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rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities

Primary Purpose

Sexually Transmitted Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rPlan dual protection waiting room app intervention
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infection

Eligibility Criteria

15 Years - 24 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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)
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
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
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
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
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
Results of STI Test
Results of sexually transmitted infection (STI) test, at baseline and 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)
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
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
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
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
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

Full Information

First Posted
June 16, 2015
Last Updated
August 10, 2020
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02498067
Brief Title
rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Official Title
rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
rPlan dual protection waiting room app intervention
Primary Outcome Measure Information:
Title
Change in Frequency of Recent Dual Method Use
Description
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
Title
Change in Frequency of Recent Condom Use (by Itself, With no Other Method)
Description
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
Secondary Outcome Measure Information:
Title
Change in Consistency of Recent Contraceptive Use
Description
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
Title
Current Main Method of Contraception
Description
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
Title
Change in Future Intentions to Use IUD
Description
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
Title
Change in Future Intentions to Use Implant
Description
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
Title
Change in Future Intentions to Use Condoms
Description
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
Title
Change in Self-efficacy for Contraceptive Use
Description
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
Title
Change in Self-efficacy for Condom Use
Description
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
Title
Results of STI Test
Description
Results of sexually transmitted infection (STI) test, at baseline and 3 months
Time Frame
Baseline, 3 months
Title
Change in Number of Recent Sexual Partners
Description
Self-reported number of sexual partners in the past three months (for those who were sexually active)
Time Frame
Baseline, 3 months
Title
Change in Negative Condom Attitudes
Description
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
Title
Change in Endorsement of Positive Motivators for Condom Use
Description
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
Title
Change in Negative Contraceptive Attitudes
Description
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
Title
Change in Endorsement of Positive Motivators for Contraceptive Use
Description
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
Title
Change in Contraceptive Effectiveness Knowledge
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Gilliam, MD, MPH
Organizational Affiliation
University of Chicago, Dept. of OBGYN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities

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