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Contraceptive Awareness and Reproductive Education (CARE)

Primary Purpose

Contraception, Sexually Transmitted Diseases, Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Didactic Educational Counseling
Sponsored by
Memorial Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contraception

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Hospital of Rhode IslandRecruiting
  • Memorial Hospital of Rhode IslandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Didactic Educational Counseling

Motivation Interviewing

Arm Description

Participant will receive two sessions of personalized motivational interviewing.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 27, 2010
Last Updated
September 8, 2010
Sponsor
Memorial Hospital of Rhode Island
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01132950
Brief Title
Contraceptive Awareness and Reproductive Education
Acronym
CARE
Official Title
Empowering Women to Make Contraceptive Choices While Incarcerated
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Hospital of Rhode Island
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Sexually Transmitted Diseases, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Didactic Educational Counseling
Arm Type
Active Comparator
Arm Title
Motivation Interviewing
Arm Type
Experimental
Arm Description
Participant will receive two sessions of personalized motivational interviewing.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Didactic Educational Counseling
Intervention Description
Participant will watch an educational video while in jail and a second educational video at 3 months post release.
Primary Outcome Measure Information:
Title
Contraceptive initiation
Description
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).
Time Frame
5 years
Title
Continuous use of highly effective contraceptives at follow-up
Description
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.
Time Frame
5 years
Title
Incident STIs
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Incident pregnancy
Description
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.
Time Frame
5 years
Title
Risk for unintended pregnancy and STIs
Description
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.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer G Clarke, MD, MPH
Phone
401-729-3400
Email
Jennifer_Clarke@mhri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer A Mello, MPH
Phone
401-729-3573
Email
Jennifer_Mello@mhri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer G Clarke, MD, MPH
Organizational Affiliation
Memorial Hosptial of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer G Clarke, MD
Phone
401-729-3400
Email
Jennifer_Clarke@mhri.org
First Name & Middle Initial & Last Name & Degree
Jennifer A Mello, MPH
Phone
401-729-3573
Email
Jennifer_Mello@mhri.org
First Name & Middle Initial & Last Name & Degree
Jennifer G Clarke, MD
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
22747705
Citation
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.
Results Reference
derived

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Contraceptive Awareness and Reproductive Education

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