Contraceptive Awareness and Reproductive Education

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Pregnancy
Sexually Transmitted Infections
Behavioral: Motivational Intervention
Behavioral: Didactic Educational Counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contraceptive Awareness and Reproductive Education

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Intervention 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.
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.
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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627574

Contacts
Contact: Lynda Stein, Ph.D. 401-874-4261 LARStein@uri.edu

Locations
United States, Rhode Island
Juvenile Probation Recruiting
Cranston, Rhode Island, United States, 02920
Principal Investigator: Lynda Stein, Ph.D.         
Sponsors and Collaborators
University of Rhode Island
Brown University
Investigators
Principal Investigator: Lynda Stein, Ph.D. University of Rhode Island
  More Information

No publications provided

Responsible Party: Lynda Stein, Ph.D., Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01627574     History of Changes
Other Study ID Numbers: HD065942, R01HD065942
Study First Received: June 15, 2012
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
Pregnancy
STI prevention
adolescents
probation

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014