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Contraceptive Awareness and Reproductive Education

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ClinicalTrials.gov Identifier: NCT01627574
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : December 1, 2020
Last Update Posted : December 1, 2020
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

Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Sexually Transmitted Infections Behavioral: Motivational Intervention Behavioral: Didactic Educational Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contraceptive Awareness and Reproductive Education
Actual Study Start Date : February 2013
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. [ Time Frame: 9 month follow-up ]
    Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective.

  2. Number of Participants With a Positive STI Test After A Baseline Negative Test. [ Time Frame: 9 month follow-up ]
    Conducted STI testing 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.

  3. Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months. [ Time Frame: 9 month follow up ]
    Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months.


Secondary Outcome Measures :
  1. Number of Participants With a Positive Pregnancy Test After Baseline Assessment [ Time Frame: 9 month follow up ]
    The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks.

  2. Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs. [ Time Frame: 9 month follow up ]
    Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627574


Locations
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United States, Rhode Island
Juvenile Probation
Cranston, Rhode Island, United States, 02920
Sponsors and Collaborators
University of Rhode Island
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brown University
Investigators
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Principal Investigator: Lynda Stein, Ph.D. University of Rhode Island
  Study Documents (Full-Text)

Documents provided by Lynda Stein, Ph.D., University of Rhode Island:
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Responsible Party: Lynda Stein, Ph.D., Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01627574    
Other Study ID Numbers: HD065942
R01HD065942 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2012    Key Record Dates
Results First Posted: December 1, 2020
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Sexually Transmitted Diseases
Communicable Diseases
Infections
Disease Attributes
Pathologic Processes