HIVNCT02311699

Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission

A study testing Intervention to reduce IPV and HIV in people with HIV, run by Abdul Latif Jameel Poverty Action Lab at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Intervention to reduce IPV and HIV
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6,800 participants
Where: 1 siteEthiopia
Study dates: Dec 2014to Apr 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

eligible women who do not consent

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

Ethiopian Public Health Association
Addis Ababa

Other trials in Ethiopia

About this study

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.

Conditions: HIV
Being tested: Intervention to reduce IPV and HIV
Keywords: Gender, Physical Violence, Sexual Violence, HIV, AIDS, Prevention, Community Intervention, Ethiopia, Intimate Partner Violence
Medical subject headings: Coitus, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention to reduce IPV and HIVBehavioural
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.

Study groups in NCT02311699
Study group	Role	What they receive
Women Only	Experimental	Groups of women will receive the behavioral intervention to reduce IPV and HIV. Sessions will be led by female facilitators. Receives: 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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Perpetration of physical violence towards an intimate partner in previous 12 months (among married or co-habitating men)
Measured: 12 months
Perpetration of sexual violence towards an intimate partner in previous 12 months (among married or co-habitating men)
Measured: 12 months
Proportion with comprehensive HIV/AIDS knowledge (among married or co-habitating men or women)
Measured: 18 months
Proportion using a condom at last high risk sexual intercourse (among married or co-habitating men or women)
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Apr 2018

First posted8 Dec 2014 (estimated)
Study startDec 2014
Primary completionApr 2018
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6,800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02311699
Sponsor's protocol ID: ALJameelPAL
Status last verified: Jan 2019
First submitted: 2 Dec 2014
Last updated: 15 Jan 2019
Results posted: No
Data monitoring committee: No

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.
PubMed 33782020
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.
PubMed 33509840
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.
PubMed 32810147
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.
PubMed 32810146

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission
ClinicalTrials.gov ID: NCT02311699
Acronym / sponsor ID: ALJameelPAL
Conditions: HIV
Keywords: Gender, Physical Violence, Sexual Violence, HIV, AIDS, Prevention, Community Intervention, Ethiopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 6,800 participants (estimated)
Lead sponsor: Abdul Latif Jameel Poverty Action LabUniversity, hospital or other
Collaborators: Ethiopian Public Health Association, Addis Ababa University, EngenderHealth
Study start: Dec 2014
Primary completion: Apr 2018 (actual)
Study completion: Apr 2018 (actual)
First posted: 8 Dec 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Women Only	Experimental	Behavioral: Intervention to reduce IPV and HIVGroups of women will receive the behavioral intervention to reduce IPV and HIV. Sessions will be led by female facilitators.
Men Only	Experimental	Behavioral: Intervention to reduce IPV and HIVGroups of men will receive the behavioral intervention to reduce IPV and HIV. Sessions will be led by male facilitators.
Couples	Experimental	Behavioral: Intervention to reduce IPV and HIVCouples will receive the behavioural intervention to reduce IPV and HIV. Sessions will be led by a male and a female facilitator.
Control Group	No intervention	–Community members in the control villages will receive a short informational session on violence reduction.

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

eligible women who do not consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intervention to reduce IPV and HIVThe 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.	Behavioural	Couples, Men Only, Women Only

Primary outcome

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

4 secondary outcomes

Perpetration of physical violence towards an intimate partner in previous 12 months (among married or co-habitating men)
Time frame: 12 months
Perpetration of sexual violence towards an intimate partner in previous 12 months (among married or co-habitating men)
Time frame: 12 months
Proportion with comprehensive HIV/AIDS knowledge (among married or co-habitating men or women)
Time frame: 18 months
Proportion using a condom at last high risk sexual intercourse (among married or co-habitating men or women)
Time frame: 18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
Derived from this study: PubMed 33782020Leight 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.
Derived from this study: PubMed 33509840Leight 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.
Derived from this study: PubMed 32810147Leight 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.
Derived from this study: PubMed 32810146Sharma 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vandana Sharma, MD, MPH principal investigator

Massachusetts Institute of Technology

Jessica Leight, PhD principal investigator

Williams College

Negussie Deyessa, PhD principal investigator

Addis Ababa University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention to reduce IPV and HIV in people with HIV, run by Abdul Latif Jameel Poverty Action Lab at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Experience of physical violence by an intimate partner in the previous 12 months (among married or co-habitating women) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02311699, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.