Trial Outcomes & Findings for Contraceptive Awareness and Reproductive Education (NCT NCT01627574)

Last Updated: 2025-02-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

272 participants

Primary outcome timeframe

9 month follow-up

Results posted on

2025-02-25

Participant Flow

This project enrolled 272 at-risk females aged 14-21. Participants were eligible if they had sexual intercourse with a male partner in the past four months, were not pregnant and intended to have intercourse with a male in the next 6 months. Recruitment began in February of 2013 and the last participant was recruited in August of 2017.

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.
Overall Study STARTED	142	130
Overall Study COMPLETED	121	112
Overall Study NOT COMPLETED	21	18

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	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. 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.
Overall Study Withdrawal by Subject	8	5
Overall Study Lost to Follow-up	13	13

Baseline Characteristics

Contraceptive Awareness and Reproductive Education

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motivational Intervention n=142 Participants 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. 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.	Didactic Educational Intervention n=130 Participants 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. 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.	Total n=272 Participants Total of all reporting groups
Age, Continuous	16.97 years STANDARD_DEVIATION 1.71 • n=5 Participants	16.99 years STANDARD_DEVIATION 1.70 • n=7 Participants	16.98 years STANDARD_DEVIATION 1.70 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	130 Participants n=7 Participants	272 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	69 Participants n=5 Participants	51 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	79 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Race (NIH/OMB) More than one race	52 Participants n=5 Participants	40 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	142 participants n=5 Participants	130 participants n=7 Participants	272 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 month follow-up

Population: Continuous use of highly effective birth control is defined as those who are using effective birth control for 6 months or more. Thus this analysis only includes participants who initiated effective birth control for at least 6 months of data collection.

Outcome measures

Outcome measures
Measure	Motivational Intervention n=112 Participants 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. 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.	Didactic Educational Intervention n=94 Participants 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. 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.
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.	39 Participants	29 Participants

PRIMARY outcome

Timeframe: 9 month follow-up

Population: Analysis conducted on all participants who provided a urine sample at baseline. 1 participant refused.

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.

Outcome measures

Outcome measures
Measure	Motivational Intervention n=142 Participants 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. 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.	Didactic Educational Intervention n=129 Participants 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. 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.
Number of Participants With a Positive STI Test After A Baseline Negative Test.	18 Participants	13 Participants

PRIMARY outcome

Timeframe: 9 month follow up

Population: Analysis conducted on participants who initiated highly effective contraceptive use post treatment intervention. Those who initiated highly effective contraceptives at baseline (pre treatment) were not included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Motivational Intervention n=85 Participants 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. 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.	Didactic Educational Intervention n=77 Participants 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. 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.
Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.	61 Participants	51 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Motivational Intervention n=142 Participants 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. 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.	Didactic Educational Intervention n=130 Participants 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. 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.
Number of Participants With a Positive Pregnancy Test After Baseline Assessment	6 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Motivational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Didactic Educational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lynda Stein, Ph.D.

University of Rhode Island

Phone: 401-874-2830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place