ContraceptionCARENCT01132950
Contraceptive Awareness and Reproductive Education
A study testing Motivational Interviewing and Didactic Educational Counseling in people with Contraception and Sexually Transmitted Diseases, run by Memorial Hospital of Rhode Island at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Sexually Transmitted Diseases, Pregnancy
- What is being tested?
- Motivational Interviewing and Didactic Educational Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
Jennifer G Clarke, MD, 401-729-3400, Jennifer_Clarke@mhri.org
Jennifer A Mello, MPH, 401-729-3573, Jennifer_Mello@mhri.org
- Recruiting
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
About this study
Official title: Empowering Women to Make Contraceptive Choices While Incarcerated
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.
Read the 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.
- Conditions
- Contraception, Sexually Transmitted Diseases, Pregnancy
- Being tested
- Motivational Interviewing, Didactic Educational Counseling
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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 CounselingOther
Participant will watch an educational video while in jail and a second educational video at 3 months post release.
| Study group | Role | What they receive |
|---|---|---|
| Didactic Educational Counseling | Active comparator | Not described Receives: Other: Didactic Educational Counseling |
| Motivation Interviewing | Experimental | Participant will receive two sessions of personalized motivational interviewing. Receives: Behavioral: Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 5 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startFeb 2009
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Jennifer G Clarke, MD, MPH, Principal investigator, Memorial Hosptial of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132950
- Sponsor's protocol ID
- CARE 07-42
- Other IDs
- 5R01HD054890
- Acronym
- CARE
- Status last verified
- Sep 2010
- First submitted
- 27 May 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22747705
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Women to Make Contraceptive Choices While Incarcerated
- ClinicalTrials.gov ID
- NCT01132950
- Acronym / sponsor ID
- CARE / CARE 07-42
- Conditions
- Contraception, Sexually Transmitted Diseases, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Memorial Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Didactic Educational Counseling | Active comparator | Other: Didactic Educational Counseling |
| Motivation Interviewing | Experimental | Behavioral: Motivational InterviewingParticipant will receive two sessions of personalized motivational interviewing. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingTwo 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. | Behavioural | Motivation Interviewing |
| Didactic Educational CounselingParticipant will watch an educational video while in jail and a second educational video at 3 months post release. | Other | Didactic Educational Counseling |
Primary outcome
Contraceptive initiation
Time frame: 5 years
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).
Continuous use of highly effective contraceptives at follow-up
Time frame: 5 years
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.
Incident STIs
Time frame: 5 years
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.
2 secondary outcomes
Incident pregnancy
Time frame: 5 years
Risk for unintended pregnancy and STIs
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
- Derived from this study: PubMed 22747705Clarke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer G Clarke, MD, MPH principal investigator
Memorial Hosptial of Rhode Island
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Didactic Educational Counseling in people with Contraception and Sexually Transmitted Diseases, run by Memorial Hospital of Rhode Island at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer G Clarke, MD, MPH (401-729-3400, Jennifer_Clarke@mhri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive initiation (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2010.