Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05111899 |
| Other study ID # |
STUDY00006942 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 11, 2022 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary objective of the study is to determine the impact of a behavior change
intervention that partners Orthodox priests with members of the Health Development Army (HDA)
and train them to conduct newborn health outreach to increase rates of early initiation of
and exclusive breastfeeding through 6 months and vaccination coverage at six months.
Secondary objectives include:
- Determine the impact of the intervention on infant growth at six months, observed and
self-reported changes in nutrition and feeding practices of mother and infants, and
early identification of newborn illness.
- Design a culturally relevant, scalable intervention for community-based newborn and
infant health in Gondar in partnership with local partners, the Federal Ministry of
Health, and the Gondar Regional Health Bureau.
Description:
The study will test a model the leverages existing community networks to improve the health
of newborns in Gondar, Ethiopia. The intervention will be implemented at the community level
by pairs of trained Ethiopian Orthodox priests and members of the Heath Development Army
(HDA). A list of priests serving at the EOC churches in the intervention arm will be obtained
through the woreda diocese and their respective churches. All the priests will be contacted
through the church leadership and asked to participate in the study intervention. The
intervention will be implemented in collaboration with HDA members recruited by HEWs under
the health centers in the catchment areas of the intervention churches.
An initial 5 day training will be given to priests and HDA members. The training will focus
on newborn health topics including early initiation of and exclusive breastfeeding, maternal
nutrition, immunization, childhood illnesses, child health care services, etc. At the end of
the training action plans will be prepared by the training organizers, priests, and HDA.
Priest will be asked to integrate health messages and education into their routine family
visits around the birth of a child in structured intervals as culturally appropriate.
The trained priests and HDA members will be dispatched to their respective communities to
begin the intervention. Their primary activities will be identification of near-term pregnant
and newly delivered women, providing health education to their families, follow-up visits to
enable newborn-mother pairs to access child health care services, and to provide health
education at religious and community gatherings. Specifically, pre-planned visits of
parishioners' families will be done by the respective priests and the partnering HDA members
during the last month of pregnancy, immediately after the delivery of the baby and around the
time of baptism for the newborn. These visits will be used to educate pregnant and postpartum
women and their families on newborn health topics including initiation of breastfeeding,
duration of breastfeeding/ exclusive breastfeeding, vaccination, cord care, and utilization
of available newborn health care services. These community based activities will be monitored
through regular follow-up visits by the UoG study team and discussions with priests and HDA
members.
Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to
the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will
start one month following the start of the intervention and all reported newborn-mother pairs
who meet the screening criteria will be included in the study until the calculated sample
sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit
and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria
will be reported to the study team at the University of Gondar (UoG) who will travel to the
study site regularly for recruitment of study participants and data collection.
Newborn-mother pairs will be reported to the UoG study team both through phone calls made by
HEWs and in-person at the time of regular onsite visits by the team.
Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to
the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will
start one month following the start of the intervention and all reported newborn-mother pairs
who meet the screening criteria will be included in the study until the calculated sample
sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit
and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria
will be reported to the study team at the University of Gondar (UoG) who will travel to the
study site regularly for recruitment of study participants and data collection.
Newborn-mother pairs will be reported to the UoG study team both through phone calls made by
HEWs and in-person at the time of regular onsite visits by the team.
Eligible newborn-mother pairs will be visited by a member of the study team at their home or
at an appointed meeting location in their community to complete the verbal informed consent
process. Those pairs who attend church at a parish that received the intervention will be
assigned to the intervention arm, and those from the parishes where no intervention was
conducted will be assigned to the control arm. Initial baseline data will then be collected
and follow-up visit schedules arranged with the study team.
