Providing Birth Control Through Home Health Visits

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065078
First received: July 16, 2003
Last updated: September 9, 2005
Last verified: September 2005
  Purpose

This study will evaluate a program that provides birth control to low income and minority women through home visits by a community health nurse. The goal of the program is to reduce unwanted pregnancies.


Condition Intervention
Pregnancy
Procedure: Home dispensing of contraception

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Nurse Home Contraceptive Dispensing

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Pregnancy

Secondary Outcome Measures:
  • Sexually Transmitted Disease Screening

Estimated Enrollment: 600
Study Start Date: June 2003
Estimated Study Completion Date: July 2005
Detailed Description:

Unintended pregnancy is associated with significant public health problems, including inadequate prenatal care, low birth weight infants, infant mortality, and maternal morbidity and mortality. Children born as a result of unplanned pregnancies are at greater risk for poor outcomes such as poor mental health and developmental disabilities. This research project will determine whether providing contraception in the home can reduce the incidence of unintended pregnancy in low income and minority women. The project will also determine whether delaying a pelvic exam encourages or discourages the utilization of clinic-based preventive services to screen for sexually transmitted diseases (STDs) and cervical cancer.

Participants will be randomized to either an experimental group or a comparison group. Each participant will receive family planning counseling during a home visit by a community health nurse. Participants in the experimental group will be offered a three-month supply of oral contraceptives or a depo-provera shot; both forms of contraceptives will be delivered during home visits. Each participant will complete a survey during the initial visit and during a 1-year follow-up. The study will last approximately three years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of child bearing age
  • Not pregnant
  • Interested in delaying pregnancy using oral contraceptives or a depo-provera shot
  • Had sex in the last month or are planning to have sex in the next month
  • Have not used contraception during every sexual encounter within 3 months prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065078

Locations
United States, Oregon
Clackamas County Public Health Division
Oregon City, Oregon, United States, 97045
Sponsors and Collaborators
Investigators
Principal Investigator: Alan L Melnick, MD, MPH Oregon Health and Science University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00065078     History of Changes
Other Study ID Numbers: 5R01HD42423
Study First Received: July 16, 2003
Last Updated: September 9, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Home-visits
Community nurse
Unintended pregnancy

ClinicalTrials.gov processed this record on April 16, 2014