Contraceptive Awareness and Reproductive Education
CARE
Empowering Women to Make Contraceptive Choices While Incarcerated
2 other identifiers
interventional
400
1 country
2
Brief Summary
The purpose of this study is to increase the initiation and continuation of highly effective contraceptive use while incarcerated and upon release, as well as decrease unsafe sexual activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 27, 2010
CompletedFirst Posted
Study publicly available on registry
May 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 9, 2010
September 1, 2010
3.3 years
May 27, 2010
September 8, 2010
Conditions
Outcome Measures
Primary Outcomes (3)
Contraceptive initiation
Initiation of a highly effective contraceptive method prior to release from jail will be limited to methods that are 98% or more effective in preventing pregnancy (Table 1).41 Initiation of these methods will be verified through review of the RI DOC medical records (as we have done in the past).
5 years
Continuous use of highly effective contraceptives at follow-up
If a participant switches from one highly effective contraceptive method to another she 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 confirmed through both TLFB and medical record review.
5 years
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 treated and she will be asked to follow-up in six weeks for a test for cure. Any positive test after a baseline negative test will be documented as an incident infection.
5 years
Secondary Outcomes (2)
Incident pregnancy
5 years
Risk for unintended pregnancy and STIs
5 years
Study Arms (2)
Didactic Educational Counseling
ACTIVE COMPARATORMotivation Interviewing
EXPERIMENTALParticipant will receive two sessions of personalized motivational interviewing.
Interventions
Two personalized sessions of motivational interviewing. The first one is given while the participant is in jail and the second one is given at 3 months post release.
Participant will watch an educational video while in jail and a second educational video at 3 months post release.
Eligibility Criteria
You may qualify if:
- Age 18-35;
- Currently sexually active with men defined as having coital sex at least monthly in the past three non-institutionalized months;
- Expected place of residence after release in Providence County or within 15 miles of follow-up site;
- Willing to comply with protocol, follow-up and provide at least one locator;
- Fluent in English.
You may not qualify if:
- Inability to give informed consent secondary to organic brain dysfunction, not having own legal guardianship, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that impair ability to participate in computerize assessment or counseling);
- Pregnant or trying to become pregnant within the next year;
- Hysterectomy, bilateral oophorectomy, tubal ligation, IUD or Essure (coil), implantable contraceptive devices (Implanon) or other procedures which make it very unlikely to become pregnant;
- Women who are monogamous for more than one year whose partner has had a vasectomy;
- Housed in segregation as we will be unable to recruit them for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Related Publications (1)
Clarke J, Gold MA, Simon RE, Roberts MB, Stein L. Motivational interviewing with computer assistance as an intervention to empower women to make contraceptive choices while incarcerated: study protocol for randomized controlled trial. Trials. 2012 Jul 2;13:101. doi: 10.1186/1745-6215-13-101.
PMID: 22747705DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer G Clarke, MD, MPH
Memorial Hosptial of Rhode Island
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 27, 2010
First Posted
May 28, 2010
Study Start
February 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2013
Last Updated
September 9, 2010
Record last verified: 2010-09