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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01226433
Other study ID # 10227
Secondary ID
Status Completed
Phase N/A
First received October 8, 2010
Last updated March 28, 2013
Start date October 2010
Est. completion date December 2010

Study information

Verified date March 2013
Source FHI 360
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardKenya: Kenya Medical Research Institute Ethics Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 319
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:females aged 18-49 receiving health services at a field day event -

Exclusion Criteria:

Study Design

N/A


Related Conditions & MeSH terms

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

Locations

Country Name City State
Kenya 5 Community Outreach Events Various Rift Valley & Central

Sponsors (2)

Lead Sponsor Collaborator
FHI 360 United States Agency for International Development (USAID)

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health Services Research Unmet need for family planning among women attending Field Days aged 18-49 1 year No
Secondary Health Services Research Interest in receiving health services through Field Day model 1 year No