Contraceptive Awareness and Reproductive Education
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 population in great need.
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for girls involved with the justice system 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 250 girls from juvenile probation and randomize them to two interventions: two sessions of personalized MI combined with one session of skill building or three sessions of Didactic Educational Counseling (DEC), both delivered individually by trained counselors. CAMI 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. The DEC provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy Sexually Transmitted Infections |
Behavioral: Motivational Intervention Behavioral: Didactic Educational Counseling |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Contraceptive Awareness and Reproductive Education |
- Timeline Followback (TLFB): Contraceptive, sexual and drug-related risk behaviors will be measured via a calendar recall behavioral assessment for both. interventions. [ Time Frame: 3, 6, 9 month follow-up ] [ Designated as safety issue: No ]Initiation and Continuous Use of Highly Effective Contraceptives at 3, 6, and 9 Months: A participant switching from one highly effective contraceptive method to another will be recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective. Use of contraceptive methods will be assessed through the TLFB. Thus, changes from Baseline to 3, 6, and 9 month follow-ups will will be investigated.
- Vaginal swab [ Time Frame: Baseline ] [ Designated as safety issue: No ]Incident STIs: At baseline participants will be tested for T. vaginalis, N. gonorrhoeae, and C. trachomatis through self obtained vaginal swabs. If a participant is diagnosed with an STI at baseline she will be referred for treatment at a Title X clinic and will be retested at her next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection.
| Estimated Enrollment: | 250 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Motivational Intervention |
Behavioral: Motivational Intervention
There are 3, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, one week following the initial visit, and at 3 month follow-up.
|
|
Active Comparator: Didactic Educational Counseling
There are 3, 30-45 minutes sessions of didactic information related to contraception and STI prevention. The first session occurs at the enrollment of the study, the second at one week following the initial visit, and the last at 3 month follow-up.
|
Behavioral: Didactic Educational Counseling
There are 3, 30-45 minute didactic sessions designed to provide information on contraception and STI prevention. The first session occurs after enrollment in the study, the second at one week following the initial visit, and the last at 3 month follow-up.
|
Eligibility| Ages Eligible for Study: | 13 Years to 18 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 1) Age 13-18;
- 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.
Contacts and Locations| Contact: Lynda Stein, Ph.D. | 401-874-4261 | LARStein@uri.edu |
| United States, Rhode Island | |
| Juvenile Probation | Recruiting |
| Cranston, Rhode Island, United States, 02920 | |
| Principal Investigator: Lynda Stein, Ph.D. | |
| Principal Investigator: | Lynda Stein, Ph.D. | University of Rhode Island |
More Information
No publications provided
| Responsible Party: | Lynda Stein, Ph.D., Professor, University of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT01627574 History of Changes |
| Other Study ID Numbers: | HD065942, R01HD065942 |
| Study First Received: | June 15, 2012 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rhode Island:
|
Pregnancy STI prevention adolescents probation |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013