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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02498067
Other study ID # IRB14-0379
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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
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