Text-message Program to Reduce Risky Sexual Behavior in Y... | NCT01548183

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

NCT01548183

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

52Actual

Phase

Phase 2

Conditions

Education, Sex

Interventions

Lifestyle counseling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Feb 22, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle counseling	Experimental	Weekly SMS assessing risky sexual encounters and providing feedback including concern, goal-setting and tools to reduce risk	Behavioral: Lifestyle counseling
Usual care	No Intervention	Usual care includes ED provider counseling as per normal clinical care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle counseling	Behavioral	Weekly SMS assessments of risky sexual encounters with feedback	Lifestyle counseling

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Mercy Hospital		Pittsburgh	Pennsylvania	15221	United States

ID	Term
D012725	Sexual Behavior
D001519	Behavior