Clinical trial NCT02311699: Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission
Official title: Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Gender
Physical Violence
Sexual Violence
HIV
AIDS
Prevention
Community Intervention
Ethiopia
Intimate Partner Violence
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Ethiopian Public Health Association
name: Addis Ababa University
name: EngenderHealth
First posted: 2014-12-08
Enrollment: 6800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Experience of physical violence by an intimate partner in the previous 12 months (among married or co-habitating women)
timeFrame: 12 months
measure: Experience of sexual violence by an intimate partner in the previous 12 months (among married or co-habitating women)
timeFrame: 12 months
Secondary outcomes:
measure: Perpetration of physical violence towards an intimate partner in previous 12 months (among married or co-habitating men)
timeFrame: 12 months
measure: Perpetration of sexual violence towards an intimate partner in previous 12 months (among married or co-habitating men)
timeFrame: 12 months
measure: Proportion with comprehensive HIV/AIDS knowledge (among married or co-habitating men or women)
timeFrame: 18 months
measure: Proportion using a condom at last high risk sexual intercourse (among married or co-habitating men or women)
timeFrame: 18 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Ethiopian Public Health Association
Study officials:
affiliation: Massachusetts Institute of Technology
name: Vandana Sharma, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Williams College
name: Jessica Leight, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Ababa University
name: Negussie Deyessa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.