Contraceptive UseMyNewOptionsNCT02100124
MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning
A study testing Reproductive Life Planning (RLP), Contraceptive Action Planning and Contraception information in people with Contraceptive Use and Unintended Pregnancy, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Contraceptive Use, Unintended Pregnancy
- What is being tested?
- Reproductive Life Planning (RLP), Contraceptive Action Planning and Contraception information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 987 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2016
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- not currently pregnant
- sexually active with a male partner in the past 6 months OR anticipate being sexually active with a male partner in the next 6 months
- does not intend pregnancy in the next 12 months
- has Internet access and email address
Who cannot join
- tubal sterilization
- hysterectomy
- partner with vasectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning
The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.
Read the detailed description
Most US families want 2 children, resulting in the average woman spending 3 decades of her life trying to avoid pregnancy. However, most women have at least one unintended pregnancy, resulting in 1.5 million abortions and 1.7 million unintended births annually. Women and couples try to avoid unintended pregnancy for a range of personal, social, and economic reasons, but also due to the increased physical and mental health effects for children that result from unintended pregnancy. Healthcare reform now requires that private health insurance companies cover all FDA-approved contraceptive methods with no copays or deductibles to the patient, creating a great opportunity for women with health insurance to get contraceptive methods they previously could not afford. In this study, women with health insurance will be randomly assigned to one of three groups: (1) Reproductive Life Planning (RLP)-women will complete a reproductive life plan that guides them to think about if and when they would want any future pregnancies, and to determine what contraceptive method(s) are best suited to them; (2) Reproductive Life Planning Plus (RLP+) which additionally includes "if-then planning," where women determine what they will do when they encounter difficult situations that make it difficult to use their contraceptive method perfectly; or (3) an information-only control group. The online format of the study allows for the potential of wide dissemination. The RLP and RLP+ interventions are expected to result in greater likelihood of contraceptive use, continuity of contraceptive use, and contraceptive adherence, and thus reduce overall risk of unintended pregnancy.
- Conditions
- Contraceptive Use, Unintended Pregnancy
- Being tested
- Reproductive Life Planning (RLP), Contraceptive Action Planning, Contraception information
- Keywords
- reproductive life planning, action planning, contraceptive use, unintended pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive Life Planning (RLP)Behavioural
Contraceptive Action PlanningBehavioural
Contraception informationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Reproductive Life Planning (RLP) | Experimental | RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Receives: Behavioral: Reproductive Life Planning (RLP); Behavioral: Contraception information |
| Reproductive Life Planning Plus (RLP+) | Experimental | RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Receives: Behavioral: Reproductive Life Planning (RLP); Behavioral: Contraceptive Action Planning; Behavioral: Contraception information |
| Information-only control | Active comparator | The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Receives: Behavioral: Contraception information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Use
Percentage of surveys with any contraceptive use
Measured: 24 months
Secondary outcomes (3)
Effectiveness of Contraceptive Method
Percentage of surveys where most effective contraceptive method used
Measured: 24 months
Contraceptive Method Satisfaction
percentage of surveys where very satisfied with contraceptive method
Measured: 24 months
Contraceptive Adherence
Percentage of surveys where contraceptive adherence was high
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionSep 2016
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 (4)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UseStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Cynthia Chuang, Milton S. Hershey Medical Center
- Investigators
- Cynthia H Chuang, MD, MSc, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100124
- Sponsor's protocol ID
- CD-1304-6117
- Other IDs
- CD-1304-6117
- Acronym
- MyNewOptions
- Status last verified
- Sep 2017
- First submitted
- 16 Nov 2013
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zheng A, Nelson HN, McCall-Hosenfeld JS, Lehman EB, Chuang CH. Recent Intimate Partner Violence and Oral Contraceptive Pill Adherence in a Cohort of Reproductive-Aged Women. J Womens Health (Larchmt). 2022 Dec;31(12):1703-1709. doi: 10.1089/jwh.2021.0622. Epub 2022 Sep 20.
PubMed 36126298Lauring JR, Lehman EB, Deimling TA, Legro RS, Chuang CH. Combined hormonal contraception use in reproductive-age women with contraindications to estrogen use. Am J Obstet Gynecol. 2016 Sep;215(3):330.e1-7. doi: 10.1016/j.ajog.2016.03.047. Epub 2016 Apr 5.
PubMed 27059507Chuang CH, Velott DL, Weisman CS, Sciamanna CN, Legro RS, Chinchilli VM, Moos MK, Francis EB, Confer LN, Lehman EB, Armitage CJ. Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial. Womens Health Issues. 2015 Nov-Dec;25(6):641-8. doi: 10.1016/j.whi.2015.06.010. Epub 2015 Aug 22.
PubMed 26307564Weisman CS, Lehman EB, Legro RS, Velott DL, Chuang CH. How do pregnancy intentions affect contraceptive choices when cost is not a factor? A study of privately insured women. Contraception. 2015 Nov;92(5):501-7. doi: 10.1016/j.contraception.2015.05.007. Epub 2015 May 19.
