A Prospective Observational Study of the Performance of Z... | NCT01334190

Studies
A Prospective Observational Study of the Performance of Zarin in Kenya

NCT01334190

Sponsor

FHI 360

Status

Completed

Last Update Posted

Jul 2, 2013Estimated

Enrollment

602Actual

Phase

Not provided

Conditions

Contraceptive Usage

Interventions

Not provided

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Apr 11, 2011

First Submission Date that Met QC Criteria

Apr 12, 2011

First Posted Date

Apr 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2013

Last Update Posted Date

Jul 2, 2013Estimated

Name	Class
United States Agency for International Development (USAID)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

602Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The cumulative probability of pregnancy		1 year

Secondary Outcomes

Measure	Description	Time Frame
Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal		1 year
Prevalence and incidence rate of adverse events		1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

healthy women aged 18-44

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vera Halpern, MD	FHI 360	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FHI		Nairobi	Nairobi County		Kenya

Condition Browse Module

MeSH Terms

ID	Term
D003268	Contraception Behavior
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D043762	Reproductive Behavior
D001519	Behavior
D015658	HIV Infections
D000086982	Blood-Borne Infections

Browse Leaves

Not provided

Browse Branches

Not provided