- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188250
Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya
June 14, 2017 updated by: Astrid Christoffersen-Deb, Moi University
Increasing Pregnancy Health Services Uptake Through Integrated Peer Support Groups in Kenya: A Prospective Cohort Study
Preventing maternal and newborn deaths remain high on the global agenda.
To address this, the Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women together in pregnancy and infancy.
Central to the chama approach is the integration of health, social and financial literacy education with a savings/loans program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To evaluate the feasibility of chamas, we analysed group attendance rates, GISE participation, membership retention, and continuation of the groups beyond the one year.
To evaluate the effect of chamas, the investigators compared data from a prospective cohort of women in chamas with a group of controls who did not belong to a chama, matched for age, parity, and location of prenatal care.
To evaluate the acceptability of chamas, FGDs were carried out with chama and non-chama participants, health providers and community health workers.
Study Type
Interventional
Enrollment (Actual)
515
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant women in communities where chamas were taking place
- Any woman attending chama
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chama cha MamaToto
Pregnant women in communities where chama cha mamatoto is taking place will be invited to join and participate in bi-weekly group meetings for a year
|
Chama cha Mamatoto is a community-based model of peer support group in pregnancy and infancy that combines health education, relationship building and a savings and loans program, led by community health workers
|
No Intervention: Referent
Pregnant women attending at least one prenatal visit in communities where chama cha mamatoto was implemented three months later served as the comparison
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facility delivery
Time Frame: 22 months
|
Proportion of women giving birth in a health facility based on questionnaire
|
22 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
4 ANC visits
Time Frame: 22 months
|
attendance at 4 or more ANC visits in pregnancy based on questionnaire
|
22 months
|
CHV homevisit
Time Frame: 22 months
|
CHW homevisit within 48 hours of birth based on questionnaire
|
22 months
|
Exclusive breastfeeding
Time Frame: 22 months
|
Initiation of solids to the infant after 6 months based on questionnaire
|
22 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Astrid Christoffersen-Deb, MDCM, Moi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
May 31, 2017
First Submitted That Met QC Criteria
June 14, 2017
First Posted (Actual)
June 15, 2017
Study Record Updates
Last Update Posted (Actual)
June 15, 2017
Last Update Submitted That Met QC Criteria
June 14, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- UMoi3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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