NCT02498067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 9, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

June 16, 2015

Results QC Date

May 21, 2020

Last Update Submit

August 10, 2020

Conditions

Sexually Transmitted Infection

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (14)

  • Change in Consistency of Recent Contraceptive Use

    Baseline, 3 months

  • Current Main Method of Contraception

    Baseline, 3 months

  • Change in Future Intentions to Use IUD

    Baseline (pre-app use), Immediately post-app use

  • Change in Future Intentions to Use Implant

    Baseline (pre-app use), Immediately post-app use

  • Change in Future Intentions to Use Condoms

    Baseline (pre-app use), Immediately post-app use

  • +9 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: rPlan dual protection waiting room app intervention

Interventions

rPlan dual protection waiting room app interventionBEHAVIORAL
Intervention

Eligibility Criteria

Age15 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Not currently pregnant or intending pregnancy within the next 6 months
  • Not currently using the implant or intrauterine device (IUD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Loss of participants to follow-up, missing STI results for 15 participants. No control arm, so cannot infer the independent effects of the rPlan intervention on behavior, self-efficacy, attitude, and knowledge outcomes.

Results Point of Contact

Title
Soo Young Lee
Organization
University of Chicago
sooyoungl@uchicago.edu
6513430045

Study Officials

  • Melissa Gilliam, MD, MPH

    University of Chicago, Dept. of OBGYN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

July 15, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

August 18, 2020

Results First Posted

June 9, 2020

Record last verified: 2020-08

Locations

US(1)