NCT04442152

Brief Summary

This proposed study will assess how COVID-19 and the associated 'stay at home' orders are affecting low-income Rwandan couples' relationships and family dynamics. The study builds on an existing randomized controlled trial of the Bandebereho fathers/couples intervention (NCT02694627), which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
998

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

22 days

First QC Date

June 19, 2020

Last Update Submit

March 11, 2022

Conditions

Keywords

gender, caregiving, Covid-19, couple relations

Outcome Measures

Primary Outcomes (6)

  • Gender division of caregiving/domestic tasks

    Question about how caregiving is distributed in the wake of Covid-19

    ~5 years post intervention

  • Couple communication

    Frequency of couple communication in the wake of Covid-19

    ~5 years post intervention

  • Couple conflict

    Frequency of couple quarreling in the wake of Covid-19

    ~5 years post intervention

  • Men's alcohol use

    Frequency of men's alcohol use in the wake of Covid-19

    ~5 years post intervention

  • Household economic situation

    Changes in household economic situation in the wake of Covid-19

    ~5 years post intervention

  • Stress and frustration

    Feelings of stress and frustration in the wake of Covid-19

    ~5 years post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

See intervention description

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

Control

NO INTERVENTION

Participants who were randomized into the control arm were and will be surveyed at the same time point as intervention participants, but did not receive any intervention.

Interventions

MenCare+/Bandebereho is 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 engages 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 focus 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

Age26 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rwanda Men's Resource Centre (Rwamrec)

Kigali, Rwanda

Location

Related Publications (1)

  • 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: 29617375BACKGROUND

MeSH Terms

Conditions

CoitusCOVID-19

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Kate E Doyle, MA

    Promundo-US

    PRINCIPAL INVESTIGATOR
  • Ruti G Levtov, PhD

    Promundo-US

    PRINCIPAL INVESTIGATOR
  • Felix Sayingoza, MD, MSc

    Ministry of Health/Rwanda Biomedical Center

    PRINCIPAL INVESTIGATOR
  • Fidele Rutayisire, MA

    Rwanda Men's Resource Center

    PRINCIPAL INVESTIGATOR
  • Shamsi Kazimbaya, MA

    Promundo-US

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Note that we are collecting new data from participants previously randomly assigned to intervention and control arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

August 13, 2020

Primary Completion

September 4, 2020

Study Completion

September 4, 2020

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations