rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities

Sexually Transmitted Infection Clinical Trial

Official title:

rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498067
• Other study ID #: IRB14-0379
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 24 Years

Eligibility

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).

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

Behavioral:
• rPlan dual protection waiting room app intervention

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline, 3 months
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	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	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)	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	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	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	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	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	Baseline (pre-rPlan), 3 months
Secondary	Results of STI Test	Results of sexually transmitted infection (STI) test, at baseline and 3 months	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)	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	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	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	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	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	Baseline (pre-app use), 3 months