEnrolling by invitationIntimate Partner Violence (IPV)United States, Canada
-
University of California, San DiegoNot yet recruitingSexual Violence | Safety | Alcohol | Intimate Partner Violence (IPV)
-
Abant Izzet Baysal UniversityEnrolling by invitationNursing Students | Intimate Partner Violence (IPV)Turkey (Türkiye)
-
University of California, San DiegoBill and Melinda Gates Foundation; Population Council; International Planned...CompletedUnintended Pregnancy | Family Planning | Intimate Partner Violence (IPV)United States
-
University of California, San DiegoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedUnintended Pregnancy | Family Planning | Intimate Partner Violence (IPV)United States, Mexico
-
Boromarajonani College of Nursing, Khon KaenJohns Hopkins University; Fogarty International Center of the National Institute... and other collaboratorsRecruitingmHealth | Social Support | Empowerment | Effectiveness | Intimate Partner Violence (IPV)Thailand
-
Africa Institute of Mental and Brain Health (AFRIMEB)National Institute of Mental Health (NIMH)Not yet recruitingStress (Psychology) | Climate Change | Intimate Partner Violence (IPV)
Clinical Trials on SASA! Together
-
George Washington UniversityUniversity of Cape Town; Global Women's InstituteRecruitingIntimate Partner Violence (IPV) | Norms, Social | Gender Inequitable BehaviorMalawi
-
London School of Hygiene and Tropical MedicineMakerere University; Raising Voices; Centre for Domestic Violence Prevention,... and other collaboratorsUnknownHIV | Intimate Partner ViolenceUganda
-
York UniversityMcMaster University; University of TorontoCompletedFamily Conflict | Internet-Based InterventionCanada
-
York UniversityUniversity of TorontoNot yet recruitingYoung Adults | Interpersonal Relations | Parent Child RelationshipCanada
-
Dana-Farber Cancer InstituteRecruitingInsomnia | Survivorship | Insomnia ChronicUnited States
-
University of ConnecticutNational Heart, Lung, and Blood Institute (NHLBI); Worcester Polytechnic InstituteCompleted
-
York UniversityMcMaster University; University of TorontoActive, not recruitingMarital Relationship | Family Conflict | Internet-Based Intervention | Interparental Conflict | Marital ConflictCanada
-
Centre hospitalier de Ville-Evrard, FranceRecruitingSchizophrenia | Bipolar Disorder | Major Depressive Disorder | Severe Mental IllnessFrance
-
University of British ColumbiaPublic Health Agency of Canada (PHAC); The Bridge Youth and Family Services...CompletedOverweight and Obesity | Health Knowledge, Attitudes, PracticeCanada
-
Caroline RowlandCompletedLanguage DevelopmentUnited Kingdom