NCT03188237

Brief Summary

This proposal is a program evaluation of a group care delivery model designed for pregnant women that was implemented as a pilot project in Teso District, Kenya in 2012.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

May 31, 2017

Last Update Submit

June 14, 2017

Conditions

Pregnancy RelatedGroup, Peer

Outcome Measures

Primary Outcomes (1)

  • Facility 4 Antenatal Care (ANC) visits

    Average monthly number 4 or more ANC facility visits

    18 months

Secondary Outcomes (4)

  • Facility New Family Planning (FP)

    18 months

  • Facility Total FP

    18 months

  • Facility Delivery Rate

    18 months

  • Facility Oral Polio Vaccine 0 (OPV0)

    18 months

Study Arms (2)

AfyaJamii facility

EXPERIMENTAL

Facilities using AfyaJamii

Behavioral: AfyaJamii

Referent facility

NO INTERVENTION

Facilities using Focused Antenatal Care Individual Model

Interventions

AfyaJamiiBEHAVIORAL

AfyaJamii is a group antenatal and well-child care program developed in Kenya for use in Kenyan health centers

AfyaJamii facility

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All facilities that participated in AfyaJamii

You may not qualify if:

  • Any facility that did not offer AfyaJamii and was not been selected as a comparison facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teso North Ministry of Health Centers

Kocholya, Kenya

Location

Study Officials

  • Julia Songok, MBChB

    Moi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: AfyaJamii is a group care model in pregnancy facilitated by Government of Kenya (GOK) Community Health Volunteers (CHVs) and Ministry of Health (MOH) nurses. Pregnant women are assigned to specific care groups according to their Expected Date of Delivery (EDD) and meet 3 times antenatally and 4 times postnatally. These groups are meant to provide women with antenatal and postnatal care, peer support, and knowledge to improve their health outcomes and the health outcomes of their infants. This model of group prenatal and postnatal care is being evaluated as an alternative to the existing policy of focused antenatal care that individualizes care to a single woman at a time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Lecturer

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 15, 2017

Study Start

January 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)