Contraceptive Awareness and Reproductive Education

Study Overview
=================
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.

Official Title
-----------------
Empowering Women to Make Contraceptive Choices While Incarcerated

Conditions
-----------------
Contraception, Sexually Transmitted Diseases, Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing
* Other: Didactic Educational Counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Didactic Educational Counseling<br> | Other: Didactic Educational Counseling<br>* Participant will watch an educational video while in jail and a second educational video at 3 months post release.<br>|
| Experimental: Motivation Interviewing<br>Participant will receive two sessions of personalized motivational interviewing. | Behavioral: Motivational Interviewing<br>* 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.<br>|

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 |