Text-message Program to Reduce Risky Sexual Behavior in Young Adult Female Emergency Department (ED) Patients (StARSS)

Mobile Phone Text-message Program to Reduce Risky Sexual Behavior in Young Females Discharged From the Emergency Department

The US preventative services task force (USPSTF) recommends behavioral counseling in the primary care setting for prevention of sexually transmitted diseases, however, screening and counseling rarely occur. Text messaging (TM) is increasingly being used as a tool to affect behavior change in patients, but its effect on patients that report at-risk sexual behavior in the emergency department (ED) is unknown. The investigators seek to assess the feasibility of ED-based screening of young adult females for at-risk sexual behavior and enrolling them in a 3 month trial using TM to deliver information and skill building to improve health behavior.

Study Overview

• Status: Completed
• Conditions: Education, Sex
• Intervention / Treatment: Behavioral: Lifestyle counseling

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15221
      • UPMC Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Age 18-25 years
• AUDIT-C score > 2
• (Drugs or alcohol prior to last sex OR No condom with last sex OR > 1 partner in last 3 months)

Exclusion Criteria:

• No personal cell phone with SMS features
• Prisoner
• Pregnant or planning in next 3 months
• Current or past drug/alcohol treatment or psychiatric treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle counseling; Weekly SMS assessing risky sexual encounters and providing feedback including concern, goal-setting and tools to reduce risk	Behavioral: Lifestyle counseling; Weekly SMS assessments of risky sexual encounters with feedback
No Intervention: Usual care; Usual care includes ED provider counseling as per normal clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex without condom	Participants will be called for phone follow-up at 12 weeks post-ED discarge	3 months after ED discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unprotected vaginal sexual encounters	Participants will be called for phone follow-up at 12 weeks post ED discharge	3 months post-ED discharge

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: PRO10100400