Contraceptive Awareness and Reproductive Education (CARE)

Memorial Hospital of Rhode Island

Status: Unknown

Conditions: Sexually Transmitted Diseases; Contraception; Pregnancy

Treatments: Behavioral: Motivational Interviewing; Other: Didactic Educational Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01132950

CARE 07-42

5R01HD054890 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Didactic Educational Counseling

Active Comparator group

Treatment:

Other: Didactic Educational Counseling

Motivation Interviewing

Experimental group

Description:

Participant will receive two sessions of personalized motivational interviewing.

Treatment:

Behavioral: Motivational Interviewing