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Completed

NCT Number: NCT01627574

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.

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Key information

Conditions

Pregnancy Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Infections Urogenital Diseases

Age range

14 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Juvenile Probation, Cranston, Rhode Island, United States

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About this study

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 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Intervention

Behavioral

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 names: Motivational Interviewing (MI)

Didactic Educational Intervention

Behavioral

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 names: Awareness of Sexual Health (ASH)

Primary outcomes

  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 outcomes

  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.

  3. Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.

    Time frame: 9 month follow-up

    Using the Timeline Follow-back (TLFB): Condom and substance use were measured via a calendar recall for both interventions. Participants indicate whether or not condoms and substances were used each time sex was reported.

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Collaborators

  • Brown University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2012
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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