rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Infection
• Intervention / Treatment: Behavioral: rPlan dual protection waiting room app intervention

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: rPlan dual protection waiting room app intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Melissa Gilliam, MD, MPH, University of Chicago, Dept. of OBGYN

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: IRB14-0379