Clinical trial NCT01334190: A Prospective Observational Study of the Performance of Zarin in Kenya
Official title: A Prospective Observational Study of the Performance of Zarin in Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraceptive Usage
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
post-marketing monitoring
safety
efficacy
acceptability
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2011-04-13
Enrollment: 602
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy women aged 18-44

Brief summary: This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and
* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Detailed description: A non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and
* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Eligibility criteria: Inclusion Criteria:

* be aged 18-44 years, inclusive
* be willing to sign an informed consent document
* be willing to give contact information for follow up
* agree to return for follow-up visits
* have decided to receive Zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception

Primary outcomes:
measure: The cumulative probability of pregnancy
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal
timeFrame: 1 year
measure: Prevalence and incidence rate of adverse events
timeFrame: 1 year
measure: The cumulative probability of early discontinuation of Zarin through one year
timeFrame: 1 year
measure: Reasons for discontinuation
timeFrame: 1 year
measure: Level of women's satisfaction with Zarin services
timeFrame: 1 year
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: FHI
Study officials:
affiliation: FHI 360
name: Vera Halpern, MD
role: PRINCIPAL_INVESTIGATOR
References: