Sexually Transmitted Infection
Conditions
Brief summary
The investigators will develop a digital application (app)-rPlan dual protection (rPlan)-to be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The goal of this research is to develop the app and conduct a feasibility, acceptability and effectiveness assessment of rPlan to examine improvement in dual protection behaviors, enhancement of contraceptive adherence and continuation, increase of condom use and decrease of sexually transmitted infection (STI) and human immunodeficiency virus(HIV) infection. The research will consist of baseline activities and a 12-week in-clinic survey and STI test, as well as a retrospective chart review.
Detailed description
Using the investigators' experience in digital media, behavior theory, client-centered interventions, and family planning, the investigators will develop a digital application (app)-rPlan-to be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The goal of this research is to develop the app and conduct a feasibility, acceptability and effectiveness assessment of rPlan. This study will develop rPlan, a three-part intervention that includes a precounseling app that promotes dual protection, motivational interviewing-informed counseling, and concomitant printed educational materials. The research will proceed in two phases. In Phase I, the investigators will assemble a 10-member stakeholder advisory team to enhance the PreCounselor app to focus on dual protection, train reproductive health counselors in motivational interviewing, and create concomitant printed educational materials. In Phase II, the feasibility, acceptability, and effectiveness of the intervention will be assessed. The specific aims are to: Aim 1: Develop the rPlan intervention by (1) enhancing the pretested PreCounselor app to focus on dual protection, (2) training reproductive health counselors, and (3) creating concomitant printed educational materials. Aim 2: Conduct a pre/post feasibility, acceptability, and effectiveness assessment of rPlan to examine improvement in dual protection behaviors, enhancement of contraceptive adherence and continuation, increase of condom use, and decrease of STI/HIV infection. The primary outcome is engagement in dual protection (either using a condom with another effective method, or using a condom alone), which will be measured via patient report at 12 weeks post enrollment. The secondary outcomes are contraceptive adherence/uptake (measured at 12 weeks post enrollment), contraceptive decisional balance/self-efficacy (measured at 12 weeks post enrollment), contraceptive effectiveness knowledge, and STI infection (12 weeks post enrollment). The research will consist of baseline activities as well as a 12-week in-clinic survey and STI test, and a retrospective chart review to capture interceding visits (e.g., initial contraceptive method selection, method switching, etc.) and diagnoses (e.g., pregnancy, STI/HIV).
Interventions
BEHAVIORALrPlan dual protection waiting room app intervention
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* African American (AA) female and sexually active with a male partner(s) within the past 6 months; * Age 15-24 years; * Initiating contraception; * English speaking
Exclusion criteria
* Not currently pregnant or intending pregnancy within the next 6 months * Not currently using the implant or intrauterine device (IUD).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Frequency of Recent Dual Method Use | Baseline, 3 months | Reported frequency of use of condoms with another contraceptive method in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time |
| Change in Frequency of Recent Condom Use (by Itself, With no Other Method) | Baseline, 3 months | Reported frequency of use of condoms alone (without another method) in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Future Intentions to Use IUD | Baseline (pre-app use), Immediately post-app use | Participants' self-reported likelihood of using an IUD in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely |
| Change in Future Intentions to Use Implant | Baseline (pre-app use), Immediately post-app use | Participants' self-reported likelihood of using a contraceptive implant in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely |
| Change in Future Intentions to Use Condoms | Baseline (pre-app use), Immediately post-app use | Participants' self-reported likelihood of using condoms in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely |
| Change in Self-efficacy for Contraceptive Use | Baseline, 3 months | Participants' self-reported contraceptive self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up |
| Change in Self-efficacy for Condom Use | Baseline (pre-rPlan), 3 months | Participants' self-reported condom self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up |
| Results of STI Test | Baseline, 3 months | Results of sexually transmitted infection (STI) test, at baseline and 3 months |
| Change in Consistency of Recent Contraceptive Use | Baseline, 3 months | Self-reported answer (yes or no) to whether participants used contraception every time they had sex in the past three months |
| Change in Negative Condom Attitudes | Baseline, 3 months | Participants' self-reported degree to which they endorse negative condom attitudes (Brown, 1984), on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up |
| Change in Endorsement of Positive Motivators for Condom Use | Baseline (pre-rPlan), 3 months | Participants' self-reported degree to which they endorse positive motivators for condom use, on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up |
| Change in Negative Contraceptive Attitudes | Baseline (pre-rPlan), 3 months | Participants' self-reported importance of negative contraceptive attitudes (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up |
| Change in Endorsement of Positive Motivators for Contraceptive Use | Baseline (pre-rPlan), 3 months | Participants' self-rated importance of positive motivators for contraceptive use (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up |
| Change in Contraceptive Effectiveness Knowledge | Baseline (pre-app use), 3 months | Percentage of participants who correctly answered questions of which contraceptive methods were more effective at preventing pregnancy, between baseline (pre-app use) and 3-month follow-up |
| Change in Number of Recent Sexual Partners | Baseline, 3 months | Self-reported number of sexual partners in the past three months (for those who were sexually active) |
| Current Main Method of Contraception | Baseline, 3 months | Participants' current main method of contraception, by method type: no method or withdrawal, condom, short-term/combined hormonal (pill, patch, shot, ring), Long acting reversible contraception (LARC: IUD or implant) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.
