rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities

Not Applicable

Completed

• Conditions: Sexually Transmitted Infection
• Interventions: Behavioral: rPlan dual protection waiting room app intervention

• Registration Number: NCT02498067
• Lead Sponsor: University of Chicago

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-16
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-15
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Results First Submitted: 2020-05-21
• Results First Submitted QC: 2020-05-21
• Results First Posted: 2020-06-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

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Exclusion Criteria

• Not currently pregnant or intending pregnancy within the next 6 months
• Not currently using the implant or intrauterine device (IUD).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	rPlan dual protection waiting room app intervention	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 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
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)
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 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
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)
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 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 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 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
Results of STI Test	Baseline, 3 months	Results of sexually transmitted infection (STI) test, at baseline and 3 months
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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States