NCT00140296

Brief Summary

Consistent and correct use of an effective contraceptive method is a primary determinant in preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately address women's contraceptive needs. We have developed a standardized behavioral-based contraceptive counseling model that can be used by providers and other clinic staff to address this limitation. The model, ESP, is an adaptation of motivational interviewing and involves: Exploring discrepancies between pregnancy intention and contraceptive use and between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce risk. Study question: Does ESP counseling lead to an increase in consistency and effectiveness of contraceptive use among women at risk of unintended pregnancy? Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in North Carolina. Intervention participants received individualized ESP counseling from a health educator to address barriers to effective and consistent contraceptive use. Risk reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were assessed at baseline and follow-up. "Highly effective" contraceptive use was defined as a combination of effectiveness and consistency. Women in the control arm received general preventive health counseling (e.g., smoking and exercise). Differences between the study arms at 12-months may illustrate the longer term influence of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
747

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

September 1, 2005

Status Verified

August 1, 2005

First QC Date

August 30, 2005

Last Update Submit

August 30, 2005

Conditions

PregnancyChlamydia

Outcome Measures

Primary Outcomes (3)

  • Contraceptive use

  • Chlamydia infection

  • Pregnancy

Interventions

Contraceptive counselingBEHAVIORAL

Eligibility Criteria

Age16 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women aged 16-44
  • English-speaking
  • Do not wish to be pregnant or unsure of pregnancy intention
  • Have an appointment for non-acute care
  • Currently using no method of contraception, inconsistent use of methods, pills, condoms, diaphragms, periodic abstinence, or methods associated with higher pregnancy rates
  • Ability to read at least at 8th grade level
  • Willing to participate in follow-up visits at 2, 8, and 12 months
  • Able to be contacted by telephone

You may not qualify if:

  • Women less than 16 or greater than 44 years
  • Women who are sterilized, or whose partners are sterilized or who use the IUD for contraception
  • Appointments for acute care
  • Non-English speaking
  • Inability to read at or above 8th grade level
  • Pregnant at time of enrollment
  • Lack of ability for telephone contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Women's Health Research, Universoty of North Carolina

Chapel Hill, North Carolina, 27599-7521, United States

Location

Related Publications (1)

  • Petersen R, Payne P, Albright J, Holland H, Cabral R, Curtis KM. Applying motivational interviewing to contraceptive counseling: ESP for clinicians. Contraception. 2004 Mar;69(3):213-7. doi: 10.1016/j.contraception.2003.10.007.

    PMID: 14969669BACKGROUND

MeSH Terms

Conditions

Chlamydia Infections

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Ruth Petersen, MD, MPH

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

March 1, 2003

Study Completion

September 1, 2005

Last Updated

September 1, 2005

Record last verified: 2005-08

Locations

US(1)