ContraceptionNCT00829517
Computer-Assisted Provision of Reproductive Health Care
A study testing computer-assisted provision of hormonal contraception and STI module in people with Contraception and Sexually Transmitted Diseases, run by University of Pittsburgh at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception, Sexually Transmitted Diseases
- What is being tested?
- computer-assisted provision of hormonal contraception and STI module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women who speak English or Spanish who visit a study clinic
Who cannot join
- women who do not speak English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC
Pittsburgh, Pennsylvania, 15213
University of California, San Francisco
San Francisco, California, 94122
About this study
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).
Read the detailed description
Data collection has been completed
- Conditions
- Contraception, Sexually Transmitted Diseases
- Being tested
- computer-assisted provision of hormonal contraception, STI module
- Keywords
- Contraception, sexually transmitted diseases
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted provision of hormonal contraceptionOther
Also called Family planning kiosk
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.
STI moduleOther
Also called Chlamydia kiosk
computer module available at a kiosk that will encourage women to be screened for chlamydia
| Study group | Role | What they receive |
|---|---|---|
| STI kiosk | Active comparator | computer-assisted provision of screening for chlamydia Receives: Other: STI module |
| contraceptive kiosk | Experimental | computer-assisted provision of hormonal contraception Receives: Other: computer-assisted provision of hormonal contraception |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported use of hormonal or more effective contraception
Measured: 3 months
receipt of screening for sexually transmitted infection
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleanor Bimla Schwarz, University of Pittsburgh
- Investigators
- Eleanor B Schwarz, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829517
- Sponsor's protocol ID
- SFP2-8
- Status last verified
- Feb 2012
- First submitted
- 23 Jan 2009
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Provision of Reproductive Health Care
- ClinicalTrials.gov ID
- NCT00829517
- Acronym / sponsor ID
- SFP2-8
- Conditions
- Contraception, Sexually Transmitted Diseases
- Keywords
- Contraception, sexually transmitted diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Data collection has been completed
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STI kiosk | Active comparator | Other: STI modulecomputer-assisted provision of screening for chlamydia |
| contraceptive kiosk | Experimental | Other: computer-assisted provision of hormonal contraceptioncomputer-assisted provision of hormonal contraception |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women who speak English or Spanish who visit a study clinic
Key exclusion criteria (1 listed)
- women who do not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer-assisted provision of hormonal contraceptionAlso: Family planning kioska 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. | Other | contraceptive kiosk |
| STI moduleAlso: Chlamydia kioskcomputer module available at a kiosk that will encourage women to be screened for chlamydia | Other | STI kiosk |
Primary outcome
self-reported use of hormonal or more effective contraception
Time frame: 3 months
receipt of screening for sexually transmitted infection
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor B Schwarz, MD, MS principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-assisted provision of hormonal contraception and STI module in people with Contraception and Sexually Transmitted Diseases, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported use of hormonal or more effective contraception (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.