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Contraceptive Awareness and Reproductive Education

This study is currently recruiting participants.
Verified June 2017 by Lynda Stein, Ph.D., University of Rhode Island
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627574
First Posted: June 26, 2012
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brown University
Information provided by (Responsible Party):
Lynda Stein, Ph.D., University of Rhode Island
June 15, 2012
June 26, 2012
June 5, 2017
August 2012
August 2018   (Final data collection date for primary outcome measure)
  • Timeline Followback (TLFB): Contraceptive, sexual and substance-related risk behaviors will be measured via a calendar recall for both interventions. [ Time Frame: Baseline, 3, 6, and 9 month follow-up ]
    Initiation and Continuous use of highly effective contraceptives at Baseline 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.
  • Urine Collection for STI Testing [ Time Frame: 3, 6 and 9 month follow-up ]
    Incident STIs: At baseline participants will be tested for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection.
  • 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 ]
    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 ]
    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.
Complete list of historical versions of study NCT01627574 on ClinicalTrials.gov Archive Site
  • Urine Collection for Pregnancy Testing [ Time Frame: 3, 6 and 9 month follow up ]
    The secondary outcome is pregnancy as documented by a positive pregnancy test at each follow-up visit.
  • Timeline Followback (TLFB): Contraceptive, sexual and substance-related risk behaviors will be measured via a calendar recall for both interventions. [ Time Frame: 3, 6 and 9 month follow up ]
    The secondary outcome is intercourse that is poorly protected against STIs at 3, 6, and 9 months as determined by the TLFB.
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 at-risk youth population.
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth 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 325 at risk youth from Juvenile Justice programs, alternative schools, group homes, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI 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. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Pregnancy
  • Sexually Transmitted Infections
  • Behavioral: Motivational Intervention
    There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.
    Other Name: Motivational Interviewing (MI)
  • Behavioral: Didactic Educational Intervention
    There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.
    Other Name: Awareness of Sexual Health (ASH)
  • Experimental: Motivational Intervention
    There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.
    Intervention: Behavioral: Motivational Intervention
  • Active Comparator: Didactic Educational Intervention
    There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.
    Intervention: Behavioral: Didactic Educational Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
325
October 2018
August 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1) Age 14-21;
  • 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.
Sexes Eligible for Study: Female
14 Years to 21 Years   (Child, Adult)
Yes
Contact: Lynda Stein, Ph.D. 401-874-4261 LARStein@uri.edu
United States
 
 
NCT01627574
HD065942
R01HD065942 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
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
June 2017

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