N/A
N=104
rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Sexually Transmitted Infection
Bottom Line
View on ClinicalTrials.gov: NCT02498067 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in Frequency of Recent Dual Method Use — 3.17; 3.45 score on a scale — p=.177
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rPlan dual protection waiting room app intervention (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of Chicago
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frequency of Recent Dual Method Use |
3.17; 3.45 | .177 |
| PRIMARY Change in Frequency of Recent Condom Use (by Itself, With no Other Method) |
3.15; 2.93 | .318 |
| SECONDARY Change in Consistency of Recent Contraceptive Use |
35; 20; 46; 9 | .000 sig |
| SECONDARY Current Main Method of Contraception |
24; 13; 34; 0; 15; 5 | — |
| SECONDARY Change in Future Intentions to Use IUD |
2.38; 2.70 | .030 sig |
| SECONDARY Change in Future Intentions to Use Implant |
2.45; 2.66 | .140 |
| SECONDARY Change in Future Intentions to Use Condoms |
4.22; 4.11 | .315 |
| SECONDARY Change in Self-efficacy for Contraceptive Use |
3.93; 3.71 | .028 sig |
| SECONDARY Change in Self-efficacy for Condom Use |
3.64; 3.65 | .918 |
| SECONDARY Results of STI Test |
8; 68; 17; 0; 63; 30 | — |
| SECONDARY Change in Number of Recent Sexual Partners |
1.40; 1.24 | .209 |
| SECONDARY Change in Negative Condom Attitudes |
2.03; 1.99 | .652 |
| SECONDARY Change in Endorsement of Positive Motivators for Condom Use |
4.57; 4.63 | .498 |
| SECONDARY Change in Negative Contraceptive Attitudes |
2.20; 2.20 | .977 |
| SECONDARY Change in Endorsement of Positive Motivators for Contraceptive Use |
4.61; 4.64 | .673 |
| SECONDARY Change in Contraceptive Effectiveness Knowledge |
31.4; 35.7; 16.9; 25.7 | .049 sig |
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.
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).
Data sourced from ClinicalTrials.gov (NCT02498067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.