Contraceptive UsageNCT03402217
Patient Centered Postpartum Contraception App
An observational study of Contraceptive Usage, run by University of Chicago at 1 site in United States.
Trial summary
This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Patient Centered Postpartum Contraception App
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2018to 7 Jan 2019
- Phase
- Observational
- 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 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: -Recruitment will occur at local primary care clinics.
Who may be able to join
- Pregnant
- Identify as African American or Black
- English as primary language
Who cannot join
- Not pregnant
- Not identifying as African American or Black
- Language other than English as primary language
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60605
About this study
This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app.
Read the detailed description
This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app. Participants will be asked to complete a survey after informed consent and before using the app. After using the app, participants will complete a second survey. This second survey will ask questions about the app including the following topics: Usability, user-friendliness, navigation, user interface, time spent, organization readability; Feasibility, informative, helpful, comprehensible, quality of art, interface, sound; and Acceptability breadth of content, depth of content, engaging and motivating, Innovative utility and value. Women will also rate the degree to which they promote use of the product: would use the app if available, believe the app will support contraceptive use and would recommend the app to peers. Study participation will end once participants are done with the second survey.
- Conditions
- Contraceptive Usage
- Being tested
- Patient Centered Postpartum Contraception App
- Keywords
- Contraception, Post Partum Contraception
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Centered Postpartum Contraception AppBehavioural
This is a theory-based smart phone-based application designed to provide immediate postpartum contraception information to young women aged 15-25.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Application
Feasibility, acceptability and usability of application. Mean of each item is reported. Each item has a possible score of 1-5, 1 = strongly disagree; 5= strongly agree. Higher scores indicate a better results for all items except "I found the app too complex to understand," "I think I would need tech support to use this app," "I thought there was too much inconsistency in app," "I found the app cumbersome to use," and "I needed to learn a lot before I could get going," where a lower score is a better result.
Measured: Immediately post intervention
Secondary outcomes (8)
Prior Method Use
Methods of birth control participants have ever used
Measured: Pre-Survey
Number of Pregnancies (Including Current)
Measured: Pre-Survey
Contraception Knowledge
7 questions assessing participant knowledge of different contraception methods
Measured: Pre-Survey
Patient Activation
Participant total of 13 Likert-style questions asking about how active a role they have taken in determining their health care. Measurement presented is the sum of 13 Likert items 1-5 to create a scale score. Possible score range from 13-65, with higher scores indicating more activation.
Measured: Pre-Survey, immediately post intervention
Information, Motivation and Behavioral Skills
15 questions asking participants about the information, motivation, and behavioral skills they possess relating to spacing pregnancies by 18 months or longer, split into information, motivation, and behavioral self-efficacy variables. Three subscales are presented: information subscale, motivation subscale, and behavioral skills subscale. The information scale is the summed correct answers to 7 questions, possible score 0-7. Motivation subscale is the sum of 6 Likert-type items with values from 1-4, for possible scores of 6-24; higher score is better. Behavioral skills subscale is the sum of 5 Likert-type items with values from 1-5, for possible subscales scores of 5-25; higher score is better.
Measured: immediately post intervention
Number of Children
Measured: Pre-Survey
Number of Induced Abortions
Previous miscarriages, abortions, times pregnant and children participants have
Measured: Pre-Survey
Number of Miscarriages
Previous miscarriages, abortions, times pregnant and children participants have
Measured: Pre-Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start18 May 2018
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
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.
- Other trials for Contraceptive UsageStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402217
- Sponsor's protocol ID
- IRB17-12541
- Status last verified
- May 2024
- First submitted
- 5 Jan 2018
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Postpartum Contraception App
- ClinicalTrials.gov ID
- NCT03402217
- Acronym / sponsor ID
- IRB17-12541
- Conditions
- Contraceptive Usage
- Keywords
- Contraception, Post Partum Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 3 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app.
Detailed description
This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app. Participants will be asked to complete a survey after informed consent and before using the app. After using the app, participants will complete a second survey. This second survey will ask questions about the app including the following topics: Usability, user-friendliness, navigation, user interface, time spent, organization readability; Feasibility, informative, helpful, comprehensible, quality of art, interface, sound; and Acceptability breadth of content, depth of content, engaging and motivating, Innovative utility and value. Women will also rate the degree to which they promote use of the product: would use the app if available, believe the app will support contraceptive use and would recommend the app to peers. Study participation will end once participants are done with the second survey.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- -Recruitment will occur at local primary care clinics.
Key inclusion criteria (3 listed)
- Pregnant
- Identify as African American or Black
- English as primary language
Key exclusion criteria (3 listed)
- Not pregnant
- Not identifying as African American or Black
- Language other than English as primary language
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 |
|---|---|---|
| Patient Centered Postpartum Contraception AppThis is a theory-based smart phone-based application designed to provide immediate postpartum contraception information to young women aged 15-25. | Behavioural | – |
Primary outcome
Feasibility of Application
Time frame: Immediately post intervention
Feasibility, acceptability and usability of application. Mean of each item is reported. Each item has a possible score of 1-5, 1 = strongly disagree; 5= strongly agree. Higher scores indicate a better results for all items except "I found the app too complex to understand," "I think I would need tech support to use this app," "I thought there was too much inconsistency in app," "I found the app cumbersome to use," and "I needed to learn a lot before I could get going," where a lower score is a better result.
8 secondary outcomes
Prior Method Use
Time frame: Pre-Survey
Number of Pregnancies (Including Current)
Time frame: Pre-Survey
Contraception Knowledge
Time frame: Pre-Survey
Patient Activation
Time frame: Pre-Survey, immediately post intervention
Information, Motivation and Behavioral Skills
Time frame: immediately post intervention
Number of Children
Time frame: Pre-Survey
Number of Induced Abortions
Time frame: Pre-Survey
Number of Miscarriages
Time frame: Pre-Survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Contraceptive Usage
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Enrolling by invitation
A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Contraceptive Usage, Contraceptive Behavior
Not yet recruitingPhase 3
Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System
Contraceptive Usage
Active, not recruitingObservational study
Estrogen and Microvascular Function
Estrogen, Cardiovascular Diseases
Not yet recruiting
I-CAN Uganda Effectiveness Trial
Contraception
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraceptive Usage, 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 3 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 3 May 2024. 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 3 May 2024). 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?
Feasibility of Application (time frame: Immediately post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2024.