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Contraceptive Awareness and Reproductive Education

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Lynda Stein, Ph.D., University of Rhode Island
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01627574
First received: June 15, 2012
Last updated: June 1, 2017
Last verified: June 2017
  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 at-risk youth population.

Condition Intervention
Pregnancy Sexually Transmitted Infections Behavioral: Motivational Intervention Behavioral: Didactic Educational Intervention

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

Resource links provided by NLM:


Further study details as provided by Lynda Stein, Ph.D., University of Rhode Island:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 325
Actual Study Start Date: August 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
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)

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brown University
Investigators
Principal Investigator: Lynda Stein, Ph.D. University of Rhode Island
  More Information

Responsible Party: Lynda Stein, Ph.D., Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01627574     History of Changes
Other Study ID Numbers: HD065942
R01HD065942 ( U.S. NIH Grant/Contract )
Study First Received: June 15, 2012
Last Updated: June 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lynda Stein, Ph.D., 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

ClinicalTrials.gov processed this record on August 17, 2017