Evaluation of Internet Access and Use in Adolescent Women Initiating Contraception

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00333541
First received: June 2, 2006
Last updated: April 30, 2009
Last verified: March 2008
  Purpose

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.


Condition Intervention
Contraceptive Behavior
Internet Use
Behavioral: Using internet/E-mail for follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Internet Access and Use in Women at High Risk for Unintended Pregnancy: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • and evaluate subject satisfaction with each method [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
follow-up via e-mail link to survey
Behavioral: Using internet/E-mail for follow-up
follow-up via email link to survey
No Intervention: Control
standard follow-up by phone and in-person interview
Behavioral: Using internet/E-mail for follow-up
follow-up via email link to survey

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.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333541

Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Tina Raine, MD, MPH University of California, San Francisco
Principal Investigator: Sadia Haider, MD, MPH University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tina Raine-Bennett, UCSF
ClinicalTrials.gov Identifier: NCT00333541     History of Changes
Other Study ID Numbers: R01 HD045480-03
Study First Received: June 2, 2006
Last Updated: April 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Contraceptive behavior
Internet Use
Adolescent pregnancy
Unintended pregnancy

ClinicalTrials.gov processed this record on July 08, 2014