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NCT Number: NCT01334190

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.

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Key information

Conditions

Contraceptive Usage Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Contraception Behavior Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Reproductive Behavior Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

FHI

Nairobi, Nairobi County, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The cumulative probability of pregnancy

    Time frame: 1 year

Secondary outcomes

  1. Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal

    Time frame: 1 year

  2. Prevalence and incidence rate of adverse events

    Time frame: 1 year

  3. The cumulative probability of early discontinuation of Zarin through one year

    Time frame: 1 year

  4. Reasons for discontinuation

    Time frame: 1 year

  5. Level of women's satisfaction with Zarin services

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 13, 2011
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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