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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Sexually Transmitted Infections||Behavioral: Motivational Intervention Behavioral: Didactic Educational Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||272 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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)
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Rhode Island|
|Cranston, Rhode Island, United States, 02920|
|Principal Investigator:||Lynda Stein, Ph.D.||University of Rhode Island|