Recruiting

Observational Study

Sponsor:

Memorial Hospital of Rhode Island

Code:

NCT01132950

Conditions

Contraception

Sexually Transmitted Diseases

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Motivational Interviewing

Didactic Educational Counseling

Study Details

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.

Conditions

Contraception

Sexually Transmitted Diseases

Pregnancy

Study ID

NCT01132950

Start date

Feb, 2009

Status verified date

Sep, 2010

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Didactic Educational Counseling

experimental: Motivation Interviewing

Participant will receive two sessions of personalized motivational interviewing.

Interventions

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.

Didactic Educational Counseling

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

Primary outcome measure

  • Contraceptive initiation [ Time Frame: 5 years ]
  • Continuous use of highly effective contraceptives at follow-up [ Time Frame: 5 years ]
  • Incident STIs [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Memorial Hospital of Rhode Island

Recruiting

Pawtucket, Rhode Island, United States, 02860

Contacts

Principal Investigator:

Jennifer G Clarke, MD

Memorial Hospital of Rhode Island

Recruiting

Pawtucket, Rhode Island, United States, 02860

More Information

Sponsor

Memorial Hospital of Rhode Island

Last update posted

Sep 9, 2010

Last verified

Sep, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Hospital of Rhode Island on 2010-09-09.