Sexually Transmitted InfectionNCT02498067
rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
A study testing rPlan dual protection waiting room app intervention in people with Sexually Transmitted Infection, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection
- What is being tested?
- rPlan dual protection waiting room app intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Aug 2017
- Phase
- Interventional
- 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 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Not currently pregnant or intending pregnancy within the next 6 months
- Not currently using the implant or intrauterine device (IUD).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Sexually Transmitted Infection
- Being tested
- rPlan dual protection waiting room app intervention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPlan dual protection waiting room app interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: rPlan dual protection waiting room app intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, 3 months
Secondary outcomes (14)
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
Measured: Baseline, 3 months
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (pre-rPlan), 3 months
Results of STI Test
Results of sexually transmitted infection (STI) test, at baseline and 3 months
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (pre-app use), 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017
- Study completionAug 2017
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 Sexually Transmitted InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 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, Dept. of OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498067
- Sponsor's protocol ID
- IRB14-0379
- Status last verified
- Aug 2020
- First submitted
- 16 Jun 2015
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
- ClinicalTrials.gov ID
- NCT02498067
- Acronym / sponsor ID
- IRB14-0379
- Conditions
- Sexually Transmitted Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: rPlan dual protection waiting room app interventionParticipants 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. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not currently pregnant or intending pregnancy within the next 6 months
- Not currently using the implant or intrauterine device (IUD).
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 |
|---|---|---|
| rPlan dual protection waiting room app intervention | Behavioural | Intervention |
Primary outcome
Change in Frequency of Recent Dual Method Use
Time frame: 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)
Time frame: 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
14 secondary outcomes
Change in Consistency of Recent Contraceptive Use
Time frame: Baseline, 3 months
Current Main Method of Contraception
Time frame: Baseline, 3 months
Change in Future Intentions to Use IUD
Time frame: Baseline (pre-app use), Immediately post-app use
Change in Future Intentions to Use Implant
Time frame: Baseline (pre-app use), Immediately post-app use
Change in Future Intentions to Use Condoms
Time frame: Baseline (pre-app use), Immediately post-app use
Change in Self-efficacy for Contraceptive Use
Time frame: Baseline, 3 months
Change in Self-efficacy for Condom Use
Time frame: Baseline (pre-rPlan), 3 months
Results of STI Test
Time frame: Baseline, 3 months
Change in Number of Recent Sexual Partners
Time frame: Baseline, 3 months
Change in Negative Condom Attitudes
Time frame: Baseline, 3 months
Change in Endorsement of Positive Motivators for Condom Use
Time frame: Baseline (pre-rPlan), 3 months
Change in Negative Contraceptive Attitudes
Time frame: Baseline (pre-rPlan), 3 months
Change in Endorsement of Positive Motivators for Contraceptive Use
Time frame: Baseline (pre-rPlan), 3 months
Change in Contraceptive Effectiveness Knowledge
Time frame: Baseline (pre-app use), 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melissa Gilliam, MD, MPH principal investigator
University of Chicago, Dept. of OBGYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rPlan dual protection waiting room app intervention in people with Sexually Transmitted Infection, 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 4 inclusion and 2 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 18 Aug 2020. 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 9 Jun 2020). 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?
Change in Frequency of Recent Dual Method Use (time frame: Baseline, 3 months). The study lists 2 primary outcomes in all. 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 18 Aug 2020.