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Contraceptive Awareness and Reproductive Education

NCT ID: NCT01132950

Last Updated: 2010-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Contraception Sexually Transmitted Diseases Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Didactic Educational Counseling

Group Type ACTIVE_COMPARATOR

Didactic Educational Counseling

Intervention Type OTHER

Participant will watch an educational video while in jail and a second educational video at 3 months post release.

Motivation Interviewing

Participant will receive two sessions of personalized motivational interviewing.

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Didactic Educational Counseling

Participant will watch an educational video while in jail and a second educational video at 3 months post release.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Memorial Hospital of Rhode Island

Principal Investigators

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Jennifer G Clarke, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Memorial Hosptial of Rhode Island

Locations

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Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status RECRUITING

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer G Clarke, MD, MPH

Role: CONTACT

[email protected]
401-729-3400

Jennifer A Mello, MPH

Role: CONTACT

[email protected]
401-729-3573

Facility Contacts

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Jennifer G Clarke, MD

Role: primary

[email protected]
401-729-3400

Jennifer A Mello, MPH

Role: backup

[email protected]
401-729-3573

References

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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.

Reference Type DERIVED
PMID: 22747705 (View on PubMed)

Other Identifiers

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5R01HD054890

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CARE 07-42

Identifier Type: -

Identifier Source: org_study_id