Clinical trial NCT03187873: Chamas for Change Validation
Official title: Chamas for Change: Validating an Integrated Community-based Strategy of Peer Support in Pregnancy and Infancy in Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Keywords: community participation
Maternal and child health
Kenya
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Indiana University
name: AbbVie
name: Grand Challenges Canada
First posted: 2017-06-15
Enrollment: 3040
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Skilled Delivery
timeFrame: 1 year
Secondary outcomes:
measure: Antenatal Care
timeFrame: 1 year
measure: Exclusive Breastfeeding
timeFrame: 17 months
measure: Contraception
timeFrame: 17 months
measure: Health Insurance
timeFrame: 1 year
Other outcomes:
Locations:
city: Kitale
country: Kenya
facility: Trans-Nzoia MOH Health Centers
state: Trans-Nzoia
Study officials:
affiliation: Moi University
name: Astrid Christoffersen-deb, MDCM
role: PRINCIPAL_INVESTIGATOR
affiliation: Moi University
name: Julia Songok, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.