Clinical trial NCT01226433: Family Planning Through Dairy Cooperatives
Official title: Providing Family Planning Services Sustainably Through Dairy Cooperatives in Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Study Goal is to Assess the Introduction of Sustainable Family Planning/Reproductive Health Information and Services Through
Land O' Lakes-supported Dairy Cooperatives
Keywords: 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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2010-10-22
Enrollment: 319
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females aged 18-49

Brief 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.

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

Exclusion Criteria:

-

Primary outcomes:
measure: Health Services Research
timeFrame: 1 year
Secondary outcomes:
measure: Health Services Research
timeFrame: 1 year
Other outcomes:
Locations:
city: Various
country: Kenya
facility: 5 Community Outreach Events
state: Rift Valley & Central
Study officials:
affiliation: FHI 360
name: John Bratt, MPP, MA
role: PRINCIPAL_INVESTIGATOR
References: