- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787392
Chamas for Change: Impact of the COVID-19 Pandemic
Chamas For Change: A Gender-Responsive And Microfinance-Based Approach To Empowering Women And Building Resilience To Health Emergencies in Kenya
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study objectives are:
To evaluate the effect of Chama participation on mitigating the effects of the pandemic on social and gender equity.
- Impact on economic status (assessed using the changes in the Poverty Probability index scores)
- Impact on health service utilization and behaviours (assessed using enrollment in the national health insurance scheme, number of ANC visits attended, facility delivery, maternal death, newborn death, infant death, exclusive breastfeeding, number of children fully immunized at age 1)
- Social attitudes and well-being (assessed using, attitude towards harsh punishment of children, level of parental stress)
- COVID-19 related information (assessed using COVID-19 infection, COVID-19 vaccination, and effects of COVID restrictions)
To use an equity-centered design process and narrative approach to share research findings.
The research team intends to evaluate women's experiences during the pandemic using a mixed method approach and a participatory action design method. The focus will be on 3 study cohorts: (1) women who participated in Chamas throughout the pandemic, (2) women who left Chamas during the pandemic, (3) women whose communities were randomized to not receive the Chamas intervention. To better understand the effects of Chama participation on study outcomes, we will conduct an interviewer-administered survey among the described cohorts of women. This will be followed by qualitative studies to contextualize the study findings and investigate gender dynamics as social processes. Focus group discussions (FGDs) and key informant interviews (KIIs) will be conducted to further investigate our study cohort's experiences during the pandemic and identify strategies used by participants to mitigate the negative effects of the pandemic and its associated restrictions.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Kiminini, Kenya
- Trans Nzoia county
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Kitale, Kenya
- Trans-Nzoia County
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
This research will be conducted in Trans-Nzoia County among the 1400 women that participated in the 2021 RCT study. The following groups will be included in our study population.
- RCT women who participated in Chamas throughout the pandemic.
- Women who left Chamas after March 12, 2020, the date the first case of COVID-19 was discovered in Kenya.
- Women whose communities were randomly assigned not to use Chamas during the RCT.
- CHVs in communities that had or did not have Chamas operating during the pandemic.
- County health officials.
- Fathers participating in Chama cha Babatoto.
- Adolescent girls are currently participating in Chamas adapted for adolescents.
Description
Inclusion Criteria:
- Women who participated in the 2021 Chamas study in Western Kenya
Exclusion Criteria:
- Women who did not participate in the 2021 study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Completed Chamas program
women who participated in Chamas throughout the pandemic
|
Chamas is a community health volunteer (CHV)-led group programme that engages women during pregnancy and the first 1000 days of their child's life.
The strategy focuses on promoting maternal, newborn, and child health (MNCH) by providing health education, peer support, and opportunities to access financial capital, all while addressing inequities that perpetuate poor outcomes.
|
|
Did not complete Chamas program
women who left Chamas during the pandemic
|
Chamas is a community health volunteer (CHV)-led group programme that engages women during pregnancy and the first 1000 days of their child's life.
The strategy focuses on promoting maternal, newborn, and child health (MNCH) by providing health education, peer support, and opportunities to access financial capital, all while addressing inequities that perpetuate poor outcomes.
|
|
Did not participate in Chamas program
women whose communities were randomized to not receive the Chamas intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Economic Status
Time Frame: 1 year
|
Impact of COVID-19 pandemic on the women's economic well-being based on Poverty property Index (PPI) scores obtained from 10 questions in the questionnaire.
The PPI is a relative scale in which each response is assigned a value, and the sum of the values is the participant's PPI score.
The participant's PPI is then compared with the country level score using the "look-up table" for the country (Kenya) to determine the participant's likelihood of being poor.
The investigators will compare the PPI scores at the post-pandemic period between the three cohorts in the study.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health insurance uptake
Time Frame: 1 year
|
Enrolment in health insurance based on questionnaire response.
|
1 year
|
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Health service utilization
Time Frame: 1 year
|
Use of health services during the COVID-19 pandemic based on questionnaire response to questions assessing use of healthcare services during the COVID-19 pandemic.
|
1 year
|
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Social impact of COVID19
Time Frame: 1 year
|
Parenting stress based on parental stress index scale scores in questionnaire.
Overall possible scores on the scale range from 18 - 90.
The higher the score, the higher the measured level of Parental stress
|
1 year
|
|
Attitudes towards Harsh punishment
Time Frame: 1 year
|
Attitude to child punishment based on questionnaire response.
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1 year
|
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COVID-19 experiences of key informants
Time Frame: 1 year
|
Experiences of the community during the COVID pandemic from the perspective of key informants will be explored based on qualitative interviews.
Questions to explore how different genders experienced the pandemic will be specifically explored.
The gender considerations will include an assessment of how gender interacts with resource access, the roles each gender plays in society, societal expectations, and power dynamics.
It also includes evaluating the ways in which gender power relations manifest to create inequities and/or differences in experiences during the pandemic.
|
1 year
|
|
COVID-19 experiences
Time Frame: 1 year
|
Experiences of the community during the COVID pandemic from the perspective of the three cohorts of women in the study will be explored based on qualitative focus group discussions.
Questions to explore how different genders experienced the pandemic will be specifically explored.
The gender considerations will include an assessment of how gender interacts with resource access, the roles each gender plays in society, societal expectations, and power dynamics.
It also includes evaluating the ways in which gender power relations manifest to create inequities and/or differences in experiences during the pandemic.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia Songok, AMPATH Kenya
- Study Director: Michael Scanlon, Indiana University
- Study Director: Laura Ruhl, Indiana University
- Study Director: Julie Thorne, University of Toronto
- Study Director: Violet Naanyu, Moi University
- Study Director: Sammy Masibo, Trans Nzoia county government
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MoiU7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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