Contraceptive Awareness and Reproductive Education

NCT01627574 | Completed Results DMC

• 2 other identifiers: HD065942R01HD065942
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Pregnancy; Sexually Transmitted Infections

Keywords

Pregnancy; STI prevention; adolescents; probation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  9 month follow up

Secondary Outcomes (3)

• Number of Participants With a Positive Pregnancy Test After Baseline Assessment

  9 month follow up

• Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.

  9 month follow up

• Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.

  9 month follow-up

Study Arms (2)

Motivational Intervention

EXPERIMENTAL

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

Didactic Educational Intervention

ACTIVE COMPARATOR

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

Interventions

Motivational Intervention BEHAVIORAL

There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.

Also known as: Motivational Interviewing (MI)

Motivational Intervention

Didactic Educational Intervention BEHAVIORAL

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.

Also known as: Awareness of Sexual Health (ASH)

Didactic Educational Intervention

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) Age 14-21;
• \) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
• \) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
• \) Fluent in English.

You may not qualify if:

• \) 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);
• \) Girls who are not sexually active; or
• \) Currently pregnant.

Sponsors & Collaborators

• University of Rhode Island: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Brown University: collaborator

Study Sites (5)

Juvenile Probation

Cranston, Rhode Island, 02920, United States

Location

Exeter Job Corps

Exeter, Rhode Island, 02882, United States

Location

Family Services of Rhode Island (i.e. group homes)

Providence, Rhode Island, 02905, United States

Location

MET Schools (i.e., network of alternative schools throughout Providence and Newport)

Providence, Rhode Island, 02905, United States

Location

Community Care Alliance (i.e., Community Mental Health Center)

Woonsocket, Rhode Island, 02895, United States

Location

Related Publications (1)

• Delaney DJ, Stein LAR, Bassett SS, Clarke JG. Motivational interviewing for family planning and reducing risky sexual behavior among incarcerated men nearing release: A randomized controlled pilot study. Psychol Serv. 2023 Aug;20(3):538-552. doi: 10.1037/ser0000552. Epub 2021 Nov 4.

  PMID: 34735198 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Lynda Stein, Ph.D.
• Organization: University of Rhode Island

lmurphy@uri.edu

401-874-2830

Study Officials

• Lynda Stein, Ph.D.

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 26, 2012
• Study Start: February 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 25, 2025
• Results First Posted: December 1, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)