An observational study in Contraceptive Usage, sponsored by University of Chicago. Completed at 1 site in United States. Open to female participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by University of Chicago · Observational
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.
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.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 20 is below the median of 149 across 22 observational studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Recruitment will occur at local primary care clinics.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is a theory-based smart phone-based application designed to provide immediate postpartum contraception information to young women aged 15-25.
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.
Time frame: Immediately post intervention
Prior Method Use
Methods of birth control participants have ever used
Time frame: Pre-Survey
Number of Pregnancies (Including Current)
Time frame: Pre-Survey
Contraception Knowledge
7 questions assessing participant knowledge of different contraception methods
Time frame: 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.
Time frame: 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.
Time frame: immediately post intervention
Number of Children
Time frame: Pre-Survey
Number of Induced Abortions
Previous miscarriages, abortions, times pregnant and children participants have
Time frame: Pre-Survey
Number of Miscarriages
Previous miscarriages, abortions, times pregnant and children participants have
Time frame: Pre-Survey
Sociodemographic Information
Monthly income
Time frame: Pre-Survey
All recruitment was performed in clinic waiting rooms from May 2018-January 2019.
| Milestone | Single Arm Intervention Group |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
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.
| units on a scale | Single Arm Intervention Group |
|---|---|
| How much do you like the look of the app? | 4.47 ± .70 |
| How much do you like the app itself? | 4.52 ± .70 |
| How would you rate the overall quality of this app | 4.16 ± .96 |
| Likelihood of recommending app to friends | 4.26 ± .81 |
| Rating the overall quality of the visuals | 3.94 ± 1.35 |
| Rating the overall quality of the audio | 4.42 ± 1.02 |
| Rating the overall quality of the videos | 4.32 ± .95 |
| Information discussed was easy to understand | 3.58 ± .96 |
| Information discussed valuable to my repro health | 3.42 ± 1.02 |
| Information helped me learn questions to ask Dr. | 4.32 ± .95 |
| I will use info provided by the app in the future. | 3.47 ± .61 |
| I can trust the info in the app. | 3.26 ± .81 |
| I would like to use this app frequently. | 3.05 ± .85 |
| I found the app too complex to understand. | 1.05 ± 1.31 |
| I thought the app was easy to use. | 3.42 ± .84 |
| I think I would need tech support to use this app. | 1.05 ± .74 |
| I found the various functions were well-integrated | 3.0 ± 1.05 |
| I thought there was too much inconsistency in app. | 1.15 ± .89 |
| Most people would learn to use app quickly. | 3.58 ± .51 |
| I found the app cumbersome to use. | 2.05 ± 1.58 |
| I felt very confident using the app. | 3.42 ± .69 |
| I needed to learn a lot before I could get going. | 1.16 ± 1.21 |
Methods of birth control participants have ever used
| participants | Single Arm Intervention Group |
|---|---|
| Never used a birth control method | 3 |
| Withdrawal | 6 |
| Condoms | 11 |
| Oral contraceptive pill | 6 |
| Contraceptive ring | 1 |
| Contraceptive patch | 3 |
| Contraceptive injection | 11 |
| IUD | 0 |
| Implant | 2 |
| events | Single Arm Intervention Group |
|---|---|
| Number of Pregnancies (Including Current) | 2 (1 to 4) |
7 questions assessing participant knowledge of different contraception methods
| correct answers | Single Arm Intervention Group |
|---|---|
| Contraception Knowledge | 3.35 ± 1.14 |
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.
| score on a scale | Single Arm Intervention Group |
|---|---|
| Pre-intervention | 62.0 ± 5.68 |
| Post-intervention | 62.5 ± 6.27 |
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.
| score on a scale | Single Arm Intervention Group |
|---|---|
| Information pretest | 4.0 ± 1.69 |
| Information posttest | 6.0 ± 1.18 |
| Motivation pretest | 20.0 ± 2.52 |
| Motivation posttest | 21.0 ± 2.41 |
| Behavior pretest | 22.0 ± 3.45 |
| Behavior posttest | 23.0 ± 3.27 |
| Children | Single Arm Intervention Group |
|---|---|
| Number of Children | 1 (0 to 3) |
Previous miscarriages, abortions, times pregnant and children participants have
| Abortions | Single Arm Intervention Group |
|---|---|
| Number of Induced Abortions | 0 (0 to 1) |
Previous miscarriages, abortions, times pregnant and children participants have
| Miscarriages | Single Arm Intervention Group |
|---|---|
| Number of Miscarriages | 0 (0 to 2) |
Monthly income
| Participants | Single Arm Intervention Group |
|---|---|
| Less than $500 | 6 |
| $500-999 | 9 |
| $1000-2000 | 3 |
| More than $2000 | 1 |
| No response | 1 |
Collected over Duration of participation in the study (average 30 minutes per participant).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Intervention Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Single Arm Intervention Group |
|---|---|
| <=18 years | 3 |
| Between 18 and 65 years | 17 |
| >=65 years | 0 |
| Age, Continuous(years) | Single Arm Intervention Group |
|---|---|
| Median | 21.5 (17 to 25) |
| Sex: Female, Male(Participants) | Single Arm Intervention Group |
|---|---|
| Female | 20 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Single Arm Intervention Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 20 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm Intervention Group |
|---|---|
| United States | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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