NCT03187873

Brief Summary

This team has shown that chamas can be tailored to increase the uptake of health services in pregnancy and infancy, sustain themselves beyond the period of funding and become integrated within a county's health strategy. However, further investment is warranted to validate this intervention in a new region to ensure the positive effects on MNCH are a result of chamas and can be replicated. The purpose of this study is to demonstrate that chamas are an effective service-delivery platform for improving women's and children's health and well-being in western Kenya.

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
3,040

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

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

May 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

May 31, 2017

Last Update Submit

June 13, 2017

Conditions

Pregnancy Related

Keywords

community participationMaternal and child healthKenya

Outcome Measures

Primary Outcomes (1)

  • Skilled Delivery

    Proportion of women delivering in a health facility based on questionnaire

    1 year

Secondary Outcomes (4)

  • Antenatal Care

    1 year

  • Exclusive Breastfeeding

    17 months

  • Contraception

    17 months

  • Health Insurance

    1 year

Study Arms (2)

Chama cha MamaToto

EXPERIMENTAL

Women attending chamas will meet twice per month, receive social and health education from CHVs and participate in a savings/loans program.

Behavioral: Chama cha MamaToto

Control

NO INTERVENTION

The CHVs in the control group will be given refresher training on health roles they are supposed to play according to the standard MOH activities

Interventions

Chama cha MamaTotoBEHAVIORAL

Chamas are a community-led model of peer support for women in pregnancy and infancy. Chamas are highly gendered institutions that women have relied on for survival to pool resources. Using this existing cultural script, chamas have been tailored to the needs of pregnant women. Central to the approach is the integration of health, social and financial literacy education with a savings/loans program. Chamas are designed to improve MNCH by generating positive peer support for women to advocate for themselves and account for the care they receive.

Chama cha MamaToto

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women \< 28 weeks, and their newborn infants following birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trans-Nzoia MOH Health Centers

Kitale, Trans Nzoia, Kenya

RECRUITING

Related Publications (2)

  • McHenry MS, Maldonado LY, Yang Z, Anusu G, Kaluhi E, Christoffersen-Deb A, Songok JJ, Ruhl LJ. Participation in a Community-Based Women's Health Education Program and At-Risk Child Development in Rural Kenya: Developmental Screening Questionnaire Results Analysis. Glob Health Sci Pract. 2021 Dec 21;9(4):818-831. doi: 10.9745/GHSP-D-20-00349. Print 2021 Dec 31.

    PMID: 34933978DERIVED

  • Maldonado LY, Bone J, Scanlon ML, Anusu G, Chelagat S, Jumah A, Ikemeri JE, Songok JJ, Christoffersen-Deb A, Ruhl LJ. Improving maternal, newborn and child health outcomes through a community-based women's health education program: a cluster randomised controlled trial in western Kenya. BMJ Glob Health. 2020 Dec;5(12):e003370. doi: 10.1136/bmjgh-2020-003370.

    PMID: 33293295DERIVED

Study Officials

  • Astrid Christoffersen-deb, MDCM

    Moi University

    PRINCIPAL INVESTIGATOR

  • Julia Songok, MBChB, MMed

    Moi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid Christoffersen-Deb, MDCM

CONTACT

0728908167astridcdeb@gmail.com

Justus Elung'at, BSc

CONTACT

0724171419jusmeri0658@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Lecturer

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 15, 2017

Study Start

May 1, 2017

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)