6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.
3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes. | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion criteria | 11 |
| Overall Study | Lost to Follow-up | 22 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age at First Pregnancy | 18.1 years |
| Age at First Sexual Intercourse | 16.1 years |
| Age, Categorical <=18 years | 30 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age, Continuous | 20.0 years |
| Contraceptive Method Awareness Condom | 81 participants |
| Contraceptive Method Awareness Implant | 49 participants |
| Contraceptive Method Awareness Intrauterine device (IUD) | 45 participants |
| Contraceptive Method Awareness Patch | 54 participants |
| Contraceptive Method Awareness Pill | 71 participants |
| Contraceptive Method Awareness Ring | 59 participants |
| Contraceptive Method Awareness Shot | 66 participants |
| Contraceptive Method Awareness Withdrawal | 74 participants |
| Ever Tested Positive for STI? No | 62 Participants |
| Ever Tested Positive for STI? Yes | 31 Participants |
| Highest Education Completed College degree or higher | 12 Participants |
| Highest Education Completed High school diploma or less | 37 Participants |
| Highest Education Completed Some college | 44 Participants |
| Number of Births 0 | 61 Participants |
| Number of Births 1 | 17 Participants |
| Number of Births 2+ | 15 Participants |
| Number of Living Children | 1.5 children |
| Number of Sexual Partners in Lifetime 1 partner | 17 Participants |
| Number of Sexual Partners in Lifetime 2 partners | 17 Participants |
| Number of Sexual Partners in Lifetime 3 partners | 13 Participants |
| Number of Sexual Partners in Lifetime 4 partners | 15 Participants |
| Number of Sexual Partners in Lifetime 5+ partners | 30 Participants |
| Past Contraceptive Method Use Condom | 69 participants |
| Past Contraceptive Method Use Implant | 4 participants |
| Past Contraceptive Method Use IUD | 5 participants |
| Past Contraceptive Method Use Never used method | 1 participants |
| Past Contraceptive Method Use Patch | 9 participants |
| Past Contraceptive Method Use Pill | 46 participants |
| Past Contraceptive Method Use Ring | 3 participants |
| Past Contraceptive Method Use Shot | 37 participants |
| Past Contraceptive Method Use Withdrawal | 52 participants |
| Pregnancy History 2 pregnancies | 21 Participants |
| Pregnancy History 3+ pregnancies | 12 Participants |
| Pregnancy History Never been pregnant | 60 Participants |
| Race/Ethnicity, Customized Black or African American | 93 Participants |
| Relationship Status Dating/Casual partners | 15 Participants |
| Relationship Status In relationship | 42 Participants |
| Relationship Status Single | 35 Participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 104 |
| other Total, other adverse events | 0 / 104 |
| serious Total, serious adverse events | 0 / 104 |
Outcome results
Primary
Change in Frequency of Recent Condom Use (by Itself, With no Other Method)
Reported frequency of use of condoms alone (without another method) in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time
Time frame: Baseline, 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Frequency of Recent Condom Use (by Itself, With no Other Method) | Baseline (pre-app use) | 3.15 score on a scale |
| Intervention | Change in Frequency of Recent Condom Use (by Itself, With no Other Method) | 3-month follow-up | 2.93 score on a scale |
Comparison: Paired samples t-test comparison of whether participants' mean reported scores for frequency of condom use alone (without another method) differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)p-value: 0.318t-test, 2 sided
Primary
Change in Frequency of Recent Dual Method Use
Reported frequency of use of condoms with another contraceptive method in past 3 months 5 option close-ended question, ranging from 1 - none of the time, to 5 - every time
Time frame: Baseline, 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Frequency of Recent Dual Method Use | Baseline, pre-app use | 3.17 score on a scale |
| Intervention | Change in Frequency of Recent Dual Method Use | 3-month follow-up | 3.45 score on a scale |
Comparison: Paired samples t-test comparison of whether participants' mean reported scores for frequency of dual method use differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)p-value: 0.177t-test, 2 sided
Secondary
Change in Consistency of Recent Contraceptive Use
Self-reported answer (yes or no) to whether participants used contraception every time they had sex in the past three months
Time frame: Baseline, 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample at baseline and the sample retained at followup. 16 of the 71 retained participants did not have sex during the 3-month time period.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Change in Consistency of Recent Contraceptive Use | Baseline (pre-app use) | Yes | 35 Participants |
| Intervention | Change in Consistency of Recent Contraceptive Use | Baseline (pre-app use) | No | 20 Participants |
| Intervention | Change in Consistency of Recent Contraceptive Use | 3-month follow-up | Yes | 46 Participants |
| Intervention | Change in Consistency of Recent Contraceptive Use | 3-month follow-up | No | 9 Participants |
Comparison: Paired samples t-test comparison of whether participants reported more consistent contraceptive use (i.e., using contraception every time they had sex) between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)p-value: 0t-test, 2 sided
