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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
272
There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.
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.
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
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
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.
Time frame: 9 month follow-up
Number of Participants With a Positive STI Test After A Baseline Negative Test.
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.
Time frame: 9 month follow-up
Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.
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.
Time frame: 9 month follow up
Number of Participants With a Positive Pregnancy Test After Baseline Assessment
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.
Time frame: 9 month follow up
Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.
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Community Care Alliance (i.e., Community Mental Health Center)
Woonsocket, Rhode Island, United States
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.
Time frame: 9 month follow up
Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.
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.
Time frame: 9 month follow-up