Bandebereho 6 Year Follow up RCT in Rwanda

NCT04861870 | Completed

• 1 other identifier: RWN6YR
• Study Type: interventional
• Target: 2,818
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Relations; Violence; Child Development; Contraception; Prenatal Care; Partner Communication

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Women's experiences of intimate partner violence (physical & sexual)

  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.

  Experience of violence in past 12 months, measured 6 years post intervention

• Use of violence/harsh punishment against children

  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.

  6 years post intervention

• Observation-based child development measure

  Observation-based scores on the International Development and Early Learning Assessment (IDELA) for children ages 4-7

  6 years post intervention

• Child behavior assessment

  Parent-reported scores on Strengths and Difficulties Questionnaire (SDQ)

  6 years post intervention

Secondary Outcomes (6)

• Family planning

  6 years post intervention

• Antenatal care (ANC) service utilization

  6 years post intervention

• Antenatal care (ANC) accompaniment

  6 years post intervention

• Parenting behaviors with children

  6 years post intervention

• Parenting behaviors and adjustment

  6 years post intervention

Other Outcomes (9)

• Couple communication

  6 years post intervention

• Gender-related attitudes

  6 years post intervention

• Decision-making in relationship

  6 years post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

See intervention description

Behavioral: MenCare+/Bandebereho fathers'/couples' group education

Control

NO INTERVENTION

Participants randomized into the control arm are surveyed at the same time points as intervention participants, but did not receive any intervention.

Interventions

MenCare+/Bandebereho fathers'/couples' group education BEHAVIORAL

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.

Also known as: Program P

Intervention

Eligibility Criteria

• Age: 21 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Participated in previous cycles of the same intervention

Sponsors & Collaborators

• Promundo, United States: lead
• Rwanda Men's Resource Centre: collaborator

Study Sites (1)

Rwanda Men's Resource Centre

Kigali, Rwanda

Location

Related Publications (2)

• 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.

  PMID: 29617375 RESULT

• Doyle K, Levtov RG, Karamage E, Rakshit D, Kazimbaya S, Sayinzoga F, Sibomana H, Ngayaboshya S, Rutayisire F, Barker G. Long-term impacts of the Bandebereho programme on violence against women and children, maternal health-seeking, and couple relations in Rwanda: a six-year follow-up of a randomised controlled trial. EClinicalMedicine. 2023 Sep 26;64:102233. doi: 10.1016/j.eclinm.2023.102233. eCollection 2023 Oct.

  PMID: 37781160 DERIVED

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 27, 2021
• Study Start: June 15, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)