NCT01548183

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

February 22, 2012

Last Update Submit

May 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sex without condom

    Participants will be called for phone follow-up at 12 weeks post-ED discarge

    3 months after ED discharge

Secondary Outcomes (1)

  • Number of unprotected vaginal sexual encounters

    3 months post-ED discharge

Study Arms (2)

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

Weekly SMS assessments of risky sexual encounters with feedback

Lifestyle counseling

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15221, United States

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 8, 2012

Study Start

August 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations