AfyaJamii (Parenting Well): Evaluating the Feasibility of... | NCT03188237

Studies
AfyaJamii (Parenting Well): Evaluating the Feasibility of a Group Antenatal/Well-child Care Model in Pregnancy in Kenya

NCT03188237

Sponsor

Moi University

Status

Completed

Last Update Posted

Jun 15, 2017Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Pregnancy Related
Group, Peer

Interventions

AfyaJamii

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

May 31, 2017

First Submission Date that Met QC Criteria

Jun 14, 2017

First Posted Date

Jun 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2017

Last Update Posted Date

Jun 15, 2017Actual

Name	Class
Grand Challenges Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The investigators will carry out a pre/post evaluation of this program comparing maternal and child health indicators collected at the facility and at 10 comparison facilities in the year prior to implementation (2012) and throughout the duration of the program (2013-2014). They will also analyze program attendance records, anonymous exit surveys, and training records.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AfyaJamii facility	Experimental	Facilities using AfyaJamii	Behavioral: AfyaJamii
Referent facility	No Intervention	Facilities using Focused Antenatal Care Individual Model

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AfyaJamii	Behavioral	AfyaJamii is a group antenatal and well-child care program developed in Kenya for use in Kenyan health centers	AfyaJamii facility

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Facility 4 Antenatal Care (ANC) visits	Average monthly number 4 or more ANC facility visits	18 months

Secondary Outcomes

Measure	Description	Time Frame
Facility New Family Planning (FP)	Average monthly number new FP visits	18 months
Facility Total FP	Average monthly number total FP visits

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All facilities that participated in AfyaJamii

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julia Songok, MBChB	Moi University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Teso North Ministry of Health Centers		Kocholya			Kenya

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

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.