Chamas for Change Validation

Pregnancy Related Clinical Trial

Official title:

Chamas for Change: Validating an Integrated Community-based Strategy of Peer Support in Pregnancy and Infancy in Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03187873
• Other study ID #: MoiU1
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2017
• Last updated: June 13, 2017
• Start date: May 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Moi University
• Contact: Astrid Christoffersen-Deb, MDCM
• Phone: 0728908167
• Email: astridcdeb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3040
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Behavioral:
• Chama cha MamaToto
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.

Locations

Country	Name	City	State
Kenya	Trans-Nzoia MOH Health Centers	Kitale	Trans-Nzoia

Sponsors (5)

Lead Sponsor	Collaborator
Moi University	AbbVie, Grand Challenges Canada, Indiana University, University of Toronto

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skilled Delivery	Proportion of women delivering in a health facility based on questionnaire	1 year
Secondary	Antenatal Care	Proportion of women attending 4 or more ANC visits based on questionnaire	1 year
Secondary	Exclusive Breastfeeding	Proportion of women introducing solid foods after 6 months of age based on questionnaire	17 months
Secondary	Contraception	Proportion of women initiating Long-Acting Reversible Contraception based on questionnaire	17 months
Secondary	Health Insurance	Proportion of women with Health Insurance based on questionnaire	1 year