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

Primary Purpose

Education, Sex

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Education, Sex

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle counseling

Usual care

Arm Description

Weekly SMS assessing risky sexual encounters and providing feedback including concern, goal-setting and tools to reduce risk

Usual care includes ED provider counseling as per normal clinical care

Outcomes

Primary Outcome Measures

Sex without condom
Participants will be called for phone follow-up at 12 weeks post-ED discarge

Secondary Outcome Measures

Number of unprotected vaginal sexual encounters
Participants will be called for phone follow-up at 12 weeks post ED discharge

Full Information

First Posted
February 22, 2012
Last Updated
May 26, 2015
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01548183
Brief Title
Text-message Program to Reduce Risky Sexual Behavior in Young Adult Female Emergency Department (ED) Patients
Acronym
StARSS
Official Title
Mobile Phone Text-message Program to Reduce Risky Sexual Behavior in Young Females Discharged From the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Education, Sex

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Weekly SMS assessing risky sexual encounters and providing feedback including concern, goal-setting and tools to reduce risk
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care includes ED provider counseling as per normal clinical care
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
Weekly SMS assessments of risky sexual encounters with feedback
Primary Outcome Measure Information:
Title
Sex without condom
Description
Participants will be called for phone follow-up at 12 weeks post-ED discarge
Time Frame
3 months after ED discharge
Secondary Outcome Measure Information:
Title
Number of unprotected vaginal sexual encounters
Description
Participants will be called for phone follow-up at 12 weeks post ED discharge
Time Frame
3 months post-ED discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UPMC Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States

12. IPD Sharing Statement

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

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