NCT00829517

Brief Summary

This project seeks to demonstrate that computer kiosks in a clinic waiting room can improve access to hormonal contraception and screening for sexually transmitted infections. The study will be a randomized controlled trial which will evaluate the use of a computer kiosk module to compare the proportion of women of reproductive age who receive a prescription for hormonal contraception when computer-assisted provision of hormonal contraception is offered (intervention) to encounters when the study clinic provides standard contraceptive care (control). Subjects will be contacted approximately 3 months (range 2-4 months) after the clinic visit to complete a follow-up phone interview. The study population will include English and Spanish-speaking women ages 18-45 who seek care at this clinic. Our hypothesis is that computer-assisted provision of hormonal contraception (intervention)will increase the proportion of women of reproductive age who receive a prescription for hormonal contraception versus standard contraceptive care(control).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
814

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

January 23, 2009

Last Update Submit

February 15, 2012

Conditions

Keywords

Contraceptionsexually transmitted diseases

Outcome Measures

Primary Outcomes (2)

  • self-reported use of hormonal or more effective contraception

    3 months

  • receipt of screening for sexually transmitted infection

    3 months

Study Arms (2)

STI kiosk

ACTIVE COMPARATOR

computer-assisted provision of screening for chlamydia

Other: STI module

contraceptive kiosk

EXPERIMENTAL

computer-assisted provision of hormonal contraception

Other: computer-assisted provision of hormonal contraception

Interventions

a computer program available at a kiosk will offer women information about and a prescription for hormonal contraception that they can ask their clinician to sign.

Also known as: Family planning kiosk
contraceptive kiosk

computer module available at a kiosk that will encourage women to be screened for chlamydia

Also known as: Chlamydia kiosk
STI kiosk

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women who speak English or Spanish who visit a study clinic

You may not qualify if:

  • women who do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eleanor B Schwarz, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 27, 2009

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations