Integrating Family Planning Into Postabortion Care | NCT01020552

Studies
Integrating Family Planning Into Postabortion Care

NCT01020552

Sponsor

FHI 360

Status

Completed

Last Update Posted

Apr 29, 2010Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Postabortion Care

Interventions

Provision of PAC job aids and provider training on the use of the job aids

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

Apr 2010

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

Sep 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Nov 18, 2009

First Submission Date that Met QC Criteria

Nov 24, 2009

First Posted Date

Nov 25, 2009Estimated

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

Apr 28, 2010

Last Update Posted Date

Apr 29, 2010Estimated

Name	Class
Pathfinder International	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A descriptive post-intervention study designed to provide data to decision-makers at the Kenyan Ministry of Health, the Extending Service Delivery Project (ESD), and Pathfinder International about whether and how to scale-up the ESD Project's postabortion care (PAC) services package. Approximately three months of data will be collected following the introduction of postabortion care job aids in eight public sector health facilities in Central Province and Nairobi, Kenya. Postabortion clients and providers will be interviewed; facilities providing PAC services will be inventoried using facility checklists.

Detailed Description

Conditions Module

Conditions

Postabortion Care

Keywords

APHIA II
AIDS, Population, and Health Integrated Assistance project
DCF
data collection forms
FDA
Federal Drug Administration
FP
family planning
IRB
Institutional Review Board
PAC
postabortion care
To document the ESD PAC svc pkg including the provision of services, client satisfaction with those services and provider attitudes towards PAC services
To examine any differences in implementation of the ESD PAC services package for youth and adult clients
To assess the usefulness of five Youth-Friendly PAC Job Aids developed by ESD

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Provision of PAC job aids and provider training on the use of the job aids	Other	Facility-level intervention applied to all study facilities

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knowledge, attitudes, and practice regarding PAC job aids (clients and providers)		Anticipated end of data collection 12/31/09

Secondary Outcomes

Measure	Description	Time Frame
Client-report of provider counseling, by client age		Anticipated end of analysis/report writing 4/28/10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For Facilities: APHIA II facilities supported by the ESD project in Central Province and Nairobi, Kenya where: (1) PAC services are provided, (2) at least one provider has received PAC and Youth-friendly PAC training, (3) Community mobilization has been initiated, (4) PAC equipment and supplies have been procured, (5) PAC job aids have been distributed.
For Clients: Women aged 15 years or older who have received PAC services at a study facility and who have a telephone on which they can be contacted
For Providers: Any person who offers PAC services at a study facility

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

non healthy participants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emily Evens, MPH	FHI 360	Principal Investigator
Rose Otieno-Masaba, MD	Family Health International - Nairobi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gatundu District Hospital		Gatundu	Central		Kenya
Karatina District Hospital

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided