ClinicalTrials.gg
CompletedNCT03477877Updated Aug 6, 2019

Indashyikirwa IPV Prevention Trial in Rwanda

An interventional study of Indashyikirwa Couples Training and Indashyikirwa Activist Training in Intimate Partner Violence, sponsored by Medical Research Council, South Africa. Completed. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Medical Research Council, South Africa · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Nov 2015, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
8,909
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intimate Partner Violence

Keywords

  • Intimate Partner Violence
  • Gender-Based violence
  • Spouse Abuse
  • Rwanda
  • Heterosexual Couples
  • Activists
  • Opinion Leaders
  • Social Change
  • Social-Ecological Model
  • Diffusion of Innovation
  • Cluster Randomized Controlled Trial
  • Community Randomized Controlled Trial
03

In context

Lead sponsor

Medical Research Council, South Africa is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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 (both Couples Cohort and Community Survey):

  1. Does not speak Kinyarwanda
  2. Unable to provide meaningful informed consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8,909 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Indashyikirwa Couples Training · Behavioral: Indashyikirwa Activist Training · Behavioral: Indashyikirwa Opinion Leader Training · Other: Indashyikirwa Women's Spaces

  • Active comparator
    VSLA Only

    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

  • BehavioralIndashyikirwa 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.

  • BehavioralIndashyikirwa 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.

  • BehavioralIndashyikirwa 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.

  • OtherIndashyikirwa 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.

  • BehavioralVillage Savings and Loan Association (VSLA)

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

  2. 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

    Time frame: 24 months

  3. Acceptability of wife beating (Community Survey)

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

    Time frame: 24 months

  4. 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

    Time frame: 24 months

Secondary outcomes

  1. Newly occuring intimate partner violence with main partner (Couples Cohort)

    Experience (for women) or perpetration (for men) of any physical and/or sexual in main intimate partnership during the 12 months before the assessment among participants who DID NOT report physical and/or sexual IPV at baseline

    Time frame: 24 months

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

    Experience (for women) or perpetration (for men) of any physical and/or sexual in main intimate partnership during the 12 months before the assessment among participants who DID report physical and/or sexual IPV at baseline

    Time frame: 24 months

  3. Physical intimate partner violence, main partnership (Couples Cohort)

    Experience (for women) or perpetration (for men) of any physical violence in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  4. Forced or coerced sex with main partner (Couples Cohort)

    Experience (for women) or perpetration (for men) of any forced or coerced sex in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  5. Economic abuse with main partner (Couples Cohort)

    Experience (for women) or perpetration (for men) of economic abuse in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  6. Emotional aggression with main partner (Couples Cohort)

    Experience (for women) or perpetration (for men) of emotional aggression in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  7. Acceptability of wife beating (Couples cohort)

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

    Time frame: 24 months

  8. Level of conflict in intimate partnership (Couples Cohort)

    Reported sources and frequencies of quarrels with main partner in the past 12 months

    Time frame: 24 months

  9. Quality of conflict management strategies (Couples Cohort)

    Quality of conflict management strategies used in the past 12 months in main intimate partnership (reduced use of negative strategies and increased use of positive strategies)

    Time frame: 24 months

  10. Couple communication (Couples Cohort)

    Frequency of discussing important relationship topics with main partner (her day, his day, her worries or feelings, his worries or feelings, the sexual relationship) in last 4 weeks

    Time frame: 24 months

  11. Perception of trust, care, and respect in relationship with main partner (Couples Cohort)

    Self-reported experience of trust, care, and respect with main partner

    Time frame: 24 months

  12. Depressive symptoms (Couples Cohort)

    Level of depressive symptoms in past week using Center for Epidemiologic Studies Depression Scale (CES-D) short form

    Time frame: 24 months

  13. Children in household witnessing IPV (Couples Cohort)

    Frequency of children witnessing mother being beaten in the past 12 months, per parental report

