NCT00584038

Brief Summary

The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

4.9 years

First QC Date

December 20, 2007

Last Update Submit

May 23, 2013

Conditions

Contraception

Keywords

contraceptive complianceeducational interventionoral contraception

Outcome Measures

Primary Outcomes (3)

  • Measurement of contraceptive adherence

    12 months

  • Measurement of dual method use

    12 months

  • Measurement of pregnancy rates and sexually transmitted diseases (STDs)

    12 months

Secondary Outcomes (3)

  • Measurement of contraceptive side effects

    12 months

  • Measurement of satisfaction with method

    12 months

  • Measurement of sexual activity

    12 months

Study Arms (3)

1 Standard Care (SC)

NO INTERVENTION

Participants receive usual contraceptive care administered by clinic provider.

2 Standard Care + Educational (SCE)

OTHER

Participants receive standard contraceptive care from clinic provider, followed by 45-minute educational intervention.

Behavioral: educational instruction in clinic

3 Standard Care + Educational + Phone Calls (SCEP)

OTHER

Participants receive standard contraceptive care from clinic provider, followed by phone calls weekly until onset of menses and monthly thereafter for six consecutive months.

Behavioral: educational instruction and phone follow-up

Interventions

educational instruction and phone follow-upBEHAVIORAL

Educational instruction and phone follow-up.

3 Standard Care + Educational + Phone Calls (SCEP)
educational instruction in clinicBEHAVIORAL

Educational instruction in clinic.

2 Standard Care + Educational (SCE)

Eligibility Criteria

Age16 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.

You may not qualify if:

  • Women who are currently pregnant or breastfeeding.
  • Women who wish to become pregnant within the next 12 months.
  • Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding).
  • Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring.
  • Current and previous users of oral contraceptives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

Related Publications (1)

  • Berenson AB, Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception. 2012 Dec;86(6):716-24. doi: 10.1016/j.contraception.2012.06.007. Epub 2012 Jul 25.

    PMID: 22840278DERIVED

MeSH Terms

Interventions

Ambulatory Care Facilities

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Abbey B. Berenson, MD

    The University of Texas Medical Branch, Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2010

Study Completion

March 1, 2012

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

US(1)