Intimate Partner ViolenceNCT03477877
Indashyikirwa IPV Prevention Trial in Rwanda
A study testing Indashyikirwa Couples Training, Indashyikirwa Activist Training and Indashyikirwa Opinion Leader Training in people with Intimate Partner Violence, run by Medical Research Council, South Africa.
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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Indashyikirwa Couples Training, Indashyikirwa Activist Training and Indashyikirwa Opinion Leader Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,909 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2015to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
- Willing and able to give informed consent for participation in research
- Exclusion Criteria (both Couples Cohort and Community Survey):
- Does not speak Kinyarwanda
- Unable to provide meaningful informed consent
Who cannot join
None listed.
About this study
Official title: Indashyikirwa Intervention Trial: Testing a Community-level Programme to Prevent Gender-based Violence in Rwanda
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.
- Conditions
- Intimate Partner Violence
- Being tested
- Indashyikirwa Couples Training, Indashyikirwa Activist Training, Indashyikirwa Opinion Leader Training, Indashyikirwa Women's Spaces, Village Savings and Loan Association (VSLA)
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indashyikirwa Couples TrainingBehavioural
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 TrainingBehavioural
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 TrainingBehavioural
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 SpacesOther
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.
Village Savings and Loan Association (VSLA)Behavioural
A standard Village Savings and Loan Association program as run nationwide by CARE Rwanda.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Indashyikirwa Couples Training; Behavioral: Indashyikirwa Activist Training; Behavioral: Indashyikirwa Opinion Leader Training; Other: 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 Receives: Behavioral: Village Savings and Loan Association (VSLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months
Secondary outcomes (20)
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Acceptability of wife beating (Couples cohort)
Number of justifications for wife beating endorsed on survey assessment, analyzed separately for male and female participants
Measured: 24 months
Level of conflict in intimate partnership (Couples Cohort)
Reported sources and frequencies of quarrels with main partner in the past 12 months
Measured: 24 months
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)
Measured: 24 months
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
Measured: 24 months
Perception of trust, care, and respect in relationship with main partner (Couples Cohort)
Self-reported experience of trust, care, and respect with main partner
Measured: 24 months
Depressive symptoms (Couples Cohort)
Level of depressive symptoms in past week using Center for Epidemiologic Studies Depression Scale (CES-D) short form
Measured: 24 months
Children in household witnessing IPV (Couples Cohort)
Frequency of children witnessing mother being beaten in the past 12 months, per parental report
Measured: 24 months
Problematic alcohol use (Couples Cohort, Men Only)
Measured using AUDIT (Alcohol Use Disorder Identification Test) short form
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Sources of information on IPV and number of times heard (Community Survey)
Frequency of encountering IPV prevention messages in the community
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start23 Nov 2015
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 8,909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council, South Africa
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Kristin L Dunkle, PhD, Principal investigator, Medical Research Council, South AfricaLori Heise, PhD, Principal investigator, Johns Hopkins UniversityErin Stern, PhD, Principal investigator, The London School of Hygiene & Tropical MedicineLyndsay McLean, PhD, Principal investigator, Social Development Direct
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477877
- Sponsor's protocol ID
- EC033-10/2015
- Status last verified
- Aug 2019
- First submitted
- 12 Mar 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 33355268Gibbs 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 32424011Chatterji 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indashyikirwa Intervention Trial: Testing a Community-level Programme to Prevent Gender-based Violence in Rwanda
- ClinicalTrials.gov ID
- NCT03477877
- Acronym / sponsor ID
- EC033-10/2015
- Conditions
- Intimate Partner Violence
- Keywords
- Intimate Partner Violence, Gender-Based violence, Spouse Abuse, Rwanda, Heterosexual Couples, Activists, Opinion Leaders, Social Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,909 participants (actual)
- Lead sponsor
- Medical Research Council, South AfricaUniversity, hospital or other
- 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
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Indashyikirwa | Experimental | Behavioral: Indashyikirwa Couples Training, Behavioral: Indashyikirwa Activist Training, Behavioral: Indashyikirwa Opinion Leader Training, Other: Indashyikirwa Women's SpacesSectors 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. |
| VSLA Only | Active comparator | Behavioral: Village Savings and Loan Association (VSLA)Sectors that continue to receive only the village savings and loan association (VSLA) programmes offered by CARE Rwanda |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indashyikirwa Couples TrainingA 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. | Behavioural | Indashyikirwa |
| Indashyikirwa Activist TrainingThis 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. | Behavioural | Indashyikirwa |
| Indashyikirwa Opinion Leader TrainingTraining 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. | Behavioural | Indashyikirwa |
| Indashyikirwa Women's SpacesEstablishment 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. | Other | Indashyikirwa |
| Village Savings and Loan Association (VSLA)A standard Village Savings and Loan Association program as run nationwide by CARE Rwanda. | Behavioural | VSLA Only |
Primary outcome
Intimate partner violence with main partner (Couples Cohort)
Time frame: 24 months
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
Intimate partner violence with main partner (Community Survey)
Time frame: 24 months
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
Acceptability of wife beating (Community Survey)
Time frame: 24 months
Number of justifications for wife beating endorsed on survey assessment, analyzed separately for male and female participants
Actions to support victims of gender-based violence or combat gender-based violence (Community Survey)
Time frame: 24 months
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
20 secondary outcomes
Newly occuring intimate partner violence with main partner (Couples Cohort)
Time frame: 24 months
Recurrent physical and/or sexual intimate partner violence (Couples Cohort)
Time frame: 24 months
Physical intimate partner violence, main partnership (Couples Cohort)
Time frame: 24 months
Forced or coerced sex with main partner (Couples Cohort)
Time frame: 24 months
Economic abuse with main partner (Couples Cohort)
Time frame: 24 months
Emotional aggression with main partner (Couples Cohort)
Time frame: 24 months
Acceptability of wife beating (Couples cohort)
Time frame: 24 months
Level of conflict in intimate partnership (Couples Cohort)
Time frame: 24 months
Quality of conflict management strategies (Couples Cohort)
Time frame: 24 months
Couple communication (Couples Cohort)
Time frame: 24 months
Perception of trust, care, and respect in relationship with main partner (Couples Cohort)
Time frame: 24 months
Depressive symptoms (Couples Cohort)
Time frame: 24 months
Children in household witnessing IPV (Couples Cohort)
Time frame: 24 months
Problematic alcohol use (Couples Cohort, Men Only)
Time frame: 24 months
Help seeking among survivors of IPV (Couples Cohort, Women Only)
Time frame: 24 months
Advising neighbors on relationships (Couples Cohort)
Time frame: 24 months
Participating in action to prevent IPV (Participants in couples cohort who have received activist training, only)
Time frame: 24 months
Self-efficacy for community engagement (Couples Cohort, Women only )
Time frame: 24 months
Sources of information on IPV and number of times heard (Community Survey)
Time frame: 24 months
Help seeking among survivors of IPV (Community Survey, women only)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 33355268Dunkle 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.
- Derived from this study: PubMed 32424011Gibbs 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.
- Derived from this study: PubMed 32257154Chatterji 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A study testing Indashyikirwa Couples Training, Indashyikirwa Activist Training and Indashyikirwa Opinion Leader Training in people with Intimate Partner Violence, run by Medical Research Council, South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intimate partner violence with main partner (Couples Cohort) (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03477877, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.