Mobile ApplicationsNCT02234271
Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information
A study testing Mobile Health Application and Health Educator Counseling in people with Mobile Applications and Contraception, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mobile Applications, Contraception, Contraception Behavior
- What is being tested?
- Mobile Health Application and Health Educator Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years of age
- literate in English
- not at that time using a contraceptive method
- willing to switch to a new reversible contraceptive method
- currently sexually active with a male partner and
- intending to avoid pregnancy for at least one year
Who cannot join
- women not at risk for unintended pregnancy
- those who were pregnant
- seeking pregnancy within the next 12 months
- history of surgical sterilization or
- a current partner who had had a vasectomy
- using long acting reversible birth control method
- menopausal
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method.
- Conditions
- Mobile Applications, Contraception, Contraception Behavior
- Being tested
- Mobile Health Application, Health Educator Counseling
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health ApplicationOther
Mobile Health application for contraception information
Health Educator CounselingOther
Counseling via health educator
| Study group | Role | What they receive |
|---|---|---|
| Health Educator Arm | Active comparator | Health Educator for contraception information Receives: Other: Health Educator Counseling |
| Mobile Health Application Arm | Experimental | Plan A Birth Control - iPad based application for contraception information Receives: Other: Mobile Health Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraception choice
Choice of birth control selected by participant was recorded into electronic database system and compared between the two groups.
Measured: Participants were followed for the duration of their clinic visit which was up to one day
Secondary outcomes (1)
Knowledge of contraception method chosen
A knowledge questionnaire was administered at the end of patient's visit and results were analyzed.
Measured: Participants were followed for the duration of their clinic visit which was up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Mobile ApplicationsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UCLA Women's Health Clinical Research Unit, University of California, Los Angeles
- Investigators
- Aparna Sridhar, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234271
- Sponsor's protocol ID
- UCLA_IRB_14-000821
- Status last verified
- Sep 2014
- First submitted
- 26 Aug 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
Publications
Sridhar A, Chen A, Forbes ER, Glik D. Mobile application for information on reversible contraception: a randomized controlled trial. Am J Obstet Gynecol. 2015 Jun;212(6):774.e1-7. doi: 10.1016/j.ajog.2015.01.011. Epub 2015 Jan 9.
PubMed 25582097
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information
- ClinicalTrials.gov ID
- NCT02234271
- Acronym / sponsor ID
- UCLA_IRB_14-000821
- Conditions
- Mobile Applications, Contraception, Contraception Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Sep 2014 (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 primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Educator Arm | Active comparator | Other: Health Educator CounselingHealth Educator for contraception information |
| Mobile Health Application Arm | Experimental | Other: Mobile Health ApplicationPlan A Birth Control - iPad based application for contraception information |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-45 years of age
- literate in English
- not at that time using a contraceptive method
- willing to switch to a new reversible contraceptive method
- currently sexually active with a male partner and
Key exclusion criteria (7 listed)
- women not at risk for unintended pregnancy
- those who were pregnant
- seeking pregnancy within the next 12 months
- history of surgical sterilization or
- a current partner who had had a 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 |
|---|---|---|
| Mobile Health ApplicationMobile Health application for contraception information | Other | Mobile Health Application Arm |
| Health Educator CounselingCounseling via health educator | Other | Health Educator Arm |
Primary outcome
Contraception choice
Time frame: Participants were followed for the duration of their clinic visit which was up to one day
Choice of birth control selected by participant was recorded into electronic database system and compared between the two groups.
1 secondary outcome
Knowledge of contraception method chosen
Time frame: Participants were followed for the duration of their clinic visit which was up to one day
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 9 Sep 2014.
- Derived from this study: PubMed 25582097Sridhar A, Chen A, Forbes ER, Glik D. Mobile application for information on reversible contraception: a randomized controlled trial. Am J Obstet Gynecol. 2015 Jun;212(6):774.e1-7. doi: 10.1016/j.ajog.2015.01.011. Epub 2015 Jan 9.
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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.
Aparna Sridhar, MD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Application and Health Educator Counseling in people with Mobile Applications and Contraception, run by University of California, Los Angeles 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 6 inclusion and 7 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 9 Sep 2014. 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?
Contraception choice (time frame: Participants were followed for the duration of their clinic visit which was up to one day). 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 NCT02234271, 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 2014.