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CompletedNCT02330133FemRepro_2Updated Jan 1, 2015

Mid-life Women: Preventing Unintended Pregnancy and STIs

A Phase 2 interventional study of Women's Reproductive Health and Online sexual health content in Reproductive Health, sponsored by Oregon Center for Applied Science, Inc.. Completed at 1 site in United States. Open to female participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-01.

Sponsored by Oregon Center for Applied Science, Inc. · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
333
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Reproductive Health

Keywords

  • mid-life women
  • unintended pregnancy
  • STI/HIV prevention
  • intervention
  • interactive
  • CD-ROM
  • multimedia
  • video
03

In context

Lead sponsor

Oregon Center for Applied Science, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged 25-55.

Exclusion criteria

Exclusion Criteria:

  • Males
  • Women under 25 years of age and over 55
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
333 participants (actual)

Study arms

  • Experimental
    Women's Reproductive Health

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

    Behavioral: Women's Reproductive Health

  • Active comparator
    Online sexual health content

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

    Behavioral: Online sexual health content

Interventions

  • BehavioralWomen's Reproductive Health

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

    Also known as: Women's Reproductive Health: A Guide to Staying Healthy

  • BehavioralOnline sexual health content

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

06

What researchers measure

Primary outcomes

  1. Knowledge of reproductive health issues

    A 22-item knowledge scale was created to assess content areas of the program (e.g., 3 items on anatomy \& physiology, 16 items on pregnancy prevention, and 4 items on STI prevention). For example, users were asked to answer the question "A women is most likely to become pregnant (no matter how long or short her menstrual cycle) if she has sexual intercourse about:" with choices being (a) 1 week before menstruation beings, (b) 2 weeks after menstruation begins, (c) 2 weeks before menstruation begins, (d) 1 week after menstruation begins, or (e) do not know.

    Time frame: 7-day posttest and 30-day follow-up

Secondary outcomes

  1. Attitudes about reproductive health and prevention

    Participant attitudes were measured using scales that assessed the perceived importance of using a contraceptive method to prevent pregnancy (6 items), the perceived importance of talking with your partner about contraception (4 items) and two additional items measuring the perceived importance of using a contraceptive method to prevent STIs (1 item), and the perceived importance of talking with your healthcare provider (1 item) (alpha =.74, test- retest reliability=.73).

    Time frame: 7-day posttest and 30-day follow-up

  2. Self-efficacy for engaging in strategies to prevent pregnancy and communicate with partner about health risks

    Participant self-efficacy was measured using scales that assessed confidence in preventing pregnancy (6 items), and talking with the partner (2 items) (alpha=84, test-retest reliability=.68).

    Time frame: 7-day posttest and 30-day follow-up

  3. Intentions to engage in strategies to prevent pregnancy and communicate with

    Participant behavioral intentions were measured using scales that assessed intention of using a contraceptive method (2 items), preventing an STI (4 items), and talking with a sexual partner (4 items) (alpha=.74, test-retest reliability=.69).

    Time frame: 7-day posttest and 30-day follow-up

07

Study locations

1 site
  • Oregon Center for Applied Science
    Eugene, Oregon 97401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02330133
Lead sponsor
Oregon Center for Applied Science, Inc.
Responsible party
Lynne Swartz (Research Scientist, Oregon Center for Applied Science, Inc.) — Principal investigator
First posted
Jan 1, 2015
Start date
May 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jan 1, 2015

Study contacts

Lynne H Grilley Swartz, MPH, CHES
principal investigator · Oregon Center for Applied Science

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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