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Completed

NCT Number: NCT02498067

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.

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Key information

Conditions

Sexually Transmitted Infection Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

15 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

rPlan dual protection waiting room app intervention

Behavioral

Primary outcomes

  1. Change in Frequency of Recent Dual Method Use

    Time frame: 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

  2. Change in Frequency of Recent Condom Use (by Itself, With no Other Method)

    Time frame: 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

Secondary outcomes

  1. Change in Consistency of Recent Contraceptive Use

    Time frame: Baseline, 3 months

    Self-reported answer (yes or no) to whether participants used contraception every time they had sex in the past three months

  2. Current Main Method of Contraception

    Time frame: 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)

  3. Change in Future Intentions to Use IUD

    Time frame: 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

  4. Change in Future Intentions to Use Implant

    Time frame: 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

  5. Change in Future Intentions to Use Condoms

    Time frame: 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

  6. Change in Self-efficacy for Contraceptive Use

    Time frame: 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

  7. Change in Self-efficacy for Condom Use

    Time frame: 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

  8. Results of STI Test

    Time frame: Baseline, 3 months

    Results of sexually transmitted infection (STI) test, at baseline and 3 months

  9. Change in Number of Recent Sexual Partners

    Time frame: Baseline, 3 months

    Self-reported number of sexual partners in the past three months (for those who were sexually active)

  10. Change in Negative Condom Attitudes

    Time frame: 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

  11. Change in Endorsement of Positive Motivators for Condom Use

    Time frame: 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

  12. Change in Negative Contraceptive Attitudes

    Time frame: 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

  13. Change in Endorsement of Positive Motivators for Contraceptive Use

    Time frame: 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

  14. Change in Contraceptive Effectiveness Knowledge

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2015
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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