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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04442152
Other study ID # 265A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 13, 2020
Est. completion date September 4, 2020

Study information

Verified date March 2022
Source Promundo, United States
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. It will contribute to documenting whether and how this disruptive moment might be changing or influencing relationship dynamics, conflict, and the distribution of care-work. We will build on an existing randomized controlled trial of the Bandebereho fathers/couples intervention, 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. The Bandebereho fathers/couples intervention was 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 Rwamagana districts from 2013-2015. Results from a randomized controlled study of Bandebereho, a gender transformative intervention for expectant couples originally implemented in 4 districts in 2015, showed positive results across multiple outcomes after 21 months.


Recruitment information / eligibility

Status Completed
Enrollment 998
Est. completion date September 4, 2020
Est. primary completion date September 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 26 Years to 40 Years
Eligibility Original inclusion criteria in the original RCT study included, for men: being between the ages of 21-35, expecting a child or having one or more children under the age of five, living in a stable partnership, and residing in the study site. For women, the criteria were simply being the partner of one of the men selected for the study. Inclusion criteria for this study include previous participation in the RCT, and that the respondent indicated they or their partner owned a telephone/phone in the 21-month follow up that was conducted in November/December 2016. Based on data from the 21-month followup, approximately 80% of respondents reported a cell phone owned by them or their partner.

Study Design


Intervention

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

Locations

Country Name City State
Rwanda Rwanda Men's Resource Centre (Rwamrec) Kigali

Sponsors (3)

Lead Sponsor Collaborator
Promundo, United States Ministry of Health/Rwanda Biomedical Center, Rwanda Men's Resource Center (Rwamrec)

Country where clinical trial is conducted

Rwanda, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gender division of caregiving/domestic tasks Question about how caregiving is distributed in the wake of Covid-19 ~5 years post intervention
Primary Couple communication Frequency of couple communication in the wake of Covid-19 ~5 years post intervention
Primary Couple conflict Frequency of couple quarreling in the wake of Covid-19 ~5 years post intervention
Primary Men's alcohol use Frequency of men's alcohol use in the wake of Covid-19 ~5 years post intervention
Primary Household economic situation Changes in household economic situation in the wake of Covid-19 ~5 years post intervention
Primary Stress and frustration Feelings of stress and frustration in the wake of Covid-19 ~5 years post intervention
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