rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities

The University of Chicago

Status: Completed

Conditions: Sexually Transmitted Infection

Treatments: Behavioral: rPlan dual protection waiting room app intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02498067

IRB14-0379

Details and patient eligibility

About

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.

Full 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).

Enrollment: 104 patients

Sex: Female

Ages: 15 to 24 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Intervention

Experimental group

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.

Treatment:

Behavioral: rPlan dual protection waiting room app intervention