| NCT ID | NCT06783400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | George Washington University |
| Condition | Intimate Partner Violence (IPV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,800 participants |
| Start Date | 2024-08-27 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,800 participants in total. It began in 2024-08-27 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06783400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying Intimate Partner Violence (IPV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06783400 currently recruiting?
Yes, NCT06783400 is actively recruiting participants. Contact the research team at jseager@gwu.edu for enrollment information.
Where is the NCT06783400 trial being conducted?
This trial is being conducted at Blantyre, Malawi.
Who is sponsoring the NCT06783400 clinical trial?
NCT06783400 is sponsored by George Washington University. The trial plans to enroll 4,800 participants.