Secondary
Change in Contraceptive Effectiveness Knowledge
Percentage of participants who correctly answered questions of which contraceptive methods were more effective at preventing pregnancy, between baseline (pre-app use) and 3-month follow-up
Time frame: Baseline (pre-app use), 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~1 retained participant did not provide data for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Change in Contraceptive Effectiveness Knowledge | Baseline (pre-rPlan): Pills vs condoms, % correct | 31.4 percentage who answered correctly |
| Intervention | Change in Contraceptive Effectiveness Knowledge | Baseline (pre-rPlan): IUD vs shot, % correct | 35.7 percentage who answered correctly |
| Intervention | Change in Contraceptive Effectiveness Knowledge | 3-month follow-up: Pills vs condoms, % correct | 16.9 percentage who answered correctly |
| Intervention | Change in Contraceptive Effectiveness Knowledge | 3-month follow-up: IUD vs shot, % correct | 25.7 percentage who answered correctly |
Comparison: Paired samples t-test comparison of proportion of participants who provided correct answers to whether pills or condoms are more effective at preventing pregnancy, before and 3 months after engaging in rPlanp-value: 0.049t-test, 2 sided
Comparison: Paired samples t-test comparison of proportion of participants who provided correct answers to whether the IUD or shot is more effective at preventing pregnancy, before and 3 months after engaging in rPlanp-value: 0.265t-test, 2 sided
Secondary
Change in Endorsement of Positive Motivators for Condom Use
Participants' self-reported degree to which they endorse positive motivators for condom use, on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up
Time frame: Baseline (pre-rPlan), 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~1 retained participant did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Endorsement of Positive Motivators for Condom Use | Baseline (pre-rPlan) | 4.57 score on a scale |
| Intervention | Change in Endorsement of Positive Motivators for Condom Use | 3-month follow-up | 4.63 score on a scale |
Comparison: Paired samples t-test comparison of participants' reported degree to which they endorse positive motivators for condom use (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlanp-value: 0.498t-test, 2 sided
Secondary
Change in Endorsement of Positive Motivators for Contraceptive Use
Participants' self-rated importance of positive motivators for contraceptive use (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up
Time frame: Baseline (pre-rPlan), 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~1 retained participant did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Endorsement of Positive Motivators for Contraceptive Use | Baseline (pre-rPlan) | 4.61 score on a scale |
| Intervention | Change in Endorsement of Positive Motivators for Contraceptive Use | 3-month follow-up | 4.64 score on a scale |
Comparison: Paired samples t-test comparison of participants' rated importance of positive motivators for contraceptive use on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlanp-value: 0.673t-test, 2 sided
Secondary
Change in Future Intentions to Use Condoms
Participants' self-reported likelihood of using condoms in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely
Time frame: Baseline (pre-app use), Immediately post-app use
Population: 3 participants did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Future Intentions to Use Condoms | Baseline (pre-app use) | 4.22 score on a scale |
| Intervention | Change in Future Intentions to Use Condoms | Immediately post-app use | 4.11 score on a scale |
Comparison: Paired samples t-test comparison of participants' reported likelihood to use condoms in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan appp-value: 0.315t-test, 2 sided
Secondary
Change in Future Intentions to Use Implant
Participants' self-reported likelihood of using a contraceptive implant in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely
Time frame: Baseline (pre-app use), Immediately post-app use
Population: 2 participants did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Future Intentions to Use Implant | Baseline (pre-app use) | 2.45 score on a scale |
| Intervention | Change in Future Intentions to Use Implant | Immediately post-app use | 2.66 score on a scale |
Comparison: Paired samples t-test comparison of participants' reported likelihood to use an implant in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan appp-value: 0.14t-test, 2 sided
Secondary
Change in Future Intentions to Use IUD
Participants' self-reported likelihood of using an IUD in the future, on a close-ended 5-point scale ranging from: 1 - very unlikely, to 5 - very likely
Time frame: Baseline (pre-app use), Immediately post-app use
Population: 1 participant did not provider data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Future Intentions to Use IUD | Baseline, pre-app use | 2.38 score on a scale |
| Intervention | Change in Future Intentions to Use IUD | Baseline, immediately post-app use | 2.70 score on a scale |
Comparison: Paired samples t-test comparison of participants' reported likelihood to use an IUD in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan appp-value: 0.03t-test, 2 sided
Secondary
Change in Negative Condom Attitudes
Participants' self-reported degree to which they endorse negative condom attitudes (Brown, 1984), on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up
