Pregnancy RelatedNCT03187873
Chamas for Change Validation
A study testing Chama cha MamaToto in people with Pregnancy Related, run by Moi University at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages Up to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Chama cha MamaToto
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,040 participants
- Where
- 1 siteKenya
- Study dates
- 1 May 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women < 28 weeks, and their newborn infants following birth
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Trans-Nzoia MOH Health Centers
Kitale, Trans Nzoia
Sheilah Chelagat, BA, 0706789313, sheilahchela@gmail.com
Julia Songok, MBCHb
About this study
Official title: Chamas for Change: Validating an Integrated Community-based Strategy of Peer Support in Pregnancy and Infancy in Kenya
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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Chama cha MamaToto
- Keywords
- community participation, Maternal and child health, Kenya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chama cha MamaTotoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Chama cha MamaToto | Experimental | Women attending chamas will meet twice per month, receive social and health education from CHVs and participate in a savings/loans program. Receives: Behavioral: Chama cha MamaToto |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skilled Delivery
Proportion of women delivering in a health facility based on questionnaire
Measured: 1 year
Secondary outcomes (4)
Antenatal Care
Proportion of women attending 4 or more ANC visits based on questionnaire
Measured: 1 year
Exclusive Breastfeeding
Proportion of women introducing solid foods after 6 months of age based on questionnaire
Measured: 17 months
Contraception
Proportion of women initiating Long-Acting Reversible Contraception based on questionnaire
Measured: 17 months
Health Insurance
Proportion of women with Health Insurance based on questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 May 2017
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moi University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Indiana University, AbbVie, Grand Challenges Canada
- Responsible party
- Principal investigator, Astrid Christoffersen-Deb, Moi University
- Investigators
- Astrid Christoffersen-deb, MDCM, Principal investigator, Moi UniversityJulia Songok, MBChB, MMed, Principal investigator, Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187873
- Sponsor's protocol ID
- MoiU1
- Status last verified
- Jun 2017
- First submitted
- 31 May 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34933978Maldonado 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.
PubMed 33293295
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chamas for Change: Validating an Integrated Community-based Strategy of Peer Support in Pregnancy and Infancy in Kenya
- ClinicalTrials.gov ID
- NCT03187873
- Acronym / sponsor ID
- MoiU1
- Conditions
- Pregnancy Related
- Keywords
- community participation, Maternal and child health, Kenya
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,040 participants (estimated)
- Lead sponsor
- Moi UniversityUniversity, hospital or other
- Collaborators
- University of Toronto, Indiana University, AbbVie, Grand Challenges Canada
- Study start
- 1 May 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chama cha MamaToto | Experimental | Behavioral: Chama cha MamaTotoWomen attending chamas will meet twice per month, receive social and health education from CHVs and participate in a savings/loans program. |
| Control | No intervention | –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 |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women < 28 weeks, and their newborn infants following birth
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chama cha MamaTotoChamas 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. | Behavioural | Chama cha MamaToto |
Primary outcome
Skilled Delivery
Time frame: 1 year
Proportion of women delivering in a health facility based on questionnaire
4 secondary outcomes
Antenatal Care
Time frame: 1 year
Exclusive Breastfeeding
Time frame: 17 months
Contraception
Time frame: 17 months
Health Insurance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Derived from this study: PubMed 34933978McHenry 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.
- Derived from this study: PubMed 33293295Maldonado 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Christoffersen-deb, MDCM principal investigator
Moi University
Julia Songok, MBChB, MMed principal investigator
Moi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chama cha MamaToto in people with Pregnancy Related, run by Moi University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Astrid Christoffersen-Deb, MDCM (0728908167, astridcdeb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skilled Delivery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187873, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.