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Contraceptive Awareness and Reproductive Education (CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132950
Recruitment Status : Unknown
Verified September 2010 by Memorial Hospital of Rhode Island.
Recruitment status was:  Recruiting
First Posted : May 28, 2010
Last Update Posted : September 9, 2010
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
Memorial Hospital of Rhode Island

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.

Condition or disease Intervention/treatment Phase
Contraception Sexually Transmitted Diseases Pregnancy Behavioral: Motivational Interviewing Other: Didactic Educational Counseling Not Applicable

Detailed Description:
Unplanned pregnancies and sexually transmitted infections are important and costly public health problems in the United States resulting from unprotected sexual activity. Women with a history of incarceration are at increased risk for these problems given the high rates of substance abuse and commercial sex work in this population. This proposal is designed to evaluate an innovative intervention Motivational Interviewing with Computer Assistance (MICA) designed to improve contraceptive use for incarcerated women who do not want a pregnancy and are soon to be released into the community. The investigators will utilize the Title X program which, in conjunction with RI Department of Corrections (RI DOC), provides reproductive health services in jail and then transitional services in the community after release. The investigators plan to recruit 400 women from the RI DOC women's jail and randomize them to two interventions: two sessions of personalized MICA or two sessions of Didactic Educational Counseling (DEC), both delivered individually by trained counselors. The two counseling interventions will be similar in length and timing, but will vary in content, counseling style and the individualized computer generated feedback that is reviewed with the counselor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Empowering Women to Make Contraceptive Choices While Incarcerated
Study Start Date : February 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2013

Arm Intervention/treatment
Active Comparator: Didactic Educational Counseling Other: Didactic Educational Counseling
Participant will watch an educational video while in jail and a second educational video at 3 months post release.

Experimental: Motivation Interviewing
Participant will receive two sessions of personalized motivational interviewing.
Behavioral: Motivational Interviewing
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.

Primary Outcome Measures :
  1. Contraceptive initiation [ Time Frame: 5 years ]
    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).

  2. Continuous use of highly effective contraceptives at follow-up [ Time Frame: 5 years ]
    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.

  3. Incident STIs [ Time Frame: 5 years ]
    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.

Secondary Outcome Measures :
  1. Incident pregnancy [ Time Frame: 5 years ]
    An incident pregnancy will be defined as having occurred if there is a baseline negative pregnancy test and a positive urine Beta-HCG test through the study or a self reported pregnancy confirmed with a positive urine or serum Beta-hCG test through medical record review during the time of study participation. If a participant reports a positive pregnancy test outside of the study then she will be asked to sign a release of medical information form and a copy of the test results will be obtained.

  2. Risk for unintended pregnancy and STIs [ Time Frame: 5 years ]
    Risk behaviors will be determined through the TLFB. No or low risk for an unintended pregnancy will include either continuous use of a highly effective contraceptive method, abstinence, or use of a condom with a spermicide during every act of intercourse. No or low risk for STIs include abstinence or use of a condom with every act of intercourse and with every partner.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age 18-35;
  2. Currently sexually active with men defined as having coital sex at least monthly in the past three non-institutionalized months;
  3. Expected place of residence after release in Providence County or within 15 miles of follow-up site;
  4. Willing to comply with protocol, follow-up and provide at least one locator;
  5. Fluent in English.

Exclusion Criteria:

  1. 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);
  2. Pregnant or trying to become pregnant within the next year;
  3. Hysterectomy, bilateral oophorectomy, tubal ligation, IUD or Essure (coil), implantable contraceptive devices (Implanon) or other procedures which make it very unlikely to become pregnant;
  4. Women who are monogamous for more than one year whose partner has had a vasectomy;
  5. Housed in segregation as we will be unable to recruit them for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132950

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Contact: Jennifer G Clarke, MD, MPH 401-729-3400
Contact: Jennifer A Mello, MPH 401-729-3573

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United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Jennifer G Clarke, MD    401-729-3400   
Contact: Jennifer A Mello, MPH    401-729-3573   
Principal Investigator: Jennifer G Clarke, MD         
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Memorial Hospital of Rhode Island
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Jennifer G Clarke, MD, MPH Memorial Hosptial of Rhode Island
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jennifer G. Clarke, MD, MPH, Memorial Hospital of Rhode Island Identifier: NCT01132950    
Other Study ID Numbers: CARE 07-42
5R01HD054890 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Communicable Diseases
Disease Attributes
Pathologic Processes