FemRepro_2: Mid-life Women: Preventing Unintended Pregnancy and STIs

Sponsor
Oregon Center for Applied Science, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02330133
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
333
1
2
16
20.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Women's Reproductive Health
  • Behavioral: Online sexual health content
Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
333 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Mid-life Women: Preventing Unintended Pregnancy and STIs
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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
Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections
Other Names:
  • Women's Reproductive Health: A Guide to Staying Healthy
  • Active Comparator: Online sexual health content

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Knowledge of reproductive health issues [7-day posttest and 30-day follow-up]

      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.

    Secondary Outcome Measures

    1. Attitudes about reproductive health and prevention [7-day posttest and 30-day follow-up]

      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).

    2. Self-efficacy for engaging in strategies to prevent pregnancy and communicate with partner about health risks [7-day posttest and 30-day follow-up]

      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).

    3. Intentions to engage in strategies to prevent pregnancy and communicate with [7-day posttest and 30-day follow-up]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women aged 25-55.
    Exclusion Criteria:
    • Males

    • Women under 25 years of age and over 55

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Center for Applied Science Eugene Oregon United States 97401

    Sponsors and Collaborators

    • Oregon Center for Applied Science, Inc.
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Lynne H Grilley Swartz, MPH, CHES, Oregon Center for Applied Science

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lynne Swartz, Research Scientist, Oregon Center for Applied Science, Inc.
    ClinicalTrials.gov Identifier:
    NCT02330133
    Other Study ID Numbers:
    • SBIR64R-2
    • R44HD044374
    First Posted:
    Jan 1, 2015
    Last Update Posted:
    Jan 1, 2015
    Last Verified:
    Dec 1, 2014
    Keywords provided by Lynne Swartz, Research Scientist, Oregon Center for Applied Science, Inc.

    Study Results

    No Results Posted as of Jan 1, 2015