A Prospective Observational Study of the Performance of Zarin in Kenya

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Observational Study of the Performance of Zarin in Kenya

Conditions
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Contraceptive Usage

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative probability of pregnancy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| The cumulative probability of early discontinuation of Zarin through one year |  | 1 year | 
| Reasons for discontinuation |  | 1 year | 
| Level of women's satisfaction with Zarin services |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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