Indashyikirwa IPV Prevention Trial in Rwanda

Intimate Partner Violence Clinical Trial

Official title:

Indashyikirwa Intervention Trial: Testing a Community-level Programme to Prevent Gender-based Violence in Rwanda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477877
• Other study ID #: EC033-10/2015
• Status: Completed
• Phase: N/A
• Start date: November 23, 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2019
• Source: Medical Research Council, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8909
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• 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.
• 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.
• 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.

Other:
• 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.

Behavioral:
• Village Savings and Loan Association (VSLA)
A standard Village Savings and Loan Association program as run nationwide by CARE Rwanda.

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Medical Research Council, South Africa	CARE Rwanda, Department for International Development, United Kingdom, Johns Hopkins University, Laterite, London School of Hygiene and Tropical Medicine, RWAMREC, Rwanda Women's Network, Social Development Direct, Wellspring Advisors

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Household earnings (Couples Cohort)	Reported household level earnings in past month	24 months
Other	Household debt payments (Couples Cohort)	Reported household debt payments in past month	24 months
Other	Food security (Couples Cohort)	Score on standard 2 item assessment of food security	24 months
Other	Support physical punishment of children (Couples Cohort)	Endorses statements supporting corporal punishment	24 months
Other	Self-rated health (Couples Cohort)	Standard single item assessment	24 months
Other	Problematic alcohol use (Couples Cohort, Women only)	Measured using AUDIT (Alcohol Use Disorder Identification Test) short form	24 months
Other	PTSD symptoms(Couples Cohort)	Self reports some symptoms indicative of PTSD	24 months
Other	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	24 months
Other	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	24 months
Other	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	24 months
Other	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	24 months
Other	Children in household witnessing IPV (Community Survey)	Frequency of children witnessing mother being beaten in the past 12 months, per parental report	24 months
Other	Support for women working outside the home (Community Survey)	Endorses items supportive of women working outside the home	24 months
Other	Change in strategies used to address IPV (Community Survey, women only)	Changes in frequency of checklist of possible strategies for addressing IPV	24 months
Primary	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
Primary	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
Primary	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
Primary	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	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	Acceptability of wife beating (Couples cohort)	Number of justifications for wife beating endorsed on survey assessment, analyzed separately for male and female participants	24 months
Secondary	Level of conflict in intimate partnership (Couples Cohort)	Reported sources and frequencies of quarrels with main partner in the past 12 months	24 months
Secondary	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)	24 months
Secondary	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	24 months
Secondary	Perception of trust, care, and respect in relationship with main partner (Couples Cohort)	Self-reported experience of trust, care, and respect with main partner	24 months
Secondary	Depressive symptoms (Couples Cohort)	Level of depressive symptoms in past week using Center for Epidemiologic Studies Depression Scale (CES-D) short form	24 months
Secondary	Children in household witnessing IPV (Couples Cohort)	Frequency of children witnessing mother being beaten in the past 12 months, per parental report	24 months
Secondary	Problematic alcohol use (Couples Cohort, Men Only)	Measured using AUDIT (Alcohol Use Disorder Identification Test) short form	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	Sources of information on IPV and number of times heard (Community Survey)	Frequency of encountering IPV prevention messages in the community	24 months
Secondary	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	24 months