Indashyikirwa IPV Prevention Trial in Rwanda

NCT ID: NCT03477877

Last Updated: 2019-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8909 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-23

Study Completion Date

2018-07-01

Brief Summary

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The purpose of this study is to test whether the Indashyikirwa ("Agents of Change") program is effective at preventing intimate partner violence (IPV) in communities in Rwanda.

Because IPV has many causes, including factors that operate at the individual, couple, and community levels, the Indashyikirwa program is designed with multiple elements targeting multiple levels. A training program for couples covers gender, power, and relationship skills. Individual graduates this program who are interested and eligible go on to an activist training program to help support sustained change in their communities. Parallel activities operate at the Sector level to create and support change at the community level. Sector level activities include (1) training in gender and IPV prevention for local opinion leaders. (2) Establishment of "Women's Spaces," which are drop in centers that provide support and referrals for women experiencing IPV as well as a wide range of community outreach services to educate communities about, gender, power, women's rights, and violence prevention.

Because the intervention is comprised of multiple components and includes elements designed to be delivered at the Sector level, Sectors were chosen as the unit of randomization. 28 sectors spread across 7 districts are participating; randomization as intervention or control was stratified across Districts to ensure adequate geographical spread of program delivery (Rwandan geographic administrative units are: Province \> District \> Sector \> Cell \> Village). Within each randomized sector are two separate assessments of program impact: (1) A "Couple Cohort" comprised of heterosexual couples who enrol together in the couples training program (some of whom continue into the activist training) compared to similarly situated couples in control communities who participate only in a standard, ongoing VSLA (village savings and loan association) program. Couples cohort members (both intervention and control) are surveyed at enrolment, 12 months post-baseline, and 24 months post-baseline. (2) A "Community Survey" designed to measure community diffusion of the intervention through the activities of the Women's Spaces, Opinion Leader Trainings, and activities of graduates of the activist training. The community survey comprises a repeat cross-sectional population-based household survey of married/cohabiting adults in intervention communities who are NOT direct participants in any of the formal trainings delivered by intervention implementation partners, conducted at baseline and 24 months only. This survey is designed to look at community level shifts in the occurrence of IPV, as well as changes in support for survivors and changes in attitudes among the general population.

Detailed Description

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Conditions

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Intimate Partner Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a community randomised controlled trial, randomized at the level of sector (Rwandan geographic administrative units are: Province \> District \> Sector \> Cell \> Village). 28 sectors spread across 7 districts are participating; randomisation as intervention or control was stratified across districts to ensure adequate geographical spread of program delivery. Within each randomised sector are two separate assessments of impact: (1) A "Couple Cohort" comprised of heterosexual couples who enrol together in a couples training program or similarly situated couples in control communities, surveyed at enrolment, 12 months post-baseline, and 24 months post-baseline. (2) A "Community Survey" designed to measure community diffusion which comprises a repeat cross-sectional population-based household survey of married/cohabiting adults in intervention/control communities who are NOT direct participants in the couples cohort, surveyed at baseline and 24 months.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Indashyikirwa

Sectors which receive the full Indashyikirwa programme, including (1) couples training and activist training and support by RWAMREC, and (2) opinion leader training and establishment of women's spaces by the Rwanda Women's Network.

Group Type EXPERIMENTAL

Indashyikirwa Couples Training

Intervention Type BEHAVIORAL

A training curriculum for heterosexual couples in Rwanda comprising 20 3-hour modules (60 hours total) delivered to groups of 15 couples (30 people). Each module facilitated by male and 1 female facilitator. Curriculum topics include: types and uses of personal and interpersonal power (power within, power over, power with, power to), gender, gender based violence, triggers for intimate partner violence, conflict management, economic development, sexuality, alcohol, social norms and community change. Delivered by RWAMREC.

Indashyikirwa Activist Training

Intervention Type BEHAVIORAL

This training is offered to a subset of individuals who complete the couples curriculum (randomly selected from among those who are are willing and eligible). These individuals are trained to serve as community activists, teach peers about the types of power (power within, power over, power with, power to), and advocate for community change to prevent intimate partner violence. Delivered by RWAMREC.

Indashyikirwa Opinion Leader Training

Intervention Type BEHAVIORAL

Training delivered to "opinion leaders" (political office holders, religious leaders, service providers), in intervention communities. Training comprised 8 x 3 hour sessions (24 hours) delivered for groups of up to 40 participants. Introduces Opinion Leaders to the concepts of power (power within, power over, power with, power to) and to essential concepts around women's legal rights. Delivered by Rwanda Women's Network.

Indashyikirwa Women's Spaces

Intervention Type OTHER

Establishment of 1 "Women's Space" per intervention sector -- a physical space with trained facilitators on duty from which support and referrals for women experiencing IPV could be offered and ad hoc programming responsive to community needs and interest can be run. Typical activities include once-off open trainings for community members on the concepts of power (power within, power over, power with, power to), essential concepts around women's legal rights, conflict management in families, etc. Delivered by Rwanda Women's Network.

