A Prospective Observational Study of the Performance of Zarin in Kenya

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.

Study Overview

• Status: Completed
• Conditions: Contraceptive Usage

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.

• Study Type: Observational
• Enrollment (Actual): 602

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • FHI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

healthy women aged 18-44

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The cumulative probability of pregnancy	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence and incidence rate of adverse events	1 year
Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal	1 year
Reasons for discontinuation	1 year
The cumulative probability of early discontinuation of Zarin through one year	1 year
Level of women's satisfaction with Zarin services	1 year

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: United States Agency for International Development (USAID)
• Investigators: Principal Investigator: Vera Halpern, MD, FHI 360

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (Estimate): April 13, 2011

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: July 1, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: safety; efficacy; acceptability; 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; 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; IU international units; post-marketing monitoring
• Other Study ID Numbers: 10264 (Other Identifier: CTEP)