Mid-life Women: Preventing Unintended Pregnancy and STIs

NCT ID: NCT02330133

Last Updated: 2015-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-09-30

Brief Summary

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Mid-life women, aged 35-50, are currently an underserved population in the areas of unintended pregnancy and STI prevention interventions. Common perception is that women in this age range are no longer sexually active, or are past the menopause transition, but in reality, sexual activity remains stable through mid-life and into the post-menopausal years. Additionally, physiological and relationship status changes (e.g. divorce or death of a partner) put these women at increased risk for both unintended pregnancy and STI's. This project developed and evaluated a theoretically-based multimedia intervention designed to assist mid-life women in protecting themselves from sexually transmitted infections and unintended pregnancy.

Detailed Description

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The primary aim of this project was to create and evaluate a theoretically-based, interactive multimedia program for women aged 35-55 to assist them in avoiding unintended pregnancy and sexually transmitted infections (STIs). The intervention, titled "Women's Reproductive Health: A guide to staying healthy," addressed these concerns across the life span and was designed to increase knowledge about (a) pregnancy risk; (b) STI risk; (c) strategies to prevent STIs and unintended pregnancy; (d) influences of sexual partners on risk reduction decisions and behaviors; (e) partner communication techniques; and (f) health care provider communication techniques.Overall features of the program include video, interactive tools, animations, text information pages, and various links both across and within specific modules to link related information. A feature titled "My Notes" allowed the user to save content from the program into an easily retrievable repository.

Motivational videos featuring friendly mid-life hosts could be viewed on the first page of each module, as well as on the home page and topic introduction pages. These videos not only provided specific information about the content, they also provided message framing and set the tone of the program segment. Other videos included testimonials on topics such as contraceptive methods, sexually transmitted infections, and other health information. Interactive materials include an assessment checklist for STI risk, a quiz to help the user identify the types of birth control methods that best fit her lifestyle and preferences, as well as several checklists

Conditions

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Reproductive Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Women's Reproductive Health

Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections

Group Type EXPERIMENTAL

Women's Reproductive Health

Intervention Type BEHAVIORAL

Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections

Online sexual health content

Online general text-based information about reproductive health issues and STD prevention strategies

Group Type ACTIVE_COMPARATOR

Online sexual health content

Intervention Type BEHAVIORAL

Online general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections

Interventions

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Women's Reproductive Health

Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections

Intervention Type BEHAVIORAL

Online sexual health content

Online general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections

Intervention Type BEHAVIORAL

Other Intervention Names

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Women's Reproductive Health: A Guide to Staying Healthy

Eligibility Criteria

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Inclusion Criteria

* Women aged 25-55.

Exclusion Criteria

* Males
* Women under 25 years of age and over 55
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Oregon Center for Applied Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Lynne Swartz

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynne H Grilley Swartz, MPH, CHES

Role: PRINCIPAL_INVESTIGATOR

Oregon Center for Applied Science

Locations

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Oregon Center for Applied Science

Eugene, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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R44HD044374

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBIR64R-2

Identifier Type: -

Identifier Source: org_study_id

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