Evaluation of Internet Access and Use in Adolescent Women Initiating Contraception

March 3, 2015 updated by: University of California, San Francisco

Internet Access and Use in Women at High Risk for Unintended Pregnancy: A Randomized Clinical Trial

This purpose of this study is determine whether the use of internet technology to communicate with adolescents about contraception is feasible and to determine whether it is more effective than traditional methods. Study subjects will complete baseline and follow-up surveys at 3, 6, and 12 months about their contraceptive practice and sexual behaviors.

Subjects with internet access will be randomized to either completing surveys remotely over the internet through email or to follow-up in clinic on laptop computers.

Our hypothesis is that women who have access to the internet as well as use the internet regularly are more likely to complete follow-up surveys. This will then in turn allow us to get a better understanding of contraceptive practices amongst high risk teens.

Study Overview

Detailed Description

Despite the wide range of contraceptive technologies currently available the rate of unintended pregnancies in the U.S. remains high. In particular, adolescents, unmarried, low income, and minority women are amongst the highest risk populations for unintended pregnancy . Improving contraceptive use is critical for addressing this problem. Many programs have been developed and implemented to reduce sexual risk-taking behavior, one of the precursors to unintended pregnancies. Unfortunately, most of them have met with mixed results. Gaining insight into contraceptive practice and sexual behavior in this population is the first step towards improving contraceptive use. Many other disciplines have successfully used the internet for purposes of research (ie. asthma management, smoking cessation,etc), but this use of the internet has not been explored with adolescent women.

The study we are proposing is a randomized control trial to evaluate the use of internet technology in communicating with adolescent women about contraceptive practice. This study is a sub-study within an ongoing 12-month, longitudinal observational study of a cohort of "high-risk" women and their contraceptive practices and sexual behavior. Our hypothesis is that women who have access to the internet are more likely to complete follow-up surveys while enrolled in this longitudinal study, thus enabling us to obtain a greater understanding about contraceptive practice within this population via the internet. Furthermore, if internet proves to be a more effective means of communicating with adolescents because of the potential convenience and privacy of the method we may increase our impact on contraceptive use by embracing internet technology in the future.

Participants with internet access within the larger study will be identified and entered into a sub-study and randomized to either in clinic follow-up surveys or remote access completion of surveys via email over the internet. All participants will undergo the same screening, consent, and entry criteria for the study.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age 15-24
  • Sexually active
  • Single
  • Initiating contraception: either OCP's, the patch, the ring, or depoprovera
  • English speaking
  • Have an active email account
  • Use email use ≥1 per wk

Exclusion Criteria:

  • Lack of email account
  • Email use < 1 per wk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
follow-up via e-mail link to survey
follow-up via email link to survey
No Intervention: Control
standard follow-up by phone and in-person interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary outcome: total # of subjects who complete all 3 follow-up surveys at 3, 6, and 12 months in each arm of the study
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcome: evaluate the feasibility of using internet technology in this population by looking at how many subjects actually has access to the internet and report regular use in the entire cohort
Time Frame: 1 year
1 year
and evaluate subject satisfaction with each method
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tina Raine, MD, MPH, University of California, San Francisco
  • Principal Investigator: Sadia Haider, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 5, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • R01HD045480-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraceptive Behavior

Clinical Trials on Using internet/E-mail for follow-up

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