Providing Birth Control Through Home Health Visits

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00065078
Collaborator
(none)
600
1
25
24

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Home dispensing of contraception
N/A

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effectiveness of Nurse Home Contraceptive Dispensing
Study Start Date :
Jun 1, 2003
Study Completion Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Pregnancy []

Secondary Outcome Measures

  1. Sexually Transmitted Disease Screening []

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Clackamas County Public Health Division Oregon City Oregon United States 97045

Sponsors and Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Alan L Melnick, MD, MPH, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00065078
Other Study ID Numbers:
  • 5R01HD042423
First Posted:
Jul 18, 2003
Last Update Posted:
Sep 13, 2005
Last Verified:
Sep 1, 2005

Study Results

No Results Posted as of Sep 13, 2005