Clinical trial NCT03477877: Indashyikirwa IPV Prevention Trial in Rwanda
Official title: Indashyikirwa Intervention Trial: Testing a Community-level Programme to Prevent Gender-based Violence in Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Medical Research Council, South Africa
Sponsor class: OTHER
Collaborators: name: Department for International Development, United Kingdom
name: CARE Rwanda
name: RWAMREC
name: Laterite
name: London School of Hygiene and Tropical Medicine
name: Social Development Direct
name: Wellspring Advisors
name: Johns Hopkins University
name: Rwanda Women's Network
First posted: 2018-03-27
Enrollment: 8909
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.


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

Primary outcomes:
measure: Intimate partner violence with main partner (Couples Cohort)
timeFrame: 24 months
measure: Intimate partner violence with main partner (Community Survey)
timeFrame: 24 months
measure: Acceptability of wife beating (Community Survey)
timeFrame: 24 months
measure: Actions to support victims of gender-based violence or combat gender-based violence (Community Survey)
timeFrame: 24 months
Secondary outcomes:
measure: Newly occuring intimate partner violence with main partner (Couples Cohort)
timeFrame: 24 months
measure: Recurrent physical and/or sexual intimate partner violence (Couples Cohort)
timeFrame: 24 months
measure: Physical intimate partner violence, main partnership (Couples Cohort)
timeFrame: 24 months
measure: Forced or coerced sex with main partner (Couples Cohort)
timeFrame: 24 months
measure: Economic abuse with main partner (Couples Cohort)
timeFrame: 24 months
measure: Emotional aggression with main partner (Couples Cohort)
timeFrame: 24 months
measure: Acceptability of wife beating (Couples cohort)
timeFrame: 24 months
measure: Level of conflict in intimate partnership (Couples Cohort)
timeFrame: 24 months
measure: Quality of conflict management strategies (Couples Cohort)
timeFrame: 24 months
measure: Couple communication (Couples Cohort)
timeFrame: 24 months
measure: Perception of trust, care, and respect in relationship with main partner (Couples Cohort)
timeFrame: 24 months
measure: Depressive symptoms (Couples Cohort)
timeFrame: 24 months
measure: Children in household witnessing IPV (Couples Cohort)
timeFrame: 24 months
measure: Problematic alcohol use (Couples Cohort, Men Only)
timeFrame: 24 months
measure: Help seeking among survivors of IPV (Couples Cohort, Women Only)
timeFrame: 24 months
measure: Advising neighbors on relationships (Couples Cohort)
timeFrame: 24 months
measure: Participating in action to prevent IPV (Participants in couples cohort who have received activist training, only)
timeFrame: 24 months
measure: Self-efficacy for community engagement (Couples Cohort, Women only )
timeFrame: 24 months
measure: Sources of information on IPV and number of times heard (Community Survey)
timeFrame: 24 months
measure: Help seeking among survivors of IPV (Community Survey, women only)
timeFrame: 24 months
Other outcomes:
measure: Household earnings (Couples Cohort)
timeFrame: 24 months
measure: Household debt payments (Couples Cohort)
timeFrame: 24 months
measure: Food security (Couples Cohort)
timeFrame: 24 months
measure: Support physical punishment of children (Couples Cohort)
timeFrame: 24 months
measure: Self-rated health (Couples Cohort)
timeFrame: 24 months
measure: Problematic alcohol use (Couples Cohort, Women only)
timeFrame: 24 months
measure: PTSD symptoms(Couples Cohort)
timeFrame: 24 months
measure: Physical intimate partner violence, main partnership (Community Survey)
timeFrame: 24 months
measure: Forced or coerced sex with main partner (Community Survey)
timeFrame: 24 months
measure: Economic abuse with main partner (Community Survey)
timeFrame: 24 months
measure: Emotional aggression with main partner (Community Survey)
timeFrame: 24 months
measure: Children in household witnessing IPV (Community Survey)
timeFrame: 24 months
measure: Support for women working outside the home (Community Survey)
timeFrame: 24 months
measure: Change in strategies used to address IPV (Community Survey, women only)
timeFrame: 24 months
Locations:
Study officials:
affiliation: Medical Research Council, South Africa
name: Kristin L Dunkle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Lori Heise, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The London School of Hygiene & Tropical Medicine
name: Erin Stern, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Social Development Direct
name: Lyndsay McLean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.