Contraceptive Awareness and Reproductive Education

This study is currently recruiting participants.
Verified March 2014 by University of Rhode Island
Sponsor:
Collaborators:
Brown University
Information provided by (Responsible Party):
Lynda Stein, Ph.D., University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01627574
First received: June 15, 2012
Last updated: March 20, 2014
Last verified: March 2014

June 15, 2012
March 20, 2014
August 2012
September 2015   (final data collection date for primary outcome measure)
  • Timeline Followback (TLFB): Contraceptive, sexual and drug-related risk behaviors will be measured via a calendar recall behavioral assessment for both. interventions. [ Time Frame: 3, 6, 9 month follow-up ] [ Designated as safety issue: No ]
    Initiation and Continuous Use of Highly Effective Contraceptives at 3, 6, and 9 Months: A participant switching from one highly effective contraceptive method to another will be recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective. Use of contraceptive methods will be assessed through the TLFB. Thus, changes from Baseline to 3, 6, and 9 month follow-ups will will be investigated.
  • Vaginal swab [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Incident STIs: At baseline participants will be tested for T. vaginalis, N. gonorrhoeae, and C. trachomatis through self obtained vaginal swabs. If a participant is diagnosed with an STI at baseline she will be referred for treatment at a Title X clinic and will be retested at her next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection.
Same as current
Complete list of historical versions of study NCT01627574 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Contraceptive Awareness and Reproductive Education
Contraceptive Awareness and Reproductive Education

The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually transmitted infections (STIs) for a highly under-served population in great need.

This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for girls involved with the justice system for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 girls from juvenile probation and randomize them to two interventions: two sessions of personalized MI combined with one session of skill building or three sessions of Didactic Educational Counseling (DEC), both delivered individually by trained counselors. CAMI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. The DEC provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Pregnancy
  • Sexually Transmitted Infections
  • Behavioral: Motivational Intervention
    There are 3, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, one week following the initial visit, and at 3 month follow-up.
  • Behavioral: Didactic Educational Counseling
    There are 3, 30-45 minute didactic sessions designed to provide information on contraception and STI prevention. The first session occurs after enrollment in the study, the second at one week following the initial visit, and the last at 3 month follow-up.
  • Experimental: Motivational Intervention
    Intervention: Behavioral: Motivational Intervention
  • Active Comparator: Didactic Educational Counseling
    There are 3, 30-45 minutes sessions of didactic information related to contraception and STI prevention. The first session occurs at the enrollment of the study, the second at one week following the initial visit, and the last at 3 month follow-up.
    Intervention: Behavioral: Didactic Educational Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
June 2016
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1) Age 13-18;
  • 2) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
  • 3) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
  • 4) Fluent in English.

Exclusion Criteria:

  • 1) Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling);
  • 2) Girls who are not sexually active; or
  • 3) Currently pregnant.
Female
13 Years to 18 Years
Yes
Contact: Lynda Stein, Ph.D. 401-874-4261 LARStein@uri.edu
United States
 
NCT01627574
HD065942, R01HD065942
Yes
Lynda Stein, Ph.D., University of Rhode Island
University of Rhode Island
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Brown University
Principal Investigator: Lynda Stein, Ph.D. University of Rhode Island
University of Rhode Island
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP