Chamas for Change Validation

Not Applicable

• Conditions: Pregnancy Related
• Interventions: Behavioral: Chama cha MamaToto

• Registration Number: NCT03187873
• Lead Sponsor: Moi University

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.

Detailed Description

The objectives are:

To test the effectiveness of chamas as an intervention on improving:

* Health services uptake (Facility delivery, attendance of 4 or more ANC visits, Visit by a CHV within 48 hours of birth, immunization uptake at 6 months-of-age, long-term FP uptake)

* Health behaviors and care practices (exclusive breastfeeding to 6 months)

* Women's Empowerment, peer support, parental stress, and harsh punishmennt within the home

* Maternal and infant morbidity (low birth weight, diarrhea in the last month, preterm deliveries)

* Maternal, perinatal, neonatal and infant mortality

To perform a qualitative evaluation to better understand women's and CHV's experience with chamas and understand how chamas affect peer support

To perform a process evaluation

To perform a cost effectiveness analysis on chamas.

The investigators plan to use a cluster randomized controlled design because the intervention is delivered in groups that are based within Community Units (CUs). We know that some of the positive effects of chamas expand to the community surrounding the chama. By randomizing clusters, we will hope to isolate these communities in order to understand the individual effects of chamas. The unit of randomization and implementation will be Community Units (CU). Because there are only 77 of the 163 CUs with active Community Health Workers trained by AMPATH, we will draw our intervention and control groups from these active units. By doing this, the control group is receiving the standard of care per the MOH and AMPATH community strategy. We will randomly assign each of the 77 active CUs in the four sub-counties to the chama intervention (arm 1) or to act as a control region (arm 2). We will evaluate individual outcomes on women enrolled in the study. The CUs that do not participate in the study will serve as buffer areas.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-31
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-15
• Last Update Posted: 2017-06-15
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3040

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Skilled Delivery	1 year	Proportion of women delivering in a health facility based on questionnaire

Secondary Outcome Measures

Name	Time	Method
Health Insurance	1 year	Proportion of women with Health Insurance based on questionnaire
Antenatal Care	1 year	Proportion of women attending 4 or more ANC visits based on questionnaire
Exclusive Breastfeeding	17 months	Proportion of women introducing solid foods after 6 months of age based on questionnaire
Contraception	17 months	Proportion of women initiating Long-Acting Reversible Contraception based on questionnaire

Trial Locations

Locations (1)

Trans-Nzoia MOH Health Centers; 🇰🇪 Kitale, Trans-Nzoia, Kenya