PregnancyNCT01627574
Contraceptive Awareness and Reproductive Education
A study testing Motivational Intervention and Didactic Educational Intervention in people with Pregnancy and Sexually Transmitted Infections, run by University of Rhode Island at 5 sites in United States.
Trial summary
The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population. Read more about this study
- Who is it for?
- Ages 14 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Sexually Transmitted Infections
- What is being tested?
- Motivational Intervention and Didactic Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2013to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1) Age 14-21;
- 2) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
- 3) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
- 4) Fluent in English.
Who cannot join
- 1) Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling);
- 2) Girls who are not sexually active; or
- 3) Currently pregnant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Juvenile Probation
Cranston, Rhode Island, 02920
Exeter Job Corps
Exeter, Rhode Island, 02882
Family Services of Rhode Island (i.e. group homes)
Providence, Rhode Island, 02905
MET Schools (i.e., network of alternative schools throughout Providence and Newport)
Providence, Rhode Island, 02905
Community Care Alliance (i.e., Community Mental Health Center)
Woonsocket, Rhode Island, 02895
About this study
The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.
Read the detailed description
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.
- Conditions
- Pregnancy, Sexually Transmitted Infections
- Being tested
- Motivational Intervention, Didactic Educational Intervention
- Keywords
- Pregnancy, STI prevention, adolescents, probation
- 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 InterventionBehavioural
Also called Motivational Interviewing (MI)
There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.
Didactic Educational InterventionBehavioural
Also called Awareness of Sexual Health (ASH)
There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Intervention | Experimental | There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. Receives: Behavioral: Motivational Intervention |
| Didactic Educational Intervention | Active comparator | There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. Receives: Behavioral: Didactic Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective.
Measured: 9 month follow-up
Number of Participants With a Positive STI Test After A Baseline Negative Test.
Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection.
Measured: 9 month follow-up
Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.
Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months.
Measured: 9 month follow up
Secondary outcomes (3)
Number of Participants With a Positive Pregnancy Test After Baseline Assessment
The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks.
Measured: 9 month follow up
Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.
Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported.
Measured: 9 month follow up
Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.
Using the Timeline Follow-back (TLFB): Condom and substance use were measured via a calendar recall for both interventions. Participants indicate whether or not condoms and substances were used each time sex was reported.
Measured: 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startFeb 2013
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brown University
- Responsible party
- Principal investigator, Lynda Stein, Ph.D., University of Rhode Island
- Investigators
- Lynda Stein, Ph.D., Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627574
- Sponsor's protocol ID
- HD065942
- Other IDs
- R01HD065942
- Status last verified
- Feb 2025
- First submitted
- 15 Jun 2012
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delaney DJ, Stein LAR, Bassett SS, Clarke JG. Motivational interviewing for family planning and reducing risky sexual behavior among incarcerated men nearing release: A randomized controlled pilot study. Psychol Serv. 2023 Aug;20(3):538-552. doi: 10.1037/ser0000552. Epub 2021 Nov 4.
PubMed 34735198
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Awareness and Reproductive Education
- ClinicalTrials.gov ID
- NCT01627574
- Acronym / sponsor ID
- HD065942
- Conditions
- Pregnancy, Sexually Transmitted Infections
- Keywords
- Pregnancy, STI prevention, adolescents, probation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Brown University
- Study start
- Feb 2013 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Posted 1 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.
Detailed description
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Intervention | Experimental | Behavioral: Motivational InterventionThere are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. |
| Didactic Educational Intervention | Active comparator | Behavioral: Didactic Educational InterventionThere are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 1) Age 14-21;
- 2) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
- 3) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
- 4) Fluent in English.
Key exclusion criteria (3 listed)
- 1) Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling);
- 2) Girls who are not sexually active; or
- 3) Currently pregnant.
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 InterventionAlso: Motivational Interviewing (MI)There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up. | Behavioural | Motivational Intervention |
| Didactic Educational InterventionAlso: Awareness of Sexual Health (ASH)There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up. | Behavioural | Didactic Educational Intervention |
Primary outcome
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
Time frame: 9 month follow-up
Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective.
Number of Participants With a Positive STI Test After A Baseline Negative Test.
Time frame: 9 month follow-up
Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection.
Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.
Time frame: 9 month follow up
Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months.
3 secondary outcomes
Number of Participants With a Positive Pregnancy Test After Baseline Assessment
Time frame: 9 month follow up
Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.
Time frame: 9 month follow up
Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.
Time frame: 9 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34735198Delaney DJ, Stein LAR, Bassett SS, Clarke JG. Motivational interviewing for family planning and reducing risky sexual behavior among incarcerated men nearing release: A randomized controlled pilot study. Psychol Serv. 2023 Aug;20(3):538-552. doi: 10.1037/ser0000552. Epub 2021 Nov 4.
- Individual participant dataSharing planned: No
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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.
Lynda Stein, Ph.D. principal investigator
University of Rhode Island
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Intervention and Didactic Educational Intervention in people with Pregnancy and Sexually Transmitted Infections, run by University of Rhode Island at 5 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. (time frame: 9 month follow-up). 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 NCT01627574, 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 25 Feb 2025.