Clinical trial NCT01132950: Contraceptive Awareness and Reproductive Education
Official title: Empowering Women to Make Contraceptive Choices While Incarcerated
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraception
Sexually Transmitted Diseases
Pregnancy
Lead sponsor: Memorial Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-05-28
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Contraceptive initiation
timeFrame: 5 years
measure: Continuous use of highly effective contraceptives at follow-up
timeFrame: 5 years
measure: Incident STIs
timeFrame: 5 years
Secondary outcomes:
measure: Incident pregnancy
timeFrame: 5 years
measure: Risk for unintended pregnancy and STIs
timeFrame: 5 years
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Memorial Hosptial of Rhode Island
name: Jennifer G Clarke, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.