- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02311699
Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission
Violence against women (VAW), the most extreme manifestation of the unequal power balance between women and men, is a major global public health concern. One of the most common forms of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of women reported having experienced physical and/or sexual intimate partner violence (IPV) in their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence has also linked IPV and HIV risk.
This study is a cluster randomized controlled trial assessing the impact of a community-based intervention focused on Intimate Partner Violence and HIV delivered in the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion and conflict resolution. Villages will be randomly assigned to one of 4 study arms (3 intervention and one control arm): 1) Women only participate in the intervention, 2) Men only participate, 3) Both men and women (couples) participate, 4) Women and men receive the control intervention comprising a short informational session on violence reduction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Addis Ababa, Ethiopia
- Ethiopian Public Health Association
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- currently married or cohabitating with partner
- residing in selected village for at least 6 months
Exclusion Criteria:
- eligible women who do not consent
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 |
---|---|
Experimental: Women Only
Groups of women will receive the behavioral intervention to reduce IPV and HIV.
Sessions will be led by female facilitators.
|
The Ethiopian traditional coffee ceremony will be used as an entry point for a community based intervention to provide information, change behaviour around IPV and improve gender equity and intra-couple relations.
The coffee ceremony is a culturally established forum for community discussion and conflict resolution and an integral part of Ethiopian life.
The intervention will involve regular coffee ceremonies, during which approximately 20 members of the community will participate in education and discussions centred on gender issues, sexuality, communication and conflict resolution, HIV/AIDS and its link with violence, as well as HIV/AIDS prevention.
Each coffee ceremony will be moderated by a female or male facilitator trained in participatory learning, moderation, HIV/AIDS prevention, counselling, and gender issues.
The intervention will involve 14 two-hour session per group of participants.
|
Experimental: Men Only
Groups of men will receive the behavioral intervention to reduce IPV and HIV.
Sessions will be led by male facilitators.
|
The Ethiopian traditional coffee ceremony will be used as an entry point for a community based intervention to provide information, change behaviour around IPV and improve gender equity and intra-couple relations.
The coffee ceremony is a culturally established forum for community discussion and conflict resolution and an integral part of Ethiopian life.
The intervention will involve regular coffee ceremonies, during which approximately 20 members of the community will participate in education and discussions centred on gender issues, sexuality, communication and conflict resolution, HIV/AIDS and its link with violence, as well as HIV/AIDS prevention.
Each coffee ceremony will be moderated by a female or male facilitator trained in participatory learning, moderation, HIV/AIDS prevention, counselling, and gender issues.
The intervention will involve 14 two-hour session per group of participants.
|
Experimental: Couples
Couples will receive the behavioural intervention to reduce IPV and HIV.
Sessions will be led by a male and a female facilitator.
|
The Ethiopian traditional coffee ceremony will be used as an entry point for a community based intervention to provide information, change behaviour around IPV and improve gender equity and intra-couple relations.
The coffee ceremony is a culturally established forum for community discussion and conflict resolution and an integral part of Ethiopian life.
The intervention will involve regular coffee ceremonies, during which approximately 20 members of the community will participate in education and discussions centred on gender issues, sexuality, communication and conflict resolution, HIV/AIDS and its link with violence, as well as HIV/AIDS prevention.
Each coffee ceremony will be moderated by a female or male facilitator trained in participatory learning, moderation, HIV/AIDS prevention, counselling, and gender issues.
The intervention will involve 14 two-hour session per group of participants.
|
No Intervention: Control Group
Community members in the control villages will receive a short informational session on violence reduction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Experience of physical violence by an intimate partner in the previous 12 months (among married or co-habitating women)
Time Frame: 12 months
|
12 months
|
Experience of sexual violence by an intimate partner in the previous 12 months (among married or co-habitating women)
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perpetration of physical violence towards an intimate partner in previous 12 months (among married or co-habitating men)
Time Frame: 12 months
|
12 months
|
Perpetration of sexual violence towards an intimate partner in previous 12 months (among married or co-habitating men)
Time Frame: 12 months
|
12 months
|
Proportion with comprehensive HIV/AIDS knowledge (among married or co-habitating men or women)
Time Frame: 18 months
|
18 months
|
Proportion using a condom at last high risk sexual intercourse (among married or co-habitating men or women)
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vandana Sharma, MD, MPH, Massachusetts Institute of Technology
- Principal Investigator: Jessica Leight, PhD, Williams College
- Principal Investigator: Negussie Deyessa, PhD, Addis Ababa University
Publications and helpful links
General Publications
- Leight J, Deyessa N, Sharma V. Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial. BMJ Open. 2021 Mar 29;11(3):e042365. doi: 10.1136/bmjopen-2020-042365.
- Leight J, Deyessa N, Verani F, Tewolde S, Sharma V. Community-level spillover effects of an intervention to prevent intimate partner violence and HIV transmission in rural Ethiopia. BMJ Glob Health. 2021 Jan;6(1):e004075. doi: 10.1136/bmjgh-2020-004075.
- Leight J, Deyessa N, Verani F, Tewolde S, Sharma V. An intimate partner violence prevention intervention for men, women, and couples in Ethiopia: Additional findings on substance use and depressive symptoms from a cluster-randomized controlled trial. PLoS Med. 2020 Aug 18;17(8):e1003131. doi: 10.1371/journal.pmed.1003131. eCollection 2020 Aug.
- Sharma V, Leight J, Verani F, Tewolde S, Deyessa N. Effectiveness of a culturally appropriate intervention to prevent intimate partner violence and HIV transmission among men, women, and couples in rural Ethiopia: Findings from a cluster-randomized controlled trial. PLoS Med. 2020 Aug 18;17(8):e1003274. doi: 10.1371/journal.pmed.1003274. eCollection 2020 Aug.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ALJameelPAL
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