Clinical trial NCT04861870: Bandebereho 6 Year Follow up RCT in Rwanda
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender Relations
Violence
Child Development
Contraception
Prenatal Care
Partner Communication
Keywords: Gender
Violence
Early childhood development (ECD)
Caregiving
Parenting
MNCH
Reproductive health
Lead sponsor: Promundo, United States
Sponsor class: OTHER
Collaborators: name: Rwanda Men's Resource Centre
First posted: 2021-04-27
Enrollment: 2818
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Women's experiences of intimate partner violence (physical & sexual)
timeFrame: Experience of violence in past 12 months, measured 6 years post intervention
measure: Use of violence/harsh punishment against children
timeFrame: 6 years post intervention
measure: Observation-based child development measure
timeFrame: 6 years post intervention
measure: Child behavior assessment
timeFrame: 6 years post intervention
Secondary outcomes:
measure: Family planning
timeFrame: 6 years post intervention
measure: Antenatal care (ANC) service utilization
timeFrame: 6 years post intervention
measure: Antenatal care (ANC) accompaniment
timeFrame: 6 years post intervention
measure: Parenting behaviors with children
timeFrame: 6 years post intervention
measure: Parenting behaviors and adjustment
timeFrame: 6 years post intervention
measure: Time spent/gender division of caregiving/domestic tasks and paid work
timeFrame: 6 years post intervention
Other outcomes:
measure: Couple communication
timeFrame: 6 years post intervention
measure: Gender-related attitudes
timeFrame: 6 years post intervention
measure: Decision-making in relationship
timeFrame: 6 years post intervention
measure: Frequency of quarreling
timeFrame: 6 years post intervention
measure: Relationship quality and conflict resolution
timeFrame: 6 years post intervention
measure: Relationship conflict resolution
timeFrame: 6 years post intervention
measure: Alcohol use
timeFrame: 6 years post intervention
measure: Depression/Mental health
timeFrame: 6 years post intervention
measure: Reproductive coercion
timeFrame: Coercion in the past year, measured 6 years post intervention
Locations:
city: Kigali
country: Rwanda
facility: Rwanda Men's Resource Centre
Study officials:
affiliation: Promundo-US
name: Kate E Doyle
role: PRINCIPAL_INVESTIGATOR
affiliation: Prevention Collaborative
name: Ruti G Levtov
role: PRINCIPAL_INVESTIGATOR
affiliation: Rwanda Men's Resource Centre
name: Fidele Rutayisire
role: PRINCIPAL_INVESTIGATOR
affiliation: Promundo-US
name: Shamsi Kazimbaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Rwanda Biomedical Centre
name: Felix Sayinzoga
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.