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Bandebereho 6 Year Follow up RCT in Rwanda

NCT ID: NCT04861870

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2021-09-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gender Relations Violence Child Development Contraception Prenatal Care Partner Communication

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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Group Type EXPERIMENTAL

MenCare+/Bandebereho fathers'/couples' group education

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Program P

Eligibility Criteria

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Inclusion Criteria

* 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

\- Participated in previous cycles of the same intervention
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rwanda Men's Resource Centre

UNKNOWN

Sponsor Role collaborator

Promundo, United States

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kate E Doyle

Role: PRINCIPAL_INVESTIGATOR

Promundo-US

Ruti G Levtov

Role: PRINCIPAL_INVESTIGATOR

Prevention Collaborative

Fidele Rutayisire

Role: PRINCIPAL_INVESTIGATOR

Rwanda Men's Resource Centre

Shamsi Kazimbaya

Role: PRINCIPAL_INVESTIGATOR

Promundo-US

Felix Sayinzoga

Role: PRINCIPAL_INVESTIGATOR

Rwanda Biomedical Centre

Locations

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Rwanda Men's Resource Centre

Kigali, , Rwanda

Site Status

Countries

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Rwanda

References

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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.

Reference Type RESULT
PMID: 29617375 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37781160 (View on PubMed)

Other Identifiers

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RWN6YR

Identifier Type: -

Identifier Source: org_study_id