N/A Completed N=272 Randomized Double-blind Treatment

Contraceptive Awareness and Reproductive Education

Pregnancy · Sexually Transmitted Infections

Source: ClinicalTrials.gov NCT01627574 ↗

Enrolled (actual)

272

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcomePrimary: Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. — 39; 29 Participants — p=>.05

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.	39; 29	>.05
PRIMARY Number of Participants With a Positive STI Test After A Baseline Negative Test.	18; 13	—
PRIMARY Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.	61; 51	—
SECONDARY Number of Participants With a Positive Pregnancy Test After Baseline Assessment	6; 10	—
SECONDARY Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.	—	—
SECONDARY Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.	—	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01627574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.