Time frame: Baseline, 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~5 retained participants did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Negative Condom Attitudes | 3-month follow-up | 1.99 score on a scale |
| Intervention | Change in Negative Condom Attitudes | Baseline (pre-rPlan) | 2.03 score on a scale |
Comparison: Paired samples t-test comparison of participants' reported degree to which they endorse negative condom attitudes (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlanp-value: 0.652t-test, 2 sided
Secondary
Change in Negative Contraceptive Attitudes
Participants' self-reported importance of negative contraceptive attitudes (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up
Time frame: Baseline (pre-rPlan), 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~4 retained participants did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Negative Contraceptive Attitudes | Baseline (pre-rPlan) | 2.20 score on a scale |
| Intervention | Change in Negative Contraceptive Attitudes | 3-month follow-up | 2.20 score on a scale |
Comparison: Paired samples t-test comparison of participants' rated importance of negative contraceptive attitudes on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlanp-value: 0.977t-test, 2 sided
Secondary
Change in Number of Recent Sexual Partners
Self-reported number of sexual partners in the past three months (for those who were sexually active)
Time frame: Baseline, 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~21 retained participants did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Number of Recent Sexual Partners | Baseline | 1.40 number of sexual partners |
| Intervention | Change in Number of Recent Sexual Partners | 3-month follow-up | 1.24 number of sexual partners |
Comparison: Paired samples t-test comparison of participants' self-reported number of sexual partners in the past 3 months (for those were sexually active) between baseline and 3-month follow-upp-value: 0.209t-test, 2 sided
Secondary
Change in Self-efficacy for Condom Use
Participants' self-reported condom self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up
Time frame: Baseline (pre-rPlan), 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~3 retained participants did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Self-efficacy for Condom Use | Baseline (pre-rPlan) | 3.64 score on a scale |
| Intervention | Change in Self-efficacy for Condom Use | 3-month follow-up | 3.65 score on a scale |
Comparison: Paired samples t-test comparison of participants' reported condom use self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlanp-value: 0.918t-test, 2 sided
Secondary
Change in Self-efficacy for Contraceptive Use
Participants' self-reported contraceptive self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up
Time frame: Baseline, 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.~4 retained participants did not provide data for this measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Self-efficacy for Contraceptive Use | Baseline (pre-rPlan) | 3.93 score on a scale |
| Intervention | Change in Self-efficacy for Contraceptive Use | 3-month follow-up | 3.71 score on a scale |
Comparison: Paired samples t-test comparison of participants' reported contraceptive self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlanp-value: 0.028t-test, 2 sided
Secondary
Current Main Method of Contraception
Participants' current main method of contraception, by method type: no method or withdrawal, condom, short-term/combined hormonal (pill, patch, shot, ring), Long acting reversible contraception (LARC: IUD or implant)
Time frame: Baseline, 3 months
Population: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 1 participant at 3-month follow-up did not give a response.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Current Main Method of Contraception | Baseline (pre-app use) | No method or withdrawal | 24 Participants |
| Intervention | Current Main Method of Contraception | Baseline (pre-app use) | Condom | 13 Participants |
| Intervention | Current Main Method of Contraception | Baseline (pre-app use) | Hormonal, short-term (pill, patch, shot, ring) | 34 Participants |
| Intervention | Current Main Method of Contraception | Baseline (pre-app use) | LARC (IUD or implant) | 0 Participants |
| Intervention | Current Main Method of Contraception | 3-month follow-up | No method or withdrawal | 15 Participants |
| Intervention | Current Main Method of Contraception | 3-month follow-up | Condom | 5 Participants |
| Intervention | Current Main Method of Contraception | 3-month follow-up | Hormonal, short-term (pill, patch, shot, ring) | 31 Participants |
| Intervention | Current Main Method of Contraception | 3-month follow-up | LARC (IUD or implant) | 19 Participants |
Secondary
Results of STI Test
Results of sexually transmitted infection (STI) test, at baseline and 3 months
Time frame: Baseline, 3 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Results of STI Test | Baseline | Positive | 8 Participants |
| Intervention | Results of STI Test | Baseline | Negative | 68 Participants |
| Intervention | Results of STI Test | Baseline | None ordered/Missing | 17 Participants |
| Intervention | Results of STI Test | 3-month follow-up | Positive | 0 Participants |
| Intervention | Results of STI Test | 3-month follow-up | Negative | 63 Participants |
| Intervention | Results of STI Test | 3-month follow-up | None ordered/Missing | 30 Participants |