- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627574
Contraceptive Awareness and Reproductive Education
February 8, 2024 updated by: Lynda Stein, Ph.D., University of Rhode Island
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
272
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Cranston, Rhode Island, United States, 02920
- Juvenile Probation
-
Exeter, Rhode Island, United States, 02882
- Exeter Job Corps
-
Providence, Rhode Island, United States, 02905
- Family Services of Rhode Island (i.e. group homes)
-
Providence, Rhode Island, United States, 02905
- MET Schools (i.e., network of alternative schools throughout Providence and Newport)
-
Woonsocket, Rhode Island, United States, 02895
- Community Care Alliance (i.e., Community Mental Health Center)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9 month follow-up
|
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.
|
9 month follow-up
|
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.
|
9 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9 month follow up
|
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.
|
9 month follow up
|
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.
|
9 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynda Stein, Ph.D., University of Rhode Island
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2013
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
June 15, 2012
First Submitted That Met QC Criteria
June 25, 2012
First Posted (Estimated)
June 26, 2012
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD065942
- R01HD065942 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
-
Turku University HospitalUniversity of TurkuCompleted
-
Centre Hospitalier René DubosCompletedDeciduitis; Complicating Pregnancy
Clinical Trials on Motivational Intervention
-
San Diego State UniversityCompletedDrug AbuseUnited States
-
Jordi Gol i Gurina FoundationUniversity Rovira i VirgiliUnknown
-
Louis BhererCompleted
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Instituto de Salud Carlos IIIUnknown
-
Rhode Island HospitalNational Institute on Drug Abuse (NIDA)CompletedHepatitis C | HIV | Drug UseUnited States
-
Centers for Disease Control and PreventionUnknownAccidents, Traffic
-
VA Connecticut Healthcare SystemUnknown
-
Oregon Health and Science UniversityCompletedMotivation | Ultraviolet RaysUnited States
-
University of Wisconsin, MadisonNational Institute on Aging (NIA)Completed
-
University of CalgaryCompleted