NCT02311699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,800

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

December 2, 2014

Last Update Submit

January 14, 2019

Conditions

Keywords

GenderPhysical ViolenceSexual ViolenceHIVAIDSPreventionCommunity InterventionEthiopiaIntimate Partner Violence

Outcome Measures

Primary Outcomes (2)

  • Experience of physical violence by an intimate partner in the previous 12 months (among married or co-habitating women)

    12 months

  • Experience of sexual violence by an intimate partner in the previous 12 months (among married or co-habitating women)

    12 months

Secondary Outcomes (4)

  • Perpetration of physical violence towards an intimate partner in previous 12 months (among married or co-habitating men)

    12 months

  • Perpetration of sexual violence towards an intimate partner in previous 12 months (among married or co-habitating men)

    12 months

  • Proportion with comprehensive HIV/AIDS knowledge (among married or co-habitating men or women)

    18 months

  • Proportion using a condom at last high risk sexual intercourse (among married or co-habitating men or women)

    18 months

Study Arms (4)

Women Only

EXPERIMENTAL

Groups of women will receive the behavioral intervention to reduce IPV and HIV. Sessions will be led by female facilitators.

Behavioral: Intervention to reduce IPV and HIV

Men Only

EXPERIMENTAL

Groups of men will receive the behavioral intervention to reduce IPV and HIV. Sessions will be led by male facilitators.

Behavioral: Intervention to reduce IPV and HIV

Couples

EXPERIMENTAL

Couples will receive the behavioural intervention to reduce IPV and HIV. Sessions will be led by a male and a female facilitator.

Behavioral: Intervention to reduce IPV and HIV

Control Group

NO INTERVENTION

Community members in the control villages will receive a short informational session on violence reduction.

Interventions

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.

CouplesMen OnlyWomen Only

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • currently married or cohabitating with partner
  • residing in selected village for at least 6 months

You may not qualify if:

  • eligible women who do not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethiopian Public Health Association

Addis Ababa, Ethiopia

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

CoitusAcquired Immunodeficiency Syndrome

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Vandana Sharma, MD, MPH

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR
  • Jessica Leight, PhD

    Williams College

    PRINCIPAL INVESTIGATOR
  • Negussie Deyessa, PhD

    Addis Ababa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 8, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations