Bandebereho 6 Year Follow up RCT in Rwanda

• ClinicalTrials.gov Identifier: NCT04861870
• Recruitment Status: Completed
• First Posted: April 27, 2021
• Last Update Posted: October 29, 2021
• Sponsor: Promundo, United States
• Collaborator: Rwanda Men's Resource Centre
• Information provided by (Responsible Party): Promundo, United States

Study Description

Brief Summary:

This study seeks to conduct a six-year follow-up of the Bandebereho randomized control trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children. The Bandebereho program was implemented by the Rwanda Men's Resource Centre (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities between 2013 and 2015. A two-arm RCT collected three rounds of data from 1,199 couples (575 treatment; 624 control) starting in 2015-16: baseline (pre-intervention), 9 month follow-up, and 21-month follow-up. The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes. This study will conduct surveys with men enrolled in the RCT and their female partners 6 years after the intervention, to assess its long-term impact on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development. In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.

Condition or disease	Intervention/treatment	Phase
Gender Relations; Violence; Child Development; Contraception; Prenatal Care; Partner Communication	Behavioral: MenCare+/Bandebereho fathers'/couples' group education	Not Applicable

Detailed Description:

This study seeks to conduct a six-year follow-up of the Bandebereho randomized controlled trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children. The Bandebereho program being assessed was first implemented by the Rwanda Men's Resource Center (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities in Karongi, Musanze, Nyaruguru and Nyaruguru districts between 2013 and 2015. A two-arm RCT was conducted with 1,199 couples (575 treatment; 624 control) in 2015-16. Three rounds of data were collected: baseline (pre-intervention), 9 month follow-up (4 months post-intervention), and 21-month follow-up (16 months post-intervention). The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes. The proposed study will conduct surveys with men enrolled in the RCT and their female partners, to assess the longer-term impact of the intervention on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development. In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2818 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Bandebereho Randomized Control Trial: Six Year Follow-up to Assess the Impact of a Gender-transformative Intervention With Couples to Promote Men's Engagement in Maternal, Newborn and Child Health, Caregiving and Healthier Couple Relations
• Actual Study Start Date: June 15, 2021
• Actual Primary Completion Date: September 7, 2021
• Actual Study Completion Date: September 7, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; See intervention description	Behavioral: MenCare+/Bandebereho fathers'/couples' group education; MenCare+/Bandebereho was a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda. A core component of the project is fathers'/couples' group education. The target participants were first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities. The MenCare+/Bandebereho fathers'/couples' group education engaged men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual. Men's partners participate in 6-8 sessions. The sessions focused on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.; Other Name: Program P
No Intervention: Control; Participants randomized into the control arm are surveyed at the same time points as intervention participants, but did not receive any intervention.

Outcome Measures

Primary Outcome Measures :

1. Women's experiences of intimate partner violence (physical & sexual) [ Time Frame: Experience of violence in past 12 months, measured 6 years post intervention ]
   A composite capturing self-reported exposure to a standard set of violent acts by a partner in past 12 months, adapted from World Health Organisation's multi-country study on violence against women.
2. Use of violence/harsh punishment against children [ Time Frame: 6 years post intervention ]
   A composite capturing respondents' self reported use of various harsh discipline acts in the past month, adapted from the UNICEF Multiple Indicator Cluster Surveys (MICS) study.
3. Observation-based child development measure [ Time Frame: 6 years post intervention ]
   Observation-based scores on the International Development and Early Learning Assessment (IDELA) for children ages 4-7
4. Child behavior assessment [ Time Frame: 6 years post intervention ]
   Parent-reported scores on Strengths and Difficulties Questionnaire (SDQ)

Secondary Outcome Measures :

1. Family planning [ Time Frame: 6 years post intervention ]
   Self reported responses on current use of family planning methods, using Demographic and Health Survey (DHS) measure.
2. Antenatal care (ANC) service utilization [ Time Frame: 6 years post intervention ]
   Self reported responses on women's frequency of ANC visits during most recent pregnancy, using DHS measure (women only).
3. Antenatal care (ANC) accompaniment [ Time Frame: 6 years post intervention ]
   Self reported responses on men's frequency of accompaniment to ANC visits during most recent pregnancy, adapted from International Men and Gender Equality Survey.
4. Parenting behaviors with children [ Time Frame: 6 years post intervention ]
   Composite variable capturing behaviors with children in the past week (e.g. reading stories, playing, etc.) adapted from IDELA HOME and select items related to parenting behaviors adapted from the Parenting and Family Adjustment Scales (PAFAS).
5. Parenting behaviors and adjustment [ Time Frame: 6 years post intervention ]
   Select items related to parenting behaviors and feelings adapted from the Parenting and Family Adjustment Scales (PAFAS).
6. Time spent/gender division of caregiving/domestic tasks and paid work [ Time Frame: 6 years post intervention ]
   a) A composite measure of self-reported time spent on specific tasks in the past week; and b) self-reported distribution of tasks between partners.

Other Outcome Measures:

1. Couple communication [ Time Frame: 6 years post intervention ]
   A composite capturing frequency of communication across multiple topics.
2. Gender-related attitudes [ Time Frame: 6 years post intervention ]
   A continuous scale variable, adapted from the validated Gender Equitable Men (GEM) scale; scores range from 1 to 5, with higher scores indicating more equitable attitudes.
3. Decision-making in relationship [ Time Frame: 6 years post intervention ]
   Self-reported responses on who makes the decision in the relationship, adapted from the DHS.
4. Frequency of quarreling [ Time Frame: 6 years post intervention ]
   Self-reported response to one item capturing frequency of quarreling in the couple.
5. Relationship quality and conflict resolution [ Time Frame: 6 years post intervention ]
   Self-reported relationship quality items adapted from the relationship quality scale from the Decision Making in Low-Income Couples scale.
6. Relationship conflict resolution [ Time Frame: 6 years post intervention ]
   Self-reported items on couple communication and resolution in conflict adapted from the Couple Functionality Assessment.
7. Alcohol use [ Time Frame: 6 years post intervention ]
   Self reported alcohol use (men & women) and women's reports on partners' alcohol use (women) in past year, adapted from the Alcohol Use Disorders Identification Test (AUDIT).
8. Depression/Mental health [ Time Frame: 6 years post intervention ]
   Self reported symptoms in past week, adapted from the Center for Epidemiologic Studies Depression Scale (CES-D) short form.
9. Reproductive coercion [ Time Frame: Coercion in the past year, measured 6 years post intervention ]
   Women's self reported experience with reproductive coercion from their current partner in the past year, adapted from the Reproductive Autonomy coercion subscale.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria at baseline:

• Men aged 21-35 years
• Living with a partner
• Expectant (or soon to be) father or father of young children under-5
• Living in an area with a group facilitator

Exclusion Criteria at baseline:

- Participated in previous cycles of the same intervention

Contacts and Locations

Locations

Rwanda

Rwanda Men's Resource Centre

Kigali, Rwanda

Sponsors and Collaborators

Promundo, United States

Rwanda Men's Resource Centre

Investigators

• Principal Investigator: Kate E Doyle; Promundo-US
• Principal Investigator: Ruti G Levtov; Prevention Collaborative
• Principal Investigator: Fidele Rutayisire; Rwanda Men's Resource Centre
• Principal Investigator: Shamsi Kazimbaya; Promundo-US
• Principal Investigator: Felix Sayinzoga; Rwanda Biomedical Centre

More Information

Publications of Results:

Doyle K, Levtov RG, Barker G, Bastian GG, Bingenheimer JB, Kazimbaya S, Nzabonimpa A, Pulerwitz J, Sayinzoga F, Sharma V, Shattuck D. Gender-transformative Bandebereho couples' intervention to promote male engagement in reproductive and maternal health and violence prevention in Rwanda: Findings from a randomized controlled trial. PLoS One. 2018 Apr 4;13(4):e0192756. doi: 10.1371/journal.pone.0192756. eCollection 2018.

• Responsible Party: Promundo, United States
• ClinicalTrials.gov Identifier: NCT04861870
• Other Study ID Numbers: RWN6YR
• First Posted: April 27, 2021
• Last Update Posted: October 29, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Promundo, United States:

Gender; Violence; Early childhood development (ECD); Caregiving; Parenting; MNCH; Reproductive health