Evaluation of Internet Access and Use in Adolescent Women Initiating Contraception

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00333541

Collaborator

National Institutes of Health (NIH) (NIH)

100

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Contraceptive Behavior Internet Use	Behavioral: Using internet/E-mail for follow-up	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [1 year]

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 [1 year]
and evaluate subject satisfaction with each method [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 24 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

University of California, San Francisco
National Institutes of Health (NIH)

Investigators

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