VSLA Only

Sectors that continue to receive only the village savings and loan association (VSLA) programmes offered by CARE Rwanda

Group Type ACTIVE_COMPARATOR

Village Savings and Loan Association (VSLA)

Intervention Type BEHAVIORAL

A standard Village Savings and Loan Association program as run nationwide by CARE Rwanda.

Interventions

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Indashyikirwa Couples Training

A training curriculum for heterosexual couples in Rwanda comprising 20 3-hour modules (60 hours total) delivered to groups of 15 couples (30 people). Each module facilitated by male and 1 female facilitator. Curriculum topics include: types and uses of personal and interpersonal power (power within, power over, power with, power to), gender, gender based violence, triggers for intimate partner violence, conflict management, economic development, sexuality, alcohol, social norms and community change. Delivered by RWAMREC.

Intervention Type BEHAVIORAL

Indashyikirwa Activist Training

This training is offered to a subset of individuals who complete the couples curriculum (randomly selected from among those who are are willing and eligible). These individuals are trained to serve as community activists, teach peers about the types of power (power within, power over, power with, power to), and advocate for community change to prevent intimate partner violence. Delivered by RWAMREC.

Intervention Type BEHAVIORAL

Indashyikirwa Opinion Leader Training

Training delivered to "opinion leaders" (political office holders, religious leaders, service providers), in intervention communities. Training comprised 8 x 3 hour sessions (24 hours) delivered for groups of up to 40 participants. Introduces Opinion Leaders to the concepts of power (power within, power over, power with, power to) and to essential concepts around women's legal rights. Delivered by Rwanda Women's Network.

Intervention Type BEHAVIORAL

Indashyikirwa Women's Spaces

Establishment of 1 "Women's Space" per intervention sector -- a physical space with trained facilitators on duty from which support and referrals for women experiencing IPV could be offered and ad hoc programming responsive to community needs and interest can be run. Typical activities include once-off open trainings for community members on the concepts of power (power within, power over, power with, power to), essential concepts around women's legal rights, conflict management in families, etc. Delivered by Rwanda Women's Network.

Intervention Type OTHER

Village Savings and Loan Association (VSLA)

A standard Village Savings and Loan Association program as run nationwide by CARE Rwanda.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

For the Couples Cohort Study:

1. Member of an active village savings and loan association (VSLA) group or the partner of a VSLA member
2. Between 18 and 49 years old
3. Living with or married to current partner for at least 6 months at baseline
4. Willing and able to give informed consent for participation in research
5. Willing to give contact information of 3 friends, neighbours, or family members who can be used to contact participant over the next 2.5 years
6. Has no current plans to move out of the study area in the next 2.5 years

For the Community Surveys:

1. Resident in the target community for at least 6 months prior to data collection
2. Between 18 and 49 years old
3. Living with or be married to current partner for at least 6 months
4. NOT enrolled in the couples cohort, opinion leader training, or serving as a women's space facilitator (i.e. not otherwise involved in the study)

d. Willing and able to give informed consent for participation in research

Exclusion Criteria

1. Does not speak Kinyarwanda
2. Unable to provide meaningful informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role collaborator

CARE Rwanda

UNKNOWN

Sponsor Role collaborator

RWAMREC

UNKNOWN

Sponsor Role collaborator

Laterite

UNKNOWN

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Social Development Direct

UNKNOWN

Sponsor Role collaborator

Wellspring Advisors

UNKNOWN

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Rwanda Women's Network

UNKNOWN

Sponsor Role collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin L Dunkle, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council, South Africa

Lori Heise, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Erin Stern, PhD

Role: PRINCIPAL_INVESTIGATOR

The London School of Hygiene & Tropical Medicine

Lyndsay McLean, PhD

Role: PRINCIPAL_INVESTIGATOR

Social Development Direct

References

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Dunkle K, Stern E, Chatterji S, Heise L. Effective prevention of intimate partner violence through couples training: a randomised controlled trial of Indashyikirwa in Rwanda. BMJ Glob Health. 2020 Dec;5(12):e002439. doi: 10.1136/bmjgh-2020-002439.

Reference Type DERIVED
PMID: 33355268 (View on PubMed)

Gibbs A, Dunkle K, Mhlongo S, Chirwa E, Hatcher A, Christofides NJ, Jewkes R. Which men change in intimate partner violence prevention interventions? A trajectory analysis in Rwanda and South Africa. BMJ Glob Health. 2020 May;5(5):e002199. doi: 10.1136/bmjgh-2019-002199.

Reference Type DERIVED
PMID: 32424011 (View on PubMed)

Chatterji S, Stern E, Dunkle K, Heise L. Community activism as a strategy to reduce intimate partner violence (IPV) in rural Rwanda: Results of a community randomised trial. J Glob Health. 2020 Jun;10(1):010406. doi: 10.7189/jogh.10.010406.

Reference Type DERIVED
PMID: 32257154 (View on PubMed)

Other Identifiers

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EC033-10/2015

Identifier Type: -

Identifier Source: org_study_id

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