Contraceptive Awareness and Reproductive Education (CARE)

Empowering Women to Make Contraceptive Choices While Incarcerated

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.

Study Overview

• Status: Unknown
• Conditions: Sexually Transmitted Diseases; Pregnancy; Contraception
• Intervention / Treatment: Other: Didactic Educational Counseling; Behavioral: Motivational Interviewing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer G Clarke, MD, MPH; Phone Number: 401-729-3400; Email: Jennifer_Clarke@mhri.org

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Recruiting
      • Memorial Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident pregnancy	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.	5 years
Risk for unintended pregnancy and STIs	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.	5 years

Collaborators and Investigators

• Sponsor: Memorial Hospital of Rhode Island
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jennifer G Clarke, MD, MPH, Memorial Hosptial of Rhode Island

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ANTICIPATED): June 1, 2012
• Study Completion (ANTICIPATED): June 1, 2013

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (ESTIMATE): May 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 8, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: CARE 07-42; 5R01HD054890 (NIH)