Nurse Family Partnership (NFP) Contraceptive Study

NCT00928538 | Completed Phase 4

• 1 other identifier: 832
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether nurses can help at-risk women reduce the incidence of unintended pregnancy by providing them access to hormonal contraceptives in their homes.

Conditions

Pregnancy; Effective Contraceptive Use; Family Planning

Keywords

Female Contraception; Home Visits; CONTRACEPTIVE AGENTS; CONTRACEPTIVE DEVICES

Outcome Measures

Primary Outcomes (1)

• One month gaps in effective contraceptive use (defined as methods with which < 10% of women experience an accidental pregnancy during a year of typical use)

  Every three months after delivery for two years

Secondary Outcomes (1)

• Unintended pregnancy

  Every three months after delivery for two years

Study Arms (2)

Usual NFP Care

NO INTERVENTION

Usual NFP care includes pregnancy planning and contraceptive advice during nurse home visits, with the prescription and dispensing of contraceptives provided through the women's primary care settings.

Enhanced NFP Care

EXPERIMENTAL

Enhanced NFP intervention includes usual NFP care plus the intervention that includes contraceptive administration and distribution in the home

Other: Enhanced NFP Care

Interventions

Enhanced NFP Care OTHER

Usual NFP care plus the enhanced care that includes contraceptive administration and distribution during nurse home visits. Participants will have a choice of combined hormonal contraception (oral, patches or vaginal rings)or progestin-only contraception (oral or depomedroxyprogesterone acetate injections.

Enhanced NFP Care

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English or Spanish speaking (or both)
• Enrolled in the NFP (Nurse Family Partnership) program
• weeks or less gestation.

You may not qualify if:

• Not enrolled in the NFP program
• More than 32 weeks gestation

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Colorado, Denver: collaborator
• Clark County Department of Public Health: collaborator
• Thurston County Department of Public Health and Social Services: collaborator
• Public Health - Seattle and King County: collaborator

Study Sites (3)

Thurston County Public Health

Olympia, Washington, 98506, United States

Location

Seattle - King County Public Health

Seattle, Washington, United States

Location

Clark County Public Health

Vancouver, Washington, 98666, United States

Location

Related Publications (2)

• Melnick AL, Rdesinski RE, Creach ED, Choi D, Harvey SM. The influence of nurse home visits, including provision of 3 months of contraceptives and contraceptive counseling, on perceived barriers to contraceptive use and contraceptive use self-efficacy. Womens Health Issues. 2008 Nov-Dec;18(6):471-81. doi: 10.1016/j.whi.2008.07.011. Epub 2008 Oct 15.

  PMID: 18926726 BACKGROUND

• Rdesinski RE, Melnick AL, Creach ED, Cozzens J, Carney PA. The costs of recruitment and retention of women from community-based programs into a randomized controlled contraceptive study. J Health Care Poor Underserved. 2008 May;19(2):639-51. doi: 10.1353/hpu.0.0016.

  PMID: 18469433 BACKGROUND

Study Officials

• Alan L Melnick, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

US (3)