Clinical trial NCT02498067: rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Official title: rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infection
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 104
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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).

Primary outcomes:
measure: Change in Frequency of Recent Dual Method Use
timeFrame: Baseline, 3 months
measure: Change in Frequency of Recent Condom Use (by Itself, With no Other Method)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Consistency of Recent Contraceptive Use
timeFrame: Baseline, 3 months
measure: Current Main Method of Contraception
timeFrame: Baseline, 3 months
measure: Change in Future Intentions to Use IUD
timeFrame: Baseline (pre-app use), Immediately post-app use
measure: Change in Future Intentions to Use Implant
timeFrame: Baseline (pre-app use), Immediately post-app use
measure: Change in Future Intentions to Use Condoms
timeFrame: Baseline (pre-app use), Immediately post-app use
measure: Change in Self-efficacy for Contraceptive Use
timeFrame: Baseline, 3 months
measure: Change in Self-efficacy for Condom Use
timeFrame: Baseline (pre-rPlan), 3 months
measure: Results of STI Test
timeFrame: Baseline, 3 months
measure: Change in Number of Recent Sexual Partners
timeFrame: Baseline, 3 months
measure: Change in Negative Condom Attitudes
timeFrame: Baseline, 3 months
measure: Change in Endorsement of Positive Motivators for Condom Use
timeFrame: Baseline (pre-rPlan), 3 months
measure: Change in Negative Contraceptive Attitudes
timeFrame: Baseline (pre-rPlan), 3 months
measure: Change in Endorsement of Positive Motivators for Contraceptive Use
timeFrame: Baseline (pre-rPlan), 3 months
measure: Change in Contraceptive Effectiveness Knowledge
timeFrame: Baseline (pre-app use), 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago, Dept. of OBGYN
name: Melissa Gilliam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: