NCT03477877

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,909

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

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

November 23, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

March 12, 2018

Last Update Submit

August 5, 2019

Conditions

Keywords

Intimate Partner ViolenceGender-Based violenceSpouse AbuseRwandaHeterosexual CouplesActivistsOpinion LeadersSocial ChangeSocial-Ecological ModelDiffusion of InnovationCluster Randomized Controlled TrialCommunity Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

  • Intimate partner violence with main partner (Couples Cohort)

    Experience (for women) or perpetration (for men) of physical or sexual intimate partner violence as assessed by the WHO (World Health Organization) Violence Against Women questions as standardized for the What Works to Prevent Violence Against Women and Girls Programme

    24 months

  • Intimate partner violence with main partner (Community Survey)

    Experience (for women) or perpetration (for men) of physical or sexual intimate partner violence as assessed by the WHO Violence Against Women questions as standardized for the What Works to Prevent Violence Against Women and Girls Programme

    24 months

  • Acceptability of wife beating (Community Survey)

    Number of justifications for wife beating endorsed on survey assessment, analyzed separately for male and female participants

    24 months

  • Actions to support victims of gender-based violence or combat gender-based violence (Community Survey)

    Scores on a checklist of items assessing actions taken to support women who have experienced gender-based violence and/or combat gender-based violence in the community

    24 months

Secondary Outcomes (20)

  • Newly occuring intimate partner violence with main partner (Couples Cohort)

    24 months

  • Recurrent physical and/or sexual intimate partner violence (Couples Cohort)

    24 months

  • Physical intimate partner violence, main partnership (Couples Cohort)

    24 months

  • Forced or coerced sex with main partner (Couples Cohort)

    24 months

  • Economic abuse with main partner (Couples Cohort)

    24 months

  • +15 more secondary outcomes

Other Outcomes (14)

  • Household earnings (Couples Cohort)

    24 months

  • Household debt payments (Couples Cohort)

    24 months

  • Food security (Couples Cohort)

    24 months

  • +11 more other outcomes

Study Arms (2)

Indashyikirwa

EXPERIMENTAL

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.

Behavioral: Indashyikirwa Couples TrainingBehavioral: Indashyikirwa Activist TrainingBehavioral: Indashyikirwa Opinion Leader TrainingOther: Indashyikirwa Women's Spaces

VSLA Only

ACTIVE COMPARATOR

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

Behavioral: Village Savings and Loan Association (VSLA)

Interventions

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

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

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

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.

Indashyikirwa

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

VSLA Only

Eligibility Criteria

Age18 Years - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWe did no confirmation of biological sex and accepted all participants as they self-identified.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For the Couples Cohort Study:
  • Member of an active village savings and loan association (VSLA) group or the partner of a VSLA member
  • Between 18 and 49 years old
  • Living with or married to current partner for at least 6 months at baseline
  • Willing and able to give informed consent for participation in research
  • 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
  • Has no current plans to move out of the study area in the next 2.5 years
  • For the Community Surveys:
  • Resident in the target community for at least 6 months prior to data collection
  • Between 18 and 49 years old
  • Living with or be married to current partner for at least 6 months
  • 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

You may not qualify if:

  • Does not speak Kinyarwanda
  • Unable to provide meaningful informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Kristin L Dunkle, PhD

    Medical Research Council, South Africa

    PRINCIPAL INVESTIGATOR
  • Lori Heise, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Erin Stern, PhD

    The London School of Hygiene & Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Lyndsay McLean, PhD

    Social Development Direct

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 27, 2018

Study Start

November 23, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 6, 2019

Record last verified: 2019-08