Chamas for Change Validation

Moi University

Status: Unknown

Conditions: Pregnancy Related

Treatments: Behavioral: Chama cha MamaToto

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03187873

MoiU1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,040 estimated patients

Sex: All

Ages: Under 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,040 participants in 2 patient groups

Chama cha MamaToto

Experimental group

Description:

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

Treatment:

Behavioral: Chama cha MamaToto

Control

No Intervention group

Description:

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