NCT05787392

Brief Summary

In Kenya, the chamas strategy (a peer support approach aimed at improving MNCH and reducing gender and social inequalities) has been shown to significantly improve maternal and child health outcomes while also providing social and financial support to participating women. However, the COVID-19 pandemic caused significant disruptions in women's work and MNCH services around the world due to reallocation of health care resources, COVID-19 fears, transportation restrictions, and lockdowns. These consequences appeared to disproportionately affect the poor, particularly poor women. The purpose of this participatory action design study is to determine how Chamas participation intersected with other factors to mitigate the effects of the COVID-19 pandemic on the health and economic well-being of women and children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2025

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

March 23, 2023

Last Update Submit

April 21, 2023

Conditions

Gender Equity

Keywords

participatory researchGender equitymaternal and child well-beingKenyaMixed-methods

Outcome Measures

Primary Outcomes (1)

  • Economic Status

    Impact of COVID-19 pandemic on the women's economic well-being based on Poverty property Index (PPI) scores obtained from 10 questions in the questionnaire. The PPI is a relative scale in which each response is assigned a value, and the sum of the values is the participant's PPI score. The participant's PPI is then compared with the country level score using the "look-up table" for the country (Kenya) to determine the participant's likelihood of being poor. The investigators will compare the PPI scores at the post-pandemic period between the three cohorts in the study.

    1 year

Secondary Outcomes (6)

  • Health insurance uptake

    1 year

  • Health service utilization

    1 year

  • Social impact of COVID19

    1 year

  • Attitudes towards Harsh punishment

    1 year

  • COVID-19 experiences of key informants

    1 year

  • +1 more secondary outcomes

Study Arms (3)

Completed Chamas program

women who participated in Chamas throughout the pandemic

Behavioral: Chamas cha MamaToto program

Did not complete Chamas program

women who left Chamas during the pandemic

Behavioral: Chamas cha MamaToto program

Did not participate in Chamas program

women whose communities were randomized to not receive the Chamas intervention

Interventions

Chamas cha MamaToto programBEHAVIORAL

Chamas is a community health volunteer (CHV)-led group programme that engages women during pregnancy and the first 1000 days of their child's life. The strategy focuses on promoting maternal, newborn, and child health (MNCH) by providing health education, peer support, and opportunities to access financial capital, all while addressing inequities that perpetuate poor outcomes.

Completed Chamas programDid not complete Chamas program

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This research will be conducted in Trans-Nzoia County among the 1400 women that participated in the 2021 RCT study. The following groups will be included in our study population. * RCT women who participated in Chamas throughout the pandemic. * Women who left Chamas after March 12, 2020, the date the first case of COVID-19 was discovered in Kenya. * Women whose communities were randomly assigned not to use Chamas during the RCT. * CHVs in communities that had or did not have Chamas operating during the pandemic. * County health officials. * Fathers participating in Chama cha Babatoto. * Adolescent girls are currently participating in Chamas adapted for adolescents.

You may qualify if:

  • Women who participated in the 2021 Chamas study in Western Kenya

You may not qualify if:

  • Women who did not participate in the 2021 study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Trans Nzoia county

Kiminini, Kenya

Location

Trans-Nzoia County

Kitale, Kenya

Location

Study Officials

  • Julia Songok

    AMPATH Kenya

    PRINCIPAL INVESTIGATOR

  • Sammy Masibo

    Trans Nzoia county government

    STUDY DIRECTOR

  • Michael Scanlon

    Indiana University

    STUDY DIRECTOR

  • Laura Ruhl

    Indiana University

    STUDY DIRECTOR

  • Julie Thorne

    University of Toronto

    STUDY DIRECTOR

  • Violet Naanyu

    Moi University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2023

First Posted

March 28, 2023

Study Start

March 14, 2023

Primary Completion

March 13, 2024

Study Completion

March 13, 2025

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

KE(2)