Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will complete a 10-15 minute questionnaire . After completing the questionnaire, a research assistant (RA) will provide a brief orientation to the rPlan app and use the rPlan app for up to 15 minutes. After viewing rPlan, participants will be asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant will also be given an STI test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rPlan dual protection waiting room app intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months |
| 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 | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months |
| Current Main Method of Contraception |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melissa Gilliam, MD, MPH | University of Chicago, Dept. of OBGYN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Inclusion criteria: Black, assigned female sex at birth, between 15-25 years in age (inclusive), sexually active with at least one male partner in past six months, initiating contraception, not currently pregnant or intending pregnancy within next six months, English speaking, not currently using a LARC method
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline, 3 months |
|
11 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Loss of participants to follow-up, missing STI results for 15 participants. No control arm, so cannot infer the independent effects of the rPlan intervention on behavior, self-efficacy, attitude, and knowledge outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Soo Young Lee | University of Chicago | 6513430045 | sooyoungl@uchicago.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2017 | May 21, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
| Baseline, 3 months |
| 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 | Baseline (pre-app use), Immediately post-app use |
| 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 | Baseline (pre-app use), Immediately post-app use |
| 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 | Baseline (pre-app use), Immediately post-app use |
| 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 | Baseline, 3 months |
| 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 | Baseline (pre-rPlan), 3 months |
| Results of STI Test | Results of sexually transmitted infection (STI) test, at baseline and 3 months | Baseline, 3 months |
| Change in Number of Recent Sexual Partners | Self-reported number of sexual partners in the past three months (for those who were sexually active) | Baseline, 3 months |
| 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 | Baseline, 3 months |
| 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 | Baseline (pre-rPlan), 3 months |
| 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 | Baseline (pre-rPlan), 3 months |
| 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 | Baseline (pre-rPlan), 3 months |
| 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 | Baseline (pre-app use), 3 months |
| Count of Participants |
| Participants |
|
| Age, Continuous | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline | Mean | Full Range | years |
|
| Sex: Female, Male | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline | Count of Participants | Participants |
|
| Relationship Status | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure. | Count of Participants | Participants |
|
| Highest Education Completed | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. | Count of Participants | Participants |
|
| Age at First Sexual Intercourse | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. | Mean | Full Range | years |
|
| Number of Sexual Partners in Lifetime | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure. | Count of Participants | Participants |
|
| Ever Tested Positive for STI? | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. | Count of Participants | Participants |
|
| Pregnancy History | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. | Count of Participants | Participants |
|
| Age at First Pregnancy | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 60 participants did not provide data for this measure, as they had never been pregnant. | Mean | Full Range | years |
|
| Number of Births | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. | Count of Participants | Participants |
|
| Number of Living Children | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 61 participants did not provide data for this measure. | Mean | Full Range | children |
|
| Contraceptive Method Awareness | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. | Number | participants |
|
| Past Contraceptive Method Use | 11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. | Number | participants |
|
|
|
|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline, 3 months |
|
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline, 3 months |
|
|
|
|
| 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) | 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. | Posted | Count of Participants | Participants | Baseline, 3 months |
|
|
|
| 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 | 1 participant did not provider data for this measure. | Posted | Mean | Full Range | score on a scale | Baseline (pre-app use), Immediately post-app use |
|
|
|
|
| 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 | 2 participants did not provide data for this measure. | Posted | Mean | Full Range | score on a scale | Baseline (pre-app use), Immediately post-app use |
|
|
|
|
| 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 | 3 participants did not provide data for this measure. | Posted | Mean | Full Range | score on a scale | Baseline (pre-app use), Immediately post-app use |
|
|
|
|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline, 3 months |
|
|
|
|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline (pre-rPlan), 3 months |
|
|
|
|
| Secondary | Results of STI Test | Results of sexually transmitted infection (STI) test, at baseline and 3 months | Posted | Count of Participants | Participants | Baseline, 3 months |
|
|
|
| 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) | 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. | Posted | Mean | Full Range | number of sexual partners | Baseline, 3 months |
|
|
|
|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline, 3 months |
|
|
|
|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline (pre-rPlan), 3 months |
|
|
|
|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline (pre-rPlan), 3 months |
|
|
|
|
| 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 | 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. | Posted | Mean | Full Range | score on a scale | Baseline (pre-rPlan), 3 months |
|
|
|
|
| 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 | 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. | Posted | Number | percentage who answered correctly | Baseline (pre-app use), 3 months |
|
|
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 0 |
| 104 |
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| No |
|
| Hormonal, short-term (pill, patch, shot, ring) |
|
| LARC (IUD or implant) |
|
| 3-month follow-up |
|
|
| 3-month follow-up |
|
|
| 3-month follow-up: IUD vs shot, % correct |
|
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 rPlan
| t-test, 2 sided |
| .265 |
a priori threshold for statistical significance: p<.05 |
| Other |