NCT01020552

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 29, 2010

Status Verified

April 1, 2010

Enrollment Period

7 months

First QC Date

November 18, 2009

Last Update Submit

April 28, 2010

Conditions

Postabortion Care

Keywords

APHIA IIAIDS, Population, and Health Integrated Assistance projectDCFdata collection formsFDAFederal Drug AdministrationFPfamily planningIRBInstitutional Review BoardPACpostabortion careTo document the ESD PAC svc pkg including the provision of services, client satisfaction with those services and provider attitudes towards PAC servicesTo examine any differences in implementation of the ESD PAC services package for youth and adult clientsTo assess the usefulness of five Youth-Friendly PAC Job Aids developed by ESD

Outcome Measures

Primary Outcomes (1)

  • Knowledge, attitudes, and practice regarding PAC job aids (clients and providers)

    Anticipated end of data collection 12/31/09

Secondary Outcomes (1)

  • Client-report of provider counseling, by client age

    Anticipated end of analysis/report writing 4/28/10

Interventions

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

Facility-level intervention applied to all study facilities

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

non healthy participants

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Gatundu District Hospital

Gatundu, Central, Kenya

Location

Karatina District Hospital

Karatina, Central, Kenya

Location

Kerugoya District Hospital

Kerugoya, Central, Kenya

Location

Muranga District Hospital

Muranga, Central, Kenya

Location

Thika District Hospital

Thika, Central, Kenya

Location

Tigoni District Hospital

Tigoni, Central, Kenya

Location

Muthethania Maternity

Nairobi, Nairobi-West, Kenya

Location

Mbagathi District Hospital

Nairobi, West, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Emily Evens, MPH

    FHI 360

    PRINCIPAL INVESTIGATOR

  • Rose Otieno-Masaba, MD

    Family Health International - Nairobi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 25, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 29, 2010

Record last verified: 2010-04

Locations

KE(8)