PubMed 26002807
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning
- ClinicalTrials.gov ID
- NCT02100124
- Acronym / sponsor ID
- MyNewOptions / CD-1304-6117
- Conditions
- Contraceptive Use, Unintended Pregnancy
- Keywords
- reproductive life planning, action planning, contraceptive use, unintended pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 987 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Posted 11 Jul 2018
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 web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.
Detailed description
Most US families want 2 children, resulting in the average woman spending 3 decades of her life trying to avoid pregnancy. However, most women have at least one unintended pregnancy, resulting in 1.5 million abortions and 1.7 million unintended births annually. Women and couples try to avoid unintended pregnancy for a range of personal, social, and economic reasons, but also due to the increased physical and mental health effects for children that result from unintended pregnancy. Healthcare reform now requires that private health insurance companies cover all FDA-approved contraceptive methods with no copays or deductibles to the patient, creating a great opportunity for women with health insurance to get contraceptive methods they previously could not afford. In this study, women with health insurance will be randomly assigned to one of three groups: (1) Reproductive Life Planning (RLP)-women will complete a reproductive life plan that guides them to think about if and when they would want any future pregnancies, and to determine what contraceptive method(s) are best suited to them; (2) Reproductive Life Planning Plus (RLP+) which additionally includes "if-then planning," where women determine what they will do when they encounter difficult situations that make it difficult to use their contraceptive method perfectly; or (3) an information-only control group. The online format of the study allows for the potential of wide dissemination. The RLP and RLP+ interventions are expected to result in greater likelihood of contraceptive use, continuity of contraceptive use, and contraceptive adherence, and thus reduce overall risk of unintended pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reproductive Life Planning (RLP) | Experimental | Behavioral: Reproductive Life Planning (RLP), Behavioral: Contraception informationRLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. |
| Reproductive Life Planning Plus (RLP+) | Experimental | Behavioral: Reproductive Life Planning (RLP), Behavioral: Contraceptive Action Planning, Behavioral: Contraception informationRLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. |
| Information-only control | Active comparator | Behavioral: Contraception informationThe information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- not currently pregnant
- sexually active with a male partner in the past 6 months OR anticipate being sexually active with a male partner in the next 6 months
- does not intend pregnancy in the next 12 months
- has Internet access and email address
Key exclusion criteria (3 listed)
- tubal sterilization
- hysterectomy
- partner with vasectomy
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 |
|---|---|---|
| Reproductive Life Planning (RLP) | Behavioural | Reproductive Life Planning (RLP), Reproductive Life Planning Plus (RLP+) |
| Contraceptive Action Planning | Behavioural | Reproductive Life Planning Plus (RLP+) |
| Contraception information | Behavioural | Information-only control, Reproductive Life Planning (RLP), Reproductive Life Planning Plus (RLP+) |
Primary outcome
Contraceptive Use
Time frame: 24 months
Percentage of surveys with any contraceptive use
3 secondary outcomes
Effectiveness of Contraceptive Method
Time frame: 24 months
Contraceptive Method Satisfaction
Time frame: 24 months
Contraceptive Adherence
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36126298Zheng A, Nelson HN, McCall-Hosenfeld JS, Lehman EB, Chuang CH. Recent Intimate Partner Violence and Oral Contraceptive Pill Adherence in a Cohort of Reproductive-Aged Women. J Womens Health (Larchmt). 2022 Dec;31(12):1703-1709. doi: 10.1089/jwh.2021.0622. Epub 2022 Sep 20.
- Derived from this study: PubMed 27059507Lauring JR, Lehman EB, Deimling TA, Legro RS, Chuang CH. Combined hormonal contraception use in reproductive-age women with contraindications to estrogen use. Am J Obstet Gynecol. 2016 Sep;215(3):330.e1-7. doi: 10.1016/j.ajog.2016.03.047. Epub 2016 Apr 5.
- Derived from this study: PubMed 26307564Chuang CH, Velott DL, Weisman CS, Sciamanna CN, Legro RS, Chinchilli VM, Moos MK, Francis EB, Confer LN, Lehman EB, Armitage CJ. Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial. Womens Health Issues. 2015 Nov-Dec;25(6):641-8. doi: 10.1016/j.whi.2015.06.010. Epub 2015 Aug 22.
- Derived from this study: PubMed 26002807Weisman CS, Lehman EB, Legro RS, Velott DL, Chuang CH. How do pregnancy intentions affect contraceptive choices when cost is not a factor? A study of privately insured women. Contraception. 2015 Nov;92(5):501-7. doi: 10.1016/j.contraception.2015.05.007. Epub 2015 May 19.
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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.
Cynthia H Chuang, MD, MSc principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reproductive Life Planning (RLP), Contraceptive Action Planning and Contraception information in people with Contraceptive Use and Unintended Pregnancy, run by Milton S. Hershey Medical Center at 1 site 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 11 Jul 2018). 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?
Contraceptive Use (time frame: 24 months). 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 NCT02100124, which also lists 4 linked publications.
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 11 Jul 2018.