Family Planning Through Dairy Cooperatives

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01226433
First received: October 8, 2010
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

This observational study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya.


Condition
The Study Goal is to Assess the Introduction of Sustainable Family Planning/Reproductive Health Information and Services Through
Land O' Lakes-supported Dairy Cooperatives

Study Type: Observational
Official Title: Providing Family Planning Services Sustainably Through Dairy Cooperatives in Kenya

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Health Services Research [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Unmet need for family planning among women attending Field Days aged 18-49


Secondary Outcome Measures:
  • Health Services Research [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Interest in receiving health services through Field Day model


Enrollment: 319
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Access to family planning and other reproductive health services remains difficult in much of rural Kenya. One option for improving rural access to family planning is to use existing community events outside of the health sector as platforms for delivering information and services. This study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya. During these events, known as Field Days, a healthcare provider will have a tent in which Field Day attendees can receive basic family health services free of charge. The services offered will be: family planning counseling and methods, immunizations, antenatal care, screening and treatment for sexually transmitted infections, and HIV counseling and testing. Since the services are no different than those that could be obtained at Ministry of Health or some private facilities, the service provision is not considered to be part of the research.

Women receiving any service from the health care provider will be recruited for an interview that will measure their demand for family planning and attitudes about receiving services during the field day. In addition, the study will track the number of different types of services provided, the total number of Field Day attendees, and the cost of the service model. The study will be carried out at five Field Days in Rift Valley and Central provinces.

Participants will not be tested for STI/HIV as part of this research; however, at their request, they may have received a test from the provider prior to the research interview. At the time of consent, they will have already received the test, so the consent form will not include anything specific to testing. In Kenya, all STI/HIV test results are reported to the national public health authorities. These reports are not used for contacting patients but for planning purposes.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Females aged 18-49

Criteria

Inclusion Criteria:females aged 18-49 receiving health services at a field day event -

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226433

Locations
Kenya
5 Community Outreach Events
Various, Rift Valley & Central, Kenya
Sponsors and Collaborators
FHI 360
United States Agency for International Development (USAID)
Investigators
Principal Investigator: John Bratt, MPP, MA FHI 360
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01226433     History of Changes
Other Study ID Numbers: 10227
Study First Received: October 8, 2010
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board
Kenya: Kenya Medical Research Institute Ethics Review Board

Keywords provided by FHI 360:
AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonisation
IND Investigational New Drug Application
IRB Institutional Review Board
IU International units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
WB Western Blot

ClinicalTrials.gov processed this record on April 16, 2014