Unintended PregnancyNCT02396602
miPlan: A Trial of miPlan Intervention vs. Standard of Care
A study testing miPlan intervention in people with Unintended Pregnancy, run by University of Chicago at 1 site in United States.
Trial summary
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. Read more about this study
- Who is it for?
- Ages 15 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unintended Pregnancy
- What is being tested?
- miPlan intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Aug 2016
- 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 15 to 29 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- African American or Latina female and sexually active with a male partner(s) within the past 6 months,
- age 15 to 29 years
- present for contraception initiation
- English speaking
Who cannot join
- not currently pregnant or intending pregnancy within the next 6 months
- and not currently using LARC
- not highly intending LARC at enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Illinois, Englewood Health Center
Chicago, Illinois, 60636
About this study
Official title: miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge, self-efficacy and decisional balance for highly effective contraception post-app use, contraceptive satisfaction, and intention to continue method use. The research will consist of baseline activities as well as a three-month follow-up call.
Read the detailed description
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care contraceptive counseling. The aim of this study is to understand miPlan's impact in terms of contraceptive knowledge, intentions and behaviors. The primary outcome is LARC uptake, which will be measured via chart review at clinic discharge, i.e. immediately following a patient's family planning visit. The secondary outcomes are contraceptive use at discharge (measured via chart review immediately following patient's family planning visit), self-efficacy and decisional balance (both measured via adapted validated scales for each) for highly effective contraception post-app use (measured immediately following intervention and prior to contraceptive counseling session), contraceptive satisfaction (measured at 3 months post baseline), and intention to continue method use (measured at 3 months post baseline). The research will consist of baseline activities as well as a three-month follow-up call.
- Conditions
- Unintended Pregnancy
- Being tested
- miPlan intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miPlan interventionBehavioural
miPlan mobile contraceptive counseling waiting room app intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | After completing baseline the baseline questionnaire, women randomized to the intervention group will receive an iPad, along with a brief tutorial on iPad navigation, and use the miPlan app for up to 15 minutes. They will complete a post-intervention survey before proceeding to standard of care contraceptive counseling. Receives: Behavioral: miPlan intervention |
| Control | No intervention | After completing baseline the baseline questionnaire, women randomized to the control arm will proceed to standard of care contraceptive counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARC uptake
uptake of the implant or IUD at time of intervention (measured via contraceptive method choice and delivery by checkbox)
Measured: at time of intervention (baseline (0 weeks)
Secondary outcomes (5)
contraceptive use
use of contraceptive methods at time of intervention (measured via contraceptive method choice and delivery by checkbox)
Measured: at time of intervention (baseline (0 weeks))
change in self-efficacy for contraception at 12 weeks
change in self efficacy for contraceptive method use (measured via validated 5-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks
Measured: baseline (0 weeks) and 12 weeks
change in decisional balance for highly effective methods at 12 weeks
change in decisional balance for highly effective methods (measured via validated 10-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks
Measured: baseline (0 weeks) and 12 weeks
contraceptive satisfaction
satisfaction with contraceptive method choice (measured by 4-point Likert scale)
Measured: 12 weeks post-enrollment
intention to continue method use
intention to continue contraceptive method use (measured dichotomously)
Measured: 12 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionAug 2016
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 Unintended PregnancyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Gilliam, MD, MPH, Principal investigator, University of Chicago, Dept. of OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396602
- Sponsor's protocol ID
- 14-0599
- Status last verified
- Aug 2016
- First submitted
- 16 Feb 2015
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hebert LE, Hill BJ, Quinn M, Holl JL, Whitaker AK, Gilliam ML. Mobile contraceptive application use in a clinical setting in addition to standard contraceptive counseling: A randomized controlled trial. Contraception. 2018 Oct;98(4):281-287. doi: 10.1016/j.contraception.2018.07.001. Epub 2018 Jul 10.
PubMed 30006030
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care
- ClinicalTrials.gov ID
- NCT02396602
- Acronym / sponsor ID
- 14-0599
- Conditions
- Unintended Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Mar 2015 (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.
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge, self-efficacy and decisional balance for highly effective contraception post-app use, contraceptive satisfaction, and intention to continue method use. The research will consist of baseline activities as well as a three-month follow-up call.
Detailed description
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care contraceptive counseling. The aim of this study is to understand miPlan's impact in terms of contraceptive knowledge, intentions and behaviors. The primary outcome is LARC uptake, which will be measured via chart review at clinic discharge, i.e. immediately following a patient's family planning visit. The secondary outcomes are contraceptive use at discharge (measured via chart review immediately following patient's family planning visit), self-efficacy and decisional balance (both measured via adapted validated scales for each) for highly effective contraception post-app use (measured immediately following intervention and prior to contraceptive counseling session), contraceptive satisfaction (measured at 3 months post baseline), and intention to continue method use (measured at 3 months post baseline). The research will consist of baseline activities as well as a three-month follow-up call.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: miPlan interventionAfter completing baseline the baseline questionnaire, women randomized to the intervention group will receive an iPad, along with a brief tutorial on iPad navigation, and use the miPlan app for up to 15 minutes. They will complete a post-intervention survey before proceeding to standard of care contraceptive counseling. |
| Control | No intervention | –After completing baseline the baseline questionnaire, women randomized to the control arm will proceed to standard of care contraceptive counseling. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- African American or Latina female and sexually active with a male partner(s) within the past 6 months,
- age 15 to 29 years
- present for contraception initiation
- English speaking
Key exclusion criteria (3 listed)
- not currently pregnant or intending pregnancy within the next 6 months
- and not currently using LARC
- not highly intending LARC at enrollment
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 |
|---|---|---|
| miPlan interventionmiPlan mobile contraceptive counseling waiting room app intervention | Behavioural | Intervention |
Primary outcome
LARC uptake
Time frame: at time of intervention (baseline (0 weeks)
uptake of the implant or IUD at time of intervention (measured via contraceptive method choice and delivery by checkbox)
5 secondary outcomes
contraceptive use
Time frame: at time of intervention (baseline (0 weeks))
change in self-efficacy for contraception at 12 weeks
Time frame: baseline (0 weeks) and 12 weeks
change in decisional balance for highly effective methods at 12 weeks
Time frame: baseline (0 weeks) and 12 weeks
contraceptive satisfaction
Time frame: 12 weeks post-enrollment
intention to continue method use
Time frame: 12 weeks post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Derived from this study: PubMed 30006030Hebert LE, Hill BJ, Quinn M, Holl JL, Whitaker AK, Gilliam ML. Mobile contraceptive application use in a clinical setting in addition to standard contraceptive counseling: A randomized controlled trial. Contraception. 2018 Oct;98(4):281-287. doi: 10.1016/j.contraception.2018.07.001. Epub 2018 Jul 10.
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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.
Melissa Gilliam, MD, MPH principal investigator
University of Chicago, Dept. of OBGYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miPlan intervention in people with Unintended Pregnancy, run by University of Chicago 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 25 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LARC uptake (time frame: at time of intervention (baseline (0 weeks)). 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 NCT02396602, 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 Aug 2016.