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Contraceptive Awareness and Reproductive Education

Not Applicable
Completed
Conditions
Pregnancy
Sexually Transmitted Infections
Interventions
Behavioral: Didactic Educational Intervention
Behavioral: Motivational Intervention
Registration Number
NCT01627574
Lead Sponsor
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.

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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
272
Inclusion Criteria
    1. Age 14-21;
    1. Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
    1. Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
    1. 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);
    1. Girls who are not sexually active; or
    1. Currently pregnant.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Didactic Educational InterventionDidactic Educational InterventionThere 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.
Motivational InterventionMotivational InterventionThere 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.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.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.

Number of Participants With a Positive STI Test After A Baseline Negative Test.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.

Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.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
NameTimeMethod
Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.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.

Number of Participants With a Positive Pregnancy Test After Baseline Assessment9 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.

Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.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.

Trial Locations

Locations (5)

Juvenile Probation

🇺🇸

Cranston, Rhode Island, United States

Exeter Job Corps

🇺🇸

Exeter, Rhode Island, United States

Family Services of Rhode Island (i.e. group homes)

🇺🇸

Providence, Rhode Island, United States

MET Schools (i.e., network of alternative schools throughout Providence and Newport)

🇺🇸

Providence, Rhode Island, United States

Community Care Alliance (i.e., Community Mental Health Center)

🇺🇸

Woonsocket, Rhode Island, United States

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