    Time frame: 24 months

  14. Problematic alcohol use (Couples Cohort, Men Only)

    Measured using AUDIT (Alcohol Use Disorder Identification Test) short form

    Time frame: 24 months

  15. Help seeking among survivors of IPV (Couples Cohort, Women Only)

    Help seeking in past 12 months among women in couples cohort who report experience of physical and/or sexual IPV in the past 12 months

    Time frame: 24 months

  16. Advising neighbors on relationships (Couples Cohort)

    Offering direct support or advice to neighbors regarding IPV or relationship conflict comparing participants who received both couples training and activist training, couples training only, and control participants

    Time frame: 24 months

  17. Participating in action to prevent IPV (Participants in couples cohort who have received activist training, only)

    In past 12 months, participated in a meeting, march, rally or gathering aiming to raise awareness and mobilize people around the issue of family violence comparing participants who received both couples training and activist training, couples training only, and control participants

    Time frame: 24 months

  18. Self-efficacy for community engagement (Couples Cohort, Women only )

    Confidence to speak at community meetings / to speak at community meetings if people disagree among comparing women who received both couples training and activist training, couples training only, and control participants

    Time frame: 24 months

  19. Sources of information on IPV and number of times heard (Community Survey)

    Frequency of encountering IPV prevention messages in the community

    Time frame: 24 months

  20. Help seeking among survivors of IPV (Community Survey, women only)

    Help seeking in past 12 months among women in community survey who report experience of physical and/or sexual IPV in the past 12 months

    Time frame: 24 months

Other outcomes

  1. Household earnings (Couples Cohort)

    Reported household level earnings in past month

    Time frame: 24 months

  2. Household debt payments (Couples Cohort)

    Reported household debt payments in past month

    Time frame: 24 months

  3. Food security (Couples Cohort)

    Score on standard 2 item assessment of food security

    Time frame: 24 months

  4. Support physical punishment of children (Couples Cohort)

    Endorses statements supporting corporal punishment

    Time frame: 24 months

  5. Self-rated health (Couples Cohort)

    Standard single item assessment

    Time frame: 24 months

  6. Problematic alcohol use (Couples Cohort, Women only)

    Measured using AUDIT (Alcohol Use Disorder Identification Test) short form

    Time frame: 24 months

  7. PTSD symptoms(Couples Cohort)

    Self reports some symptoms indicative of PTSD

    Time frame: 24 months

  8. Physical intimate partner violence, main partnership (Community Survey)

    Experience (for women) or perpetration (for men) of any physical violence in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  9. Forced or coerced sex with main partner (Community Survey)

    Experience (for women) or perpetration (for men) of any forced or coerced sex in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  10. Economic abuse with main partner (Community Survey)

    Experience (for women) or perpetration (for men) of economic abuse in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  11. Emotional aggression with main partner (Community Survey)

    Experience (for women) or perpetration (for men) of emotional aggression in main intimate partnership during the 12 months before the assessment

    Time frame: 24 months

  12. Children in household witnessing IPV (Community Survey)

    Frequency of children witnessing mother being beaten in the past 12 months, per parental report

    Time frame: 24 months

  13. Support for women working outside the home (Community Survey)

    Endorses items supportive of women working outside the home

    Time frame: 24 months

  14. Change in strategies used to address IPV (Community Survey, women only)

    Changes in frequency of checklist of possible strategies for addressing IPV

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 33355268 ↗
  • 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. PubMed 32424011 ↗
  • 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. PubMed 32257154 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477877
Lead sponsor
Medical Research Council, South Africa
Collaborators
Department for International Development, United Kingdom, CARE Rwanda, RWAMREC, Laterite, London School of Hygiene and Tropical Medicine, Social Development Direct, Wellspring Advisors, Johns Hopkins University, Rwanda Women's Network
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Nov 23, 2015
Primary completion
Jul 1, 2018
Completion
Jul 1, 2018
Last update
Aug 6, 2019

Study contacts

Kristin L Dunkle, PhD
principal investigator · Medical Research Council, South Africa
Lori Heise, PhD
principal investigator · Johns Hopkins University
Erin Stern, PhD
principal investigator · The London School of Hygiene & Tropical Medicine
Lyndsay McLean, PhD
principal investigator · Social Development Direct

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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