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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01548183
First received: February 22, 2012
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Education, Sex
Behavioral: Lifestyle counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mobile Phone Text-message Program to Reduce Risky Sexual Behavior in Young Females Discharged From the Emergency Department

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Sex without condom [ Time Frame: 3 months after ED discharge ] [ Designated as safety issue: No ]
    Participants will be called for phone follow-up at 12 weeks post-ED discarge


Secondary Outcome Measures:
  • Number of unprotected vaginal sexual encounters [ Time Frame: 3 months post-ED discharge ] [ Designated as safety issue: No ]
    Participants will be called for phone follow-up at 12 weeks post ED discharge


Estimated Enrollment: 68
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01548183

Locations
United States, Pennsylvania
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15221
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01548183     History of Changes
Other Study ID Numbers: PRO10100400
Study First Received: February 22, 2012
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014