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

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.

Study Overview

• Status: Completed
• Conditions: Reproductive Health
• Intervention / Treatment: Behavioral: Women's Reproductive Health; Behavioral: Online sexual health content

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 Type: Interventional
• Enrollment (Actual): 333
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oregon Center for Applied Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women aged 25-55.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7-day posttest and 30-day follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7-day posttest and 30-day follow-up
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).	7-day posttest and 30-day follow-up
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).	7-day posttest and 30-day follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): January 1, 2015

Study Record Updates

• Last Update Posted (Estimate): January 1, 2015
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: intervention; video; unintended pregnancy; multimedia; interactive; CD-ROM; mid-life women; STI/HIV prevention
• Other Study ID Numbers: SBIR64R-2; R44HD044374 (U.S. NIH Grant/Contract)