Clinical trial NCT05787392: Chamas for Change: Impact of the COVID-19 Pandemic
Official title: Chamas For Change: A Gender-Responsive And Microfinance-Based Approach To Empowering Women And Building Resilience To Health Emergencies in Kenya
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Equity
Keywords: participatory research
Gender equity
maternal and child well-being
Kenya
Mixed-methods
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: International Development Research Centre, Canada
name: University of British Columbia
name: Indiana University
name: University of Toronto
First posted: 2023-03-28
Enrollment: 444
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Women who participated in the 2021 Chamas study in Western Kenya

Exclusion Criteria:

* Women who did not participate in the 2021 study.

Primary outcomes:
measure: Economic Status
timeFrame: 1 year
Secondary outcomes:
measure: Health insurance uptake
timeFrame: 1 year
measure: Health service utilization
timeFrame: 1 year
measure: Social impact of COVID19
timeFrame: 1 year
measure: Attitudes towards Harsh punishment
timeFrame: 1 year
measure: COVID-19 experiences of key informants
timeFrame: 1 year
measure: COVID-19 experiences
timeFrame: 1 year
Other outcomes:
Locations:
city: Kiminini
country: Kenya
facility: Trans Nzoia county
city: Kitale
country: Kenya
facility: Trans-Nzoia County
Study officials:
affiliation: AMPATH Kenya
name: Julia Songok
role: PRINCIPAL_INVESTIGATOR
affiliation: Trans Nzoia county government
name: Sammy Masibo
role: STUDY_DIRECTOR
affiliation: Indiana University
name: Michael Scanlon
role: STUDY_DIRECTOR
affiliation: Indiana University
name: Laura Ruhl
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Julie Thorne
role: STUDY_DIRECTOR
affiliation: Moi University
name: Violet Naanyu
role: STUDY_DIRECTOR
References: