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Contraceptive Awareness and Reproductive Education

Primary Purpose

Pregnancy, Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Intervention
Didactic Educational Intervention
Sponsored by
University of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, STI prevention, adolescents, probation

Eligibility Criteria

14 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Juvenile Probation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Intervention

Didactic Educational Intervention

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2012
Last Updated
May 16, 2022
Sponsor
University of Rhode Island
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT01627574
Brief Title
Contraceptive Awareness and Reproductive Education
Official Title
Contraceptive Awareness and Reproductive Education
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rhode Island
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 325 at risk youth from Juvenile Justice programs, alternative schools, group homes, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Sexually Transmitted Infections
Keywords
Pregnancy, STI prevention, adolescents, probation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Didactic Educational Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Intervention
Other Intervention Name(s)
Motivational Interviewing (MI)
Intervention Description
There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Didactic Educational Intervention
Other Intervention Name(s)
Awareness of Sexual Health (ASH)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
Description
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.
Time Frame
9 month follow-up
Title
Number of Participants With a Positive STI Test After A Baseline Negative Test.
Description
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.
Time Frame
9 month follow-up
Title
Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.
Description
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.
Time Frame
9 month follow up
Secondary Outcome Measure Information:
Title
Number of Participants With a Positive Pregnancy Test After Baseline Assessment
Description
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.
Time Frame
9 month follow up
Title
Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.
Description
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.
Time Frame
9 month follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda Stein, Ph.D.
Organizational Affiliation
University of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juvenile Probation
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34735198
Citation
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.
Results Reference
derived

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Contraceptive Awareness and Reproductive Education

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