Gender EquityNCT05787392
Chamas for Change: Impact of the COVID-19 Pandemic
An observational study of Gender Equity, run by Moi University at 2 sites in Kenya.
Trial summary
In Kenya, the chamas strategy (a peer support approach aimed at improving MNCH and reducing gender and social inequalities) has been shown to significantly improve maternal and child health outcomes while also providing social and financial support to participating women. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Gender Equity
- What is being tested?
- Chamas cha MamaToto program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 444 participants
- Where
- 2 sitesKenya
- Study dates
- 14 Mar 2023to 13 Mar 2025
- Phase
- Observational
- 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 15 to 50 years
- Women only
- Child, Adult
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.
Who may be able to join
- Women who participated in the 2021 Chamas study in Western Kenya
Who cannot join
- Women who did not participate in the 2021 study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Chamas For Change: A Gender-Responsive And Microfinance-Based Approach To Empowering Women And Building Resilience To Health Emergencies in Kenya
In Kenya, the chamas strategy (a peer support approach aimed at improving MNCH and reducing gender and social inequalities) has been shown to significantly improve maternal and child health outcomes while also providing social and financial support to participating women. However, the COVID-19 pandemic caused significant disruptions in women's work and MNCH services around the world due to reallocation of health care resources, COVID-19 fears, transportation restrictions, and lockdowns. These consequences appeared to disproportionately affect the poor, particularly poor women. The purpose of this participatory action design study is to determine how Chamas participation intersected with other factors to mitigate the effects of the COVID-19 pandemic on the health and economic well-being of women and children.
Read the 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.
- Conditions
- Gender Equity
- Being tested
- Chamas cha MamaToto program
- Keywords
- participatory research, Gender equity, maternal and child well-being, Kenya, Mixed-methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chamas cha MamaToto programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Completed Chamas program | women who participated in Chamas throughout the pandemic Receives: Behavioral: Chamas cha MamaToto program | |
| Did not complete Chamas program | women who left Chamas during the pandemic Receives: Behavioral: Chamas cha MamaToto program | |
| Did not participate in Chamas program | women whose communities were randomized to not receive the Chamas intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Economic Status
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.
Measured: 1 year
Secondary outcomes (6)
Health insurance uptake
Enrolment in health insurance based on questionnaire response.
Measured: 1 year
Health service utilization
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.
Measured: 1 year
Social impact of COVID19
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
Measured: 1 year
Attitudes towards Harsh punishment
Attitude to child punishment based on questionnaire response.
Measured: 1 year
COVID-19 experiences of key informants
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.
Measured: 1 year
COVID-19 experiences
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.
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 posted28 Mar 2023
- Study start14 Mar 2023
- Primary completion13 Mar 2024 (estimated)
- Study completion13 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender EquityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moi University
- Sponsor type
- University, hospital or other
- Collaborators
- International Development Research Centre, Canada, University of British Columbia, Indiana University, University of Toronto
- Responsible party
- Principal investigator, Astrid Christoffersen-Deb, Moi University
- Investigators
- Julia Songok, Principal investigator, AMPATH KenyaSammy Masibo, Study director, Trans Nzoia county governmentMichael Scanlon, Study director, Indiana UniversityLaura Ruhl, Study director, Indiana UniversityJulie Thorne, Study director, University of TorontoViolet Naanyu, Study director, Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787392
- Sponsor's protocol ID
- MoiU7
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chamas For Change: A Gender-Responsive And Microfinance-Based Approach To Empowering Women And Building Resilience To Health Emergencies in Kenya
- ClinicalTrials.gov ID
- NCT05787392
- Acronym / sponsor ID
- MoiU7
- Conditions
- Gender Equity
- Keywords
- participatory research, Gender equity, maternal and child well-being, Kenya, Mixed-methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Moi UniversityUniversity, hospital or other
- Collaborators
- International Development Research Centre, Canada, University of British Columbia, Indiana University, University of Toronto
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 13 Mar 2024 (estimated)
- Study completion
- 13 Mar 2025 (estimated)
- First posted
- 28 Mar 2023 (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.
In Kenya, the chamas strategy (a peer support approach aimed at improving MNCH and reducing gender and social inequalities) has been shown to significantly improve maternal and child health outcomes while also providing social and financial support to participating women. However, the COVID-19 pandemic caused significant disruptions in women's work and MNCH services around the world due to reallocation of health care resources, COVID-19 fears, transportation restrictions, and lockdowns. These consequences appeared to disproportionately affect the poor, particularly poor women. The purpose of this participatory action design study is to determine how Chamas participation intersected with other factors to mitigate the effects of the COVID-19 pandemic on the health and economic well-being of women and children.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Completed Chamas program | – | Behavioral: Chamas cha MamaToto programwomen who participated in Chamas throughout the pandemic |
| Did not complete Chamas program | – | Behavioral: Chamas cha MamaToto programwomen who left Chamas during the pandemic |
| Did not participate in Chamas program | – | –women whose communities were randomized to not receive the Chamas intervention |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Women who participated in the 2021 Chamas study in Western Kenya
Key exclusion criteria (1 listed)
- Women who did not participate in the 2021 study.
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 |
|---|---|---|
| Chamas cha MamaToto programChamas 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. | Behavioural | Completed Chamas program, Did not complete Chamas program |
Primary outcome
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.
6 secondary outcomes
Health insurance uptake
Time frame: 1 year
Health service utilization
Time frame: 1 year
Social impact of COVID19
Time frame: 1 year
Attitudes towards Harsh punishment
Time frame: 1 year
COVID-19 experiences of key informants
Time frame: 1 year
COVID-19 experiences
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 25 Apr 2023.
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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.
Julia Songok principal investigator
AMPATH Kenya
Sammy Masibo study director
Trans Nzoia county government
Michael Scanlon study director
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Equity, run by Moi University at 2 sites 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Economic Status (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2023.